Protocol - Risk Factor Assessment in Blood Donors

Transfusion-Transmissible Infections Monitoring System (TTIMS)
Laboratory and Risk Factor Database Coordinating Center (LRCC)

Risk Factor Assessment in Blood Donors

Protocol 1

29 February 2016

Protocol Synopsis

The Transfusion-Transmissible Infections Monitoring System (TTIMS) Laboratory and Risk Factor
Database Coordinating Center (LRCC) project has two primary responsibilities in TTIMS. The first
responsibility is to lead the collection, evaluation and analysis of risk factors in blood donors who have
HIV (NAT yield and seropositive), HCV (NAT yield) and HBV (NAT yield) positive blood donors (Protocol
1). The second responsibility is to establish a biospecimen repository, conduct laboratory analyses of HIV
seroprevalent infections to be able to classify them as newly acquired or long standing, and to
determine genotypes and, where applicable, drug resistance profiles for HIV (NAT yield and
seropositive), HCV (NAT yield) and HBV (NAT yield) infections (these activities are described in a
separate Protocol 2 document).

The overall objectives of Protocol 1 procedures are to: a.) Coordinate the collection of risk factor data by
the participating blood centers from enrolled donors meeting consensus definitions, b.) Combine risk
factor data and disease marker surveillance information across different blood collection organizations;
c.) Evaluate and monitor risk factor data of donors and their donations confirmed to be positive for
transfusion-transmissible viral infections; and d.) Compare/analyze risk factor data to those obtained in
the REDS-II TTI Marker Prevalence and Donor Risk Factor Study. The specific aim of this part of LRCC
activities is to catalog contemporary risk factors for the purpose of understanding how blood donors
became infected with a transfusion-transmissible virus. While the likely risk factors for acquisition of
HIV, HCV, and HBV are known, the relative frequency of such risk factors in US blood donors is not well
known, and could change over time as blood donor eligibility criteria are modified. Blood donors with
infections that meet the study consensus case definitions as well as false-positive control donors at the
American Red Cross, Blood Systems, Inc., New York Blood Center, and OneBlood will be asked to
complete a risk factor questionnaire following notification of their test results via routine blood center
procedures. Each organization will interview its own blood donors. Consent and interview responses will
be captured electronically. A participation incentive linked to completion of the risk factor interview will
be provided to each participant. Data analysts at the LRCC will generate monthly, quarterly, and annual
reports of risk factors. Analyses will be stratified by infection, donor demographics, and US Department
of Health and Human Services Public Health Service region so that the relative proportion of specific risk
behaviors such as men having sex with men (MSM), multiple heterosexual partners (MHP), and injection
drug use (IDU) can be monitored for proportional changes over time. In addition, research publications
will be developed to more completely describe the risk factor findings reported by blood donors who
have HIV (NAT yield and seropositive), HCV (NAT yield) or HBV (NAT yield) infections in combination with
other results from the TTIMS program.

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Table of Contents

Protocol Synopsis ................................................................................................................... 2
Background and Significance .................................................................................................. 4
Objectives .............................................................................................................................. 8
Specific Aims of Risk Factor Assessment ................................................................................. 8
Study Procedures and Tasks .................................................................................................. 10
Study Population ........................................................................................................................... 10

Risk Factor Survey Administration ........................................................................................ 17
Analyses and Reporting ........................................................................................................ 18
Triggered Follow-up Investigations ....................................................................................... 19
Statistical Considerations ...................................................................................................... 19
Risk Factor Questionnaire Content ....................................................................................... 22
Prospective and Retrospective Interviews ............................................................................ 22
Human Subjects Considerations ............................................................................................ 22
Timeline ............................................................................................................................... 24
References ............................................................................................................................ 25
Appendices ........................................................................................................................... 27
Appendix 1 – TTIMS DDCC and LRCC Information Flow Diagram ..................................................... 27
Appendix 2 – Risk Factor Frequencies Reported by Donors During the REDS-II Study ..................... 28
Appendix 3 – TTIMS Study Information Mailer for Cases (English version) ...................................... 31
Appendix 4 – TTIMS Study Information Mailer for Cases (Spanish version) .................................... 33
Appendix 5 – TTIMS Study Information Mailer for Controls (English version) ................................. 34
Appendix 6 – TTIMS Study Information Mailer for Controls (Spanish version) ................................ 36
Appendix 7 – Study Management System Core Content ................................................................. 37
Appendix 8 – TTIMS Risk Factor Questionnaire (English version) .................................................... 39
Appendix 9 – TTIMS Risk Factor Questionnaire (Spanish version) ................................................... 61

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Laboratory and Risk Factor Coordinating Center
Protocol 1 – Risk Factor Assessment and Analysis
Background and Significance
Approximately 4.5 million US patients receive red cell transfusions each year and millions of other
patients receive platelets and/or plasma.1 Preventing the transmission of infections to persons requiring
transfusion is of paramount importance. Information on current risk factors for viral infections in blood
donors was largely unavailable in the US until the REDS-II Marker Rates and Donor Risk Factor Study
(DRFS) was completed.2 Blood donors from four large blood centers were included in a case-control
study of donors with confirmed infections (cases) and a comparison population of donors with repeat
reactive unconfirmed infections (false positive donors, classified as controls).
American Red Cross (ARC), Blood Systems, Inc. (BSI), New York Blood Center (NYBC), and OneBlood
participated in the case-control study from 2010 to 2013. Donors with serologic and nucleic acid testing
(NAT) or NAT-only confirmed human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C
virus (HCV) infections (cases) and donors with false-positive results (controls) were interviewed for
putative behavioral and demographic risks.

Frequencies of putative risk factors from that study are provided separately for males and females with
regard to sexual exposures and grouped together for other exposures (Appendix 2 Table 1). Male HIV
and HBV cases had similar numbers of female sexual partners as did controls (median 4 and 6,
respectively), but male HCV and HTLV cases reported higher numbers of female partners (median 15
and 10, respectively). Over 60% of male HIV cases reported MSM behavior, including over 50% in the
last 12 months; this was not common for HBV, HCV or controls. For females, higher numbers of sexual
partners were reported for HIV (median 10) and HCV (median 9) cases, but not for HBV or controls.
Sexually transmitted diseases were frequently reported by female HIV, and HCV-infected donors (3536%); HCV-infected female donors also frequently reported sex with an injection drug user (IDU). When
both sexes were combined, HCV-infected donors reported the highest frequencies of injecting drugs,
steroids or vitamins, or using non-injection drugs, or receiving a blood transfusion in the period of 19582011 with 50% of transfusions occurring ≤1990. Reporting having ever spent three or more days in jail, a
detention center, shelter or group home was associated with all four viral infections, but was highest
among HCV cases. In contrast, HBV-infected donors were more likely to report having lived abroad or
immigrated to the US, or having an HBV or HCV infected family member.

Before the DRFS, other studies of risk factor profiles among HIV-infected donors were funded by the
CDC for approximately 10 years after implementation of serologic screening in the mid-1980s, and
studies of HCV-seropositive donors were conducted in the early 1990s.3 A study of risk factors for HCV
infection in nucleic acid positive (NAT) anti-HCV negative donors from the early 2000s was also
reported.4

ARC has conducted infection trend analyses.5,6 The findings show continued HIV risk with the prevalence
of HIV in first-time donors hovering around 10 per 100,000 donations in each year of the 10-year period
studied and the incidence in repeat donors increasing from 1.49 per 100,000 person-years in 1999-2000
to 2.16 per 100,000 persons-years in 2007-2008.7 While the prevalence of HCV in first-time donors
decreased over this time interval from 345 to 163 per 100,000 donations, the incidence in repeat donors
did not decrease and evidence of incident infection in first-time donors increased. Moreover specific
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age, gender and minority race/ethnicity groups were over-represented. Significantly increased incidence
of both HIV and HCV were observed in 2007-2008 compared to 2005-2006. Similar analyses for HBV
have shown an incidence in all donors of 3.4 per 100,000 person-years which is lower than earlier
estimates, but remains higher than for HIV and HCV.8

Brief reviews of older studies of HIV, HCV, HBV risk factors are provided to establish a historical context
for the epidemiology of each of these infections in blood donors.

HIV
Among 38,000 persons in 33 states with confidential name-based HIV infection reporting in 2004, malemale sex was the most frequently reported transmission category, followed by heterosexual contact and
IDU.9 The 1999-2002 National Health and Nutrition Examination Survey (NHANES) results show that nonHispanic black participants (N=1283) who reported ever using cocaine/street drugs, in addition to those
who tested positive for the presence of HSV-2 antibody, had a higher prevalence of HIV infection.10 In
blood donors, risk factors reported by HIV seropositive donors from over 20 years ago were different for
males and females. In males, male-male sex was most common followed by IDU, then sex with an IDU,
but 27% did not disclose or could not identify a risk, whereas in females, sex with males at risk for HIV
was most common (81% of whom were IDU) followed by IDU, but 41% did not disclose or could not
identify a risk.11,12

HCV
Hepatitis C is the most common blood-borne infection in the United States, and risk factors are
associated with percutaneous or mucosal exposures to blood or blood-derived body fluids. A national
population-based survey NHANES III, 1988-1994) surveyed approximately 15,000 participants and found
that a history of injection drug use was the strongest risk factor for HCV infection.13 Other significant risk
factors included 20 or more lifetime sexual partners, and blood transfusion before 1992. Among blood
donors, a matched case-control study of 2,300 participants showed that injection drug use was highly
associated with HCV seropositivity and was the most common risk factor reported by US blood donors
(about 50%).14 Data from the Centers for Disease Control and Prevention from 1995-2000 demonstrate
that most newly acquired infections are associated with injection drug use, followed by exposure to an
infected sex partner or to multiple sex partners, health care work with frequent exposure to blood, and
rarely, nosocomial, iatrogenic and perinatal exposures.15 HCV NAT positive, anti-HCV negative blood
donors had the following risk factors, recent injection drug use (IDU), followed by occupational
exposure, sexual contact with an HCV-infected partner (who was an IDU), and perinatal exposure.4

HBV
The 1988-1994 NHANES data (N=40,000) demonstrate that black race, increasing number of sexual
partners, and non-US place of birth were highly associated with HBV infection.16 Centers for Disease
Control and Prevention surveillance data from 1990-2004 show that the proportion of acute HBV cases
reporting multiple sexual partners and male-male sex doubled over this time period, indicating that
these behaviors are associated with increased risk of HBV transmission.17

The greatest improvements in infectious disease blood safety come from preventing the donation of
blood from infected donors. To increase the probability of preventing such donations, blood collection
organizations need to be able to aggregate data to understand larger patterns across organizations.
Standardized data coding, research database processes, and data collection procedures across
organizations will benefit transfusion safety. Identifying and reporting risk factors for viral infections in
confirmed-positive viremic and seropositive donors is not mandated by the US FDA or required by blood
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organizations or standard-setting bodies. Risk factor assessment by blood organizations is currently
done as part of individual donor notification and counseling by blood centers, but not in a systematic
way within or across organizations. A systematic collection of risk factor data will enhance the
information already contained in the centers’ databases and allow the FDA and other agencies to
monitor the impact of changes in donor eligibility policies.

In the REDS-II Infection Marker Rates and DRFS, donors with donations that tested false positive
(controls) were interviewed as a comparison population. These false-positive donors included donors
who tested HIV, HCV, HBV, or HTLV serology repeat reactive on one screening test but were not
confirmed to have infection. Controls were not matched to cases on any demographics or other factors.
The inclusion of controls allowed for an analytical assessment of the statistical association and odds of
infection comparing risk behaviors and demographics between those with confirmed infections (cases)
to uninfected donors. Table 1 provides risk behavior results showing the odds of HIV infection between
cases and controls from the REDS-II study and Table 2 provides risk behavior results associated with HCV
infection.

Table 1. Statistical measures of behavioral risk factors associated with HIV infection in blood donors
from the REDS-II US Risk Factor Study.2
Adjusted Odds Ratio,*
95% Confidence Interval & p-value
Sex with someone who is HIV+
131.7
26.7 – 650.1
<0.001
MSM
62.3
27.6 – 140.4
<0.001
Injection drug use
3.1
0.3 – 28.5
0.30
3+ nights in detention/jail
2.4
1.2 – 4.8
<0.01
Tattoo, body piercing, or 3+ ear piercings
2.8
1.6 – 4.8
<0.001
Multiple sexual partners in last year
2.3
1.4 – 3.8
<0.01
* Adjusted for gender, age, race/ethnicity, income, first time/repeat donor status.

Table 2. Statistical measures of behavioral risk factors associated with HCV infection in blood donors
from the REDS-II US Risk Factor Study.2
Factors Associated with HCV Infection in Blood
Adjusted Odds Ratio*, 95%
Donors
Confidence Interval & p-value
IDU
42.1
13.0 – 136.3
<0.001
Household member with Hepatitis
15.4
5.9 – 40.3
<0.001
Sex with IDU
9.7
4.4 – 21.2
<0.001
3+ nights in detention/jail
7.5
4.3 – 12.9
<0.001
Transfusion Ever
5.1
2.7 – 9.6
<0.001
Tattoo or body piercing
3.5
2.0 – 5.9
<0.001
*Adjusted for gender, age, race/ethnicity, education, first-time/repeat status, born in the US

Controls are equally important as part of TTIMS for understanding the behavioral characteristics of the
uninfected donor population. The controls that were interviewed for the REDS-II Study would not serve
as appropriate comparison controls for blood donors with infections during the TTIMS period (2015 –
2019) for two reasons. First, directly comparing risk behaviors between false-positive donors from the
REDS-II Study (2011 – 2012) with cases from TTIMS would involve a time period difference of 4 to 8
years depending on when the TTIMS cases are interviewed. Secular and other changes in the donor base
between the two time periods could lead to substantial bias, particularly with respect to the
Factors Associated with HIV Infection in Blood Donors

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demographics of donors as the number of blood donations and the approach to donor recruitment in
the US have significantly changed over the this time period. Second, because the blood donation
eligibility rule for MSM has now changed, it is important to assess if there have been changes in
undisclosed risk behaviors in accepted donors with and without infection. Further, by conducting control
interviews in TTIMS, we will also be able to assess if the rates of undisclosed risk behaviors such as MSM
are different between the REDS-II Study and TTIMS time periods.

This project represents a collaborative study that will include a comprehensive interview study of viral
infection positive blood donors at the ARC, BSI, NYBC and OneBlood in order to identify the current
predominant risk factors for virus-positive donations and will also establish a donor biovigilance capacity
that currently does not exist in the US. Combined data are critical for appropriate national donor
infectious disease monitoring efforts. In addition, with implementation of changes in the indefinite
donor deferral for men who have sex with men (MSM) to a 1-year deferral since last MSM contact,18
monitoring the relative prevalence of risk behaviors in donors with confirmed infection is important for
the assessing changes in risk following modification of the deferral.19 Data collected by TTIMS will be
useful for both regulatory and educational reasons. For example, this information could be used to
target educational interventions to reduce donations from persons with high risk behaviors. This is
particularly important in the case of behaviors associated with incident (recently acquired) infections;
these donations have the greatest potential transmission risk because they could be missed during
routine testing. The combined database will capture infectious disease and risk factor information on
nearly 60% of all blood donors and donations in the country.

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Objectives

The LRCC project has two primary responsibilities in TTIMS. The first responsibility is to lead the
collection, evaluation and analysis of risk factors data in blood donors who have HIV (NAT yield and
seropositive), HCV (NAT yield) and/or HBV (NAT yield) positive donations and also donors who test
repeat reactive but do not confirm positive based on supplemental/confirmatory testing for the same
infections will be interviewed. The unconfirmed (false positive) donors will serve as a comparison group
to the confirmed positive donors (items 1 – 4 below). The second responsibility is to establish a
biospecimen repository, conduct laboratory analyses of HIV seroprevalent infections to be able to
classify them as newly acquired or long standing, and to determine genotypes and, where applicable,
drug resistance profiles for HIV (NAT yield and seropositive), HCV (NAT yield) and HBV (NAT yield)
infections (these activities are described in a separate Protocol 2 document).

The TTIMS LRCC project purpose is to serve as the coordinating, laboratory, and analytical center for
analyses relevant to the evaluation and monitoring of HIV (NAT yield and seropositive), HCV (NAT yield)
and HBV (NAT yield) positive blood donor risk factor data, molecular surveillance data and HIV recency
testing data. Specifically, the primary objectives are to:

1. Coordinate the collection of risk factor data by the participating blood centers where donors with
infections and donors who tested false positive donated.
2. Integrate risk factor data and disease marker surveillance information across different blood
collection organizations.
3. Evaluate and monitor risk factor characteristics of donors and donations confirmed-positive for
transfusion-transmissible infections.
4. Compare/analyze risk factor data to those obtained in the REDS-II Marker Prevalence and DRFS.
5. Provide logistical support for the TTIMS project and for the Committee/Subcommittee meetings,
conferences, and donation(s) transfer/shipment.
6. Serve as the biospecimen repository for the TTIMS project.
7. Perform recency testing on HIV plasma samples from donors with seropositive infection to establish
estimates of time of HIV acquisition.
8. Conduct viral genetic sequence analyses on plasma samples for HIV (NAT yield and seropositive),
HCV (NAT yield) and HBV (NAT yield) positive blood donors to determine genotypes and drug
resistance (where applicable) of donor infections.
Specific Aims of Risk Factor Assessment

1) Determine current behavioral risk factors associated with all HIV-infected donors, and HCV and HBV
NAT yield donors, including parenteral and sexual risks, across the participating blood collection
organizations.

Hypotheses:
The distribution of risk factors for viral infections in donated blood reported by donors in studies
from more than 10 years ago will not be same as those reported today. We expect that factors
such as injection drug use will comprise a lower proportion of identified risk in blood donors

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with infections, and those sexual exposures, including multiple heterosexual partners (MHP) and
male-to-male sex (MSM), will comprise a larger proportion of reported risks for infection.

2) Analyze integrated risk factor, recency and genotype data together because when taken together
these may show that blood centers are not achieving the same degree of success in educational efforts
to prevent donation by donors with risk behaviors across all demographic groups.

The primary contribution this project can add to a national biovigilance system is to monitor routes and
rates of viral infection acquisition that could lead to transfusion transmission. Thus results from this
study could also be used to assist in formulating guidelines, informing policy decisions, planning
prevention programs, and targeting risk reduction interventions. National reporting systems with
coordinated collection and analysis of data have led to specific recommendations that underpin key
transfusion safety initiatives in other jurisdictions.20

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Study Procedures and Tasks

Study Population

The study population for the risk factor interviews will be allogeneic and directed donation blood donors
from the four participating blood centers who have specific screening results obtained from routine
donation screening from either ARC or Creative Testing Solutions (CTS) laboratories.

Inclusion Criteria

Donors eligible to be interviewed for the risk factor study as part of LRCC activities will be donors who
have confirmed HIV, HCV NAT yield, or HBV NAT yield infections and donors who test repeat reactive
but do not confirm positive based on confirmatory testing. Table 3 provides the types of each confirmed
positive viral infection that will qualify as eligible cases for risk factor interviews.

Defining Infection Status

Consensus Positive Donors

The Donation Database Coordinating Center (DDCC) portion of TTIMS includes development and use of
interpretation algorithms to consistently define infections based on routine testing at ARC or CTS. NAT
yield donors are considered incident infections versus those of HIV seropositive donors where the time
of infection acquisition is unknown using standard laboratory screens. Testing conducted as part of LRCC
Protocol 2 will be used to further classify seropositive HIV infections into recent or long-standing status.

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Table 3. Summary of consensus positive definitions for HIV, HCV, and HBV cases used to define eligible
donors for risk factor interviews as cases.
Donation Test Results
Study Definition

HIV

NAT-yield
• Anti-HIV nonreactive (NR) and
(Incident HIV)
• HIV NAT-discriminated reactive (dHIV) and
• HIV NAT-discriminated reactive (dHIV) in an independent
sample (e.g. retrieved plasma component) or confirmed HIV
NAT-reactive with or without anti-HIV seroconversion in a
donor follow-up sample
Seroreactive + NAT-reactive
• Anti-HIV repeat reactive (RR) and
(Prevalent HIV)
• HIV NAT-discriminated reactive (dHIV)
Seroreactive + low-level
• Anti-HIV repeat reactive (RR) and
viremia or virologic control
• HIV MP-NAT NR and
(Prevalent HIV)
• Anti-HIV confirmed reactive (IFA, EIA, WB, ChLIA) in an
independent sample (e.g. retrieved plasma component)
Note: 10x replicate testing with at least 1 reactive on dHIV
NAT required to define as HIV controller

HCV
NAT-yield
• Anti-HCV nonreactive (NR) and
(Incident HCV)
• HCV NAT-discriminated reactive (dHCV) and
• HCV NAT-discriminated reactive (dHCV) in an independent
index donation sample (e.g. retrieved plasma component) or
confirmed HCV NAT-reactive with or without anti-HCV
seroconversion in a donor follow-up sample

HBV
NAT-yield
• Anti-HBV nonreactive (NR) and
(Incident HBV)
• HBV NAT-discriminated reactive (dBIV) and
• HBV NAT-discriminated reactive (dHBV) in an independent
sample (e.g. retrieved plasma component) or confirmed HBV
NAT-reactive with or without anti-HBV seroconversion in a
donor follow-up sample

Exclusion Criteria

Donors with results from any blood donation not meeting the specific testing results defined in Table 3
will not be eligible for risk factor interviews as cases. Autologous donors meeting these infection
definitions are not eligible.

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False-Positive Donors

Robust confirmation procedures are used to ensure donors who are repeat reactive on one of the
screening tests, but negative on all others, are verified by further supplemental testing to be falsepositive. These donors are not the same as donors who are classified as having indeterminate testing
results.21 Donors with indeterminate confirmation results will not be eligible as controls for TTIMS.
Donations from donors who test repeat reactive but are not confirmed by supplemental testing are
believed to be random events and therefore they represent an appropriate sample of the blood donor
population. Studies of infected and uninfected blood donors have previously used this strategy to
identify controls for case-case control studies2,22-24 and research has shown that donors with falsepositive results on an initial screening test are not infected.25-27 A recent study has suggested that some
false-positive test results for HTLV and HCV may be associated with certain demographics, but for antiHIV or HBsAg false-positive results no demographic associations were evident.28

For TTIMS, we will use anti-HIV screening false-positive donors as controls for all HIV cases. The
frequency of false-positive testing results varies according to the sensitivity and specificity and other
aspects of the screening tests used. For anti-HIV testing the ratio of false-positive to confirmed positive
donors is greater than 15:1. This ratio means that we will have far more false-positive donors than
confirmed positive donors as potential participants for the study. Similarly, HBsAg false-positive are
straightforward to confirm as uninfected and will serve as an additional source of potential controls. Use
of donors with HBsAg, non-neutralized, false-positive donations is of particular relevance to serve as
controls for incident [serology negative, nucleic acid test positive (NAT yield)] HBV and HCV cases.

The operational processes that are used for blood screening results notification for false-positive donors
represent an opportunity to sample an informative control group that has interacted with each blood
center in a largely similar manner to that of cases. These donors are contacted by mail informing them
of the results of testing and their false-positive status. Because they have to be contacted and provided
the results, which include the false-positive screening tests, these donors may be interested and
motivated to complete the questionnaire as part of the counseling process even though they do not
have infection. In the REDS-II Risk Factor Study, enrollment of false-positive donors for control
interviews was readily achieved.

Control interviews will be conducted using the same study procedures as planned for case interviews
with each blood center interviewing its own donors by telephone using the internet-based survey, and
the web-based study management system. Controls would be interviewed in years 2 through 5 of the
TTIMS program, but would be enrolled in numbers to reflect an overall 1:2 case:control ratio for the
entire TTIMS project period, i.e. the total number of cases for the 5 year period will be used to conduct
control interviews to achieve a final 1:2 ratio.

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Donor Enrollment and Study Management

General Approach

The reports of confirmed infections (HIV NAT yield and seropositive and HCV and HBV NAT yield) and
false positive donors provided to each blood center by the DDCC will also be sent to the LRCC and will
serve as the denominator data of consensus eligible donors for LRCC activities.

First, we will use a system internal to the LRCC that will not be accessible by other organizations for the
purpose of tracking completion of each aspect of LRCC project procedures for each qualifying consensus
eligible donor. The DDCC consensus eligible donor reports data will be entered into an activity tracking
database at Blood Systems Research Institute (BSRI). We are not planning to maintain TTIMS data in this
BSRI-internal activity tracking log, but rather we will use it as the record of LRCC tasks for each
participant and specimen set. BSRI will use these data with the donation identification number (DIN) as
the key unique, but de-identified, tracking identifier to establish a sample and participant tracking log.

Second, a study management system (SMS) will be developed that will be used by each blood center to
monitor recruitment, consent, enrollment, provision of incentives and communication of relevant
results back to each participant. Through BSRI’s affiliation with UCSF, we will use the study management
software Online Collaborative Research Environment (OnCore, Forte Research Systems, Madison, WI).
This is a state-of-the-art study management system software package capable of tracking activities
related to donors (recruitment, consent, enrollment, completion of study activities, provision of
participation incentives), specimens (receipt of specimens, provision to specific testing laboratories,
indication of completed testing), and can be used to generate summary reports of each of these
activities. For the SMS we will utilize a specific component of the OnCore platform, the Unified
Registries Management (URM) system to guide study procedures at each site and to monitor progress.
This is a customizable set of study and participant tracking tools that will serve as the SMS for LRCC. The
OnCore URM module enables management of clinical research data sets that are configured around an
event (e.g., a blood donation) and the ability to create a coordinated cascade of data capture at the
person or event level, including deployment of common forms for all participating blood centers and
data export tools for analysis in statistical programs.

The OnCore system will be implemented in accord with all required data security and privacy
protections, and current standard best practices. Outside of the OnCore URM, each site will have access
to donor-specific, personally identifying information (PII) that the LRCC will not have access to. PII will be
maintained by each blood center per standard, regulated procedures. These data will be accessed by
LRCC project staff within each center for the purpose contacting and recording completion of TTIMS
LRCC project activities.

Within the OnCore URM, access levels for all study staff are controlled by LRCC senior staff based on job
function. At the donor level, the data captured will include recruitment status (e.g., consented, refusal,
pending, lost to follow-up), risk factor interview completed, and participation incentive provided. At the
donation or sample level the data captured will include an indicator of successful retrieval of the frozen
plasma unit from the index donation, bio-specimens obtained from plasma unit or from alternate
sources, specimens accessioned into the repository, recency testing completed, and molecular
surveillance testing completed.

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The LRCC will create a centralized repository of samples from consensus HIV-positive, HCV NAT yield,
and HBV NAT yield blood donations to serve future research uses such as availability for HIV, HCV, and
HBV evolutionary geneticists investigating changes in virulence and pathogenicity over time. These
mechanisms for obtaining additional specimens shall be ready for implementation to capture other
specimens if an emerging agent of concern is identified. The repository is described in Protocol 2.

Control donor interviews will be based on a random sample of anti-HIV, or HBsAg false positive donors
in a ratio of 1 case to 2 controls within each blood collection organization.

Description of LRCC Activities

The LRCC will use reports developed by the DDCC subcontractor, Quality Analytics, to initially identify
those potential donors who are eligible for participation in the LRCC portion of TTIMS. The diagram
titled Transfusion Transmissible Infections Monitoring System (TTIMS), Donation Database Coordinating
Center (DDCC) and Laboratory and Risk Factor Coordinating Center (LRCC) maps out the data and
specimen flow that will be used to conduct blood center specific activities under the LRCC (Appendix 1).
Communication of all study-related data files will occur via secure channels (username and password
protected computers, secure file transfer protocols (FTP), and as required per the terms of the contract
will use Secure Sockets Layer (SSL) and Transport Layer Security (TLS) or encrypted SSL/TLS connections).

The approach to identifying eligible cases will be driven by data directly obtained from donation testing
by ARC and CTS. ARC and CTS testing data will be provided according to donation identification numbers
(DINs) and will be electronically transferred to the DDCC data server, as described in the TTIMS DDCC
Protocol. These data will define HIV, HBV, and HCV consensus positives. Quality Analytics will use the
consensus infectious marker testing algorithms developed for this project and will run interpretation
programs to define which combinations of test results meet the required study eligibility definitions.
These reports will then be sent back to each participating blood center organization and to CTS by DIN,
and will serve as the list uses to retrieve plasma units (if available), residual volumes from testing and for
the recruitment of risk factor interview participants. This process removes the need for local blood
center IT expertise in running these algorithms and will ensure that eligible donors are defined in the
same across all participating sites. BSI, NYBC, and OneBlood testing results will be provided to the DDCC
by CTS. Similarly, ARC data will be provided to the DDCC by ARC testing laboratories. The data will flow
to the DDCC data server separately, but in parallel from CTS and ARC testing labs.

The LRCC will coordinate and facilitate the activities that individual blood centers will use for recruiting,
enrolling and characterizing risk behaviors in seroprevalent and NAT yield HIV blood donors and NAT
yield HCV and HBV blood donors. Donors with false-positive results will also be enrolled. Donor
counselors at participating blood centers will conduct risk factor interviews. Each blood center will be
responsible for recruiting its own blood donors, enrollment of these donors, conducting the web-based
risk factor interview, and working with ARC, CTS, and BSRI to provide plasma specimens for the
repository and testing at the LRCC.

The four participating blood centers in LRCC estimate they have the following annual number of
infections that will qualify for LRCC activities (Table 4).

14

Table 4. Annual estimates of donors with infections that will qualify for TTIMS participation.
Blood Center
Serology + NAT
HIV NAT yield HCV NAT yield HBV NAT yield
HIV Positive
ARC
150
20
50
20
BSI
24
1
4
1
NYBC
22
1
4
3
OneBlood
64
1
35
11
Total
260
23
93
35

After routine notification of having donated a confirmed HIV-positive donation, HCV NAT yield, or HBV
NAT yield, donors will be asked to complete an interviewer-administered telephone questionnaire. The
LRCC will build on current operational procedures to facilitate the ease of use of the risk factor interview
instrument. As per operational procedures, except in rare circumstances, donors who are HIV positive
are notified in person by blood center professional medical staff (physician or qualified donor counselor)
and will be asked to complete the questionnaire at the time of notification, or based on professional
judgment at a future in-person meeting or by telephone call if agreement for future contact is obtained.
Donors with false positive test results will be contacted in the same manner. Trained donor counselors
will conduct the interview over the telephone. There are strict operational procedures at all blood
centers in place to verify that a person contacted by phone is the donor. If the donor’s identity cannot
be confirmed via standard operational procedures the interview will not be conducted. Donor
counselors will try to contact donors by phone to follow-up to see if the donor received the routine
notification letter and counseling materials. Donor counselors will attempt to contact donors up to 3
times by phone, email, or letter. If counselors are unable to reach a donor after 3 attempts the donor
will be classified as lost to follow-up. Study information mailer templates in English and Spanish are
provided in Appendices 5 and 6. The LRCC will work with each blood center to include the project
information mailer as part of the notification letter sent to donors who are eligible for interview.

Although each organization will seek to enroll all persons who meet the study case definitions, it is
unrealistic to expect 100% participation. We will strive to achieve no less than 50% and target 75%
participation as our enrollment goal for each qualifying consensus definition donor. We believe the
provision of a $100 participation incentive to each donor who consents and completes the risk factor
interview may be very helpful in reaching the target participation proportion. Total potential enrollment
per year is provided in Table 5. Importantly, year 1 enrollment will likely be lower than in subsequent
years because risk factor interviews for the first year will mostly be conducted retrospectively following
Office of Management and Budget (OMB) clearance to interview donors. An enrollment of less than 50%
in the first year is likely the maximum that will be achievable due to the elapsed time before we can
contact donors for interviews and the associated likely increased loss to follow-up because of potentially
out of date contact information at the time we seek to recruit study participants.

15

Table 5. Annual estimates of donor risk factor interviews based on different assumed participation
proportions.
Assumed
participation of
Serology + NAT
donors with
HIV NAT yield HCV NAT yield HBV NAT yield
HIV Positive
confirmed
infection
100%
260
23
93
35
75%
195
17
70
26
50%
130
12
47
18

Assessment and Measurement Procedures

The LRCC will use similar study procedures to those from the REDS-II DRFS study to compile risk factor
data for all qualifying HIV infections and HCV/HBV NAT yield infections across different blood collection
organizations. Because TTIMS requires both consistency and timeliness in capturing risk factor
responses, interviewer administered questionnaires will be performed. This also creates an opportunity
for donor counselors to provide additional counseling. Interviews will be electronically transferred to the
LRCC as part of a consolidated database of all completed interviews. Data form scanning or key punch
entry will not be necessary. The LRCC will conduct quality control and assurance processes that include
allowed and out-of-range values; interview quality control reports will be generated and provided back
to each blood center on a monthly basis to check and, where necessary, correct and resubmit updated
interviews. The DDCC overall database for TTIMS will serve a similar role as in the previous REDS-II
Marker Prevalence and DRFS by allowing additional cross-checking of some types of donor-reported
information. For example, self-reported first-time or repeat donor status is difficult to verify, therefore
we will rely on blood center records to determine first-time or repeat donor status. These blood center
data are more reliable than donor self-reported information.

Although not specifically relevant to LRCC Protocol 1, the LRCC will coordinate with the DDCC and
participating blood collection organizations regarding collection, tracking, shipping (including freight),
storage, and retrieval of all biospecimens for lab characterizations. The primary path by which we will
achieve coordination with the DDCC will be through the “Numerator Test Data” reports provided to
each blood center and BSRI for the purpose of tracking information (Appendix 1). This information will
be integrated into the SMS so that bio-specimen and participant tracking, as well as availability of results
from interviews and testing are traceable in monitoring reports. Each participating blood center will
have access to only data from its own donors and not to that of other centers.

The unique identifier to be used in this study is ISBT 128 DIN.

The DIN is the ISBT 128 term used to identify the specific unit number assigned to a particular donation.
The DIN is composed of three data elements structured in a way that allows each collection to be
globally unique. For example, this prevents hospitals from receiving duplicate unit numbers, originating
from multiple locations. DIN is not linkable to any other records except by the blood collection
organization where the donation was given and the DIN was assigned.

16

Risk Factor Survey Administration

Each organization, ARC, BSI, NYBC, and OneBlood, will interview its own donors. The LRCC will
coordinate and train blood centers in conducting risk factor interviews by donor counselors via
telephone. A tailored plan will be developed for each site based on language administration capability
(i.e. Spanish-language capability or English-only). The risk factor interview is targeted to be conducted
within 30-days of the date the index donation is confirmed to meet TTIMS eligibility definitions (once
prospective interviewing is approved by OMB and IRBs, and training is completed).

BSRI is a UCSF affiliate and as such has access to the web-based survey data collection software
program, Qualtrics™ (Qualtrics, Provo, UT). Data collected using the web-based interviews are stored on
Qualtrics servers in AZ, CO, and UT but can be downloaded at any time (multiple formats, Stata, SAS,
Excel, CSV, PDF, etc.). The survey tool will be designed to automatically email or print out individual
survey responses at the completion of the interview. Printed copies will be kept by each blood center. In
addition, the software can also be programmed to send the output to a designated person upon survey
completion or at set intervals. The LRCC will use this feature to collect the survey data in the project
database as soon as each interview is finished.

For the purpose of administration of risk factor interviews, all LRCC project staff will access the
electronic survey using individually defined usernames and passwords that will be provided by UCSF IT
Services. Access will be granted or revoked by BSRI and UCSF. The coordinators and donor counselors
will access the interview form via a permanent hyperlink and create a new record by entering data for a
new participant using the DIN as the study subject number.

A risk factor questionnaire has been developed that focuses on the risk behaviors associated with
human-to-human transmission of viral infections for which blood centers universally screen donated
blood (English and Spanish versions included as Appendices 8 and 9). The ability to ask questions about
all three viruses on a single instrument is feasible since infected individuals often share risk factors for
routes of virus acquisition. Although the risk of transmission varies for each virus, HBV, HCV, and HIV
can all be acquired through the following routes: parenteral (examples: blood or blood product
transfusion, transplantation, injection drug use, tattooing, body piercing, needle stick injury), sexual,
perinatal (examples: during pregnancy, labor, delivery or breastfeeding), and household contact
(examples: sharing toothbrushes or razor blades with an infected individual). These routes of acquisition
and risk factors have all been previously identified in the literature and are considered to be wellestablished.4,14,29-32 Our study is designed to assess the frequency of these routes of self-reported
infection acquisition. The study is not designed to assess very rare or newly hypothesized routes of
infection acquisition.

We estimate that it will take 5 minutes time to complete verbal informed consent, the questionnaire will
require approximately 40 minutes of the donor’s time. The instrument has been developed with skip
patterns so that the time of administration may vary substantially based on the risk behaviors of
different donors. Donors will be interviewed by counselors who are employed by the organization
where the donor gave blood. Interviews will be conducted in English or Spanish based on the preference
stated by each donor and site capability. Consent will be obtained in the same language as the
interview. Data from completed questionnaires from all four participating organizations will be collected
in a secure database managed by BSRI. BSRI researchers will not have access to the names or any other
personally identifying information, except biometric identifiers.

17

Analyses and Reporting

The OnCore study management system is designed to keep track of the route of study subject contact,
including capturing basic demographic information on donors whom we contact, those who refuse to
participate and those we are unable to contact following recruitment efforts (classification categories
will include; enrolled, refused, pending, unable to contact, lost to follow-up, interview complete). This
information will be analyzed to assess whether demographic differences are evident for donors who
participate compared to donors who refuse or are lost-to follow-up.

The LRCC will establish ongoing data analysis capabilities to evaluate and monitor results obtained from
risk factor interviews, recency testing, and genotype and drug resistance testing. Prevalence and
incidence trends will be primarily monitored by the DDCC. Stratified analyses will be conducted by the
LRCC using information captured from the confirmed case listings provided by the DDCC to each center
and to the LRCC as well as the additional data collected from risk factor interviews.

Risk factor analyses will include overall analyses, as well as comparison of results to centers that fully
participated in the REDS-II study (ARC, BSI and NYBC). This will enable us to compare the risk behavior
proportions for HIV infection observed in TTIMS to those determined during the REDS-II DRFS, i.e., to
the proportions of donors with HIV that reported IDU, MSM or MHP. We will assess whether the
proportion of infection attributable to each risk behavior is approximately the same or different from
those observed previously. The comparison of risk factors for new HBV and HCV infections will also be
possible, but given small numbers of NAT yield infections, it is unlikely quantitative statistical
comparisons can be achieved.

The analysis and reporting of results to the TTIMS Steering Committee (SC) and FDA will be delayed by at
least a month following the close of a quarter in order to allow sufficient time for quality control,
cleaning and analysis of information. The one month delay following the close of a quarter is important
to be confident the data are as complete and accurate as possible. The planned report content and
reporting periods are:

A. Quarterly reports (based on achieved enrollment and completed testing at the close of the quarter)
1. For each type of viral infection:
a. Number of completed interviews in the quarter by center and overall
b. Frequency tables of age, gender, race/ethnicity, first-time or repeat status, DHHS public
health region, and donation type of interviewed donors
c. Frequency tables of reported risk factors
2. Results of HIV recency testing (once LRCC Protocol 2 is implemented)
a. Frequency tables of HIV recency results by the same categories listed in A.1.b
3. Frequency tables of combined analyses of recent infections and risk factors

B. Semi-annual reports (based on achieved enrollment and completed testing at the close of the semiannual period)
1. Genotype results for HIV, HCV, and HBV and drug resistance results for HIV and HBV
2. Frequency tables of combined analyses of recent infections, risk factors, and genotypes for each
of the three viruses
18

3. Separate frequency tables of risk factors in HIV NAT yield infections
Triggered Follow-up Investigations

The LRCC will coordinate with the DDCC and participating blood collection organizations to conduct
follow-up investigations triggered by significant changes in TTI incidence/prevalence rates and risk
factors, as defined by consensus agreement between FDA and the TTIMS SC. One approach might be to
rely on 95% Confidence Intervals calculated on quarterly or semi-annual datasets. If the 95% confidence
intervals for incidence, prevalence and risk factor frequencies are non-overlapping this may represent
evidence of “significant changes”. Even so, some random variability is expected in all of these data, and
so an alternate approach could be to conduct trend analyses by month or quarter to assess the
possibility of sustained change. The shorter the period the data are compared, the higher the likelihood
of variability that could appear, but is not in fact significant. Ultimately, the TTIMS SC using the data that
have been provided by DDCC and LRCC activities will determine if an investigation is required.

If an investigation is prompted, the investigation will include verifying that the processes of donor and
donation qualification for each blood establishment participating in LRCC have been performed in
accordance with FDA regulations, cGMP and all standard operating procedures of the blood
establishment. This also includes adhering to all manufacturers’ instructions, acting on all information
provided by the donor at the time of donation and any additional information provided by the donor
post-donation (e.g., disclosure of any high-risk behavior). These investigations, should they be triggered,
will be conducted within 30 days of their identification.
Statistical Considerations

Power and Sample Size

Power analyses to help guide the understanding of what levels of excess risk can be estimated assuming
a case to control ratio of 1:2 with 50% case enrollment was conducted and the expected number of HIV,
HCV and HBV cases during the TTIMS period was conducted. The detailed results from the REDS-II Study
(Appendix 2) provide information on the prevalence of risk behaviors reported by HIV, HCV and HBV
cases and false-positive controls from that study. In addition, a survey study of undisclosed risk factors
in accepted male donors conducted as part of REDS-III, found non-compliance with the MSM deferral in
uninfected male blood donors of 2.6%.19 For HIV, we assume a maximum expected prevalence of
undisclosed risks in the control group during TTIMS based on these recent data. Power to detect
significant associations depending on the excess risk in cases and the baseline prevalence of each
behavior in controls with a sample size of 710 confirmed HIV-positive, interviewed donors compared to
1420 interviewed controls is provided in Table 6. The table shows the power at α=0.05 to detect
significant associations between risk factors with a prevalence of 2.6, 1.7, 0.5 and 0.25% in controls
donors assuming 10, 5, 3, and 2-fold higher odds of specific risk behaviors in confirmed-positive donors.

To place these estimates in context, we will have sufficient power to detect odds ratios just above 2-fold
higher for any behavior reported by 2.6% of controls. In addition, although the adjusted odds ratio in the
REDS-II study was 3.1 for the association between HIV infection and intravenous drug use (IDU), it was
not statistically significant. In that study 0.4% of false-positive controls reported IDU. With the proposed
number of controls we will have sufficient power to detect an odds ratio of 5 or higher for IDU if 0.5% of
19

controls report IDU history. Overall, the proposed ratio of cases to controls for HIV in TTIMS will be able
to achieve similar power levels as achieved in the REDS-II study.

Table 6. Power for various risk factor prevalence combinations for HIV cases compared to controls,
assuming 50% case enrollment and a 1:2 case:control ratio.
Infectious Marker
Prevalence of risk

case/control sample factor in controls –
Odds ratio to detect in cases
sizes
[Reference]
10
5
3
2
Power

2.6%19
1.0
1.0
1.0
0.79
HIV
1.7%2
1.0
1.0
0.97
0.62
710/1420
0.5%
1.0
0.94
0.58
0.23
0.25%
0.99
0.71
0.33
0.14

The inclusion of control interviews for NAT-only HCV and HBV cases will increase the number of cases
and controls over the five year period to a projected 1030 and 2060, respectively. The additional 560
control interviews will be triggered based on being HBsAg false-positive. HBsAg confirmation testing
when non-neutralized along with being anti-HBc and NAT negative indicate that any HBsAg false-positive
does not have an HBV infection. These controls would be informative for comparing to the up to 280
NAT-only HCV and HBV infections that are planned to be interviewed as part of TTIMS. Power to detect
significant associations depending on the excess risk in cases and the baseline prevalence of each
behavior in controls with a sample size of 280 incident HCV and HBV confirmed positive, interviewed
donors compared to 560 interviewed controls is provided in Table 7. The table shows the power at
α=0.05 to detect significant associations between risk factors with a prevalence of 5.2, 2.3, 0.5 and
0.25% in controls donors assuming 10, 5, 3, and 2-fold higher odds of specific risk behaviors in
confirmed-positive donors. The estimates are based on risk behaviors that were significantly associated
with HCV or HBV infection in controls from the REDS-II Study; 5.2% of controls from that study reported
spending 3 or more nights in jail, detention or a group home, and 2.3% of controls reported sex with an
IDU.

Table 7. Power for various risk factor prevalence combinations for HCV and HBV cases compared to
controls, assuming 50% case enrollment and a 1:2 case:control ratio.
Infectious Marker
Prevalence of risk

case/control sample factor in controls –
Odds ratio to detect in cases
sizes
[Reference]
10
5
3
2
Power

5.2% 2
1.0
1.0
0.98
0.67
2
HBV & HCV
2.3%
1.0
1.0
0.81
0.38
280/560
0.5%
0.96
0.60
0.27
0.12
0.25%
0.76
0.35
0.16
0.09

For the assessment of the association between IDU and incident HCV, we will be able to estimate a
significant odds ratio of less than 9 in cases compared to controls. In the REDS-II Study the association
between HCV and IDU was highly significant with an odds ratio of 42.

For other uncommon risk behaviors in the uninfected population, such as those with frequency of
0.25%, if all interviewed false-positive donors are included in the analysis of infection risk factors 2060
20

controls can be compared to each case group. If this is done, we will have sufficient power (1-β > 0.80)
to detect odds ratios of 10 or higher in cases. Similarly, we will have sufficient power (1-β = 0.80) to
detect odds ratios of 5 or higher if the behavioral prevalence in uninfected donors is around 0.65%.

Statistical Analyses

We will compute descriptive statistics, such as frequencies and measures of central tendency (means
and medians) in order to characterize the infected population and catalog donor-reported risk factors
likely to be the route of virus acquisition in case groups. We will compare the risk factors reported by
donors according to demographics and in different regions of the country to determine if patterns of
infection acquisition vary using the Chi-square or t-test depending on the structure of the predictor
variable included in the analysis. Independently for each virus, univariable and multivariable logistic
regression analysis will be used to compare risk factors when the outcome variable, infection status, can
be defined in a dichotomous manner. For example, to assess the association between risk behaviors and
demographics when comparing recently acquired HIV to long-standing HIV infection. The multivariable
analyses will be important so that we may account for potential confounding with regard to factors such
as socio-economic status and education level.

The inclusion of controls will allow for more advanced statistical analyses. In addition to descriptive
statistics, such as frequencies, we will be able to use multivariable logistic regression analysis to
compare confirmed-positive and false-positive donors to determine the association between risk
behaviors, while adjusting for demographics, Public Health Service (PHS) regions, or other factors. The
multivariable analysis will be important so that we may account for potential differences between cases
and controls with regard to factors such as socio-economic status. Furthermore, advanced exploratory
analyses may also be possible, such as multilevel modeling and potentially structural equation modeling.
Use of these techniques could generate novel interpretations of patterns of infection in blood donors
and also provide for a more direct assessment of how similar or dissimilar infections in blood donors are
to the larger sets of data on infections identified through other public health surveillance, and higher
risk groups surveillance. These analyses will allow for a deeper level of monitoring of the data from
TTIMS and, if other public health datasets can be accessed, a direct comparison to other sources.
Examples of published studies using these techniques show there is potential for new insights if these
methods are applied to blood donor data.33-35

Survey Considerations and OMB Requirements

The LRCC will develop and perform standardized risk interview survey(s), in accordance with
administrative processes such as review and approval by Institutional Review Boards (IRBs) and Office of
Management and Budget (OMB). We will obtain OMB clearance to allow for the use of the risk factor
interview instrument and the planned $100 participation compensation we intend to provide to donors
who complete the risk factor interview. Furthermore, all required IRB approvals and other
administrative approvals will be obtained. As the lead institution for LRCC activities, BSRI will obtain IRB
approval for all activities. Each blood center and CTS will obtain any necessary IRB approvals for their
respective activities. We will work with FDA to prepare the required OMB submission documents at
each stage of that process.

21

Risk Factor Questionnaire Content

The risk factor interview covers content on common routes of exposure and also less common routes
(Appendices 8 and 9, for English and Spanish versions). In addition the questionnaire will provide each
confirmed-positive donor the opportunity to report how he/she believes he/she may have been
infected. Four versions of the questionnaire introduction will be developed in consultation with the
participating blood centers to reflect the required content for administration of verbal consent as
mandated by local IRBs. The risk factor and related survey content is identical for all centers. The risk
factor interview is based on the same content that was used in the REDS-II DRFS. That interview was
previously approved by OMB (OMB Control Number 0925-0630, expiration date 4/30/2014). Content
has been updated to reflect changes in our understanding of risk factors and to address new content
relevant in the current time period.
Prospective and Retrospective Interviews

The majority of risk factor interviews during TTIMS will be conducted soon after confirmatory testing is
completed from donors who have been newly classified as consensus positive for each infection based
on blood donation testing (prospective interviews). We will also obtain human subjects approvals to
conduct risk factor interviews of donors from the beginning (September 25, 2015) in order to capture
data from the beginning of the contract period (retrospective interviews).

Participant Incentives

Incentives will be provided. Donors meeting consensus interview definitions will receive $100 for
completing the interview. As for cases, controls will be compensated $100 for completing the interview.
Incentives will be provided through the same operational procedures within each organization that
allow for personally identifying each donor. The study investigators and LRCC staff at BSRI will not have
access to PII and will not be responsible for providing the incentive payments to participants; each
participating blood center will be responsible for ensuring participation incentives are provided to
participants.
Human Subjects Considerations

All human subjects and other approval requirements will be met before the donor interviews can begin.
Confirmed-positive donors will be asked to complete the questionnaire proximate to the time that they
are notified of their infection status. This represents an emotionally difficult and challenging time for
donors. Some donors may be completely surprised or even in denial about at the results of testing. The
notification process is intended to be as benign as possible. The addition of a questionnaire designed to
assess risk behaviors into the notification process may be difficult for some donors to complete.
Participation in the risk factor interview is optional and is not a condition for future counseling. Using
their professional knowledge and insight, the donor counselors will decide if each donor is in an
appropriate state of mind to be interviewed. Donors will be given the option of being contacted at a
later time to complete the questionnaire. Donors may refuse participation and future contact.

Each infection has potentially serious consequences for the future health of the blood donor. Part of
standard counseling is to encourage that donors seek full medical evaluation by their physician. This is
22

particularly important for HIV where the seriousness of the infection for long-term health and the
potential for stigma is likely to bring distress. As per required operational procedures, no donor
identifiers that could reasonably be used to identify specific individuals will be available to the study
researchers.

For false positive donors, the interview may also be useful in helping donor counselors with the
counseling message and in identifying or ruling-out possible types of behaviors that could lead to false
positive testing results. Again, as per required operational procedures no donor identifiers that could
reasonably be used to identify specific individuals will be available to the study researchers.

A DHHS Certificate of Confidentiality will be obtained to prevent the project from being compelled to
release any information reported by the persons who participate in this study, except under the special
circumstances as specified by the Certificate.

Qualtrics™ HIPAA and HITECH Compliance

HIPAA Statement: With some restrictions, Qualtrics may be designated as a Business Associate when the
Qualtrics BA Agreement is signed with a Covered Entity—those organizations that are required to
comply with HIPAA privacy rules. All client data are considered confidential, and treated as such, with no
specific designation (such as medical (protected health information, PHI), PII, or public). Although, there
is a duty of care that Qualtrics maintains with respect to PII data, for the LRCC tasks, PII will not be
captured on Qualtrics servers.

Related to HIPAA, HITECH (Health Information Technology for Economic and Clinical Health Act) are
updated assessment rules to ensure that data are properly protected and best security practices
followed. By using secure and certified data centers, Qualtrics ensures the highest protection and testing
as per HITECH requirements.

If the Qualtrics/UCSF partnership dissolves (Qualtrics is a Business Associate), the data remains on the
Qualtrics servers for an additional 12 months. All interview data will be held in parallel on servers at the
LRCC for the purpose of analysis which will be backed-up on regular schedules. At project completion,
the LRCC will request data be purged from Qualtrics servers using existing request procedures. We will
request a final transfer of data and deletion from Qualtrics servers at the end of the LRCC contract
performance period as part of Transition Out or upon dissolution of the Qualtrics/UCSF partnership.

23

Timeline
TTIMS LRCC Protocol 1 - Risk Factors
Study Activities
Administrative
Protocol Development
Protocol Finalization
Manual of Procedures
IRB Approvals
OMB Clearance

2015
2016
2017
2018
2019
2020
S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S

Study Monitoring System (SMS)
SMS Content Development and Testing
SMS Training
Study Monitoring
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Risk Factor Survey
Survey Content Development
Survey Interviewer Training
Survey Administration
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Risk Factor Surveillance
Data Cleaning and Analysis
Reporting of Results to FDA and TTIMS SC
Manuscript Preparation and Submission

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the UK. Transfusion medicine reviews 2006;20:273-82.
21.
Dodd RY, Stramer SL. Indeterminate results in blood donor testing: what you don't know can
hurt you. Transfusion medicine reviews 2000;14:151-60.
22.
Custer B, Kamel H, Kiely NE, Murphy EL, Busch MP. Associations between West Nile virus
infection and symptoms reported by blood donors identified through nucleic acid test screening.
Transfusion 2009;49:278-88.
23.
Orton SL, Stramer SL, Dodd RY. Self-reported symptoms associated with West Nile virus
infection in RNA-positive blood donors. Transfusion 2006;46:272-7.
24.
Zou S, Foster GA, Dodd RY, Petersen LR, Stramer SL. West Nile fever characteristics among
viremic persons identified through blood donor screening. The Journal of infectious diseases
2010;202:1354-61.
25.
McAuley JD, Caglioti S, Williams RC, et al. Clinical significance of nondiscriminated reactive
results with the Chiron Procleix HIV-1 and HCV assay. Transfusion 2004;44:91-6.
26.
Ownby HE, Korelitz JJ, Busch MP, et al. Loss of volunteer blood donors because of unconfirmed
enzyme immunoassay screening results. Retrovirus Epidemiology Donor Study. Transfusion
1997;37:199-205.
27.
Sharma UK, Stramer SL, Wright DJ, et al. Impact of changes in viral marker screening assays.
Transfusion 2003;43:202-14.
28.
Vo MT, Bruhn R, Kaidarova Z, Custer B, Murphy EL, Bloch EM. A retrospective analysis of falsepositive infectious screening results in blood donors. Transfusion 2015.
29.
Cleary PD, Singer E, Rogers TF, et al. Sociodemographic and behavioral characteristics of HIV
antibody-positive blood donors. American journal of public health 1988;78:953-7.
30.
Carneiro-Proietti AB, Catalan-Soares BC, Castro-Costa CM, et al. HTLV in the Americas:
challenges and perspectives. Rev Panam Salud Publica 2006;19:44-53.
31.
Custer B, Sullivan SD, Hazlet TK, Iloeje U, Veenstra DL, Kowdley KV. Global epidemiology of
hepatitis B virus. Journal of clinical gastroenterology 2004;38:S158-68.
32.
Van der Bij AK, Coutinho RA, Van der Poel CL. Surveillance of risk profiles among new and repeat
blood donors with transfusion-transmissible infections from 1995 through 2003 in the Netherlands.
Transfusion 2006;46:1729-36.
33.
McMahon JM, Pouget ER, Tortu S. Individual and couple-level risk factors for hepatitis C
infection among heterosexual drug users: a multilevel dyadic analysis. The Journal of infectious diseases
2007;195:1572-81.
34.
Frew PM, Alhanti B, Vo-Green L, et al. Multilevel factors influencing hepatitis B screening and
vaccination among Vietnamese Americans in Atlanta, Georgia. The Yale journal of biology and medicine
2014;87:455-71.
35.
Bowleg L, Neilands TB, Tabb LP, Burkholder GJ, Malebranche DJ, Tschann JM. Neighborhood
context and Black heterosexual men's sexual HIV risk behaviors. AIDS and behavior 2014;18:2207-18.

26

Appendices
Appendix 1 – TTIMS DDCC and LRCC Information Flow Diagram

27

Appendix 2 – Risk Factor Frequencies Reported by Donors During the REDS-II Study

Table 1. Risk Factor Frequencies Reported by Donors During the REDS-II Study: Sexual, behavioral and
other risk factors for participating blood donors by infection status, published in.2
Sexual risk behavior
HIV cases
HBV cases HCV cases False-positives
controls
Males
n= 149 (%) n= 190 (%) n= 186 (%)
n= 761 (%)
Number of female sexual

partners, median (IQR)
Lifetime
4 (1-13)
6 (2-13)
15 (7-30)
5 (2-10)
Last 5 years
1 (0-3)
1 (1-3)
2 (1-3)
1 (1-2)
Number of male sexual

partners, median (IQR)
Lifetime
2 (0-8)
0 (0-0)
0 (0-0)
0 (0-0)
Last 5 years
MSM or Sex with MSM, ever
Yes

2 (0-5)

92 (61.7)

0 (0-0)

11 (5.8)

0 (0-0)

9 (4.8)

0 (0-0)

13 (1.7)

Monogamous, last 12 months
Yes
Male sexual partner, last 12
months
Yes
Used condom, always*
Yes
Sexually transmitted disease
Yes
Sex for money or drugs
Yes
Sex with injecting drug user
Yes
Not specified, D/N*
Sex with hepatitis positive
partner
Yes
Not specified, D/N*
Sex with HIV-positive partner
Yes
Not specified, D/N*
Sex with blood transfusion
recipient
Yes
Not specified, D/N*

60 (40.3)

119 (62.6)

136 (73.1)

574 (75.4)

78 (52.4)

21 (26.9)

33 (22.3)

5 (3.4)

7 (4.7)
20 (13.4)

7 (3.7)

2 (28.6)

28 (14.7)

6 (3.2)

18 (9.5)
19 (10.0)

2 (1.1)

0 (0.0)

45 (24.2)

4 (2.2)

49 (26.3)
17 (9.1)

2 (0.3)

1 (50.0)

53 (7.0)

9 (1.2)

15 (2.0)
26 (3.4)

4 (2.7)
17 (11.4)

39 (26.2)
19 (12.8)

8 (4.2)
26 (13.7)

2 (1.1)
5 (2.6)

12 (6.5)
13 (7.0)

1 (0.5)
2 (1.1)

5 (0.7)
18 (2.4)

0 (0.0)
9 (1.2)

1 (0.7)
20 (13.4)

4 (2.1)
15 (7.9)

10 (5.4)
18 (9.7)

26 (3.4)
46 (6.0)

28

Appendix 2 Table 1: Cont’d

HIV cases

HBV cases

HCV cases

False-positives
controls
n= 825 (%)

Females
Number of male sexual
partners, median (IQR)
Lifetime
Last 5 years
Number of female sexual
partners, median (IQR)
Lifetime
Last 5 years
Sex with MSM, ever
Yes
Monogamous, last 12 months
Yes
Male sexual partner, last 12
months
Yes
Used condom, always†
Yes
Sexually transmitted disease
Yes
Sex for money or drugs
Yes
Sex with injecting drug user
Yes
Not specified, D/N*
Sex with hepatitis positive
partner
Yes
Not specified, D/N*
Sex with HIV-positive partner
Yes
Not specified, D/N*
Sex with blood transfusion
recipient
Yes
Not specified, D/N*

n= 47 (%)

n= 102 (%)

n= 130 (%)

10 (4-15)
3 (1-5)

3 (1-10)
1 (1-2)

9 (4-20)
1 (1-2)

4 (1-7)
1 (1-1)

0 (0-1)
0 (0-0)

3 (6.4)

28 (59.6)

0 (0-0)
0 (0-0)

3 (2.9)

71 (69.6)

0 (0-0)
0 (0-0)

4 (3.1)

86 (66.2)

0 (0-0)
0 (0-0)

11 (1.3)

653 (79.2)

43 (91.5)
76 (74.5)

6 (14.0) 13 (17.1)

17 (36.2)
13 (12.8)

10 (21.3)
4 (3.9)

6 (12.8)
10 (9.8)
6 (12.8)
5 (4.9)

91 (70.0)

9 (9.9)

48 (36.9)

12 (9.2)

60 (46.2)
9 (6.9)

676 (81.9)

92 (13.6)

106 (12.9)

0 (0.0)

19 (2.3)
32 (3.9)

3 (6.4)
3 (6.4)

13 (27.7)
5 (10.6)

6 (5.9)
11 (10.8)

1 (1.0)
1 (1.0)

19 (14.6)
8 (6.2)

0 (0.0)
1 (0.8)

15 (1.8)
21 (2.6)

3 (0.4)
13 (1.6)

1 (2.1)
3 (6.4)

6 (5.9)
8 (7.8)

9 (6.9)
12 (9.2)

41 (5.0)
39 (4.7)

29

Appendix 2 Table 1: Cont’d

HIV cases

HBV cases

HCV cases

False-positives
controls
n= 316 (%)
n= 1,587 (%)

Both sexes, lifetime (ever)
n= 196 (%) n= 292 (%)
Other exposures

Injected illegal drugs, steroid

or vitamins
Yes
6 (3.1)
14 (4.8) 116 (36.7)
6 (0.4)
Any illegal drug use (non

injecting)
Yes
48 (24.5)
59 (20.2) 197 (62.3)
193 (12.2)
Tattoo or body piercing‡

Yes
128 (65.3) 124 (42.5) 218 (69.0)
671 (42.3)
Jail, prison, detention, shelter

or group home (3 nights or
more)
Yes
47 (24.0)
54 (18.5) 181 (57.3)
83 (5.2)
Blood transfusion

Yes
5 (2.6)
20 (6.9)
57 (18.0)
105 (6.6)
Medical or dental exposure§

Yes
166 (84.7) 235 (80.5) 308 (97.5)
1,477 (93.1)
HCV/HBV infected member in

the household
Yes
3 (1.5)
44 (15.1)
37 (11.7)
30 (1.9)
Family/self living abroad or

immigrated to the US
Yes
21 (10.7) 149 (51.0)
13 (4.1)
88 (5.6)
* Not specified, D/N is included as a category when ≥10% of cases or controls did not
respond or selected “don’t know” in response for this topic
†Always used condom with male sexual partners if had one or more male partners in the last
12 months
‡ Tattoo or body piercing or 3+ ear piercings
§ Includes any IM/IV injections, tissue or organ transplant, endoscopy, colonoscopy, dental
injection, acupuncture, needle stick injury or body fluid exposure ever

30

Appendix 3 – TTIMS Study Information Mailer for Cases (English version)

Research Study Invitation
TEMPLATE TO BE MODIFIED FOR LOCAL USE [Text in Brackets Requires Local Information]

We want to invite you to participate in a research study with [Blood Systems, Inc]. The study can be
done in person or over the telephone and takes about 45 minutes of your time. The following is a
description of the research study.

If you choose to participate and complete the interview you will receive $100 for your time. This will be
mailed to your home address after you complete the study.

This study is being conducted at four U.S. blood centers: the American Red Cross (ARC), Blood Systems,
Inc. (BSI), New York Blood Center (NYBC), and OneBlood in order to obtain a nationwide understanding
of risk factors for donating virus positive blood. The goal of the study is to identify self-reported risk
factors for donations that test positive for one of three possible viruses, human immunodeficiency virus
(HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). The study protects your identity because
the information submitted to the coordinating center will not include your name or other personally
identifying information.

This project is being funded by the US Food and Drug Administration (FDA) and the National Heart Lung
and Blood Institute of the National Institutes of Health.

What will happen with the answers I give during the interview?

You will be asked about known risk factors for HIV, HBV, and/or HCV. Each virus is spread in different
ways and you may not have had any of the risk factors that we ask about. Your responses will be
grouped with other donors who complete the interview. The study will determine how common
different risk factors are and will report summary measures on patterns of risk factors in all of the
donors that tested positive for the same virus.
If you tell us something during the interview that would have made you ineligible to donate, we will
have to add this to your donor record and this may lead to deferral from future blood donation.
However, there will be no other repercussions if the answers you give now are different than those you
gave when you donated.
How will the privacy of your responses be protected?

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the US
Department of Health and Human Services.
What is a Certificate of Confidentiality?
With a Certificate of Confidentiality, the researchers cannot be forced to disclose information that may
identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. The researchers will use the Certificate to resist any demands for
information that would identify you, except as explained below.
31

The Certificate cannot be used to resist a demand for information from personnel of the United States
Government that is used for auditing or evaluation of federally funded projects.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your
family from voluntarily releasing information about yourself or your involvement in this research. If an
insurer, employer, or other person obtains your written consent to receive research information, then
the researchers may not use the Certificate to withhold that information.
The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without
your consent, information that would identify you as a participant in the research project under specific
circumstances. For example, we will voluntarily disclose information about incidents such as intent to
hurt yourself or others.
Who can answer my questions about the study?
Your participation in the study is voluntary and you may decide you do not want your interview
responses included. If you have questions about the study or you want to have your interview responses
excluded at any time, you may call [Dr. Brian Custer at Blood Systems Research Institute at (415) 9010756].

If you have any questions about the testing results from your blood donation please call [Donor
Counseling and Notification Services at (800) 289-4923 or Dr. Hany Kamel at Blood Systems
headquarters at (480) 675-5659].

If you have any questions about your rights as a research participant in this study, please call the
[University of California San Francisco, Committee on Human Research, which is also known as an
Institutional Review Board (a group of people who review the research to protect your rights) at 415476-1814].

How do I join the study?
Simply call [(800) 289-4923] and one of our specially trained counselors will be happy to enroll you in
the study. If we do not hear from you we will likely give you a call to give you a chance to enroll.

32

Appendix 4 – TTIMS Study Information Mailer for Cases (Spanish version)

To Be Added

33

Appendix 5 – TTIMS Study Information Mailer for Controls (English version)

Research Study Invitation
TEMPLATE TO BE MODIFIED FOR LOCAL USE [Text in Brackets Requires Local Information]

We want to invite you to participate in a research study with [Blood Systems Inc.] The study can be
done in person or over the telephone and takes less than 45 minutes of your time. The following is a
description of the research study.

If you choose to participate and complete the interview you will receive $100 for your time. This will be
mailed to your home address after you complete the study.

This study is being conducted at four U.S. blood centers: the American Red Cross (ARC), Blood Systems,
Inc. (BSI), New York Blood Center (NYBC), and OneBlood in order to obtain a nationwide understanding
of risk factors for donating virus positive blood. The goal of the study is to identify self-reported risk
factors for donations that test positive for one of three possible viruses, human immunodeficiency virus
(HIV), hepatitis B virus (HBV), and/or hepatitis C virus (HCV). We will also be comparing responses from
donors who tested confirmed positive to donors, like you, who tested unconfirmed (false positive) to
find out if risk factors are different between these two groups of donors. The study protects your
identity because the information submitted to the coordinating center will not include your name or
other personally identifying information.

This project is being funded by the US Food and Drug Administration (FDA) and the National Heart Lung
and Blood Institute of the National Institutes of Health.

What will happen with the answers I give during the interview?

You will be asked about known risk factors for HIV, HBV, and/or HCV. Each virus is spread in different
ways and you may not have had any of the risk factors that we ask about. Your responses will be
grouped with other donors who complete the interview. The study will determine how common
different risk factors are and will report summary measures on patterns of risk factors in all of the
donors that tested positive for the same virus compared to donors who tested false positive.
If you tell us something during the interview that would have made you ineligible to donate, we will
have to add this to your donor record and this may lead to deferral from future blood donation.
However there will be no other repercussions if the answers you give now are different than those you
gave when you donated.
How will the privacy of your responses be protected?

To help us protect your privacy, we have obtained a Certificate of Confidentiality from the US
Department of Health and Human Services.
What is a Certificate of Confidentiality?
With a Certificate of Confidentiality, the researchers cannot be forced to disclose information that may
identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative,
legislative, or other proceedings. The researchers will use the Certificate to resist any demands for
34

information that would identify you, except as explained below.
The Certificate cannot be used to resist a demand for information from personnel of the United States
Government that is used for auditing or evaluation of federally funded projects.
You should understand that a Certificate of Confidentiality does not prevent you or a member of your
family from voluntarily releasing information about yourself or your involvement in this research. If an
insurer, employer, or other person obtains your written consent to receive research information, then
the researchers may not use the Certificate to withhold that information.
The Certificate of Confidentiality does not prevent the researchers from disclosing voluntarily, without
your consent, information that would identify you as a participant in the research project under specific
circumstances. For example, we will voluntarily disclose information about incidents such as an intent to
hurt yourself or others.
Who can answer my questions about the study?
Your participation in the study is voluntary and you may decide you do not want your interview
responses included. If you have questions about the study or you want to have your interview responses
excluded at any time, you may call [Dr. Brian Custer at Blood Systems Research Institute at (415) 9010756].

If you have any questions about the testing results from your blood donation please call [Donor
Counseling and Notification Services at (800) 289-4923 or Dr. Hany Kamel at Blood Systems
headquarters at (480) 675-5659].

If you have any questions about your rights as a research participant in this study, please call the
[University of California San Francisco, Committee on Human Research, which is also known as an
Institutional Review Board (a group of people who review the research to protect your rights) at 415476-1814].

How do I join the study?
Simply call [(800) 289-4923] and one of our specially trained counselors will be happy to enroll you in
the study. If we do not hear from you we will likely give you a call to give you a chance to enroll.

35

Appendix 6 – TTIMS Study Information Mailer for Controls (Spanish version)

To Be Added

36

Appendix 7 – Study Management System Core Content

A. DONATION DATA

Donation Identification Number (DIN): _________________________

Donor Identification Number (Donor ID): _______________________

Blood Collection Center: __________________________

Center Code: ________

Donation Date: Day _____ Month _____ Year _____

Donor Zip code of Residence: _________________

B. TESTING RESULTS

Please identify the virus and the confirmed test results from blood donation testing. Please note, all
HIV positive donors are eligible for interview. HCV NAT only or HBV NAT only confirmed-positive
donors are eligible for interview. Donors eligible for interview as controls include those serology
only false positive for HIV and/or HBV.

Confirmed Positive:
Virus: o HIV

Markers:
o Anti HIV -1, -2

o HIV NAT

If available:

o HIV-1 o HIV -2

o HCV

o HCV NAT

o Anti-HBc

Markers:
o Anti-HCV

o HBV
Markers:
o HBsAg

o HBV NAT

Unconfirmed (False) Positive:

o anti-HIV false positive
o HBsAg false positive
37

C. RECRUITMENT

The date and method of each attempt to contact the donor and the results of that attempt will be
recorded using this form.

D. PLASMA UNIT TRACKING

The status of plasma unit, retention tube, and testing lab residual sample retrieval will be
documented using this form. Entries include whether retrieval was necessary, successful, and date
shipped to CTS or LRCC.

E. SPECIAL SAMPLE COLLECTION AND TRACKING

If there is a need for additional sample collection, the status (successful/date shipped to CTS or
LRCC) will be tracked using this form.

38

Appendix 8 – TTIMS Risk Factor Questionnaire (English version)

OMB Control Number: XXXX-XXXX
OMB Clearance Expiration Date: MM-DD-YYYY

SECTION A - DONATION DATA AND VERBAL CONSENT

Notes to interviewer:
1. Administer this survey as early as possible after the date that disease and marker testing,
including confirmation testing, is completed for the donation.
2. Review the infection marker testing results before contacting the donor.
3. Complete the Donation Data section before contacting the donor.
4. Be sure to properly identify the donor according to standard operational procedures
5. When reading the possible answers to the donor, do not say “ Don’t know” or “Refuse to
answer”
DONATION DATA

Donation Identification Number (DIN): _________________________
Donor Identification Number (Donor ID): _______________________
Blood Collection Center: __________________________
Center Code: ________
Donation Date: Day _____ Month _____ Year _____
Donor Type (select one): ¡ Case ¡ Control
Date of Interview: Day____ Month _____ Year ____
Interviewer Initials: ______________

Interview Language (select one): ¡ English ¡ Spanish

VERBAL CONSENT – PLEASE READ THE FOLLOWING TO THE DONOR:

I am asking you to be part of a research study about risk factors for infectious diseases in blood donors.
The study is being done by [Your Organization], other blood centers, the US Food and Drug
Administration, and the National Institutes of Health, National Heart Lung and Blood Institute.
FOR CONFIRMED POSITIVES: I am contacting you because testing on your donation confirmed-positive
for a viral infection the last time you donated blood. If you agree to participate, I will ask you questions
about possible ways you could have gotten infected.
FOR FALSE POSITIVES: I am contacting you because your recent donation tested unconfirmed or false
positive. If you agree to participate, I will ask you questions about risk factors for viral infections so we
can compare answers from false positive donors, like you, to answers that true positive donors give on
the same questions.
39

The interview should take no more than 45 minutes. Your participation is voluntary and you may refuse to
answer any question. Some of the questions are about private matters such as sexual experiences and
drug use. Our purpose in asking these questions is to improve the safety of donated blood. If you tell us
something during the interview that would have made you ineligible to donate, I will have to add
this to your donor record and this may lead to deferral from future blood donation. However, there
will be no consequences if the answers you give now are different than those you gave when you
donated blood.
We will keep your responses confidential. To help us protect your privacy, we have obtained a
Certificate of Confidentiality from the US Department of Health and Human Services. With this
Certificate, the researchers cannot be forced to disclose information that may identify you. The risk
of participating in this study is if the information you give is not kept confidential. However no
information that identifies you by name will be entered into the database, only the answers to these
questions. There is no direct benefit to you of participation other than the knowledge that you are
helping efforts to maintain a safe blood supply by allowing us to understand risks and motivations of
blood donors.
If you have any questions, feel free to ask me now. You may also call XXX-XXXX. Do you have any
questions before we begin?

Do you agree to participate in this study?
¡ Yes (If YES, verbal consent obtained)
¡ No

[For printed record maintained at blood center]

Signature of Interviewer:

____________________________________ Date: __________________

40

SECTION B – DONOR DEMOGRAPHIC DATA

(Please read the following:) First, I will ask you some questions about you and about blood
donation. I remind you that your answers will be kept confidential.

1. What sex do you consider yourself to be?
¡ Male
¡ Female
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

2. What sex were you assigned at birth?
¡ Male
¡ Female
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

3. What is your birth date?
Day ____ Month ____ Year ____
¡ (Don’t know)
¡ (Refuse to answer)

4. What is your country of birth?
¡ USA
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

5. At the time of your last blood donation, what was the highest level of education you
had completed?
¡ Never been to school
¡ Elementary school
¡ Junior high school or middle school
¡ High school
¡ College or technical school
¡ Graduate school or professional degree
¡ (Don’t know)
¡ (Refuse to answer)

6. Are you of Hispanic, Latino, or Spanish origin?
¡ Yes
41

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

7. What is your race? (Please read the following:) Federal policy defines “Hispanic” not as
a race, but as an ethnicity. Hispanics can be of any race. [MARK ALL THAT APPLY]
¡ White
¡ Black or African American
¡ Asian
¡ American Indian or Alaska Native
¡ Native Hawaiian or other Pacific Islander
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

8. At the time of your last blood donation, what was your occupation? [Interviewer,
please ask as an open-ended question, then select the most applicable option below]
¡ Agriculture, Forestry, Fishing, Hunting, Mining, Quarrying, Oil and Gas Extraction
¡ Construction and Manufacturing
¡ Wholesale and Retail Trade
¡ Transportation, Warehousing, and Utilities
¡ Information Services (e.g. tv, film, radio, news, library, publishing)
¡ Finance, Insurance, Real Estate, Rental, Leasing
¡ Professional, Scientific, and Technical Services
¡ Management and Administrative Support
¡ Educational Service
¡ Healthcare and Social Assistance
¡ Arts, Entertainment, and Recreation
¡ Accommodation and Food Services
¡ Public Administration (i.e. Government)
¡ Military
¡ Retired
¡ Disabled
¡ Unemployed
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

9. At the time of your last donation, what was your annual household income from all
sources? [Interview, please read all numerical answer choices]
¡ Less than $10,000
¡ $10,000 to less than $30,000
42

¡
¡
¡
¡
¡
¡

$30,000 to less than $50,000
$50,000 to less than $75,000
$75,000 to less than $100,000
$100,000 or more
(Don’t know)
(Refuse to answer)

10.
¡
¡
¡
¡
¡
¡
¡

At the time of your last donation, what was your marital status?
Single, never married SKIP TO QUESTION 12
Living together, but not legally married
Married
Separated or divorced
Widowed SKIP TO QUESTION 12
(Don’t Know) SKIP TO QUESTION 12
(Refuse to answer) SKIP TO QUESTION 12

11. At the time of your last donation if you were married or living with a partner, what was
the gender of this person?
¡ Male
¡ Female
¡ Other (SPECIFY) ____________________________________
¡ (Don’t know)
¡ (Refuse to answer)

12.
¡
¡
¡
¡
¡
¡

Which of the following best represents how you think of yourself?
Straight/heterosexual
Bisexual
Gay/lesbian/homosexual
Something else
(Don't know)
(Refuse to answer)

13. Have you ever been vaccinated against hepatitis B virus?
¡ Yes
13.1 Were you vaccinated as an….?
¡ Infant
¡ Child
¡ Adult
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

43

14. Before your last donation did you ever take PRE-exposure prophylaxis, or PrEP?
[Interviewer, please read the following:] PrEP is antiviral medication taken daily for
months or years to reduce a person’s chance of getting HIV.
¡ Yes
¡ No SKIP TO QUESTION 16
¡ (Don’t know)
¡ (Refuse to answer)

15. In the month before your last blood donation, were you taking PRE-exposure
prophylaxis, or PrEP?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

16. Before your last donation did you ever take POST-exposure prophylaxis, or PEP?
[Interviewer, please read the following:] PEP is antiviral medication taken daily for 28
days after a person’ has had a single high-risk exposure to HIV.
¡ Yes
¡ No SKIP TO QUESTION 18 for HIV positive donors, otherwise skip to Question 19
¡ (Don’t know)
¡ (Refuse to answer)

17. In the month before your last blood donation, were you taking POST-exposure
prophylaxis, or PEP?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

18. [For HIV confirmed-positive donors only] Did you know you were infected with HIV
before you donated blood?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

19. Before your last donation, did you ever take anti-retroviral therapy for HIV infection?
¡ Yes
¡ No SKIP TO QUESTION 21
¡ (Don’t know)
¡ (Refuse to answer)

20. In the month before your blood donation, were you taking anti-retroviral therapy for
HIV infection?
¡ Yes
44

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

21. Before your last blood donation, did you do any activities that you think may have put
you at risk for an HIV infection or hepatitis infection?
¡ Yes
21.1 What was the activity or activities? [Interviewer, please ask as an open-ended
question, then select the most applicable option(s) below:]
¡ Heterosexual contact
¡ Homosexual contact
¡ Unsafe sexual contact (did not use condoms or other protective barriers)
¡ Sexual contact, not specified
¡ IDU
¡ Medical/Dental procedure
¡ Accidental needle stick
¡ Tattoo/Piercing
¡ Blood transfusion
¡ From mother at birth
¡ Non-sexual contact (work/family exposure)
¡ Travel or living in a foreign country
¡ Other (SPECIFY)________________
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

22. Can you specify the date when you think you might have got infected?
¡ Yes
22.1 Month_____ Year ______
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

23. At the time of your last donation were you aware that the activity you thought might
be the reason for your infection could place you at a higher risk for infection?
¡ Yes
23.1 How did you find out the activity could place you at higher risk for infection?
[Interviewer, please ask as an open-ended question, then select the most
applicable option below:]
¡ Healthcare provider
¡ Blood center
¡ Internet
¡ Friends
¡ Other (SPECIFY)________________
45

¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

24. Before your most recent donation had you previously donated at this or any other
blood or plasma center or blood drive? [IF YES, MARK ALL THAT APPLY]
¡ Yes
24.1 Where did you donate?
¡ This blood center
¡ Another blood center
¡ At a plasma center where I was paid for donating
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

25. Please tell me whether any of the following reasons or factors contributed to your
decision to donate blood. For each statement, please answer yes or no.
[READ SLOWLY AND MARK AN ANSWER FOR EACH]

a. I wanted to donate blood to help someone in need
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

b. In response to a TV or radio campaign, a phone call, or letter from blood bank
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

c. I was encouraged or pressured by family, friends, coworkers, or by someone at a blood
drive
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

d. I wanted to get my test results for my blood
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

e. I wanted to get the incentives for donating that the blood bank was offering
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

f. I donated to help others after a natural or man-made disaster or tragedy occurred
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

26. Is there any other reason why you came to the blood center?
¡ Yes (SPECIFY) ____________________________________
¡ No
¡ (Don’t know)
46

¡ (Refuse to answer)

27. Did any of the following factors influence your decision to come to the blood center?
For each statement, please answer yes or no.
[READ SLOWLY AND MARK AN ANSWER FOR EACH]

a. Blood center testing is confidential
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

b. Blood center testing is more accurate than at other test sites
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

c. Blood center testing is free
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

d. I think that the tests would identify any problem with my blood
¡ Yes ¡ No ¡ (Don’t know) ¡ (Refuse to answer)

28. Outside of blood donation, have you previously been tested for HIV?
¡ Yes
28.1 When was the last time you were tested for HIV?
Month_____ Year ______
¡ (Don’t know)
¡ (Refuse to answer)
28.2 What was the result of the test?
¡ Positive
¡ Negative
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

29. Outside of blood donation, have you previously been tested for HBV?
¡ Yes
29.1 When was the last time you were tested for HBV?
Month_____ Year ______
¡ (Don’t know)
¡ (Refuse to answer)

29.2 What was the result of the test?
¡ Positive
¡ Negative
¡ (Don’t know)
¡ (Refuse to answer)
47

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

30. Outside of blood donation, have you previously been tested for HCV?
¡ Yes
30.1 When was the last time you were tested for HCV?
Month_____ Year ______
¡ (Don’t know)
¡ (Refuse to answer)

30.2 What was the result of the test?
¡ Positive
¡ Negative
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

48

SECTION C – RISK FACTORS ASSESSMENT – PART I

(Please read the following:) In this next section, I will ask you some questions about
behaviors you may or may not have engaged in that can increase the risk of infection. Some
people may have had many different experiences while others have not. I am asking you for
this information because the data could help improve the safety of the blood supply. I
remind you that your answers will be kept confidential.

For the next few questions unless stated otherwise the term “sex” refer to any of the
following activities, whether or not a condom or other protection was used:
1. Vaginal Sex (contact between penis and vagina)
2. Oral Sex (mouth or tongue on someone’s vagina, penis, or anus)
3. Anal Sex (contact between penis and anus)

31. Using these definitions of sex, in the 12 months before your last donation did you have
sex?
¡ Yes
¡ No SKIP TO QUESTION 34
¡ (Don’t know)
¡ (Refuse to answer)

32. In the 12 months before your last donation did you have sex with only one partner?
¡ Yes
¡ No SKIP TO QUESTION 34
¡ (Don’t know)
¡ (Refuse to answer)

33. To the best of your knowledge, in the 12 months before your last donation did your
partner have sex with only you?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

Now I am going to ask you about sexual partners and sexual contacts you have had over
different time periods in your life.

34. How many male sexual partners have you had in your lifetime? Please include both
ongoing partners and one-time encounters with men.
_________ IF NONE, SKIP TO QUESTION 39
¡ (Don’t know)
¡ (Refuse to answer)

35. In the 5 years before your last blood donation, how many male sexual partners did you
have? Please include both ongoing partners and one-time encounters with men.
_________
49

¡ (Don’t know)
¡ (Refuse to answer)

36. In the 12 months before your last blood donation, how many male sexual partners did
you have? Please include both ongoing partners and one-time encounters with men.
_________
¡ (Don’t know)
¡ (Refuse to answer)

37. For this question do not include oral sex. Regarding your male sexual partners and onetime encounters with men in the 12 months before your last blood donation if you had
vaginal or anal sex how often did you use condoms or protective barriers?
¡ Never
¡ Sometimes
¡ Always
¡ (Don’t know)
¡ (Refuse to answer)

38. Before your most recent blood donation, when was your last sexual contact with a
male?
Month __________ Year __________
¡ (Don’t know)
¡ (Refuse to answer)

39. How many female sexual partners have you had in your lifetime? Please include both
ongoing partners and one-time encounters with women.
_________ IF NONE, SKIP TO QUESTION 44
¡ (Don’t know)
¡ (Refuse to answer)

40. In the 5 years before your last blood donation, how many female sexual partners did
you have? Please include both ongoing partners and one-time encounters with women.
_________
¡ (Don’t know)
¡ (Refuse to answer)

41. In the 12 months before your last blood donation, how many female sexual partners
did you have? Please include both ongoing partners and one-time encounters with
women.
_________
¡ (Don’t know)
¡ (Refuse to answer)
50

42. For this question do not include oral sex. Regarding your female sexual partners and
one-time encounters with women in the 12 months before your last blood donation if
you had vaginal or anal sex how often did you use condoms or protective barriers?
¡ Never
¡ Sometimes
¡ Always
¡ (Don’t know)
¡ (Refuse to answer)

43. Before your most recent blood donation, when was your last sexual contact with a
female?
Month __________ Year __________
¡ (Don’t know)
¡ (Refuse to answer)

44. Before your last donation, did you ever have a sexually transmitted disease, also known
as a STD? Examples of STDs include gonorrhea, chlamydia, syphilis, genital herpes,
genital warts, and HPV.
¡ Yes
44.1 Can you tell me which STD?
¡ Gonorrhea
¡ Chlamydia
¡ Syphilis
¡ HPV
¡ Genital herpes
¡ Genital warts
¡ (Don’t know)
¡ (Refuse to answer)
¡ No SKIP TO QUESTION 46
¡ (Don’t know)
¡ (Refuse to answer)

45. In the 12 months before your last blood donation, did you have a STD? Examples of
STDs include gonorrhea, chlamydia, syphilis, genital herpes, genital warts, and HPV.
¡ Yes
45.1 Can you tell me which STD?
¡ Gonorrhea
¡ Chlamydia
¡ Syphilis
¡ HPV
¡ Genital herpes
¡ Genital warts
51

¡ (Don’t know)
¡ (Refuse to answer)

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

46. Before your last donation, did you ever inject drugs, steroids, or vitamins not
prescribed by a health care provider?
¡ Yes
¡ No SKIP TO QUESTION 50
¡ (Don’t know)
¡ (Refuse to answer)

47. In the 12 months before your last blood donation, did you inject drugs, steroids, or
vitamins not prescribed by a health care provider?
¡ Yes
47.1 Can you tell me what substance was or substances were injected? [MARK ALL
THAT APPLY]
¡ Heroine
¡ Cocaine
¡ Methamphetamine
¡ Other (SPECIFY)____________
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

48. Before your last donation, did you ever share needles or syringes with another person?
¡ Yes
¡ No SKIP TO QUESTION 50
¡ (Don’t know)
¡ (Refuse to answer)

49. In the 12 months before your last blood donation, did you share needles or syringes
with another person?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

50. Before your last donation, did you ever use any drugs that you did not inject, that is,
drugs that are smoked, snorted, inhaled, or taken orally? Please do not include the use
of marijuana when answering this question.
¡ Yes
¡ No SKIP TO QUESTION 52
52

¡ (Don’t know)
¡ (Refuse to answer)

51. In the 12 months before your last blood donation, did you use any drugs that you did
not inject, that is, drugs that are smoked, snorted, inhaled, or taken orally? Please do
not include the use of marijuana when answering this question.
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

52. Before your last donation did you ever intentionally engage in sex while “high” or
“drunk”?
¡ Yes
¡ No SKIP TO QUESTION 54
¡ (Don’t know)
¡ (Refuse to answer)

53. In the 12 months before your last blood donation, did you intentionally engage in sex
while “high” or “drunk”?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

54. Have you ever given or received money or drugs for sex?
¡ Yes
¡ No SKIP TO QUESTION 56
¡ (Don’t know)
¡ (Refuse to answer)

55. In the 12 months before your last blood donation, did you give or receive money or
drugs for sex?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

53

SECTION C – RISK FACTORS ASSESSMENT PART II

(Please read the following:) Now I am going to ask you about other risk factors or
behaviors that can increase the chances of infection. Please answer each question to the
best of your knowledge. I am asking you for this information because it could help to
improve the safety of the blood supply. I remind you that your answers will be confidential.

56. How many tattoos do you have on your body? (When answering this question please
include permanent cosmetics (lip, brow or eyeliner), which are applied in a similar way
as tattoos).
¡ 0 (No tattoos) SKIP TO QUESTION 59
¡ 1
¡ 2
¡ 3 or more
¡ (Don’t know)
¡ (Refuse to answer)

57. In the 12 months before your last blood donation, did you get a new tattoo or had one reapplied? (Again, when answering this question please include permanent cosmetics (lip,
brow or eyeliner), which are applied in a similar way as tattoos)
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

58. Where did you go to have your most recent tattoo(s) applied?
¡ Tattoo parlor
¡ Beauty salon
¡ At home or a friend’s house
¡ At a party or rave
¡ In jail, prison or a detention center
¡ (Don’t know)
¡ (Refuse to answer)

59.
¡
¡
¡
¡
¡
¡

In total, how many ear piercings do you have?
0 (No piercings) SKIP TO QUESTION 61
1
2
3 or more
(Don’t know)
(Refuse to answer)

60. In the 12 months before your last blood donation, did you get any new ear piercings?
¡ Yes
54

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

61. In total, how many body piercings do you have?
¡ 0 (No piercings) SKIP TO QUESTION 63
¡ 1
¡ 2
¡ 3 or more
¡ (Don’t know)
¡ (Refuse to answer)

62. In the 12 months before your last blood donation, did you get any new body piercings?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

63. Have you ever spent three or more nights in a row in any of the following? (MARK ALL
THAT APPLY)
¡ Jail or Prison
¡ Detention Center (For example, juvenile detention or inpatient treatment)
¡ A Shelter or Group Home
¡ None of the above SKIP TO QUESTION 66
¡ (Don’t know)
¡ (Refuse to answer)

64. In the 12 months before your last blood donation, did you spend three or more nights
in a row in jail, prison, a detention center, a shelter, or a group home?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

65. In total, how long did you spend in jail, prison, a detention center, a shelter, or a group
home?
¡ Less than 1 month
¡ 1 month to less than 6 months
¡ 6 months or more
¡ (Don’t know)
¡ (Refuse to answer)

55

SECTION C RISK FACTOR ASSESSMENT PART III – Sexual Partner Exposures

[Please read the following:] These next questions ask about the health and risk factors of
your current and previous sexual partners. While you may not know their exact medical
histories, please answer these questions to the best of your ability.

I will now remind you of the definition of sex for the purposes of this questionnaire. The
terms “sexual contact” and “sex” refer to any of the following activities, whether or not a
condom or other protection was used:
1. Vaginal Sex (contact between penis and vagina)
2. Oral Sex (mouth or tongue on someone’s vagina, penis, or anus)
3. Anal Sex (contact between penis and anus)

66. Have you ever had sex with anyone who has injected drugs, steroids or vitamins not
prescribed by a health care provider?
¡ Yes
¡ No SKIP TO QUESTION 68
¡ (Don’t know)
¡ (Refuse to answer)

67. In the 12 months before your last blood donation, did you have sex with anyone who
has injected drugs, steroids or vitamins not prescribed by a health care provider?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

68. Have you ever had sex with a male who has had sex with another male?
¡ Yes
¡ No SKIP TO QUESTION 70
¡ (Don’t know)
¡ (Refuse to answer)

69. In the 12 months before your last blood donation, did you have sex with a male who
has had sex with another male?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

70. Have you ever had sex with anyone who has tested positive for hepatitis?
¡ Yes
¡ No SKIP TO QUESTION 72
¡ (Don’t know)
¡ (Refuse to answer)

56

71. In the 12 months before your last blood donation, did you have sex with anyone who
has tested positive for hepatitis?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

72. Before your last donation, did you ever have sex with anyone who has tested positive
for HIV?
¡ Yes
¡ No SKIP TO QUESTION 74
¡ (Don’t know)
¡ (Refuse to answer)

73. In the 12 months before your last blood donation, did you have sex with anyone who
has tested positive for HIV?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

74. Have you ever had sex with anyone who has received a blood transfusion?
¡ Yes
¡ No SKIP TO QUESTION 76
¡ (Don’t know)
¡ (Refuse to answer)

75. In the 12 months before your last blood donation, did you have sex with anyone who
has received a blood transfusion?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

57

SECTION C RISK FACTOR ASSESSMENT PART IV – Medical and Other Exposures

[Please read the following:] This next set of questions asks about medical procedures you
may have undergone or accidents you may have experienced. I once again remind you that
your answers are confidential.

76. Have you ever received a blood transfusion?
¡ Yes
76.1 When was the last time you had a blood transfusion?
Month_____ Year _____
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

77. Have you ever received an organ or tissue transplant? Examples of tissues that are
commonly transplanted include bone, skin, corneas, heart valves, stem cells.
¡ Yes

77.1 What type of organ or tissue?
(SPECIFY) ____________________________
¡ (Don’t know)
¡ (Refuse to answer)

77.2 When was the last time you received a tissue or organ transplant?
Month _____ Year _____
¡ (Don’t know)
¡ (Refuse to answer)
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

78. Have you ever received acupuncture?
¡ Yes
¡ No SKIP TO QUESTION 80
¡ (Don’t know)
¡ (Refuse to answer)

79. In the 12 months before your last blood donation, did you receive acupuncture?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

58

80. Have you ever had a needle stick injury (accidentally been stuck by a needle or other
sharp instrument after it was used for providing medical care to someone else) or some
other unintentional needle stick?
¡ Yes
¡ No SKIP TO QUESTION 82
¡ (Don’t know)
¡ (Refuse to answer)

81. In the 12 months before your last blood donation, did you have a needle stick injury?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

82. Did you ever get someone else’s blood, body fluids, vomit, or feces splashed into your
eyes, mouth, or in an open skin wound?
¡ Yes
¡ No SKIP TO QUESTION 84
¡ (Don’t know)
¡ (Refuse to answer)

83. In the 12 months before your last blood donation, did you get someone else’s blood,
body fluids, vomit, or feces splashed into your eyes, mouth, or in an open skin wound?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

84. To the best of your knowledge, before your last donation was anyone living in your
household (including family, friends or roommates) infected with HIV, hepatitis B or
hepatitis C?
¡ Yes
84.1 Can you tell me which person(s) is/are/were infected?
[MARK ALL THAT APPLY]
¡ Mother
¡ Father
¡ Sister or brother
¡ Spouse or partner
¡ Child
¡ Another relative
¡ Roommate
¡ Friend
¡ (Don’t know)
¡ (Refuse to answer)
59

¡ No
¡ (Don’t know)
¡ (Refuse to answer)

85. Are you currently taking antiviral therapy?
¡ Yes
¡ No
¡ (Don’t know)
¡ (Refuse to answer)

END OF QUESTIONNAIRE

[Please Read] Thank you for taking the time to complete this questionnaire. If you have any
questions or concerns, you may ask me now. You can also contact Donor Counseling and
Notification Services for more information at (XXX) XXX-XXXX.

[Interviewer Comments: Please provide any additional comments or impressions about the risk
factors disclosed or not disclosed by the donor]
_________________________________________________________________________________
_________________________________________________________________________________
_________________________________________________________________________________

60

Appendix 9 – TTIMS Risk Factor Questionnaire (Spanish version)

To Be Added

61