Samhsa Mai Coc OMB Ss A 8.10.16

Minority AIDS Initiative–Continuum of Care (MAI-CoC) Interviews with Grantees Integrating Behavioral Health Treatment, Prevention, and HIV and Hepatitis Medical Care Services

Supporting Statement A

A. Justification

A.1. Circumstances of Information Collection

The Substance Abuse and Mental Health Services Administration (SAMHSA) is requesting reinstatement of approval from the Office of Management and Budget (OMB) to use a revised version of a previously OMB approved interview protocol. The reinstatement of the interview protocol will allow SAMHSA to conduct two rounds of in-person and virtual (telephone and/or webinar) site visits (initial interview and follow-up interview) with Minority AIDS Initiative–Continuum of Care (MAI-CoC) Grantees Integrating Behavioral Health Treatment, Prevention, and HIV and Hepatitis Medical Care Services during the period of reinstatement. This continuing project utilizes a revised version of the site visit interview guide approved under the Minority AIDS Initiative – Targeted Capacity Expansion (MAI-TCE) Grantees Integrating HIV Primary Care, Substance Abuse, and Behavioral Health Services (OMB No. 0930-0336; Expiration Date: 06/30/2016). The two rounds of interviews (initial and follow-up) target the collection of programmatic-level data (e.g., community context, organizational structure, and staffing and staff development, services and service model, outreach, referral and enrollment into services, services/ care coordination and integration and funding for integrated services) through one-on-one and group interviews (interviews with more than one grantee staff member) with grantees who are part of the MAI-CoC program. Data collected through interviews will occur within two years of OMB approval and support the cross-site evaluation. For the purposes of this request, the MAI-CoC Evaluation Site Visit Interview Guides (Attachments A and B) have been included for review.

The goal of the MAI-CoC project is to integrate behavioral health treatment, prevention, and HIV and hepatitis medical care services for racial/ethnic minority populations at high risk for behavioral health disorders who are also at high risk for or living with HIV and hepatitis. The program is primarily intended for substance use disorder treatment and community mental health providers to provide coordinated and integrated services through the collocation and/ or integration of behavioral health treatment and HIV and hepatitis medical care. Interviews conducted with MAI-CoC grantees during initial and follow-up site visits are an integral part of evaluation efforts to: (1) Assess the impact of the SAMHSA-funded HIV and hepatitis programs in: reducing behavioral health disorders and HIV and hepatitis infections; increasing access to substance use disorder and mental disorder treatment and care; improving behavioral health outcomes; and reducing HIV and hepatitis-related disparities; (2) Describe the different integrated behavioral health and medical program models; and (3) Determine which program types or models are most effective in improving behavioral health and clinical outcomes.

The MAI-CoC grant program is authorized under Sections 509 (Substance Abuse Treatment), 516 (Substance Abuse Prevention), and 520A (Mental Health Services) of the Public Health Service (PHS) Act, as amended. The grant program also addresses Healthy People 2020 Mental Health and Mental Disorders Topic Area HP 2020-MHMD and Substance Abuse Topic Area HP 2020-SA.

SAMHSA is requesting clearance to conduct two in-person or virtual site visits with each of the 34 MAI-CoC program grantees. These specifics of the interviews are reflected in our estimates of annualized burden. Currently, MAI-CoC grantees are entering the second year of implementing SAMHSA’s vision for integrated care in their communities.

SAMHSA will conduct one-on-one and group interviews with grantee staff who will provide information on their program’s integration of HIV and hepatitis medical and primary care into behavioral health services. The first round of site visits (initial) will focus on program implementation, with the second round (follow-up) focusing on updates and changes in programming since the initial visit. While participating in the evaluation is a condition of the grantees’ funding, participating in the interview process is voluntary. The MAI-CoC Evaluation Site Visit Interview Guides are designed to collect information about: development and changes in MAI-CoC grantee program operations, staffing, training and its structure, the community context surrounding program efforts, and changes that result from MAI-CoC activities; changes in the number or nature of partnerships and collaborations both internal and external to the MAI-CoC program grantee organization.

Plans for site visit interviews among MAI-CoC grantees are summarized in Exhibit 1 below. Interviews will be conducted either in-person or remotely via telephone and/or webinars.

Exhibit 1: Plan for Conducting the Site Visits
Site Visit Interview Guide and Purpose	Estimated Number and Type of Respondents	Estimated Timeline for Data Collection
Initial: to collect early program implementation data through 17 in-person and 17 virtual site visits	Number: Approximately 306 individuals (34 site visits with 9 participants per grantee) Types of respondents: Approximately 9 individuals from each program: 1 Project Director 1 Clinical Director 3 Direct service staff providers 1 Evaluator 2 Collaborating partners 1 other supportive staff to be identified	September – December 2016 or upon receipt of OMB approval (project year 2)
Follow-up: to collect end phase program implementation data through 17 in-person and 17 remote site visits	Number: Approximately 306 individuals (34 site visits with 9 participants per grantee) Types of respondents: Approximately 9 individuals from each program: 1 Project Director 1 Clinical Director 3 Direct service staff providers 1 Evaluator 2 Collaborating partners 1 other supportive staff to be identified	October 2017 – September 2018 during last 12 months of grantees’ final year of implementation (project year 3)

A.2. Purpose and Use of Information

The goals of the SAMHSA MAI-CoC program aim to:

• Increase HIV and hepatitis testing to identify behavioral health clients who are unaware of their HIV and hepatitis status;

• Increase diagnosis of HIV and hepatitis among behavioral health clients;

• Increase the number of clients who are linked to HIV and hepatitis medical care;

• Increase the number of behavioral health clients who are retrained in HIV and hepatitis medical care;

• Increase the number of behavioral health clients who are receiving antiretroviral therapy (ART)

• Improve the adherence to behavioral treatment and ART;

• Increase the number of behavioral health clients who have sustained viral suppression; and

• Increase adherence and retention in behavioral health (both substance use and mental disorders) treatment

Interviews with grantees during the initial visit and the follow-up visit will focus on program implementation and updates to progress with program implementation. The following questions provide a sample of the program-level questions that SAMHSA plans to ask during the site visits:

• Describe some of the unique socio-economic and cultural characteristics of the community in which your clinic/facility operates, and how these characteristics influence programming for the MAI-CoC project.

• Describe your overall organizational structure.

• Have there been any changes to your organizational structure since the last visit?

• Describe your MAI-CoC staffing structure.

• How does communication occur between behavioral health and primary care providers serving your MAI-CoC clients?

• Describe your MAI-CoC project outreach strategies.

• What changes have you made to your MAI-CoC services since the previous site visit?

• What staffing changes have occurred since the previous site visit? What were the reasons for these changes?

SAMHSA will use the information obtained through the site visits to:

• Assess the impact of the SAMHSA-funded HIV programs in: reducing behavioral health disorders and HIV infections; increasing access to substance use disorder and mental disorder treatment and care; improving behavioral and mental health outcomes; and reducing HIV-related disparities in four specific groups of grantees;

• Describe the different integrated behavioral health and medical program approaches;

• Determine which program types or approaches are most effective in improving behavioral health and clinical outcomes; and

• Support the cross-site evaluation, of which site interviews are one of three components of the data collected to assess program progress and outcomes.

SAMHSA is learning more about the feasibility of integrating HIV and hepatitis medical and primary care into behavioral health services. The site visit data will enable SAMHSA to learn more about what grantees are doing how they are doing it to promote SAMHSA’s overall goals for this program. In addition, the individual respondents will benefit from participating in the data collection process. The data that are obtained will allow grantees to learn from other grantees, inform strategies for service improvement, and assist SAMHSA in providing appropriate technical assistance to grantees, as necessary.

A.3. Use of Information Technology

The Site Visit Interviews (Initial and Follow-up) will be conducted in-person and through virtual interviews (phone and/or webinar). Site visit interview data will not be collected through the use of information technology.

A.4. Efforts to Identify Duplication

The overall evaluation strategy of the MAI-CoC utilizes four sources of data. However, only the MAI-CoC Evaluation Site Visit Interview Guides (Initial and Follow-up) will be addressed within this reinstatement request for OMB approval. Site visits will focus on qualitative program-level data that will contextualize the information obtained through the other data sources and will provide data that are not captured through other mechanisms.

The site visits are necessary because there is no source of current, complete information on the status of grantee program integration approaches. This data collection is project-specific.

A.5. Involvement of Small Entities

Information collection will not have a significant impact on small entities.

A.6. Consequences If Information Collected Less Frequently

The information provided through the site visits will be vital to advance the understanding of the activities of grantees. Site visits will be conducted twice throughout the life of the project with each grantee. Without collecting this data, SAMHSA will not be able to identify progress in the implementation and the intermediate and long-term outcomes of the funding.

A.7. Consistency with the Guidelines in 5 CFR 1320.5(d)(2)

The collection of information fully complies with the guidelines in 5 CFR 1320.5(d)(2).

A.8. Consultation Outside the Agency

A Federal Register Notice was published on June 8, 2016 (Volume 81, page 36939) which solicited comments on this data collection. No comments were received.

The interview guides developed for this effort are revised versions of the guide developed under SAMHSA’s previous evaluation of the MAI-TCE 11 Cities program (2011- 2014). Similar to the site visits proposed with MAI-CoC grantees, site visits were conducted with all 11 Cities grantees to gather contextual qualitative data to inform the process and outcome evaluation. Under the 11-Cities program, the guide was pretested with three grantees who provided valuable input into its development and implementation. The lessons learned with this experience have influenced the development of the guide for MAI-CoC grantees in terms of the questions posed, who to target for interviewing, and, the approximate length of time required to complete the interviews. SAMHSA plans to pretest the present site visit interview guide to refine this data collection tool with up to three MAI CoC grantees.

A.9. Payment to Respondents

No payments or gifts are planned to respondents for participating in the site visit.

A.10. Assurance of Confidentiality

Data will be obtained from various individuals involved in implementing the program, including the: Project Director; Clinical Director; direct service staff (e.g. clinician, case manager, outreach worker); Evaluator; collaborating partners; and other supportive staff to be identified.

Reporting to SAMHSA will likely associate particular program models with specific grantee programs. Therefore, the identities of the respondents will be easily recognized. However, the questions on program policies and practices and the information from respondents is part of their regular business knowledge and there are no questions of a personal nature, including opinions or the personal choices or behaviors of respondents. Thus, Abt’s IRB has deemed the proposed activities eligible for exemption as non-sensitive data collection with professional stakeholders.

A.11. Questions of a Sensitive Nature

There are no questions of a sensitive nature in the assessment form.

A.12. Estimates of Annualized Hour Burden

The total burden for the individual for site visit participation is estimated at two hours for the initial site visit and one hour for the follow-up visit. Time estimates are based on experience with similar instruments in other studies of comparable organizations. In addition, parts of the MAI-CoC Interview Guide were based on a previous SAMHSA OMB-approved interview guide that was pretested prior to use with the MAI-TCE grantees and then used for data collection (see Section A.8).

A.12.1. Number of Respondents, Frequency of Response, and Annual Hour Burden

Each Site Visit Interview Guide will have 306 respondents [Number of grantees = 34, Number of respondents per site = 9] and will require an average of two hours for the initial site visit in year two and one hour for the follow-up visit in year three for each respondent. The interviews will be conducted over one-day with different sections of the interview guide being utilized with different types of respondents. Interviews will occur with groups of respondents (more than one staff member at a time). In some cases one-on-one interviews will be conducted with key personnel.

A.12.2. Estimates of Annualized Cost to Respondents for the Hour Burdens

Exhibit 2 offers an estimate of reporting burden for a sample of 306 respondents to a 120-minute Initial Site Visit Interview and a Follow-up Site Visit Interview (Attachments A and B). Based on U.S. Government Bureau of Labor Statistics data, the hourly wage estimate of $43.74 is used.

Exhibit 2: Estimate of Annual Reporting Burden
Data Collection Tool	Number of Respondents	Responses per Respondent	Total Responses	Hours per Response	Total Burden Hours	Cost per Hour	Total Hours Cost
Initial Site Visit Interview Guide	306	1	306	2	612	$43.74	$26,768.88
Follow-up Site Visit Interview Guide	306	1	306	1	306	$43.74	$13,384.44
TOTAL	306		612		918		$40,153.32

A.13. Estimates of Annualized Cost Burden to Respondents

There is no capital/startup or operation and maintenance cost to respondents involved in collecting the information. Other than their time to complete the interview, there are no direct monetary costs to respondents.

A.14. Estimates of Annualized Cost to the Government

The total estimated cost to the Federal Government for the Site Visits with Grantees Integrating Behavioral Health Treatment, Prevention, and HIV Medical Care Services data collection activity is $134,813. This includes the labor cost for two persons to conduct 34 site interviews per interview round ($62,406.50) plus 5% of a GS-13 SAMHSA employee’s (project officer’s) time at $100,000 annual salary ($5,000).

A.15. Changes in Burden

Currently there are 156 total burden hours in the OMB inventory. SAMHSA is requesting 918 hours. This program change of an increase of 762 hours is due to the implementation of the revised interview guides for conducting two rounds of interviews with grantees (Initial and Follow-up) over two years.

A.16. Time Schedule, Publication and Analysis Plans

An overview of data collection activities is provided below:

• Year One: OMB submission and clearance.

• Year Two: Begin Initial Site Visits including site visit planning, conducting site visits, data cleaning, analysis, and data reporting.

• Year Three: Begin Follow-up site visits with MAI-CoC grantees.

• Year Four: Final data analysis and final reporting.

SAMHSA will use the site visit interview data to develop an understanding of the following MAI-CoC integrated primary and behavioral health care program key components:

• Community Context in which the grantee project operates

• Grantees’ organizational structure

• MAI-CoC staffing and staff development

• MAI-CoC populations of focus

• Programmatic and clinical services and service model, partnerships with other organizations

• Outreach, referral and enrollment into MAI-CoC grantee services and partners’ services

• Service/care coordination & integration with internal and external providers

• Staffing, sub-recipients & partnerships

• Data systems, client tracking & referrals

• Data sharing across partners, client and referrals tracking

• Data Submission Requirements

• Programmatic and Clinical Service Continuum and Delivery

• Funding for Integrated Services

Interview notes, field notes, and any secondary data obtained will be saved in an NVivo 9.0 Database designed for this study. Data coding will occur concurrently with data collection and the data will be integrated as codes in outcome analysis. The codes will aid in the identification of patterns of effective implementation of MAI-CoC goals across the sites.

SAMHSA will use the information collected to expand their understanding of the grantees’ progress with service implementation. Impressions gathered from visits with the 34 MAI-CoC grantees will be documented in internal reports and used to inform annual reporting. Over time, the data collected through site visits will provide SAMHSA, grantees, and their partners and other stakeholders with a clearer understanding of grantee service integration processes; program successes and challenges; and strategies for the replication of promising grantee programs.

A.17. Display of Expiration Date

The expiration date will be displayed.

A.18. Exceptions to Certification Statement

This submission describing data collection requests no exceptions to the Certificate for Paperwork Reduction Act (5 CFR 1320).

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