Explanation for Program Changes or Adjustments_04DEC2024

Explanation for Program Changes or Adjustments

There are three forms, Initial Clinical and Social Survey, Contact Tracing Survey, and Sexual Contact Interview, being changed as a part of this non substantive change request. These change requests includes minor revised language, formatting and rewording to align with inclusion criteria, and one additional question added to each form.

Details of each collection instrument are as follows:

ABCs:

This non-substantive change request includes minor proposed changes to 3 approved data collection tools (form/s) detailed below: 

Approved Forms: 

1. Initial Clinical and Social Survey

2. Contact Tracing Survey

3. Sexual Contact Interview

Initial Clinical and Social Survey Form

Type of Change 

Itemized Changes / Justification 

Impact to Burden 

Revision

During your initial illness – when you first got sick, what were your symptoms?

Justification: Added “when you first got sick” to clarify what was meant by initial illness. Since some individuals will be enrolled prospectively, the language was added to differentiate the illness (initial versus relapse) to correctly capture the information.

No change to burden 

Addition

When indoors, spent time in a place with screens or air conditioning  Always  Most of the time  Sometimes  Never  Don’t know

Justification: Added to more completely capture potential risk factors for being infected with Oropouche.  

No change to burden 

Contact Tracing Survey Form

Revision

Period of interest: date of illness onset travel through 6 weeks days after symptom onset, or date of interview, whichever is earliest

Justification: Updated period of interest to align with inclusion criteria; now date of illness onset rather than the date of return from travel. More clearly noted the timeframe for the interviewer by taking blank fields and reformatting into a table. 

Date of symptom onset:	through	Six weeks after symptom onset or date of interview (whichever is earliest):
(MM/DD/YY) ___/___/___		(MM/DD/YY) ___/___/___

No change to burden 

Revision 

Did you have sexual or intimate contact with anyone between the time you became ill [give date] through [end of period of interest]?

Justification: Aligned to the period of interest by updating to “became ill” rather than “returned from travel”. 

No change to burden 

Addition/Revision 

Did this partner travel with you before your illness?  Yes  No

[If partner traveled] Did they also get sick within two weeks of returning?  Yes → move on to next partner  No  Unknown

Justification: Removed the skip (move on to next partner) from the question of whether the partner traveled and added a question to verify if the partner also got sick within two weeks of travel, adding the skip here, to allow inclusion of sexual contact who traveled with the participant with Oropouche virus disease to be included if they got sick after the incubation period associated with their travel.

No change to burden 

Sexual Contact Interview Form

Revision

Before interview: visit this website to see which countries are listed as having recent human disease cases (as of 11/27/24: Bolivia, Brazil, Colombia, Cuba, Dominican Republic, Guyana, Panama, and Peru)

Justification: Based on updated epidemiology, revised list of countries with recent human disease cases to include Panama and updated the corresponding date.

No change to burden 

Revision

Date of first sexual encounter with index case:	through	2 weeks after last sexual encounter during the period of interest:
(MM/DD/YY) ___/___/___		(MM/DD/YY) ___/___/___

Justification: More clearly noted the timeframe for the interviewer by taking blank fields and reformatting into a table. 

No change to burden 

Addition/Revision

Did you travel to [LIST COUNTRIES WITH RECENT OROPOUCHE VIRUS DISEASE CASES] since January 1, 2023?  Yes  No

If yes, obtained dates of travel from (MM/DD/YY) ____/_____/_____ to _____/_____/_____ and location ________________________; if traveled to more than one location with recent Oropouche, record additional travel dates and location:______________________________________________

Justification: Removed the skip pattern (end interview) from the first question and added a question to capture the dates and locations of travel to allow sexual contact who traveled but might have been subsequently exposed through sex to Oropouche virus and develop disease more than 2 weeks after travel.

No change to burden 

Revision

 Yes, date of first symptoms (MM/DD/YY) ___/___/___  No

Justification: Added “date of first symptoms” to allow the interviewer to verify the timing of the symptoms relative to travel.

No change to burden