PrEP Provision for Ugandan Fisherfolk
Phase: NA
Conditions: HIV
Sponsor: RAND

Official Title: Pre-Exposure Prophylaxis (PrEP) Provision for Ugandan Fisherfolk (ID: 
R34MH119924) 
NCT05084716 
Study Protocol and Statistical Analysis Plan 
March 8, 2024 
 
 
 

Study Protocol: RAND HSPC Information Online (RHINO) Application 
Date application created:   2/21/2024 10:19 AM 
STUDY BASICS 
1. * 3.1  Title of study 
Evaluation of the Implementation of PrEP Provision for Ugandan Fisherfolk 
2. * 3.2 Brief summary or abstract. Note: this was populated from question 1.1c on the pre-
screener. Using this information please provide a brief summary or abstract of the 
study.  Describe its purposes, study methods (i.e., participants, procedures, data sources), and 
expected results. 
Please note that this is a transfer from RHINO 1.0, ID 2019-0571 
Worldwide, fisherfolk are at an exponentially higher risk for HIV than the general population in 
their regions. In Ugandan fisherfolk communities, HIV prevalence is estimated to be 15-40% - 
much higher than in the general Ugandan population, for which HIV prevalence is estimated to be 
5.9% among those aged 15-49. It is estimated that fisherfolk represent 5% of the population, and 
about 10% of the labor force is involved in the fisheries sector; fishing regions (lakes, rivers, etc.) 
cover about 20% of Uganda. Fisherfolk include fishermen and their families, people who support 
the fish trade business (e.g., fish vendors, boat off loaders), and commercial sex workers (CSWs) 
who live in fishing communities. A previous RAND study (led by Bogart) with Makerere 
University School of Public Health, and Mildmay Uganda tested home-based and event-based 
antiretroviral therapy (ART) distribution models. This study will build on the previous findings 
and apply them to the development and testing of two PrEP delivery models for high-risk HIV-
negative fisherfolk following HIV testing. 
We propose to explore the acceptability and feasibility of PrEP, and to develop and compare the 
implementation of two interventions to promote PrEP use among fisherfolk: community-based vs. 
healthcare facility-based PrEP provision. We will partner with the Ministry of Health throughout 
the project, regularly meeting with its PrEP Technical Working Group to discuss study results 
and determine next steps for policy and national implementation. 
The Specific Aims are: 
1. To conduct formative qualitative research to examine barriers to and facilitators of PrEP 
uptake, and to obtain input on acceptable PrEP messaging and provision, for fisherfolk 
communities on Lake Victoria, Uganda. 
2. To conduct a mixed-methods analysis comparing the implementation of community-based vs. 
healthcare facility-based PrEP provision for fisherfolk communities on Lake Victoria, Uganda. 
When this study was initially proposed, the intent was to purchase and supply PrEP to study 
participants as it was not widely used in the country as a whole, or in fishing communities. Since 
the study was funded, PrEP use has become more widespread in Uganda and is provided by 
Mildmay Uganda via a Ugandan Ministry of Health program. As a result, the study will no longer 
purchase and provide PrEP through the grant, and instead will evaluate enhancements (i.e., 
behavioral interventions) to the standard of care for providing PrEP in Ugandan fishing 
communities. 
3. 3.3  RAND Principal Investigator and Co-Principal Investigator: 
*
  
Principal Investigator: 
Laura Bogart (lbogart@rand.org) Refresher Course - Expires 
2/13/2025 
Co-Principal Investigator (if 
any): 

4.   
5. * 3.4 Does any key staff member have a financial interest related to this research? 
No 
6.  
7. * 3.5  Do you have a protocol, proposal, or project description to upload?  (If yes, you can 
upload the document below or at the end of this form in Part 7). 
  Yes No 
Protocol Documents: 
  Document 
Category 
Date Modified 
Document History 
 There are no items to display 
8. * 3.6  Has this project already had a scientific review-that is, a review of the adequacy of the 
study design?  Check all that apply. 
Yes - by funder's proposal review committee 
9. 3.7  Who is the intended audience for the results of this study?  Where and in what form 
will you disseminate results? 
* Who is the intended audience for the results of this study: 
Our findings will be important in informing researchers and key stakeholders, including 
healthcare providers and policymakers, about barriers to implementation and potential solutions 
to address barriers suggested by stakeholders. Throughout the study, we will meet with Ugandan 
Ministry of Health policymakers to keep them apprised of the study goals and preliminary and 
final results, and to obtain their input on the PrEP intervention protocols. Importantly, we will 
engage with policymakers prior to the pilot intervention, to discuss the qualitative results and 
together determine the pilot intervention protocol, and we will engage with them throughout the 
pilot intervention implementation, in order to discuss lessons learned, and the brainstorm about 
how any challenges can be addressed. 
* Where and in what form will you disseminate results? 
Following the analysis of the qualitative and quantitative data, we will develop a presentation and 
summary report that will be shared with the Ugandan Ministry of Health, with the goal of 
obtaining policymaker input into the interpretation of the results, as well as recommendations for 
policy based on the results.  
10. STUDY FUNDING SOURCES  
11. * 3.8 Indicate the primary source of funding whether or not the funding is coming directly 
to RAND as the prime contractor or grantee. That is, if funding from an agency is being 
channeled through another organization, check that agency. Check all that apply 
Selection 
Name 
D. 
National Institutes of Health (NIH) 

12.   
  
  
13. * 3.8d Specify the NIH institute: 
F. 
National Institute of Mental Health (NIMH) 
14.  
   
 
15. RESEARCH OVERVIEW - DATES 
 
The dates below should cover the entire project and all population-procedure study 
components.  Please provide the dates below based on your best estimates at this 
time.  These dates should be taken from the contract, grant, or statement of work when 
possible. 
 
Start Dates  
16. * 3.9  Project Start Date.  Grant and non-FFRDC research should use the award date as the 
project start date.  FFRDC research should use the date on which the project task number was 
opened.  Pick the best date you can and if necessary use the text field below to explain any 
uncertainties. Enter dates in the following format: mm/dd/yyyy. 
4/1/2020 
* 3.9a  Please explain any date uncertainties below, if applicable. 
 
17. * 3.10  Anticipated Data Acquisition Start Date.  (Note: this should include pilot/pretest 
activities).  Pick the best date you can and if necessary use the text field below to explain any 
uncertainties. Enter dates in the following format: mm/dd/yyyy. 
6/15/2020 
* 3.10a  Please explain any date uncertainties below, if applicable. 
 
18. End Dates 
 
* 3.11  Anticipated Data Acquisition End Date.  Pick the best date you can and if necessary use 
the text field below to explain any uncertainties. Enter dates in the following format: 
mm/dd/yyyy. 
11/30/2023 
* 3.11a  Please explain any date uncertainties below, if applicable. 
 
19. * 3.12  Project End Date.  Pick the best date you can and if necessary use the text field below to 
explain any uncertainties. Enter dates in the following format: mm/dd/yyyy. 
3/31/2024 
  
RESEARCH OVERVIEW - EXTERNAL ORGANIZATIONS COLLABORATING IN 
THE RESEARCH 

 
This section of the study form asks questions about other institutions that are participating 
in human subjects research for this study.  All institutions participating in the research 
must undergo human subjects review either by the institution's own institutional review 
board (IRB - the HSPC is RAND's IRB) or by deferring to the IRB of another institution 
(including RAND). 
* 3.13 Are there other institutions besides RAND involved in this study? 
  Yes No 
20. * 3.13a Are you suggesting that RAND should defer to another institution's IRB for this 
study? 
  Yes No  
* 3.13a1 Is RAND the only direct recipient of funding for this project? 
Yes 
21. * 3.13a3 Which institution is the prime contractor or grantee? 
RAND 
22. List each institution involved in any aspect of this study. Click the Add button below to add 
an institution and fill in all of the required information for that institution. Repeat for each 
institution. Check with each institution listed whether they have a Federalwide Assurance 
(FWA). 
External Organizations: 
Name 
Involved Activities 
FWA 
Available? 
Makerere University 
School of Public Health 
Obtaining informed consent 
Collecting data (surveys, interviews, focus groups, record 
abstraction, observations, biometric measurements, etc) 
Receiving identifiable person-level data 
Yes 
Mildmay Uganda 
Obtaining informed consent 
Collecting data (surveys, interviews, focus groups, record 
abstraction, observations, biometric measurements, etc) 
Receiving identifiable person-level data 
Yes 
University of Illinois 
Urbana Champagne 
Sharing responsibility for research design, data analysis, 
and/or interpreting and reporting results 
No 
23. * 3.13i How do you think IRB review should be conducted for this project? RAND HSPC 
will review your suggested approach and consult with you if needed to make a decision. 
By RAND HSPC as Single IRB/IRB of record 
24.  
25.  
26.  

27. Proprietary Data  
28. * 3.17  Could the research involve proprietary information (i.e., trade or business 
information that belongs to an organization)?  Note RAND has policies regarding the 
handling of proprietary information.  Please review the policies on the intranet page before 
acquiring any such information. 
 
Yes 
 No 
 Don't know 
30.  
31. Non-Disclosure Agreement  
32. * 3.18  Are you required to sign a Non-Disclosure Agreement?  Note:  All Non-disclosure 
Agreements need to be signed by RAND Contracts (Director, Financial Operations and not 
solely by a RAND employee or other Associate).  See link to finance staff page. 
 
Yes 
 No 
 Don't know 
34. Private Health Information (HIPAA)  
35. * 3.19 Will private health information (e.g., medical records, health-related administrative 
data, health insurance claims, pharmaceutical data) be acquired? 
Yes 
* 3.19a  Who will the private information be acquired from? Check all that apply 
Medical care provider/insurer (e.g., a doctor or other health care provider, 
hospital, insurance company, managed care company, or other covered 
entity under HIPAA) 
 
* 3.19b  Does all of the private information to be acquired for this research fall under 
HIPAA? 
 
Yes 
 No 
 Don't know 
36. Agreements for Obtaining Data  

37. * 3.20  Are you required to have one or more written Data Use Agreements to acquire data 
for this study?  Note:  All Data Use Agreements need to be signed by RAND Contracts 
(Director, Financial Operations) and not solely by a RAND employee or other 
Associate).  See link to finance staff page.   
Yes 
 No 
39.  
40. Restrictive Conditions to Acquire/Access Data  
41. * 3.21  Are any of the data to be acquired or accessed available only under certain 
restrictive conditions (e.g., the data provider requires signing of a data use agreement or 
requires expedited or full committee review by the HSPC before the data will be released to 
the study)? 
Yes 
 No 
 Don't know 
43.  
44. Vulnerable Populations  
45. * 3.22  Please indicate whether any of the following vulnerable populations will be 
intentionally and knowingly included in the research.  Check all that apply.  Click on a 
category to preview Findings that HSPC might need to make. 
G. Economically or educationally disadvantaged individuals 
46.   
47.   
48. * 3.23 Could children/minors be included in your sample either inadvertently or by 
chance?  Yes No  
49.            
50.   
51.  
  
  
  
  
  
52. Exclusion Criteria  
53. * 3.24  Are you going to intentionally exclude anyone from the study procedures because of 
gender, racial/ethnic group, or language fluency?  If Yes:  please explain by study 
procedure who you are going to intentionally exclude on the basis of gender, race/ethnic 
group, or language fluency and why.   

Yes 
 No 
55. * 3.24a  Comments: 
They must speak English or Luganda (the primary language in the intervention community) 
56. * 3.25  Are there additional criteria for excluding individuals from the study procedures 
that are not described above (such as minimum time in current job, specific health 
condition, cognitive impairment, literacy)?  If Yes:  please explain the additional criteria for 
excluding individuals from each procedure.   
Yes 
 No 
58. Deception in Research Procedures  
59. * 3.26  Does the research involve any form of deception or withholding of explicit 
information about the research project?  For example, this might include mystery shopping 
protocols or withholding of key information about the research purpose or other forms of 
deception.   
Yes 
 No 
61. Merging Data  
62. * 3.27  Do you plan to merge person-level secondary data with person-level data from other 
sources (e.g., other existing records, datasets, or interview data from this study)?  Note:  Do 
not include data that will only be used to contact participants but will not be retained in the 
study data.   
Yes 
 No 
64. * 3.27a  What other information will be merged with the person-level data? Note: This does 
not include data that would not be retained in the data file, such as name or telephone 
number. 
For those who signed a medical release form, medical records data will merged with data 
collected by Mildmay staff when offering PrEP to people who test HIV-negative, such as: gender, 
age, occupation, marital status, and residency status (permanent/transient or mobile, and if so, 
number of times away from the community in the past 3 months). 
65. * 3.27b  Will merging the data as described above, increase the likelihood that individuals in 
the dataset might be identifiable by inference (i.e., comparing details in the data with other 
information to deduce a subject's identity), whether or not you plan to identify them?   
Yes 

 No 
67. Data Identifiers and Links  
68. * 3.28  Will RAND (including RAND subcontractors) have the capability to link person-
level data to the participants using a link file, crosswalk, descrambling algorithm, or other 
unique identifiers (e.g., any other unique identifying number, characteristic, code, or 
information that can be used to identify an individual), even if you don't plan to link data 
identifiers?   
Yes 
 No 
70. * 3.29  Will any individuals in the dataset be identifiable by inference (i.e., comparing 
details in the data with other information to deduce a subject’s identity), even if you don't 
plan to do this?    
Yes 
 No 
72. * 3.28a  Please specify the other information that can be used to identify an individual. 
Participant names will only appear (1) on participant consent forms and medical release forms, 
which will be stored in locked file cabinets and are only accessible to Makerere and Mildmay 
study staff, and (2) on a master list for participant tracking, which links participants’ 
identification numbers to their names, telephone numbers, and addresses/landing site location. 
This master list will be password protected and kept in a locked room on a password-protected 
encrypted computer and in a locked file cabinet that is only accessible to Makerere and Mildmay 
study staff. Thus, only study staff in Uganda will be able to link participant names with code 
numbers. The master list will be destroyed following completion of data collection, after all data 
are cleaned and analyzed. Consequently, it will not be possible to determine the identity of 
respondents from any of the research material. 
73. Destroying Data Identifiers/Link File 
74. * 3.30  Will the data identifiers or link file obtained by the project ever be destroyed? 
Yes 
* 3.30a  When do you estimate the data identifiers or link files will be destroyed?  Pick the 
best date you can and if necessary use the text field below to explain any uncertainties.  Enter 
dates in the following format: mm/dd/yyyy. 
12/31/2024 
3.30b  Please explain any date uncertainties below, if applicable. 
The study papers are under review or being written in the next few months - we may destroy 
identifiers earlier  
 
 * 3.31  Where will the data identifiers and link file be stored? 
Participant names will only appear (1) on participant consent forms and medical release forms, 
which will be stored in locked file cabinets and are only accessible to Makerere and Mildmay 
study staff, and (2) on a master list for participant tracking, which links participants’ 
identification numbers to their names, telephone numbers, and addresses/landing site location. 
This master list will be password protected and kept in a locked room on a password-protected 

encrypted computer and in a locked file cabinet that is only accessible to Makerere and Mildmay 
study staff. Thus, only study staff in Uganda will be able to link participant names with code 
numbers. The master list will be destroyed following completion of data collection, after all data 
are cleaned and analyzed. Consequently, it will not be possible to determine the identity of 
respondents from any of the research material. 
75.  
2024-N0127 
View: RAND SF: Part 4A 
 
Part 4A: Research populations & procedures 
Tips for completing Populations and Procedures table. 
Introduction 
If your study has more than one population or procedure, then it has multiple components.  To help 
reviewers understand your study, on the next screen you will be asked to identify the components by 
associating a population with a procedure in a matrix.  Refer to how to structure populations and 
procedures to see examples of a multiple population-procedure component matrix and a single component 
matrix. 
Populations 
4.1       Think about the people involved in your study.  Are they discrete groups?  Is there one group that 
has one set of inclusion criteria that doesn’t apply to another group?  If so, you will need to specify 
multiple populations, depending on your study.  These populations and the procedures defined below will 
be used to form a matrix on the next page.  When identifying populations, think about the topics listed 
below and try to combine into one population participants that are very similar and separate into different 
populations participants that are very different. Topics covered in the population detail section 
include:  Pilot or pretest, inclusion/exclusion, recruitment activities, informed consent, and 
interventions.   Note:  If doing an intervention, it is not necessary to split a population into the 
control and intervention groups.   
1.  
* 4.1a Specify Populations – Click Add to list a population. To edit, click on the Update 
button. To delete, click the X. 
 
Population:  Please provide a brief descriptive label  to the subject population (e.g., 
physicians, students, parents). 
 
Stakeholders (healthcare providers, community leaders, Ministry of Health policymakers) 
Adherence supporters of HIV-negative fisherfolk 

HIV-negative fisherfolk 
 
[IF MORE POPULATIONS ARE NEEDED, GO BACK TO 4.1a.  OTHERWISE, GO TO 
4.2]  
2.  4.2       Now that you have named the target population(s), please list each research 
procedure you will use with each population. 
3. Earlier you listed the following research procedures for this study. Please review the list 
below and update it as needed: 
4.  
* 4.2a. Specify Procedures – Click Add to add a procedure. To edit click on the Update 
button. To delete, click the X while hovering over the procedure row. 
 
 
  
Procedure Type 
Procedure Name 
View 
C. Interviews/discussions 
Semi-structured interviews 
(Aim 2) 
View 
C. Interviews/discussions 
Semi-structured interviews 
(Aim 1) 
View 
I. Analysis of OTHER previously collected 
person-level data sets 
Medical Records 
View 
N. Social behavioral or other interventions 
Intervention (social behavioral 
component) 
 
[IF MORE PROCEDURES ARE NEEDED, GO BACK TO 4.2a.  OTHERWISE, GO TO 
4B]  
2024-N0127 
View: RAND SF: Part 4B 
Part 4B: Component selection 
Select the components (combinations of Populations and Procedures) that apply to your study 
below:  
1.   
Selection Components: 

Component 
# 
Population 
Procedure 
9 
Adherence supporters of HIV-negative fisherfolk 
Intervention (social 
behavioral component) 
6 
Adherence supporters of HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 2) 
15 
HIV-negative fisherfolk 
Intervention (clinical 
component) 
14 
HIV-negative fisherfolk 
Intervention (social 
behavioral component) 
13 
HIV-negative fisherfolk 
Medical Records 
12 
HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 1) 
11 
HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 2) 
2 
Stakeholders (healthcare providers, community 
leaders, Ministry of Health policymakers) 
Semi-structured interviews 
(Aim 1) 
1 
Stakeholders (healthcare providers, community 
leaders, Ministry of Health policymakers) 
Semi-structured interviews 
(Aim 2) 
   
2024-N0127 
View: RAND SF: Part 4C 
Part 4C: Population & procedure matrix 
SHOW   Instructions for how to link populations and procedures to identify the various components of 
your study. 
Please add the following information to the population-procedures matrix for each data collection 
component: 
 
Expected number of participants 
 
Expected start and end dates 
 
Current status [drop down menu] –filled out by project 
 
Ready to upload materials for HSPC approval now 
 
Not ready to submit materials for approval 
 
Other- Explain 
 
No longer plan to do this 

1.  
Component 
# 
Population 
Procedure 
Expected 
Number of 
Participants 
Expected 
Start Date 
Expected 
End Date 
Current 
Component 
Status 
Completion 
Status 
Approva
Status 
1 
Stakeholders 
(healthcare 
providers, 
community 
leaders, 
Ministry of 
Health 
policymakers) 
Semi-
structured 
interviews 
(Aim 2) 
30 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
2 
Stakeholders 
(healthcare 
providers, 
community 
leaders, 
Ministry of 
Health 
policymakers) 
Semi-
structured 
interviews 
(Aim 1) 
30 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
6 
Adherence 
supporters of 
HIV-negative 
fisherfolk 
Semi-
structured 
interviews 
(Aim 2) 
10 
4/19/2022 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
9 
Adherence 
supporters of 
HIV-negative 
fisherfolk 
Intervention 
(social 
behavioral 
component) 
10 
4/19/2022 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
11 
HIV-negative 
fisherfolk 
Semi-
structured 
interviews 
(Aim 2) 
245 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   

12 
HIV-negative 
fisherfolk 
Semi-
structured 
interviews 
(Aim 1) 
245 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
13 
HIV-negative 
fisherfolk 
Medical 
Records 
245 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
14 
HIV-negative 
fisherfolk 
Intervention 
(social 
behavioral 
component) 
245 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
15 
HIV-negative 
fisherfolk 
Intervention 
(clinical 
component) 
245 
6/15/2020 3/31/2024 
Ready to 
upload 
materials 
for HSPC 
approval 
now 
Completed   
2.    
3.   
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 1  Stakeholders (healthcare providers, community leaders, 
Ministry of Health policymakers) /  Semi-structured interviews (Aim 2) 
  
1. * 4C.1 Expected Number of Participants: 
30 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 

5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 2  Stakeholders (healthcare providers, community leaders, 
Ministry of Health policymakers) /  Semi-structured interviews (Aim 1) 
  
1. * 4C.1 Expected Number of Participants: 
30 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 6  Adherence supporters of HIV-negative fisherfolk /  Semi-
structured interviews (Aim 2) 
  
1. * 4C.1 Expected Number of Participants: 
10 
2. * 4C.2 Expected Start Date (enter a date, or text) 
4/19/2022 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 

Population & Procedure Details for - # 9  Adherence supporters of HIV-negative 
fisherfolk /  Intervention (social behavioral component) 
  
1. * 4C.1 Expected Number of Participants: 
10 
2. * 4C.2 Expected Start Date (enter a date, or text) 
4/19/2022 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 11  HIV-negative fisherfolk /  Semi-structured interviews (Aim 
2) 
  
1. * 4C.1 Expected Number of Participants: 
245 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 12  HIV-negative fisherfolk /  Semi-structured interviews (Aim 
1) 
  

1. * 4C.1 Expected Number of Participants: 
245 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 13  HIV-negative fisherfolk /  Medical Records 
  
1. * 4C.1 Expected Number of Participants: 
245 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 14  HIV-negative fisherfolk /  Intervention (social behavioral 
component) 
  
1. * 4C.1 Expected Number of Participants: 
245 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 

4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND Population Details Popup 
 
Population & Procedure Details for - # 15  HIV-negative fisherfolk /  Intervention (clinical component) 
  
1. * 4C.1 Expected Number of Participants: 
245 
2. * 4C.2 Expected Start Date (enter a date, or text) 
6/15/2020 
3. * 4C.3 Expected End Date (enter a date, or text) 
3/31/2024 
4. * 4C.4 Current Component Status 
Ready to upload materials for HSPC approval now 
5.  
6.  
2024-N0127 
View: RAND SF: Part 5A 
 
Part 5A: Research participation identifiability 
Introduction 
In determining potential risks to human subjects, it is important for the HSPC to understand whether 
individuals involved in the research can be identified by the data you acquire and access.    Please answer 
the questions in this section about the types of identifiers you are collecting for each study population. 
You indicated in Part 4 that the following populations are involved in this study:  
 
Stakeholders (healthcare providers, community leaders, Ministry of Health policymakers) 
 
Adherence supporters of HIV-negative fisherfolk 
 
HIV-negative fisherfolk 
  
  
Research Participation Identifiability 

Update with identifiers for each population. 
1.  
Population 
Identifiers 
Stakeholders (healthcare providers, community 
leaders, Ministry of Health policymakers) 
Audio, video, or 
biometric indicators 
Names 
Location and contact 
information 
Adherence supporters of HIV-negative fisherfolk 
Audio, video, or 
biometric indicators 
Names 
Location and contact 
information 
HIV-negative fisherfolk 
Audio, video, or 
biometric indicators 
Names 
Location and contact 
information 
 
2.    
  
  
2024-N0127 
View: RAND SF: Part 5B 
 
Part 5B: Data collection 
  
5.1. Previously you indicated that you plan to do or may do the following activities involving human 
subjects.  For each of the activities listed below, click the Update button to answer questions about the 
data collection for that specific activity.  The Completion Status indicates "Complete" if you have 
answered all of the questions for that activity and "Not Completed" if you have not yet answered all of the 
questions for the activity.  The completion status for all activities must be "Completed" before you can 
submit the SmartForm. 
1.  

  
Procedure Type 
Procedure Name 
Completion 
Status 
View 
C. Interviews/discussions 
Semi-structured 
interviews (Aim 2) 
Completed 
View 
C. Interviews/discussions 
Semi-structured 
interviews (Aim 1) 
Completed 
View 
I. Analysis of OTHER previously 
collected person-level data sets 
Medical Records 
Completed 
View 
N. Social behavioral or other 
interventions 
Intervention (social 
behavioral component) 
Completed 
2.    
  
  
2024-N0127 
View: Detail Create/Edit 
 
5.2 Interviews/Discussions 
Previously you indicated that this research involves conducting interviews or discussions with individuals 
or groups. Please provide these following additional details about these interviews/discussions: 
* 5.2a Who will conduct these interviews/discussions? Check all that apply. 
C. External vendor or collaborator 
 
* 5.2b List the name(s) of organization(s) 
Makerere University School of Public Health 
  
* 5.2c What is the mode of data collection? Check all that apply. 
C. In-person (one-on-one) 
Guidance for using online video conference platforms.  
* 5.2e How often will you collect these data from the same research participants during the study 
period? 
Once 
  
* 5.2f What is the expected length of the interview (in minutes)? 
60 

  
2024-N0127 
View: Detail Create/Edit 
5.2 Interviews/Discussions 
Previously you indicated that this research involves conducting interviews or discussions with individuals 
or groups. Please provide these following additional details about these interviews/discussions: 
* 5.2a Who will conduct these interviews/discussions? Check all that apply. 
C. External vendor or collaborator 
 
* 5.2b List the name(s) of organization(s) 
Makerere University School of Public Health 
  
* 5.2c What is the mode of data collection? Check all that apply. 
C. In-person (one-on-one) 
Guidance for using online video conference platforms.  
* 5.2e How often will you collect these data from the same research participants during the study 
period? 
Once 
  
* 5.2f What is the expected length of the interview (in minutes)? 
60 
  
2024-N0127 
View: Detail Create/Edit 
5.14 Analysis of OTHER previously collected person-level datasets (not DMDC). Includes public and 
private data. Data may or may not be identifiable (e.g., educational, personnel, criminal, military that is 
not DMDC, medical records, or other previously collected individual-level data). May include merged 
datasets. 
You previously indicated that your research involves collecting the type of data listed above. Please 
provide the following additional details about these data collection procedures. 
* 5.14a Are you using individual-level data? 
  Yes No 

* 5.14b What information is included in the datasets you will be using (e.g. medical claims data, 
arrest records, student test scores, etc)? 
We will extract from Mildmay clinic testing records the number of clients tested and who screened 
positive and negative, and negative and PrEP-eligible; and from medical records whether PrEP-eligible 
clients who were offered PrEP initiated PrEP, reasons for refusal if clients who are offered PrEP decline 
to start, PrEP start-date, dates and locations of PrEP refills, and any other dates of contacts with the 
Mildmay team around PrEP (e.g., reminders, intervention sessions). We will also extract all post-PrEP 
initiation HIV testing results and dates, to assess whether any HIV-negative clients seroconverted. We 
will extract administrative data, such as attendance at intervention sessions, dates of when clinic staff 
contact participants to provide reminders, as well as client socio-demographic characteristics. We will 
also extract a larger overall dataset that contains de-identified patient-level medical records data for the 
two study communities, which only contains PrEP refill data (dates and refill duration) without any 
identifiers or any other information such as socio-demographics, so that we can compute the percentage 
of refills filled in each community 6 months before the intervention start-date, and during and after the 6-
month intervention (March 2021-Sept 2022). Update: we will extend the data collection to evaluate 
implementation of the intervention in the comparison site, which is expected to begin in early 2023. Thus, 
de-identified data will be extracted from medical records until 6 months after the intervention (likely until 
December 2023). We will request a no-cost extension from NIH to do so (and thus the project will end 
March 31, 2024). 
* 5.14c Please name the source(s) of this data and include the url (e.g. school district, health plan, 
specific city or state, etc) 
Mildmay Uganda Clinic 
  
* 5.14d Availability of data. If it falls under more than one of the options, please select Other and 
describe. 
Requires signed Data Use Agreement, Memo of Understanding, or other signed agreement to obtain 
 
  
* 5.14f Are you required to pay for this data? 
  Yes No 
* 5.14h Will you be matching this data with any other data you plan to obtain? 
  Yes No 
* 5.14i What data sets will you be matching? 
For those who signed a medical release form, medical records data will merged with data collected by 
Mildmay staff when offering PrEP to people who test HIV-negative, such as: gender, age, occupation, 
marital status, and residency status (permanent/transient or mobile, and if so, number of times away from 
the community in the past 3 months). 
* 5.14j What information will be used to perform matching (e.g. name, Social Security numbers, GPS, 
etc.)? 
Mildmay client ID 
  

2024-N0127 
View: Detail Create/Edit 
5.10 Social-Behavioral and Other Interventions 
You previously indicated that your research involves a social behavioral or other intervention.  Please 
provide the following details about the intervention. 
 
* 5.10a Provide a brief description of the intervention and how it will be carried out. 
The pilot interventions will occur on Nakiwogo and Kigungu landing sites, Wakiso District, Lake 
Victoria, Uganda. We will offer PrEP to eligible HIV-negative fisherfolk who are tested at Nakiwogo and 
Kigungu. PrEP will be provided by Mildmay Uganda through the national PrEP program, administered 
by the Ugandan Ministry of Health. 
Mildmay conducts regular (e.g., weekly) community mobilization and healthcare outreach events at the 
two landing sites, in which HIV testing and PrEP are offered, ART is given to those who test HIV-
positive, and other healthcare services are provided. Specifically, to de-stigmatize HIV testing so that 
healthcare workers are not associated solely with HIV, staff have basic medical supplies on hand in 
addition to what is needed for HIV testing (e.g., de-worming pills). During community mobilization, 
Mildmay staff, Village Health Team members (VHTs), and Beach Management Unit (BMU) leaders will 
conduct outreach with fisherfolk prior to events (e.g., home visits, radio advertisements) and mobilize 
fisherfolk during events (e.g., using bullhorns), using key messages developed from the Aim 1 formative 
research to raise awareness around PrEP. During the testing event, BMU leaders will deliver PrEP 
messages (e.g., via bullhorns), and HIV testing counselors will convey PrEP information in one-on-one 
conversations. Specifically, Mildmay HIV counseling and testing staff will introduce PrEP to adult 
fisherfolk (≥18 years-old) who test HIV-negative at post-test counseling using messages developed in 
Aim 1. 
At Nakiwogo, events will be held in a public temporary space (e.g., tent, church) in partnership with 
Entebbe Hospital, and at Kigungu, Mildmay staff will use space in the nearby public Kigungu Health 
Center III to test and treat clients during community mobilization events. In Nakiwogo only, we will 
conduct an enhanced behavioral PrEP intervention to compare to the standard of care in Kigungu. 
Specifically, in Nakiwogo, we will have a three-pronged intervention: 1) During healthcare outreach 
events in Nakiwogo, we will conduct PrEP workshops, in which people who want to know more about 
PrEP can learn basic facts about PrEP and also can be taught skills about how to advocate for PrEP in 
their community. These PrEP workshops will be conducted by master trainers, who are Mildmay staff 
who have been trained by the Ugandan Ministry of Health to conduct health workshops and trainings. 2) 
Check-in Calls: To support PrEP adherence, healthcare workers will call PrEP users regularly (e.g., every 
1-2 weeks), to check in about any questions and to remind them of the next date and place to pick up 
refills. Calls will be more frequent after PrEP initiation, to ask about side effects. 3) To support PrEP 
adherence, healthcare workers will encourage PrEP users to select an adherence supporter, who is a 
family member or friend to whom they disclose their PrEP use. The adherence supporter agrees to remind 
them to adhere to PrEP and get refills. Healthcare workers will ask the PrEP user for the name and contact 
information, as well as the age and gender, for the adherence supporter, so that the adherence supporter 
can be contacted to remind them about refills, as well as if the PrEP user does not show up for a refill. All 
Adherence Supporters will also be invited to the intervention workshop, which is open to all community 
members. Note that the first intervention component (PrEP workshop) will be adapted from our current 
work in Uganda on prevention advocacy among people living with HIV (2016-0227; 2021-N0155). The 
last two intervention components are standard practices for people living with HIV on antiretroviral 
treatment, and will be adapted for PrEP users; provider guidance for adherence supporters will also be 
adapted from our current work in Botswana (2019-0253). To train master trainers and healthcare 

providers for the intervention, we have modified Ugandan Ministry of Health PrEP training slides for 
healthcare providers and counselors, tailoring them based on the Phase 1 formative work and adding 
issues of importance to fisherfolk communities. We have received permission from the Ugandan Ministry 
of Health to make these modifications, and we are regularly meeting with the Ugandan Ministry of Health 
to update them about the study, and to help develop the intervention. 
Per their usual Ministry of Health compliant procedures for PrEP, Mildmay healthcare providers will use 
an assumed consent procedure for providing PrEP. That is, individuals who attend an HIV testing event at 
which PrEP is being provided are assumed to consent to being prescribed PrEP when appropriate per 
Uganda Ministry of Health guidelines. Mildmay providers will draw blood to screen for PrEP 
contraindications [HIV-1 infected or evidence of possible acute HIV infection; allergy to Tenofovir 
Disoproxil Fumarate (TDF) and/or Emtricitabine (FTC); poor renal function; unwilling/unable to return 
for 3-monthly HIV testing, counseling and safety monitoring visits; weight <35kg]. Those eligible can 
obtain PrEP during Mildmay's outreach events, either in a temporary community-based venue at 
Nakiwogo, at Entebbe Hospital near Nakiwogo, or at Kigungu Health Centre III. Per Ministry of Health 
guidelines, most fisherfolk are eligible for PrEP as members of a high risk key population (with a high 
prevalence of multiple partners, transactional sex, alcohol use/abuse, serodiscordant relationships, and 
inconsistent condom use). 
Update: After completion of the intervention in the intervention site, Nakiwogo (in Sept 2022), the 
implementing partner will provide the intervention to the comparison site, Kigungu. We will continue to 
collect de-identified PrEP user data to evaluate implementation at the comparison site. 
* 5.10b Does this intervention include randomization? 
  Yes No 
* 5.10c Who will implement the intervention? Check all that apply. 
C. External vendor or collaborator 
 
* 5.10d List the name(s) of organization(s) 
Mildmay Uganda 
 
* 5.10e Where will the intervention take place (e.g., schools, clinics, participants’ homes, military 
bases, etc.)? 
At Nakiwogo, events will be held in a public temporary space (e.g., tent, church) in partnership with 
Entebbe Hospital, and at Kigungu, Mildmay staff will use space in the nearby public Kigungu Health 
Center III to test and treat clients during community mobilization events. 
* 5.10f What will research participants be asked to do as part of the intervention and how much 
time will it take on average? 
Attend at least one 1-hour PrEP workshop, receive ~1 minute check-in calls, select an adherence 
supporter 
* 5.10g How often will you administer the intervention to the same research participants during the 
study? 
Participants can attend as many workshops as they would like 
* 5.10h What is the expected length of the intervention (in minutes)? 
60 

  
2024-N0127 
View: RAND SF: Part 6 
Part 6: Study-level details 
Introduction 
In this section, please provide additional details about your data collection procedures.  Major topics 
covered are: Benefits, risks, incentives, and costs to study participants;  recruitment and consent 
procedures; study inclusion/exclusion criteria;  waivers requested; types of sensitive data acquired or 
accessed; and other pertinent study level details. 
When answering these questions, please include details pertaining to all populations and procedures that 
you previously listed in the matrix. 
I.  Population-specific details 
The table below lists the populations identified on your study.  Click the Update button next to a 
population to answer the questions for that population.  The Status column indicates whether all questions 
for the given population have been completed. Note: these questions are specific to the population. If you 
have two similar populations (e.g., two populations of students), make sure both populations appear 
below. If they don't, go back to Part 4 and add the additional populations as necessary. 
1.  
Population 
Completion 
Status 
Stakeholders (healthcare providers, community leaders, Ministry of 
Health policymakers) 
Completed 
Adherence supporters of HIV-negative fisherfolk 
Completed 
HIV-negative fisherfolk 
Completed 
II.  Study-specific details 
1. Plans to Share Data 
2. * 6.13 Do you have any plans to share the individual-level data from your study in 
identifiable or de-identifiable form? 
  Yes No 
3. * 6.14 Do you have any reason to expect data might be subpoenaed, requested for an 
administrative procedure or requested by the client? 
  Yes No 
4. Data Safeguarding Plan (DSP)  
5. * 6.15 Do you have the Data Safeguarding Plan (DSP) for this study ready to upload in 
draft or final form? Please use the HSPC template here. Note: If you do not have a DSP 

your HSPC approval of your project may be delayed until a DSP is submitted. 
Yes 
You can upload the DSP in Part 7 (Project Documents) 
   
Data and Safety Monitoring Plan (DSMP) 
6. * 6.16 Does your funder require a Data and Safety Monitoring Plan (DSMP) for your 
study? The RAND HSPC will make its determination during the review process. 
Yes – by the funder and/or HSPC 
7. 6.16a Do you have the DSMP for this study ready to upload in draft or final form? 
Yes 
You can upload the DSMP in Part 7 (Project Documents) 
8. Audio/Video Recording  
9. * 6.17 Will the research team be audio or video recording any interaction procedures for 
any study participants? If yes, and if the purpose is to supplement notes or is for research 
purpose only, the informed consent needs to address handling the recordings and ask for 
permission to record unless recording is a requirement. Note: If you plan to audio or video 
record any interaction for reasons other than to transcribe or for research purpose (e.g. 
observing fidelity), you will need to prepare an Audio or Video Release Form for 
participants to sign. See further instructions and a sample template. 
  Yes No 
 
* 6.17a Provide a step-by-step description of the audio or video recording procedures. 
Specify the study population, how long the recordings will be retained and how the 
recordings will be used (e.g., training, dissemination, etc.) 
Semi-structured interviews will be audio-recorded, and transcriptions will be transmitted to 
RAND via Kiteworks. 
10. * 6.18 Do you have the questions you will be asking participants (e.g., the interview 
protocol, survey instrument, or focus group guide) in draft or final form or a list of domains 
or topics to be covered? 
  Yes No 
You will be asked to upload the questions in part 7 
11.  
2024-N0127 
View: Part 6 Population Details Popup 
 
Study Level Details for -  Stakeholders (healthcare providers, community leaders, Ministry of Health 
policymakers) 
Procedures - Participant Benefits, Incentives, Risks, and Costs 

1. Benefits 
2. * 6.1 Not counting any participation incentives, are there any specific benefits that might 
accrue directly to the study participants? 
  Yes No 
3. Incentives and Other Forms of Compensation 
4. * 6.2 Will the study participants receive incentives or some other form of compensation 
(e.g., cash, gift card, voucher, meals, lottery/prize drawing, other type of 
reimbursements)?  Note: If you plan to use some type of lottery/prize drawing, please 
review the HSPC guidance 
at https://randus.sharepoint.com/research/hspc/Documents/lotteries.pdf and obtain prior 
approval from RAND’s legal counsel) 
  Yes No 
* 6.2a Type of incentive(s) 
20,000 Ugandan Shillings 
* 6.2b Cash value of incentive (USD) 
$5.14 
* 6.2c Incentive distribution procedures 
Incentives will be distributed upon completion of the interview. The incentive will be provided 
even if the participant opts not to answer some questions or ends the interview early. 
5. Participant Risks/Harms 
6. * 6.3 Which of the following types of risk/harm might result from participation in this 
research? Use drop down menu to check all that apply to this study population. Each risk 
you indicate here or in 6.3a must appear in the consent form for the relevant population. 
 
 
D Psychological consequences (e.g., distress, embarrassment, or pressure to participate) 
7.  
  
* 6.5 Please describe the nature of the harm(s) to this study population, what it might cause, 
and steps that would be taken to mitigate it. 
Participants may experience embarrassment, discomfort, or distress when being asked about 
issues related to HIV. Participants will be given the option not to answer any question that might 
cause discomfort. 
8. Costs 
9. * 6.6 Might the study participants incur any financial costs that will not be reimbursed and 
that they would otherwise not incur? 
  Yes No 
10. Coercion or Undue Pressure to Participate 
11. * 6.7 Are any of the participants in a situation, role, or position where they could be coerced 
or feel undue pressure to participate (e.g., employer/employee, doctor/patient, 
supervisor/subordinate, teacher/student)? 
  Yes No 
 
12. Language Translation 

13. * 6.8 Will informed consent be administered in languages other than English? 
  Yes No 
* 6.8a Specify the language(s) to be used and include the following: 
  *  Procedures to access that each translation is equivalent to the approved English version and 
written at an appropriate reading level for the target population. 
  *  Qualifications of translators 
We will record interviews and use translation-by-committee (into Luganda or other local 
languages as needed). Two local translators will work independently, taking into account cultural 
assumptions, and review each other’s work for equivalence and accuracy. Transcribed interviews 
will be transmitted to RAND via Kiteworks. 
14. Informed Consent: 
15. You must provide individuals with the information they need to make an informed decision about 
participating in your study.  The list of elements normally included in an informed consent are 
shown below.  Refer to the following link to find templates to create your informed consent 
materials:  https://randus.sharepoint.com/research/hspc/Pages/consent.aspx 
1. That the project is a research study  
2. Purpose of the research  
3. That participation is voluntary and can be discontinued at any time without penalty  
4. Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
5. Risks from participation, if any (must match 6.3, 6.3a as relevant to population)  
6. Benefits to the individual from participation, if any 
7. A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all * 
8. Point of contact for questions or problems regarding the study  
9. Point of contact for HSPC  
10. Signature of participant and/or legally authorized representative 
11. *If you plan to reuse or share deidentified data following the study, state: We may use 
your deidentified data for future research studies or share your data with other qualified 
researchers for future research studies.  
  
Waiving Informed Consent 
16. In general, IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(f) 
(3), provided that the IRB finds documents that all of the following four conditions are met:  
1. (i) The research involves no more than minimal risk to subjects;  
2. (ii) The research could not practicably be carried out without the requested waiver or 
alteration;  
3. (iii) If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format;  

4. (iv) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; and  
5. (v) Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation.  
17. * 6.9 Are you seeking an HSPC approval to waive consent entirely for this population? 
  Yes No 
 
 Waiving Elements of Informed Consent 
* 6.10 Are you seeking an HSPC approval to waive or alter any of the required elements of 
informed consent for this study population? The list of elements normally included in an 
informed consent are shown below. 
  Yes No 
o 
That the project is a research study  
o 
Purpose of the research 
o 
That participation is voluntary and can be discontinued at any time without penalty  
o 
Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
o 
Risks from participation, if any  
o 
Benefits to the individual from participation, if any  
o 
A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all  
o 
Point of contact for questions or problems regarding the study  
o 
Point of contact for HSPC  
o 
Signature of participant and/or legally authorized representative  
 
Future Contact After Research Ends 
18. * 6.10e After the project ends, is there a possibility that the participants will be contacted to 
participate in any future research (including research conducted on other topics by other 
research teams) because of their participation in this study? No 
19. Recruitment Procedures 
20. * 6.11 Will you be recruiting participants for this population on this study? 
  Yes No 
* 6.11a Please describe the step-by-step recruitment procedures for this study population. 
Provide details: who, what, where, when, and how. 
All recruitment activities will be conducted by Makerere University School of Public Health 
personnel who are part of this study team. 
Aim 1: We will recruit approximately 10-15 stakeholders (including Mildmay healthcare 
providers who work with fisherfolk, Beach Management Unit (BMU) leaders, Village Health 
Team (VHT) members, and policymakers at the Ugandan Ministry of Health). Stakeholders will 
be identified by Mildmay and Makerere University School of Public Health Investigators (e.g., 
based on their professional and workplace connections, such as at Mildmay, at the Ministry of 

Health, and in fisherfolk communities) and referred to the study interviewer. Stakeholders will be 
interviewed at their workplace or a private space convenient for them. 
Aim 2: To further assess acceptability of the PrEP interventions, we will conduct semi-structured 
interviews with 10 healthcare providers (e.g., counselor, lab technician, nurse, doctor, master 
trainers who conduct intervention sessions; 5 each for Kigungu and Nakiwogo) who deliver PrEP 
and 10 community stakeholders (e.g., BMU members, VHTs; 5 each for Kigungu and Nakiwogo; 
sample can overlap if they deliver care in both communities). They will be recruited during a 
testing/PrEP delivery event or through Ugandan study team contacts (e.g., the team is works with 
other healthcare providers and community leaders at the outreach events). Interviews will be 
conducted after 6 months of implementation of the PrEP intervention. 
* 6.11b Do you have recruitment materials (e.g. advertisements, flyers, letters of 
introduction, email invitations, and reminders) in draft or final form ready to upload? 
No 
 
  
Sensitive Information 
21. * 6.12 Please indicate which of the following types of sensitive information will be 
intentionally accessed, acquired or recorded for any study population as part of data 
collection.  These types of information are legally protected, potentially distressing, or 
otherwise sensitive.  The information can also be considered sensitive because of the subject 
populations or the context of the study. 
M. None of the above 
  
22.  
23.    
2024-N0127 
View: Part 6 Population Details Popup 
 
Study Level Details for -  Adherence supporters of HIV-negative fisherfolk 
Procedures - Participant Benefits, Incentives, Risks, and Costs 
1. Benefits 
2. * 6.1 Not counting any participation incentives, are there any specific benefits that might 
accrue directly to the study participants? 
  Yes No 
3. Incentives and Other Forms of Compensation 
4. * 6.2 Will the study participants receive incentives or some other form of compensation 
(e.g., cash, gift card, voucher, meals, lottery/prize drawing, other type of 
reimbursements)?  Note: If you plan to use some type of lottery/prize drawing, please 
review the HSPC guidance 
at https://randus.sharepoint.com/research/hspc/Documents/lotteries.pdf and obtain prior 

approval from RAND’s legal counsel) 
  Yes No 
* 6.2a Type of incentive(s) 
20,000 Ugandan Shillings 
* 6.2b Cash value of incentive (USD) 
$5.14 
* 6.2c Incentive distribution procedures 
Incentives will be distributed in cash upon completion of the interview. The incentive will be 
provided even if the participant opts not to answer some questions or ends the interview early. 
5. Participant Risks/Harms 
6. * 6.3 Which of the following types of risk/harm might result from participation in this 
research? Use drop down menu to check all that apply to this study population. Each risk 
you indicate here or in 6.3a must appear in the consent form for the relevant population. 
 
 
D Psychological consequences (e.g., distress, embarrassment, or pressure to participate) 
7.  
  
* 6.5 Please describe the nature of the harm(s) to this study population, what it might cause, 
and steps that would be taken to mitigate it. 
A participant could suffer embarrassment or similar social harms if non-participants learned that 
s/he were involved in a HIV-related study, due to high levels of stigma around HIV. We have 
strong data protections and training standards in place (see DSP) to avoid a breach of 
confidentiality occurring. 
8. Costs 
9. * 6.6 Might the study participants incur any financial costs that will not be reimbursed and 
that they would otherwise not incur? 
  Yes No 
10. Coercion or Undue Pressure to Participate 
11. * 6.7 Are any of the participants in a situation, role, or position where they could be coerced 
or feel undue pressure to participate (e.g., employer/employee, doctor/patient, 
supervisor/subordinate, teacher/student)? 
  Yes No 
 
12. Language Translation 
13. * 6.8 Will informed consent be administered in languages other than English? 
  Yes No 
* 6.8a Specify the language(s) to be used and include the following: 
  *  Procedures to access that each translation is equivalent to the approved English version and 
written at an appropriate reading level for the target population. 
  *  Qualifications of translators 
We will record interviews and use translation-by-committee (into Luganda or other local 
languages as needed). Two local translators will work independently, taking into account cultural 
assumptions, and review each other’s work for equivalence and accuracy. Transcribed interviews 
will be transmitted to RAND via Kiteworks. 

14. Informed Consent: 
15. You must provide individuals with the information they need to make an informed decision about 
participating in your study.  The list of elements normally included in an informed consent are 
shown below.  Refer to the following link to find templates to create your informed consent 
materials:  https://randus.sharepoint.com/research/hspc/Pages/consent.aspx 
1. That the project is a research study  
2. Purpose of the research  
3. That participation is voluntary and can be discontinued at any time without penalty  
4. Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
5. Risks from participation, if any (must match 6.3, 6.3a as relevant to population)  
6. Benefits to the individual from participation, if any 
7. A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all * 
8. Point of contact for questions or problems regarding the study  
9. Point of contact for HSPC  
10. Signature of participant and/or legally authorized representative 
11. *If you plan to reuse or share deidentified data following the study, state: We may use 
your deidentified data for future research studies or share your data with other qualified 
researchers for future research studies.  
  
Waiving Informed Consent 
16. In general, IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(f) 
(3), provided that the IRB finds documents that all of the following four conditions are met:  
1. (i) The research involves no more than minimal risk to subjects;  
2. (ii) The research could not practicably be carried out without the requested waiver or 
alteration;  
3. (iii) If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format;  
4. (iv) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; and  
5. (v) Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation.  
17. * 6.9 Are you seeking an HSPC approval to waive consent entirely for this population? 
  Yes No 
 
  
Waiving Elements of Informed Consent 

* 6.10 Are you seeking an HSPC approval to waive or alter any of the required elements of 
informed consent for this study population? The list of elements normally included in an 
informed consent are shown below. 
  Yes No 
o 
That the project is a research study  
o 
Purpose of the research 
o 
That participation is voluntary and can be discontinued at any time without penalty  
o 
Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
o 
Risks from participation, if any  
o 
Benefits to the individual from participation, if any  
o 
A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all  
o 
Point of contact for questions or problems regarding the study  
o 
Point of contact for HSPC  
o 
Signature of participant and/or legally authorized representative  
 
Future Contact After Research Ends 
18. * 6.10e After the project ends, is there a possibility that the participants will be contacted to 
participate in any future research (including research conducted on other topics by other 
research teams) because of their participation in this study? No 
19. Recruitment Procedures 
20. * 6.11 Will you be recruiting participants for this population on this study? 
  Yes No 
* 6.11a Please describe the step-by-step recruitment procedures for this study population. 
Provide details: who, what, where, when, and how. 
Adherence supporters will be recruited through the PrEP users who are interviewed. PrEP users 
will be asked whether they agree that we can interview their adherence supporter. If so, we will 
ask the PrEP user to ask the adherence supporter for permission for the study interviewer to 
contact them for an interview, or to call the study interviewer for an interview. We will suggest 
that the PrEP user contacts the adherence supporter in the presence of the interviewer, if possible, 
so that the interviewer can talk with the adherence supporter about the study and what 
participation entails. We have successfully used similar procedures in other studies to recruit 
social network members and adherence supporters of people living with HIV (2021-N0155 and 
HSPC: 2019-0253). 
Note that all adherence supporters, regardless of whether they are interviewed, may be called to 
remind them to remind PrEP users about getting refills; during this call we will also ask 
Adherence Supporters their age and gender and invite them to the intervention workshop (which 
is open to all community members), if they wish to know more about PrEP for themselves or to 
support the PrEP user. 

* 6.11b Do you have recruitment materials (e.g. advertisements, flyers, letters of 
introduction, email invitations, and reminders) in draft or final form ready to upload? 
No 
 
  
Sensitive Information 
21. * 6.12 Please indicate which of the following types of sensitive information will be 
intentionally accessed, acquired or recorded for any study population as part of data 
collection.  These types of information are legally protected, potentially distressing, or 
otherwise sensitive.  The information can also be considered sensitive because of the subject 
populations or the context of the study. 
M. None of the above 
  
22.  
23.    
2024-N0127 
View: Part 6 Population Details Popup 
 
Study Level Details for -  HIV-negative fisherfolk 
Procedures - Participant Benefits, Incentives, Risks, and Costs 
1. Benefits 
2. * 6.1 Not counting any participation incentives, are there any specific benefits that might 
accrue directly to the study participants? 
  Yes No 
3. Incentives and Other Forms of Compensation 
4. * 6.2 Will the study participants receive incentives or some other form of compensation 
(e.g., cash, gift card, voucher, meals, lottery/prize drawing, other type of 
reimbursements)?  Note: If you plan to use some type of lottery/prize drawing, please 
review the HSPC guidance 
at https://randus.sharepoint.com/research/hspc/Documents/lotteries.pdf and obtain prior 
approval from RAND’s legal counsel) 
  Yes No 
* 6.2a Type of incentive(s) 
20,000 Ugandan Shillings 
* 6.2b Cash value of incentive (USD) 
$5.14 
* 6.2c Incentive distribution procedures 
Incentives will be distributed upon completion of the interview. The incentive will be provided 
even if the participant opts not to answer some questions or ends the interview early. 
5. Participant Risks/Harms 

6. * 6.3 Which of the following types of risk/harm might result from participation in this 
research? Use drop down menu to check all that apply to this study population. Each risk 
you indicate here or in 6.3a must appear in the consent form for the relevant population. 
 
 
D Psychological consequences (e.g., distress, embarrassment, or pressure to participate) 
E. Social harm (e.g., stigma of participation, damage to reputation) 
7.  
  
* 6.5 Please describe the nature of the harm(s) to this study population, what it might cause, 
and steps that would be taken to mitigate it. 
A participant could suffer embarrassment or similar social harms if non-participants learned that 
s/he were involved in a HIV-related study and/or taking PrEP, due to high levels of stigma around 
HIV. We have strong data protections and training standards in place (see DSP) to avoid a breach 
of confidentiality occurring. Participants may experience embarrassment, discomfort, or distress 
when being asked about issues related to HIV, due to stigma around HIV. Participants will be 
given the option not to answer any question that might cause discomfort. 
8. Costs 
9. * 6.6 Might the study participants incur any financial costs that will not be reimbursed and 
that they would otherwise not incur? 
  Yes No 
10. Coercion or Undue Pressure to Participate 
11. * 6.7 Are any of the participants in a situation, role, or position where they could be coerced 
or feel undue pressure to participate (e.g., employer/employee, doctor/patient, 
supervisor/subordinate, teacher/student)? 
  Yes No 
 
12. Language Translation 
13. * 6.8 Will informed consent be administered in languages other than English? 
  Yes No 
* 6.8a Specify the language(s) to be used and include the following: 
  *  Procedures to access that each translation is equivalent to the approved English version and 
written at an appropriate reading level for the target population. 
  *  Qualifications of translators 
We will record interviews and use translation-by-committee (into Luganda or other local 
languages as needed). Two local translators will work independently, taking into account cultural 
assumptions, and review each other’s work for equivalence and accuracy. Transcribed interviews 
will be transmitted to RAND via Kiteworks. 
14. Informed Consent: 
15. You must provide individuals with the information they need to make an informed decision about 
participating in your study.  The list of elements normally included in an informed consent are 
shown below.  Refer to the following link to find templates to create your informed consent 
materials:  https://randus.sharepoint.com/research/hspc/Pages/consent.aspx 
1. That the project is a research study  

2. Purpose of the research  
3. That participation is voluntary and can be discontinued at any time without penalty  
4. Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
5. Risks from participation, if any (must match 6.3, 6.3a as relevant to population)  
6. Benefits to the individual from participation, if any 
7. A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all * 
8. Point of contact for questions or problems regarding the study  
9. Point of contact for HSPC  
10. Signature of participant and/or legally authorized representative 
11. *If you plan to reuse or share deidentified data following the study, state: We may use 
your deidentified data for future research studies or share your data with other qualified 
researchers for future research studies.  
  
Waiving Informed Consent 
16. In general, IRB may waive or alter the requirement of informed consent under 45 CFR 46.116(f) 
(3), provided that the IRB finds documents that all of the following four conditions are met:  
1. (i) The research involves no more than minimal risk to subjects;  
2. (ii) The research could not practicably be carried out without the requested waiver or 
alteration;  
3. (iii) If the research involves using identifiable private information or identifiable 
biospecimens, the research could not practicably be carried out without using such 
information or biospecimens in an identifiable format;  
4. (iv) The waiver or alteration will not adversely affect the rights and welfare of the 
subjects; and  
5. (v) Whenever appropriate, the subjects or legally authorized representatives will be 
provided with additional pertinent information after participation.  
17. * 6.9 Are you seeking an HSPC approval to waive consent entirely for this population? 
  Yes No 
 
  
Waiving Elements of Informed Consent 
* 6.10 Are you seeking an HSPC approval to waive or alter any of the required elements of 
informed consent for this study population? The list of elements normally included in an 
informed consent are shown below. 
  Yes No 
o 
That the project is a research study  
o 
Purpose of the research 

o 
That participation is voluntary and can be discontinued at any time without penalty  
o 
Clear description of procedures and their duration. Note procedures that are experimental 
(i.e., newly developed or of unknown benefit or risk), if any  
o 
Risks from participation, if any  
o 
Benefits to the individual from participation, if any  
o 
A statement describing the extent to which confidentiality of records identifying the 
subject will be maintained, if at all  
o 
Point of contact for questions or problems regarding the study  
o 
Point of contact for HSPC  
o 
Signature of participant and/or legally authorized representative  
 
Future Contact After Research Ends 
18. * 6.10e After the project ends, is there a possibility that the participants will be contacted to 
participate in any future research (including research conducted on other topics by other 
research teams) because of their participation in this study? No 
19. Recruitment Procedures 
20. * 6.11 Will you be recruiting participants for this population on this study? 
  Yes No 
* 6.11a Please describe the step-by-step recruitment procedures for this study population. 
Provide details: who, what, where, when, and how. 
All recruitment activities will be conducted by staff at Makerere University School of Public 
Health and Mildmay who are part of the study team. 
Aim 1: We will recruit 40 fisherfolk aged 18 and older who are HIV-negative to participate in the 
Aim 1 qualitative interviews. Participants will be purposively recruited by gender and occupation 
[fishermen, other fishing industry workers (e.g., fish cleaners, fish sellers, boat off loaders), 
CSWs, unemployed]. Participants will be recruited through healthcare providers (e.g., at testing 
events or healthcare facilities), who will refer to study staff (an interviewer from Makerere 
University School of Public Health) clients who are HIV-negative. The interviewer who will be 
present at the healthcare facility or testing event, and will explain the study further. Individuals 
can participate immediately after post-test counseling, or can schedule a later time for the 
interview. 
Aim 2: Mildmay currently conducts monthly healthcare outreach events (with HIV testing and 
ART provision, as well as provision of other medical services) at the Nakiwogo and Kigungu 
landing sites (lakeside locations used by fisherfolk to launch boats), Wakiso District, Lake 
Victoria. Outreach events are provided in healthcare facilities or in temporary and other structures 
in the community. During these events, Mildmay staff, Village Health Teams (VHTs), and Beach 
Management (BMU) leaders conduct community mobilization with fisherfolk prior to these 
events (e.g., home visits, radio ads) as well as during events (e.g., using bullhorns). As part of this 
study, Mildmay staff will offer PrEP to 100 eligible HIV-negative fisherfolk who are tested at 
Nakiwogo and Kigungu landing sites (the first 50 per site). To assess acceptability of PrEP 
among fisherfolk, after PrEP is offered to HIV-negative testing clients, HIV testing staff will 
record whether the client agrees or refuses PrEP, and why, and then refer the client to a study 
interviewer, who will be present at the facility or the event, or who will follow up by phone with 
interested potential participants for interviews. The interviewer will accompany the client to a 
nearby private space for study activities (e.g., in a school or church, or outside away from others) 

for informed consent and interviewing. 
We will interview 20 PrEP-eligible HIV testing clients who refused PrEP and 20 PrEP-eligible 
HIV testing clients who accepted PrEP at baseline, within a month after HIV testing, to explore 
barriers to and facilitators of PrEP uptake, with half of clients recruited from each community 
(Kigungu, Nakiwogo). 
We will also interview 40 clients (approximately 20 men, 20 women, approximately half 
currently taking PrEP and half who discontinued PrEP; approximately half from each community 
within each category) about 6 months after their PrEP initiation, to explore barriers to adherence, 
any reasons for discontinuation, and general acceptability of PrEP and the PrEP behavioral 
interventions, as well as any gender differences. For these 6-month interviews, fisherfolk 
participants who have initiated PrEP in the last 6 months (during the study intervention period) in 
one of the study communities will be recruited by the healthcare provider team during check-in 
calls or other contacts (e.g., during healthcare outreach events, when they receive a PrEP refill) 
and referred to the study interviewer, who will be present at the facility or the event, or who will 
follow up by phone with interested potential participants. Interviews will be conducted in-person 
if possible, or by phone if the participant has traveled far from the landing site or for 
precautionary measures due to COVID-19. 
* 6.11b Do you have recruitment materials (e.g. advertisements, flyers, letters of 
introduction, email invitations, and reminders) in draft or final form ready to upload? 
No 
 
  
Sensitive Information 
21. * 6.12 Please indicate which of the following types of sensitive information will be 
intentionally accessed, acquired or recorded for any study population as part of data 
collection.  These types of information are legally protected, potentially distressing, or 
otherwise sensitive.  The information can also be considered sensitive because of the subject 
populations or the context of the study. 
B. Physical health 
including diagnosis, treatment, or other private physical health information 
22.  
23.    
2024-N0127 
View: RAND SF: Part 7 
 
Part 7: Study documents 
 
Introduction 
 
In this section, please upload the study documents (in draft or final form) that are ready for HSPC review 

and approval at this time. Please clearly label each document so the materials can be linked to the 
population-procedures matrix. Include the name of the study population-procedure, and any other 
pertinent details (such as study phase, wave, etc.) in the header of each consent document and/or file 
name so reviewers can link the materials to the research procedures-population matrix you completed in 
Part 4. 
           
Component 
# 
Population 
Procedure 
9 
Adherence supporters of HIV-negative fisherfolk 
Intervention (social 
behavioral component) 
6 
Adherence supporters of HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 2) 
15 
HIV-negative fisherfolk 
Intervention (clinical 
component) 
14 
HIV-negative fisherfolk 
Intervention (social 
behavioral component) 
13 
HIV-negative fisherfolk 
Medical Records 
12 
HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 1) 
11 
HIV-negative fisherfolk 
Semi-structured interviews 
(Aim 2) 
2 
Stakeholders (healthcare providers, community leaders, 
Ministry of Health policymakers) 
Semi-structured interviews 
(Aim 1) 
1 
Stakeholders (healthcare providers, community leaders, 
Ministry of Health policymakers) 
Semi-structured interviews 
(Aim 2) 
2024-N0127 
View: RAND SF: Part 8 
Part 8: Conclusion 
 
1. * 8.1 Does the proposed study involve any ethical issues not already discussed in the study 
application? 
  Yes No 
2. 8.2 Please enter any other comments or information that you would like to share with the 
HSPC reviewer that would be relevant to the review. 
It should be clarified that the intervention test is of the different implementation modes of PrEP 
provision (a behavioral intervention), rather than testing the effectiveness of PrEP (a biomedical 
intervention). This application notes the risks of PrEP (e.g., side effects) as part of the 

intervention, although such risks are not expected to be related to the behavioral intervention. 
 
 
 
 

Statistical Analysis Plan 
Analyses will compare data from before the intervention to during the intervention 
period. Separate logistic regression models will be used to predict the likelihood of PrEP 
persistence (i.e., PrEP possession at 6-months and PrEP possession ratio of >80% in 6-months) 
with a time indicator (before vs. during the intervention). PrEP user age and gender will be 
included as covariates. If PrEP persistence is 0% at follow-up, logistic regression, which allows 
cannot be used as the odds ratio would be undefined. Thus, in this case, Fisher’s Exact test will 
be used to evaluate change in the persistence outcome.