Adaptation of a Health Education Program for Improving the Uptake of HIV Self-Testing by Men in Rwanda: A Study Protocol.

Background and objectives: Available evidence shows a low uptake of HIV services among men in Rwanda. HIV self-testing (HIVST), a new intervention, may have the potential to improve the uptake of HIV testing services among men. The current study aims to adapt a health education program (HEP) for improving the uptake of HIVST among men in Rwanda. Materials and Methods: We propose a mixed method study, which will be conducted in four phases. In Phase 1, we will conduct a scoping review to map the available evidence on health education programs for men in low- and middle-income countries (LMICs). In Phase 2, we will conduct interviews with stakeholders in the Rwanda HIV response and healthcare providers to determine their perspectives on implementation of HIVST in Rwanda. In Phase 3, a cross-sectional survey will be used to assess HIVST awareness and acceptability among men in Rwanda. Guided by findings from Phases 1, 2, and 3, we will employ the nominal group technique to develop and optimize the HEP for improving the uptake of HIVST among men in Rwanda. In Phase 4, we will use a pragmatic pilot randomized controlled trial to assess the preliminary impact of the HEP for men in Rwanda and assess the feasibility of a later, larger study. We will employ the Stata version 16 statistical package and NVivo version 12 for the analysis of quantitative and qualitative data, respectively. We anticipate that the findings of this study will inform implementers and policy makers to guide strategies on the implementation of HIVST in Rwanda and ultimately accomplish goals set forth in the Rwanda 2019-2024 Fourth Health Sector Strategic Plan on scaling up the number of men who know their HIV status. Conclusion: It is anticipated that this study will proffer solutions and strategies that are applicable not only in Rwanda but also in similar settings of LMICs.

4. Given your experience with HIV testing serves in Rwanda, what do you think will need to be set up before HIV self-testing can be rolled up at large scale successfully?

Adaptability of HIVST in intervention in Rwanda Complexity of HIVST implementation in Rwanda Resources currently available for HIVST implementation in Rwanda and perceived shortfalls Perceptions on costs associated with HIVST implementation in Rwanda for government and for the users
Introduction question aims to explore participant perspective on adaptability of HIVST in Rwanda. The sub-questions to the introduction question will be aimed to assess perceptions toward complexity, resources and cost of HIVST implementation.
5. What are your perceptions on the existing HIV testing policies and what regulatory challenges do you perceive for HIVST policy?
To assess participant perception on the existing HIV testing policies and perceived regulatory challenges with HIVST policy. The sub-questions to the introduction question will aim to assess more information on stated potential challenges. 6. What are your general impressions on HIV self-testing?
To explore positive and negative perceptions toward HIV self-testing.
Sub-questions will be used to explore the positive and negative perceptions toward HIV self-testing based on the participant response. 7. In conclusion, what is your recommendation on how Ministry of Health should implement HIV self-testing in Rwanda to ensure uptake and increase use of HIV testing services?
This question will be used to further explore any additional perceptions on implementation. Recommendations will be explored from the participants on what they feel would make HIVST implantation a success in Rwanda. At the end of the interview, the participants will be given the opportunity to add remarks or suggestions related to the subject topic.
Supplementary File 1: Table 2 -Health care provider (HIV Clinic nurse/ counsellor) in-depth interview Question Remarks Introduction: "Hello, my name is XXX. I will conduct the interview, record and take notes. I invited you to discuss HIV self-testing and your perception on implementation of HIV self-testing in Rwanda. I will ask you several open questions. Your personal opinions and views are very important for us. There are no right or wrong answers. Please feel welcome to express yourself freely during the interview. This conversation will be recorded on tape. This is only for purpose of the research, only the lead researcher indicated on the consent form (and I) will listen to the tape. No names or personal information will be used in the report.
The interview will last for about forty minutes. Is everything clear about the course of the interview?
Before starting the interview all participants will be informed about the purpose of the discussion, confidentiality and practical issues. To assess participant perception on the existing HIV testing policies and perceived regulatory challenges with HIVST policy. The sub-questions to the introduction question will aim to assess more information on stated potential challenges. 6. What are your general impressions on HIV self-testing?
To explore positive and negative perceptions toward HIV self-testing. Sub-questions will be used to explore the positive and negative perceptions toward HIV self-testing based on the participant response. 7. What are the anticipated challenges with HIV self-testing uptake among men in your district?
To assess health care provider perceived barriers to uptake of HIVST by men 8. In conclusion, what is your recommendation on how Ministry of Health should implement HIV self-testing in Rwanda to ensure uptake and increase use of HIV testing services?
This question will be used to further explore any additional perceptions on implementation. Recommendations will be explored from the participants on what they feel would make HIVST implantation a success in Rwanda.
At the end of the interview, the participants will be given the opportunity to add remarks or suggestions related to the subject topic.
Supplementary File 1: Table 3 -National Reference Laboratory staff in-depth interview Question Remarks Introduction: "Hello, my name is XXX. I will conduct the interview, record and take notes. I invited you to discuss HIV self-testing and your perception on implementation of HIV self-testing in Rwanda. I will ask you several open questions. Your personal opinions and views are very important for us. There are no right or wrong answers. Please feel welcome to express yourself freely during the interview. This conversation will be recorded on tape. This is only for purpose of the research, only the lead researcher indicated on the consent form (and I) will listen to the tape. No names or personal information will be used in the report. The interview will last for about forty minutes. Is everything clear about the course of the interview?
Before starting the interview all participants will be informed about the purpose of the discussion, confidentiality and practical issues.

Please tell me what you know about HIV self-testing in Rwanda
For acquaintance with the participants and gradually focusing the discussion on the study topic 2. Are you involved in HIV self-testing implementation in Rwanda?

If YES what is your current role? If NO what will be your role
To probe information on participant's role in implementation of HIVST in Rwanda. 3. What is your perception toward current HIV testing services in Rwanda? What has worked? What still needs to be strengthened?

Current HIV testing services structure in Rwanda at different levels Perceived challenges with current HIV testing services in Rwanda Perceptions on system readiness for HIVST implementation in Rwanda Perception on how HIVST will complement current HIV testing services
Introduction question aims to explore participant perspective on current HIV testing services. The sub-questions to the introduction question will be aimed to assess perceptions toward current organizational characteristics, culture, implementation climate and readiness 4. Given your experience with HIV testing serves in Rwanda, what do you think will need to be set up before HIV self-testing can be rolled up at large scale successfully?

Adaptability of HIVST in intervention in Rwanda Complexity of HIVST implementation in Rwanda Resources currently available for HIVST implementation in Rwanda and perceived shortfalls Perceptions on costs associated with HIVST implementation in Rwanda for government and for the users
Introduction question aims to explore participant perspective on adaptability of HIVST in Rwanda. The sub-questions to the introduction question will be aimed to assess perceptions toward complexity, resources and cost of HIVST implementation.

What are your perceptions on the existing HIV testing policies and what regulatory challenges do you perceive for HIVST policy?
To assess participant perception on the existing HIV testing policies and perceived regulatory challenges with HIVST policy. The sub-questions to the introduction question will aim to assess more information on stated potential challenges. 6. What are your general impressions on HIV self-testing?
To explore positive and negative perceptions toward HIV self-testing.
Sub-questions will be used to explore the positive and negative perceptions toward HIV self-testing based on the participant response. 7. What are the anticipated challenges with HIV self-testing from the laboratory perspective?
To assess laboratory perceived challenges to implementation of HIVST 8. In conclusion, what is your recommendation on how Ministry of Health should implement HIV self-testing in Rwanda to ensure uptake and increase use of HIV testing services?
This question will be used to further explore any additional perceptions on implementation. Recommendations will be explored from the participants on what they feel would make HIVST implantation a success in Rwanda.
At the end of the interview, the participants will be given the opportunity to add remarks or suggestions related to the subject topic.
Supplementary File 1: Table 4 -RBC/Medical and Pharmaceutical Products Department (supply chain) staff in-depth interview Question Remarks Introduction: "Hello, my name is XXX. I will conduct the interview, record and take notes. I invited you to discuss HIV self-testing and your perception on implementation of HIV self-testing in Rwanda. I will ask you several open questions. Your personal opinions and views are very important for us. There are no right or wrong answers. Please feel welcome to express yourself freely during the interview. This conversation will be recorded on tape. This is only for purpose of the research, only the lead researcher indicated on the consent form (and I) will listen to the tape. No names or personal information will be used in the report.
The interview will last for about forty minutes. Is everything clear about the course of the interview?
Before starting the interview all participants will be informed about the purpose of the discussion, confidentiality and practical issues.

Please tell me what you know about HIV self-testing in Rwanda
For acquaintance with the participants and gradually focusing the discussion on the study topic 2. Are you involved in HIV self-testing implementation in Rwanda?

If YES what is your current role? If NO what will be your role.
To probe information on participant's role in implementation of HIVST in Rwanda. 3. What is your perception toward current HIV testing services in Rwanda? What has worked? What still needs to be strengthened?

Current HIV testing services structure in Rwanda at different levels Perceived challenges with current HIV testing services in Rwanda
Introduction question aims to explore participant perspective on current HIV testing services. The sub-questions to the introduction question will be aimed to assess

Perceptions on system readiness for HIVST implementation in Rwanda Perception on how HIVST will complement current HIV testing services
perceptions toward current organizational characteristics, culture, implementation climate and readiness 4. Given your experience with HIV testing serves in Rwanda, what do you think will need to be set up before HIV self-testing can be rolled up at large scale successfully?

Adaptability of HIVST in intervention in Rwanda Complexity of HIVST implementation in Rwanda Resources currently available for HIVST implementation in Rwanda and perceived shortfalls Perceptions on costs associated with HIVST implementation in Rwanda for government and for the users
Introduction question aims to explore participant perspective on adaptability of HIVST in Rwanda. The sub-questions to the introduction question will be aimed to assess perceptions toward complexity, resources and cost of HIVST implementation.

What are your perceptions on the existing HIV testing policies and what regulatory challenges do you perceive for HIVST policy?
To assess participant perception on the existing HIV testing policies and perceived regulatory challenges with HIVST policy. The sub-questions to the introduction question will aim to assess more information on stated potential challenges. 6. What are your general impressions on HIV self-testing?
To explore positive and negative perceptions toward HIV self-testing. Sub-questions will be used to explore the positive and negative perceptions toward HIV self-testing based on the participant response. 7. What measure need to be put in place prior to implementation of HIV self-testing from the supply chain perspective?
To assess supply chain manager perception on measures to be put in place prior to implementation of HIVST. 8. What are the anticipated challenges with implementation of HIV self-testing from the supply chain perspective?
To assess supply chain manager perceived challenges to implementation of HIVST 9. In conclusion, what is your recommendation on how Ministry of Health should implement HIV self-testing in Rwanda to ensure uptake and increase use of HIV testing services?
This question will be used to further explore any additional perceptions on implementation. Recommendations will be explored from the participants on what they feel would make HIVST implantation a success in Rwanda. At the end of the interview, the participants will be given the opportunity to add remarks or suggestions related to the subject topic.

Respondent study ID: ____________________
Thank you for agreeing to participate in this study. The first sets of questions are about your lifestyle, followed by questions related to HIV-self testing knowledge and perception. Mark with an X in the appropriate box. N/A (not applicable)