Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention — IMPERATIVE  

HIV Infections Clinical Trial

Official title: Harnessing Male Peer Networks to Enhance Engagement With HIV Prevention: A Large-scale Cluster Randomized Trial to Increase HIV Self-testing and PrEP Uptake Among Men in Eastern Zimbabwe

Status Not yet recruiting

Clinical Trial Summary

Novel strategies are needed to engage men in Sub Saharan Africa (SSA) with HIV testing, treatment and prevention services to drive the epidemic towards elimination. Suboptimal engagement with HIV prevention by men increases their risk of HIV acquisition, and is an important driver of new HIV infections in women. HIV self-testing (HIVST) addresses several key facility-based access barriers and HIVST distribution through leveraging male peer networks for HIV prevention is feasible, acceptable and effective in SSA. The objective of this project is to use an implementation science approach to establish the impact of HIVST distribution through male social networks, with phone-based support and improved risk perception, on PrEP (Pre-Exposure Prophylaxis) uptake among men in Eastern Zimbabwe. The project will leverage infrastructure and data associated with 20-year programme of HIV surveillance and behavioural research in a well-characterized population cohort hosted by the Manicaland Centre for Public Health Research, Zimbabwe. The study will utilise a cluster randomised design of 44 clusters (22 Intervention:22 control) comprising on average 81 men in each cluster (total N = 3591) followed for 6 months (giving >80% power to detect a difference in PrEP initiation among men of 2% versus 8.5%). In intervention clusters the investigators will identify initial distributors who will receive an HIVST kit for personal use and HIVST kits to distribute to local peers. These peers can subsequently become distributors, allowing the intervention to propagate through peer networks. A toll-free helpline will provide pre- and post-test support and an SMS (Short Message Service) -based risk assessment will expedite PrEP initiation at the clinic. The study team will conduct a performance (process) evaluation of the intervention. to assess implementation fidelity, causal mechanisms underlying trial effectiveness including how characteristics of peer networks affect outcomes. Results of the study will be used to quantify the population level impacts and cost-effectiveness of male peer to peer HIVST distribution strategies on the uptake of PrEP in HIV hyper-endemic settings using a fully calibrated individual-based mathematical model. The envisaged long-term impact of this research is the development of a generalizable, multicomponent male peer-based HIVST and PrEP uptake model for settings where HIV incidence is high.

Clinical Trial Description

The study will use a cluster-randomised trial design with clusters based on existing village boundaries, which have been utilised as part of an ongoing population-based HIV surveillance. In some cases, neighbouring villages will be aggregated to give approximately equal numbers of adult men in each cluster. The study cohort from which participants will be recruited is located in Manicaland province, east Zimbabwe. The intervention will proceed with the following steps: i. Potential primary distributors will be identified by the research team following engagement with local key informants, these individuals will be contacted and screened for study enrolment. The desired characteristics of these individuals would be that they are respected members of their community with strong local networks of peers. If they choose to participate, an informed consent procedure will be completed by the fieldworkers. ii. If enrolled, the distributor will be given a pack containing four HIVST kits, one for their own use and three for distribution within the cluster. The study team will collect basic demographic data (name/age/cell phone number) for the distributor and the intended recipients. They will also record the unique ID (identification number) of the pack of kits. Advice will be provided on the correct use and interpretation of the HIVST, the need for post-test confirmatory testing in a health facility and the availability of HIV prevention methods including PrEP. iii. The distributor will be asked to give the test kits to the intended recipients within a seven-day period. iv. After seven days the help-desk will contact the distributor and the intended recipients to ascertain whether kits have been received and used, to collect behavioural HIV risk data for the recipients and encourage attendance at a healthcare facility for a confirmatory test. HIVST recipients will be invited to complete the informed consent over the telephone and be enrolled in the study. Follow-up calls will be made to these individuals if necessary. Recipients will be encouraged to consider becoming distributors and advised on the location of community facilities (shops, pharmacies, hairdressers etc.) from where they can obtain the HIVST packs for distribution. Names and cell numbers will be collected for intended recipients by the study team and held confidentially. v. If the recipient chooses to become a distributor they will go to the facility and the owner will check using a real-time database that they have not already received a pack of kits for distribution. If they pass this screening, they will be given a pack of three HIVST kits for within cluster distribution to their peers. vi. After seven days the help-desk will contact the second level recipients and steps iv) and v) will be repeated until all kits allocated to a particular community have been distributed. vii. When participants attend a clinic for confirmatory testing, they will return the HIV test kit packaging with the unique label and based on their self-reported HIVST result (unreactive/reactive) be screened for PrEP or ART (Antiretroviral Therapy) . The outcome of the screening will be recorded on a referral form which will be deposited in a secure box at the clinic from where it will be collected by the study team. viii. Referral slips will be returned to the central data processing facility for data entry ix. All individuals initiating PrEP or ART will be contacted monthly for six months to provide support and to ascertain whether they are still adhering to/continuing with PrEP/ART. x. Additionally, all men who report they are still taking PrEP/ART at the end of the follow-up period will be contacted in order to obtain a dry blood spot to verify the self-report of adherence. This will be sent for analysis in order to assess the intracellular levels of tenofovir diphosphate (TFV-DP) in red blood cells . The existing Ministry of Health and Child Care programme of direct HIVST distribution in the community through community health workers (CHW) will be the standard of care in the study. Previous work has indicated that males in this community have a low level of perception of their risk of HIV infection. To address this, a tool will be developed that will allow study participants to make a self-assessment of their level of risk. Information on how to use the tool will be provided to all recipients of HIVST kits including the primary distributors as part of the kit insert. They can use this tool multiple times during the study period as their risk profile may change over this time. All SMS messages will be free, and no identifying data will be collected by the study team. After submission of an SMS users will be prompted by an automated interactive system to provide a numerical response to a series of behavioural risk questions. The questions will be the same as those used in the national PrEP screening tool. Based on the responses they will receive an automated message indicating whether they have a high level of risk and if so recommending that they consider PrEP initiation. A study helpline with a toll-free number will be established which will provide the key point of contact between the participants and the study team. In addition to the structured contact, all participants will be able to contact the helpline with any questions or concerns about the study, the interpretation of their results, for support and counselling related to HIVST or their engagement with the healthcare clinics or for any other reason. In this study, the World Health Organization approved OraQuick oral fluid test kits will be used. Follow-up calls from the study helpline will be the main strategy to support participants through HIV self-testing and engagement with HIV care. These calls will be made at monthly intervals following the initiation of ART or commencement of PrEP. Process Evaluation The process evaluation will be primarily conducted in one urban and one rural site. A trained Shona-speaking qualitative researcher will lead the evaluation, alongside a team of trained research assistants and peer researchers (men from the target population acting as local community advisors and research assistants). Qualitative data will be thematically coded and analysed in NVivo 12. The performance evaluation consists of three stages, with all data collected informing the final evaluation stage. First, a pre-intervention context analysis will be conducted to understand the context within which the intervention will be implemented, and thus to improve the fit between context and approach (months 7-12). Workshops with men who represent the target group (n=2), healthcare providers (n=2) and project implementers (n=2) will provide feedback on and help refine the intervention, further develop the evaluation logic model, and identify local resources that can support the intervention. Focus group discussions with men (n=4) will explore the structures, attitudes and practices surrounding men's social networks, to inform intervention design to maximize its reach to PrEP-eligible individuals in terms of HIVST distribution, uptake and clinic attendance. Finally, participant observations will generate notes about all planning processes. All these inputs will be used to map, and design trial adaptations to account for, barriers and facilitators for implementation and sustainment. Second, accountability mechanisms will generate real-time feedback during implementation to support the PI's in strengthening of intervention practices (months 13-42). Focus group discussions (n=4) and interviews (n=12) with implementers will capture barriers and facilitators to implementation success, what is and is not working and any unintended consequences. A designated helpline and mailboxes for anonymous feedback will be available at all study sites to allow helpline and other staff provide qualitative insights into how the intervention is processing. Focusing on the two sites subject to qualitative investigation, participant observations of intervention implementation and home and community visits will help monitor progress, as well as interactions in peer networks and between men and shopkeepers distributing HIVSTs. All this will be triangulated with real-time quantitative data on enrolment and progress of men through the intervention. Third, the post-trial process evaluation will examine "what works in which circumstances for whom" (months 43-48). Through interviews (n=24) and focus group discussions (n=8) with a mix of stakeholders, including men reached through the intervention (in combination with intra-trial data), the investigators will explore contextual factors and social network mechanisms shaping experiences of, and engagement with, intervention activities along the HIV prevention cascade. This will include examining the 'what' (social network structures and processes), the 'how' (implementation processes), 'where' (spatiality, location, community/cultural/ political/religious context), 'when' (timing, momentum, cyclicality, flow, speed, duration, frequency), and 'who' (people and organisations, interpersonal relations, social networks and norms) that influence HIVST distribution and PrEP uptake. Finally, 20 men will be invited to photographically capture 'stories of change' through the Photovoice method. The men will be invited to write captions to their photos, and to select photographs representing 'significant changes' (good or bad). These photographs will guide subsequent interviews, which will also seek to understand how the men's social networks affect the changes they report by visualizing their personal networks and using them as a tool for discussion. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT06370923
• Study type: Interventional
• Source: University of Stellenbosch
• Contact: Constance Nyamukapa, PhD
• Phone: +263 71 480 4050
• Email: nyamukapaconnie@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Completion date: December 2028