At a glance
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Optimizing PrEP Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa: Phase 2b
In Brief
A clinical study evaluating Case management, Food vouchers, and 2 other interventions for Pre-exposure Prophylaxis and HIV Infections. Completed, enrolled 304 participants across 1 site.
Signals
Detailed Summary
The goal of this trial is to understand which strategies work best to support pre-exposure prophylaxis (PrEP) use among female sex workers (FSW) and adolescent girls and youth women (AGYW) in uMgungundlovu, KwaZulu-Natal, South Africa. Participants will be randomly assigned to receive a combination of up to four support strategies encourage the participants in continuing to use PrEP. The four strategies being tested are: case management, food vouchers, peer support buddies, and community-based PrEP pick-up points. The intention of this trial is to determine which PrEP support strategy or bundle(s) of strategies best promote(s) long-term PrEP use, so that these services can be scaled up to other districts in South Africa.
Study Details
Timeline
Arms & Interventions
The TB HIV Care programme standard of care includes full-time peer educators employed by the programme to engage women, layered PrEP promotion across prevention programmes, and "refer a friend" strategies, information, education and communication (IEC) materials, service user testimonials, risk reduction posters to better align young women's perception of risk, working after hours/weekends to reach young women, working with school governing bodies, and door-to-door outreach.
Participants will receive case management layered on existing standard of care.
Participants will receive food vouchers layered on existing standard of care.
Participants will receive the PrEP support buddy intervention layered on existing standard of care.
Participants will receive the community-based PrEP pickup point intervention layered on existing standard of care.
Participants in this arm will receive both the PrEP support buddy and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive both the food voucher and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive both the food voucher and PrEP support buddy interventions in combination.
Participants in this arm will receive both the case management and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive both the case management and PrEP support buddy interventions in combination.
Participants in this arm will receive both the case management and food voucher interventions in combination.
Participants in this arm will receive the food voucher, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive the case management, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive the case management, food vouchers, and community-based PrEP pickup point interventions in combination.
Participants in this arm will receive the case management, food vouchers, and PrEP support buddy interventions in combination.
Participants in this arm will receive the case management, food vouchers, PrEP support buddy, and community-based PrEP pickup point interventions in combination.
Interventions
Participants will receive case management delivered by a peer with PrEP experience/success for seven months, with the goal of improving self-efficacy to take PrEP. The intention of this intervention is to help participants to develop individualized strategies to address and overcome barriers to PrEP use, as well as develop disclosure strategies. This strategy includes weekly face-to-face support with the case manager for the first month of the trial, followed by monthly face-to-face support for the remainder of the trial follow up period. The strategy will also include client-initiated on-demand phone consultation with the case manager and mental health/substance use screening and referrals. Participants randomized to this strategy may also opt into daily timed PrEP pill-taking reminders via short message service (SMS).
Participants will be given food vouchers with a value of 200 South African Rand at the time of PrEP initiation and at 1- and 4-month standard of care visits at which clinical checkups and PrEP refills are provided. The goal of these vouchers is to improve participants' capacity to persist on PrEP. While PrEP can be taken without food, some experience increased side effects or prefer to take pills with food, making adherence difficult if they cannot afford food at times.
Participants will identify a person in their network (such as a friend, partner, parent) that they wish to support them in their PrEP usage, with the goal of improving participants' motivation and self-efficacy to persist on PrEP and providing social support to facilitate ongoing PrEP use. Support buddies selected by FSW and AGYW randomized to this intervention will receive a one-time training session on PrEP and support strategies as well as informational materials and text reminders to assist them in providing ongoing PrEP support.
Participants will be able to pick up PrEP from alternative pick-up points within the community that are convenient for them, with the goal of making PrEP more accessible to participants. Ten pickup points will be established at existing Hubs of Hope throughout the subdistricts served by the TB HIV Care programme. Hubs of Hope are based in the War Rooms within subdistricts, where the TB HIV Care programme operates, and serve as meeting places for service users to receive support searching for jobs, completing online courses, and other personal development activities to support a multi-sectoral approach to health. A TB HIV Care ambassador is based at each Hub of Hope to coordinate activities and provide support to service users. Participants who choose to use pick-up points will have the option of either completing an HIV self-test or testing with the on-site TB HIV Care staff to confirm HIV-negative status prior to receipt of PrEP refills.