Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa

NACompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

April 16, 2024

Primary Completion Date

June 1, 2025

Study Completion Date

June 1, 2025

Conditions
Pre-exposure ProphylaxisHIV Infections
Interventions
BEHAVIORAL

Case management

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).

BEHAVIORAL

Food vouchers

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.

BEHAVIORAL

PrEP support buddy

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.

BEHAVIORAL

Community-based PrEP pickup points

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.

Trial Locations (1)

3200

TB HIV Care, Pietermaritzburg

All Listed Sponsors
collaborator

TB HIV Care

OTHER

collaborator

Unity Health Toronto

OTHER

collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Johns Hopkins Bloomberg School of Public Health

OTHER

NCT06274060 - Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa | Biotech Hunter | Biotech Hunter