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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 16 years and older
• Women only
• Healthy volunteers accepted
• Child, Adult, Older adult

Trial locations and contacts

1 site in 1 country.

About this study

Official title: Optimizing PrEP Implementation and Effectiveness Among Women at High Risk for HIV Acquisition in South Africa: Phase 2b

Conditions

Pre-exposure Prophylaxis, HIV Infections

Being tested

Case management, Food vouchers, PrEP support buddy, Community-based PrEP pickup points

Keywords

PrEP, HIV prevention, Adolescent girls and young women, Female sex workers, South Africa

Medical subject headings

HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Case managementBehavioural

  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).

• Food vouchersBehavioural

  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.

• PrEP support buddyBehavioural

  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.

• Community-based PrEP pickup pointsBehavioural

  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.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. PrEP Persistence at 7 Months After PrEP Initiation

   Participants who had PrEP in their possession 7-months after initiation, or returned for their 7-month PrEP refill visit. PrEP persistence was determined using programmatic data on PrEP visits among participants successfully linked to TB HIV Care program records.

   Measured: Month 7

2. PrEP Adherence at 7 Months After PrEP Initiation

   The investigators will use dried blood spot (DBS) samples to measure PrEP adherence as an indicator of actual pill-taking. High PrEP adherence will be defined as taking 4 doses or more/week, measured as tenofovir-diphosphate (TFV-DP) ≥700 femtomoles per DBS sample. Among participants that do not return for DBS, the investigators will assume non-adherence and they will not be included in this outcome.

   Measured: Month 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Feb 2024
2. Study start16 Apr 2024
3. Primary completion1 Jun 2025
4. Study completion1 Jun 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
• Other trials for Pre-exposure ProphylaxisStudies of the same condition, open and under way.
• More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.