Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa (NCT06274060) | Clinical Trial Compass
CompletedNot Applicable
Project Phakama: Testing Support Strategies to Empower Young Women on PrEP in South Africa
South Africa304 participantsStarted 2024-04-16
Plain-language 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.
Who can participate
Age range
16 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Initiated PrEP within the past 48 hours by the TB HIV Care PrEP programme in uMgungundlovu through the female sex worker (FSW) or adolescent girls and young women (AGYW) PrEP programme teams
Exclusion Criteria:
* Not eligible for PrEP
* Currently on PrEP, but initiated onto PrEP more than 48 hours previously
* Under 16 years of age if AGYW OR under 18 years of age if FSW
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested support strategies to help young women in South Africa stay on PrEP for 7 months — since it's now completed, can you tell me whether any results have been published, and what they showed about whether the support strategies actually helped women stick with PrEP?
2The trial focused specifically on young women using PrEP in South Africa — given that context, how relevant do you think the findings might be to my own situation, and are there similar support programs available where I receive care?
3Since this study was about PrEP persistence and adherence rather than a new drug or vaccine, what does the research tell us about the biggest real-world barriers to staying on PrEP, and how might we address those in my case?
4This trial was listed as 'Phase NA,' meaning it was a behavioral or support intervention rather than a drug trial — does that change how confident you are in applying its findings compared to a traditional medication study?
5Are there other completed or ongoing studies on PrEP support strategies that you think are worth reviewing alongside this one before we decide on the best approach to PrEP for me?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PrEP Persistence at 7 Months After PrEP Initiation
Timeframe: Month 7
2
PrEP Adherence at 7 Months After PrEP Initiation
Timeframe: Month 7
Trial details
NCT IDNCT06274060
SponsorJohns Hopkins Bloomberg School of Public Health