CompletedPhase 4

Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study

South Africa, Zimbabwe451 participantsStarted 2016-10-12

Plain-language summary

To assess the acceptance rate, adherence, acceptability, and continuation of oral pre-exposure prophylaxis (PrEP) among young southern African women.

Who can participate

Age range

16 Years – 25 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: Young women who meet all of the following criteria are eligible for inclusion in this study: * Female at birth * Age 16-25 years * Per participant report, sexually active, defined as having vaginal or anal intercourse at least once in the month prior to screening * Literate in one or more of the study languages * Willing and able to provide informed consent or assent (if parental consent is required per local regulations) * If parental consent is required per local regulations, parent/legal guardian willing and able to consent to all study procedures including HIV testing * Able and willing to provide adequate locator information, as defined in site Standard Operating Procedures (SOPs) * Have a score of 5 or greater on the Vaginal and Oral Intervention to Control the Epidemic (VOICE) risk score tool * Interest in PrEP (ascertained by selected questions from the HIV Prevention Readiness Measure (HPRM) and Prep Belief Measure (PBM) defined in the Study Specific Procedures \[SSP\] Manual) * Regular access to a mobile phone with SMS capacity * Agrees not to participate in other research studies involving drugs or medical devices for the next 12 months * Hepatitis B virus (HBV) seronegative and accepts HBV vaccination. Exclusion Criteria: Young women who meet any of the following criteria will be excluded from this study: * Planning to relocate in the next 12 months * Has a job or other obligations that would require long absences from the area (\> 4 weeks…

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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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

Number of Participants With High Adherence at Six Months

Timeframe: at month 6 from start of the study

Trial details

NCT IDNCT02732730

SponsorHIV Prevention Trials Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2018-10-25

Results submitted2025-03-31

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