CompletedNot Applicable

The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa

South Africa802 participantsStarted 2019-04-04

Plain-language summary

The project seeks to determine whether implementing a multilevel, woman-focused intervention, the Young Women's Health CoOp (YWHC), for pre-exposure prophylaxis (PrEP) readiness, uptake, and adherence is a viable complement to the HIV prevention plan for the Government of South Africa. Specifically, this project aims to: increase uptake, of sexual and reproductive health (SRH) services and readiness and uptake of PrEP among adolescent girls and young women (AGYW) aged 16 to 24 who engage in high-risk sexual behaviors; and reduce their barriers to accessing SRH services by addressing and reducing stigma and discrimination (S\&D) in clinics.

Who can participate

Age range

16 Years – 24 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: * HIV negative * identify as female; * aged 16-24; * have had condomless sex in the past 3 months with a male partner; * not be currently pregnant and not want to get pregnant for the next year; * interested in taking PrEP; * not having previously participated in the formative phase of the study; * have not previously and not currently participating in any other PrEP-related demonstration project or research study; * not previously or not currently participating in any other HIV study in Tshwane; * lives in one of the target communities; * not on multidrug-resistant tuberculosis (MDR-TB) treatment; * intends to stay in the Tshwane district for the next 12 months; * agrees to provide contact information; * be willing to undergo rapid HIV testing; * be willing to undergo pregnancy testing. Exclusion Criteria: \-

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

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: Baseline

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: 4 months

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: 8 months

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: Baseline

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: 4 months

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: 8 months

AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

Timeframe: Baseline

Trial details

NCT IDNCT04048551

SponsorRTI International

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-23

View on ClinicalTrials.gov More HIV Prevention trials

Plain-language summary

Who can participate

Age range

16 Years – 24 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.

What they're measuring

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: Baseline

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: 4 months

Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination

Timeframe: 8 months

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: Baseline

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: 4 months

Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP

Timeframe: 8 months

AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW

Timeframe: Baseline