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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

802 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-04

Study Completion Date

2022-06-23

Brief Summary

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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.

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Detailed Description

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The researchers propose a cluster randomized trial with a factorial design to evaluate the efficacy of a multi-level intervention that addresses stigma in accessing healthcare, social support, and individual risk behaviors of adolescent girls and young women (AGYW) in South Africa. The researchers engaged stakeholders from the Department of Health, a Community Collaborative Board (CCB), and a Youth Advisory Board (YAB) to inform the adaptation of the evidence-based empowerment intervention, the Women's Health CoOp (WHC)-which addresses gender-based violence (GBV), substance use, and sexual risk-to address sexual and reproductive health (SRH) and pre-exposure prophylaxis (PrEP) readiness, uptake and adherence. Through engagement with stakeholders, the researchers also adapted a stigma and discrimination (S\&D) reduction training curriculum for clinic staff.

The project plans to increase uptake of SRH services, and PrEP readiness, uptake and adherence among AGYW aged 16 to 24 who engage in high-risk sex. The investigators plan to conduct this through a multilevel HIV prevention strategy that addresses S\&D in AGYW accessing healthcare, social support, and individual risk behaviors. This cluster randomized trial with a factorial design will be conducted across 12 clinics in Pretoria.

The aims of this study are (1) To engage stakeholders, the Community Collaborative Board (CCB), and the Youth Advisory Board (YAB) in adapting the Women's Health CoOp (WHC) and stigma and discrimination (S\&D) reduction training, in the Pretoria area during a formative stage.

(2) To evaluate the impact of training on S\&D among healthcare staff on the use of HIV and reproductive health services by adolescent girls and young women (AGYW), including pre-exposure prophylaxis (PrEP), and staff attitudes and behaviors toward AGYW at 4- and 8-month follow-up.

(3) To test the efficacy of a multilevel strategy that addresses structural (stigma and discrimination), interpersonal (social support), and individual (personal agency, substance use, and gender-based violence \[GBV\]) factors on PrEP readiness and uptake, and adherence (primary outcomes) and condom use, GBV, substance use, and HIV incidence (secondary) at 3-, 6-, and 9-month follow-up among vulnerable AGYW.

Conditions

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HIV Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

This is a cluster randomized trial that utilizes a 2 x 2 factorial design to assess the impact of S\&D reduction training and the YWHC intervention, resulting in four study conditions: (1) Clinic S\&D reduction training + PrEP/SRH + YWHC, (2) Clinic S\&D reduction training + PrEP/SRH only, (3) No Clinic S\&D reduction training +PrEP/SRH + YWHC, (4) No Clinic S\&D reduction training + PrEP/SRH only. The researchers will examine two primary endpoints: (1) the proportion of AGYW who are ready to uptake and initiate PrEP and SRH services; and, (2) the differences in levels of PrEP adherence between each intervention condition and the standard of care comparison at 3-, 6- and 9-month follow-up.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No S&D Reduction Training; PrEP and SRH only

Arm 1 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).

Group Type NO_INTERVENTION

No interventions assigned to this group

No S&D Reduction Training; PrEP and SRH + YWHC

Arm 2 does not receive stigma and discrimination (S\&D) reduction training to clinic staff, but provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).

Group Type EXPERIMENTAL

Young Women's Health CoOp (YWHC)

Intervention Type BEHAVIORAL

In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.

S&D Reduction Training; PrEP and SRH only

Arm 3 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis) and SRH (sexual and reproductive health) services to AGYW (adolescent girls and young women).

Group Type ACTIVE_COMPARATOR

Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum

Intervention Type BEHAVIORAL

The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.

S&D Reduction Training; PrEP, SRH + YWHC

Arm 4 receives stigma and discrimination (S\&D) reduction training to clinic staff and provides PrEP (pre-exposure prophylaxis), SRH (sexual and reproductive health) services, and YWHC (Young Women's Health CoOp) to AGYW (adolescent girls and young women).

Group Type EXPERIMENTAL

Young Women's Health CoOp (YWHC)

Intervention Type BEHAVIORAL

In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.

Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum

Intervention Type BEHAVIORAL

The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.

Interventions

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Young Women's Health CoOp (YWHC)

In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.

Intervention Type BEHAVIORAL

Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum

The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.