Clinical trial NCT04048551: The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
Official title: The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Prevention
Keywords: PrEP (Pre-exposure Prophylaxis)
HIV (Human Immunodeficiency Virus)
Adolescent Girls and Young Women (AGYW)
Stigma and Discrimination (S&D)
Gender-based violence (GBV)
Substance use
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Setshaba Research Centre
First posted: 2019-08-07
Enrollment: 802
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 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 purpose: PREVENTION

Brief 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.

Detailed description: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
timeFrame: Baseline
measure: Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
timeFrame: 4 months
measure: Health Clinic-Level Outcome: Level of Health Clinic Stigma and Discrimination
timeFrame: 8 months
measure: Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
timeFrame: Baseline
measure: Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
timeFrame: 4 months
measure: Health Clinic-Level Outcome: The Number of AGYW who Uptake HIV and SRH services, including PrEP
timeFrame: 8 months
measure: AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
timeFrame: Baseline
measure: AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
timeFrame: 3 months
measure: AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
timeFrame: 6 months
measure: AGYW Participant Self-Report: The Level of PrEP Readiness among AGYW
timeFrame: 9 months
measure: AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
timeFrame: 3 months
measure: AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
timeFrame: 6 months
measure: AGYW Participant Self-Report: PrEP Uptake and Adherence among AGYW
timeFrame: 9 months
measure: AGYW Biological Outcome: Adherence to PrEP
timeFrame: 3 months
measure: AGYW Biological Outcome: Adherence to PrEP
timeFrame: 6 months
measure: AGYW Biological Outcome: Adherence to PrEP
timeFrame: 9 months
measure: AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
timeFrame: 3 months
measure: AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
timeFrame: 6 months
measure: AGYW Participant Self-Report: Sexual and Reproductive Health Uptake among AGYW
timeFrame: 9 months
Secondary outcomes:
measure: AGYW Participant Self-Report: Frequency of Drug Use
timeFrame: Baseline
measure: AGYW Participant Self-Report: Frequency of Drug Use
timeFrame: 3 months
measure: AGYW Participant Self-Report: Frequency of Drug Use
timeFrame: 6 months
measure: AGYW Participant Self-Report: Frequency of Drug Use
timeFrame: 9 months
measure: AGYW Participant Self-Report: Frequency of Alcohol Use
timeFrame: Baseline
measure: AGYW Participant Self-Report: Frequency of Alcohol Use
timeFrame: 3 months
measure: AGYW Participant Self-Report: Frequency of Alcohol Use
timeFrame: 6 months
measure: AGYW Participant Self-Report: Frequency of Alcohol Use
timeFrame: 9 months
measure: AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
timeFrame: baseline
measure: AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
timeFrame: 3 months
measure: AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
timeFrame: 6 Months
measure: AGYW Participant Self-Report: Frequency of Combining Drugs and Alcohol Use
timeFrame: 9 months
measure: AGYW Participant Self-Report: Frequency of Condom Use
timeFrame: Baseline
measure: AGYW Participant Self-Report: Frequency of Condom Use
timeFrame: 3 months
measure: AGYW Participant Self-Report: Frequency of Condom Use
timeFrame: 6 months
measure: AGYW Participant Self-Report: Frequency of Condom Use
timeFrame: 9 months
measure: AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
timeFrame: Baseline
measure: AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
timeFrame: 3 months
measure: AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
timeFrame: 6 months
measure: AGYW Participant Self-Report: Frequency of Alcohol and Other Drug Use Prior to or During Sex
timeFrame: 9 months
measure: AGYW Participant Self-Report: Number of Other Sex Partners
timeFrame: Baseline
measure: AGYW Participant Self-Report: Number of Other Sex Partners
timeFrame: 3 months
measure: AGYW Participant Self-Report: Number of Other Sex Partners
timeFrame: 6 months
measure: AGYW Participant Self-Report: Number of Other Sex Partners
timeFrame: 9 months
measure: AGYW Participant Self-Report: Engagement in Sex Trading
timeFrame: Baseline
measure: AGYW Participant Self-Report: Engagement in Sex Trading
timeFrame: 3 months
measure: AGYW Participant Self-Report: Engagement in Sex Trading
timeFrame: 6 months
measure: AGYW Participant Self-Report: Engagement in Sex Trading
timeFrame: 9 months
measure: AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
timeFrame: Baseline
measure: AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
timeFrame: 3 months
measure: AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
timeFrame: 6months
measure: AGYW Participant Self- Report: Engagement with multiple sex partners (≥ 2 partners)
timeFrame: 9 months
measure: AGYW Participant Self-Report: Use of Contraception
timeFrame: Baseline
measure: AGYW Participant Self-Report: Use of Contraception
timeFrame: 3 months
measure: AGYW Participant Self-Report: Use of Contraception
timeFrame: 6 months
measure: AGYW Participant Self-Report: Use of Contraception
timeFrame: 9 months
measure: Medical Record: Use of Contraception
timeFrame: Through study completion, an average of nine months
measure: AGYW Participant Self-Report: Level of Perception of HIV Risk
timeFrame: Baseline
measure: AGYW Participant Self-Report: Level of Perception of HIV Risk
timeFrame: 3 months
measure: AGYW Participant Self-Report: Level of Perception of HIV Risk
timeFrame: 6 months
measure: AGYW Participant Self- Report; Level of Perception of HIV Risk
timeFrame: 9 months
measure: AGYW Participant Self-Report: The Frequency of Experienced Stigma
timeFrame: Baseline
measure: AGYW Participant Self-Report: The Frequency of Experienced Stigma
timeFrame: 3 months
measure: AGYW Participant Self-Report: The Frequency of Experienced Stigma
timeFrame: 6 months
measure: AGYW Participant Self-Report: The Frequency of Experienced Stigma
timeFrame: 9 months
measure: AGYW Participant Self-Report: The Level of Anticipated Stigma
timeFrame: Baseline
measure: AGYW Participant Self-Report: The Level of Anticipated Stigma
timeFrame: 3 months
measure: AGYW Participant Self-Report: The Level of Anticipated Stigma
timeFrame: 6 months
measure: AGYW Participant Self-Report: The Level of Anticipated Stigma
timeFrame: 9 months
measure: AGYW Participant Self-Report: The Frequency of Observed Stigma
timeFrame: Baseline
measure: AGYW Participant Self-Report: The Frequency of Observed Stigma
timeFrame: 3 months
measure: AGYW Participant Self-Report: The Frequency of Observed Stigma
timeFrame: 6 months
measure: AGYW Participant Self-Report: The Frequency of Observed Stigma
timeFrame: 9 months
Other outcomes:
Locations:
city: Soshanguve
country: South Africa
facility: Setshaba Research Centre
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Minnis AM, Nyblade L, Speizer IS, Howard BN, Myers B, Ahmed K. The PrEPARE Pretoria Project: protocol for a cluster-randomized factorial-design trial to prevent HIV with PrEP among adolescent girls and young women in Tshwane, South Africa. BMC Public Health. 2020 Sep 15;20(1):1403. doi: 10.1186/s12889-020-09458-y.