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

RTI International

Status: Completed

Conditions: HIV Prevention

Treatments: Behavioral: Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum; Behavioral: Young Women's Health CoOp (YWHC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04048551

R01HD094629

Details and patient eligibility

About

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.

Full 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.

Enrollment: 802 patients

Sex: Female

Ages: 16 to 24 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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802 participants in 4 patient groups

No S&D Reduction Training; PrEP and SRH only

No Intervention group

Description:

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).

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

Experimental group

Description:

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).

Treatment:

Behavioral: Young Women's Health CoOp (YWHC)

S&D Reduction Training; PrEP and SRH only

Active Comparator group

Description:

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).

Treatment:

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

S&D Reduction Training; PrEP, SRH + YWHC

Experimental group

Description:

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).

Treatment:

Behavioral: Young Women's Health CoOp (YWHC)

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