The PrEPARE Project: Prevention, Empowering, and Protecting Young Women in South Africa
Condition: HIV Prevention
Study type: Interventional

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.
    

Intervention name(s): Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum; Young Women's Health CoOp (YWHC)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Factorial Assignment
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.
Masking: None (Open Label)
Primary purpose: 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