A Multilevel Comprehensive Response on Uptake and Adherence to HIV Prevention Among Adolescent Girls and Young Women

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PROJECT SUMMARY/ABSTRACT We propose a 5-year 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. We will collaborate with the Department of Health to ensure that PrEP is available for all HIV-negative AGYW who engage in condomless sex. Under the Expanded Public Works Program (EPWP), supported by the Department of Health and Social Development, female beneficiaries will help serve as peer recruiters and PrEP club leaders. We will engage all stakeholders and establish 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 reproductive health and PrEP uptake and adherence. Using a similar stakeholder engagement approach, we will also adapt a stigma and discrimination (S&D) reduction training curriculum for clinic staff. The multilevel strategy will be implemented and evaluated through two levels of randomization. First, we will randomize geographic zones (1:1) to the health clinic S&D training arm or the no training arm. Clinics located in health clinic training zones will participate in workshops aimed to reduce health providers' stigmatizing and discriminatory attitudes and behaviors. The training aims to reduce AGYW's barriers to healthcare access to enhance PrEP uptake. Second, we will randomize trained and non-trained clinics to one of three arms (1:1:1): Arm 1: provision of PrEP only; Arm 2: provision of PrEP with a PrEP club for social support to increase adherence; and Arm 3: provision of PrEP with a PrEP club as well as the WHC to address PrEP uptake and adherence alongside other risk factors such as personal agency, GBV, and substance use. Primary outcomes will include initiation of and adherence to PrEP to prevent HIV infection; secondary outcomes will include reduction of HIV risk behaviors. The proposed Specific Aims are as follows: Aim 1: To engage stakeholders, the Community Collaborative Board, and the YAB in adapting the WHC and S&D reduction training, establish PrEP clubs, and train 24 EPWP beneficiaries as recruiters to identify AGYW engaging in high-risk sex in 6 zones in the Pretoria area during a formative stage. Aim 2. To evaluate the impact of training on S&D among healthcare staff on the use of HIV and reproductive health services by AGYW, including PrEP, and staff attitudes and behaviors toward AGYW at 3-, 6-, and 12-month follow-up. Aim 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 GBV) factors on PrEP uptake and adherence (primary outcomes) and condom use, GBV, substance use, and HIV incidence (secondary) at 3-, 6-, and 12-month follow-up among vulnerable AGYW.