CARES STUDY
About CARES Study
The Comprehensive Adherence Resource and Empowerment Support (CARES) intervention is an evidence-informed program that aims to support consistent and effective use of HIV pre-exposure prophylaxis (PrEP) methods among adolescent girls and young women (AGYW). The goals are to adapt CARES to be implementable in a range of public health settings, incorporating injectable PrEP, and to evaluate the effectiveness and implementation of the adapted intervention in Zimbabwe and South Africa. To ensure that the adaptation is informed by experienced product users and providers, the proposed study will leverage two ongoing implementation projects that offer all three PrEP products, and it will be supported through extensive engagement with AGYW and other stakeholders at each site.
Objectives
- Adapt CARES to be implementable and effective in supporting AGYW’s adherence to oral, ring, and injectable PrEP in real-world delivery settings. Existing data on adherence barriers and support will be, then conduct 24 interviews with PrEP providers, program leaders, policy makers, and funders and six focus group discussions with AGYW PrEP users. Findings from this formative work will be reviewed in workshops with AGYW experts to determine how to streamline CARES while preserving its mechanisms of action. The adapted materials will be pretested with AGYW and reviewed by providers, program leaders, and policy makers before finalization.
- Test the effectiveness of CARES to increase PrEP continuation and adherence. Using a rigorous interrupted time series design, four sites from two countries have been randomly assigned staggered intervention start dates with monthly pre- and post-implementation outcome assessments for 24 months. The primary outcome will be the proportion of AGYW continuing on any PrEP product for 3 months after initiation, per clinical records. The secondary outcome will be the proportion with high PrEP adherence, assessed by clinical record review and biomarkers among a subsample of 100 AGYW per month.
- Evaluate the implementation of CARES in real-world settings, including feasibility, acceptability, and fidelity. The evaluation will employ a parallel convergent mixed methods design.
Focus Area
The study uses focus group discussions, key informant interviews and participatory adaptation workshops to develop youth-responsive PrEP adherence support tools. It also assesses PrEP use, adherence support and intervention implementation to inform sustainable HIV prevention services. The study is expected to produce adapted counselling manuals, standard operating procedures, job aids and monitoring tools. The intervention phase will assess PrEP uptake, adherence support, continuation and implementation outcomes.
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Study Sites: Chitungwiza and Cowdray Park Clinic
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Key Informant Interviews
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AGYW Focus Group Participations
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Years Study Duration
