The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study

The primary aim of this study is to adapt the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention to support adolescent girls and young women (AGYW) aged 16-24 in Zimbabwe and South Africa in effectively using various forms of pre-exposure prophylaxis (PrEP), specifically oral, ring, and injectable PrEP. Originally developed for a clinical trial setting, CARES has shown promising results in enhancing effective PrEP use through a structured mix of counseling, SMS/phone calls, and peer support for daily oral PrEP and the PrEP ring. However, its resource-intensive design requires adaptation for routine public health settings to ensure feasibility, fidelity, acceptability, and effectiveness. This adapted intervention will be tailored with input from AGYW, PrEP providers, and local stakeholders to support sustainable PrEP use and address HIV prevention needs among AGYW. Additionally, it will incorporate injectable PrEP and be modified to suit routine public health contexts. Once the components are finalized, the adapted CARES intervention will be evaluated for effectiveness, feasibility, fidelity, and acceptability.

NCT Number	NCT07666139
Lead Sponsor	RTI International Collaborators: National Institute of Mental Health (NIMH), University of Chicago, Pangaea Zimbabwe Aids Trust, Desmond Tutu Health Foundation
Conditions	HIV
Enrollment	2,100 participants
Start Date	2026-07-01
Primary Completion	2028-10-31 (estimated)
Study Completion	2028-10-31 (estimated)
Updated on ClinicalTrials.gov	2026-06-26