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NOT YET RECRUITING
NCT07666139
NA

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

Sponsor: RTI International

View on ClinicalTrials.gov

Summary

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.

Official title: Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe

Key Details

Gender

FEMALE

Age Range

16 Years - 24 Years

Study Type

INTERVENTIONAL

Enrollment

2100

Start Date

2026-07-01

Completion Date

2028-10-31

Last Updated

2026-06-24

Healthy Volunteers

Yes

Conditions

Interventions

BEHAVIORAL

Comprehensive Adherence Resource and Empowerment Support' (CARES)

The CARES intervention includes one-on-one client-centered adherence counseling, objective adherence feedback, and optional support strategies selected according to participant needs and preferences, such as two-way SMS reminders, weekly check-ins, peer buddy support, and adherence clubs. The final intervention package will be adapted for study implementation during the formative phase of the study.

Locations (2)

Desmond Tutu Health Foundation

Cape Town, South Africa

Pangaea Zimbabwe

Harare, Zimbabwe