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

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.

Conditions

• HIV

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• University of Chicago

  collaborator OTHER

• Pangaea Zimbabwe Aids Trust

  collaborator OTHER

• Desmond Tutu Health Foundation

  collaborator OTHER

• RTI International

  lead OTHER

Principal Investigators

• Sarah Roberts, PhD · RTI International

• Millicent Atujuna, PhD · Desmond Tutu Health Foundation

• Nyaradzo Mavis Mgodi, MBChB, MMed · Pangaea Zimbabwe Aids Trust

Study Design

Allocation

NA

Purpose

PREVENTION

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

16 Years

Max Age

24 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2028-10-31

Completion

2028-10-31

Countries

• South Africa
• Zimbabwe

Study Locations