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

NCT07666139 | Not Yet Recruiting DMC

• 2 other identifiers: HREC-020/2025; MRCZ/A/3293R01MH137804
• Study Type: interventional
• Target: 2,100
• Locations: 2 countries
• Sites: 2

Brief 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

Keywords

PrEP; AGYW; South Africa; Zimbabwe; Effectiveness; Feasibility; Acceptability; Fidelity

Outcome Measures

Primary Outcomes (1)

• Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation]

  Percent of AGYW per clinic per month who have received on-time PrEP resupply at all scheduled visits for 3 months after initiation for CAB injection, oral PrEP, and ring or 6 months after initiation for LEN injection. Measured among those due for resupply visit in that month. On-time resupply is defined as resupply within a 14-day window of the target date to ensure continuous coverage.

  Monthly for 27 months from the start of the pre-intervention period to the end of the intervention delivery period.

Secondary Outcomes (1)

• Percentage of participants with high PrEP adherence [High PrEP adherence]

  Monthly for a total of 21 months, from the start of the pre-intervention period to the end of the intervention delivery period with a pause during the 6-month washout period after the start of intervention delivery.

Study Arms (1)

Comprehensive Adherence Resource and Empowerment Support (CARES)

EXPERIMENTAL

Each health facility will initially offer standard of care (SOC) adherence counseling, then will transition on a randomly assigned start date to offering the CARES intervention instead of SOC adherence counseling. Choice of available PrEP methods will be available throughout the study as part of standard of care at the health facilities.

Behavioral: Comprehensive Adherence Resource and Empowerment Support' (CARES)

Interventions

Comprehensive Adherence Resource and Empowerment Support' (CARES) BEHAVIORAL

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.

Comprehensive Adherence Resource and Empowerment Support (CARES)

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

Aim 2: Inclusion (AGYW): * age 16-24 years (in Zimbabwe, participants aged 16 to 17 years must meet the legal criteria for emancipation to be eligible) * has initiated PrEP during the study, or no more than 6 months before the study initiation date (for LEN PrEP), or no more than 3 months before the study initiation date (for oral, ring, or CAB PrEP), and * willing and able to provide written informed consent for access to medical records, or assent and parental consent if applicable * fluent in one of the study languages (English, isiXhosa, Shona, Ndebele) * target date for PrEP resupply (i.e., to ensure continued coverage) falls within the month.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• RTI International: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Chicago: collaborator
• Pangaea Zimbabwe Aids Trust: collaborator
• Desmond Tutu Health Foundation: collaborator

Study Sites (2)

Desmond Tutu Health Foundation

Cape Town, South Africa

Location

Pangaea Zimbabwe

Harare, Zimbabwe

Location

Study Officials

• Sarah Roberts, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Millicent Atujuna, PhD

  Desmond Tutu Health Foundation

  PRINCIPAL INVESTIGATOR

• Nyaradzo Mavis Mgodi, MBChB, MMed

  Pangaea Zimbabwe Aids Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Roberts, PhD

CONTACT

+1919-541-6000; sroberts@rti.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Epidemiologist

Model Details: The study will use a pragmatic multiple-baseline interrupted time series (ITS) design to compare use of pre-exposure prophylaxis (PrEP) at the clinic level before and after intervention implementation at four sites. Each site will be randomly assigned to a staggered intervention start date, and outcomes will be assessed monthly over 27 months. A 6-month washout period will be included immediately after the intervention start date to allow clients time to participate in the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention before they are included in the intervention delivery period assessments. The primary outcome will be at the clinic-level as the proportion of AGYW per clinic continuing on any PrEP product. The secondary outcome will be the proportion of AGYW per clinic with high adherence to any PrEP product, which will be estimated using a repeat cross-sectional subsample of up to100 participants (25 per facility per month).

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

ZA (1); ZI (1)