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NCT Number: NCT07666139

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.

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Key information

Conditions

HIV

Age range

16 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Desmond Tutu Health Foundation, Cape Town, South Africa

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Percentage of participants with high PrEP adherence [High PrEP adherence]

    Time frame: 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.

    Percent of subsample participants per clinic per month with (1) biomarker TFVdp levels indicating consistent use (≥700 fmol/punch, corresponding to 4 doses per week) for the past 1-2 months; (2) >4mg Dapivirine released from used PrEP rings, indicating consistent use for the past 4 weeks; or (3) clinical records indicating on-time injection of injectable PrEP

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Roberts, PhD

CONTACT

[email protected]

+1919-541-6000

Sponsors and collaborators

Lead sponsor

RTI International

Other

Collaborators

  • Desmond Tutu Health Foundation
  • National Institute of Mental Health (NIMH)
  • Pangaea Zimbabwe Aids Trust
  • University of Chicago

Registry information

Official study 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

Acronym: CARES

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 24, 2026
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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