NCT07666139Not yet recruiting
The 'Comprehensive Adherence Resource and Empowerment Support' (CARES) Study
Adapting the 'Comprehensive Adherence Resource and Empowerment Support' Intervention for Multiple PrEP Methods Among Adolescent Girls and Young Women in South Africa and Zimbabwe
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 2100 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Oct 2028
- Lead sponsor
- RTI International
- Diseases
- HIV
- NCT number
- NCT07666139
What you commit to
- Study type: Interventional
- Planned participants: 2100
- From 1 Jul 2026 to the primary completion date, 31 Oct 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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.
Age in the registry: 16 years to 24 years · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Desmond Tutu Health Foundation Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| Pangaea Zimbabwe Coordinator of this site? Confirm its status | Harare | Zimbabwe | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.