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Not yet recruiting NCT07666139

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

No phase Interventional HIV

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Adherence Resource and Empowerment Support' (CARES).
Who it may be relevant to
Registry conditions: HIV. Basic parameters: 16 years — 24 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa, Zimbabwe
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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.

Primary outcome measures

  • 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.]
Secondary outcome measures (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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

South Africa · 1 center
  • Desmond Tutu Health Foundation — Cape Town
Zimbabwe · 1 center
  • Pangaea Zimbabwe — Harare

Identifiers

NCT: NCT07666139 · HREC-020/2025; MRCZ/A/3293 · R01MH137804

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗