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

Not Yet RecruitingNA

Sponsor: RTI International

Conditions: HIV

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

Countries: South Africa, Zimbabwe

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.

Eligibility overview

Sex: FEMALE

Age: 16 Years to 24 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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.

Locations (2)

Cape Town, South Africa
Harare, Zimbabwe