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

N/ANot Yet RecruitingNCT07666139

RTI International2,100 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

2,100

Conditions

HIV

Interventions

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.

Eligibility

Sex: FEMALEMin age: 16 YearsMax age: 24 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

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

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

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.