HIV
Conditions
Keywords
PrEP, AGYW, South Africa, Zimbabwe, Effectiveness, Feasibility, Acceptability, Fidelity
Brief summary
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
BEHAVIORALComprehensive 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.
Sponsors
RTI International
National Institute of Mental Health (NIMH)
University of Chicago
Pangaea Zimbabwe Aids Trust
Desmond Tutu Health Foundation
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
The study will use a pragmatic multiple-baseline interrupted time series (ITS) design to compare use of pre-exposure prophylaxis (PrEP) at the clinic level before and after intervention implementation at four sites. Each site will be randomly assigned to a staggered intervention start date, and outcomes will be assessed monthly over 27 months. A 6-month washout period will be included immediately after the intervention start date to allow clients time to participate in the Comprehensive Adherence Resource and Empowerment Support (CARES) intervention before they are included in the intervention delivery period assessments. The primary outcome will be at the clinic-level as the proportion of AGYW per clinic continuing on any PrEP product. The secondary outcome will be the proportion of AGYW per clinic with high adherence to any PrEP product, which will be estimated using a repeat cross-sectional subsample of up to100 participants (25 per facility per month).
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 24 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of AGYW receiving on-time PrEP resupply [PrEP continuation] | 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants with high PrEP adherence [High PrEP adherence] | 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 |
Countries
South Africa, Zimbabwe
Contacts
CONTACTSarah Roberts, PhD
PRINCIPAL_INVESTIGATORSarah Roberts, PhD
RTI International
PRINCIPAL_INVESTIGATORMillicent Atujuna, PhD
Desmond Tutu Health Foundation
PRINCIPAL_INVESTIGATORNyaradzo Mavis Mgodi, MBChB, MMed
Pangaea Zimbabwe Aids Trust
Outcome results
None listed