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ClinicalTrials.gov ID

NCT07666139

Lead Sponsor

RTI InternationalOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

2,100Estimated

Last Update Posted

Jun 26, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Oct 31, 2028Estimated

Completion Date

Oct 31, 2028Estimated

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

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.

• HIV

• Comprehensive Adherence Resource and Empowerment Support' (CARES)

Ages Eligible for Study

Child (0-17)Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

Yes

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.

Primary Purpose

Prevention

Allocation

N/A

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

RTI InternationalOTHER

Collaborators

National Institute of Mental Health (NIMH)NIH

University of ChicagoOTHER

Pangaea Zimbabwe Aids TrustOTHER

Desmond Tutu Health FoundationOTHER

nmgodi@uz-ctrc.org+263 772264616