Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sexually Transmitted Infection
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
Programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa are essential to meet global HIV targets. Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa (IMARA-SA) is an evidence-based HIV-prevention intervention for adolescent girls and young women (AGYW) and their female caregivers, which has been adapted for a South African audience. This pilot study will assess feasibility in preparation for a randomized controlled trial (RCT). Additionally, the pilot will examine the preliminary effectiveness of IMARA-SA in reducing sexually transmitted infections (STI) and increasing uptake of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at follow-up among AGYW. About 60 AGYW-FC dyads will be enrolled and randomized to IMARA-SA or a health-promotion control arm. Following randomization, the dyads will participate in an ~2-day group workshop (~10 hours), which includes joint and separate mother and daughter activities. AGYW and FC will complete baseline assessments and follow-up assessments approximately 6 months later. Assessments will include surveys, STIs testing (for chlamydia and gonorrhea), and uptake of HTC and a 1-month PrEP prescription. Additionally, the intervention's implementation (e.g., acceptability) will be explored.
Investigators
Natasha Crooks
Assistant Professor, Human Development Nursing Science
University of Illinois at Chicago
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- •AGYW will be excluded from the study if they do not have a FC to participate in the study.
- •AGYW and FC will be excluded from the study if they:
- •are unable to understand the consent/assent process and provide written informed consent;
- •are currently enrolled in another research study addressing HIV/STIs/PrEP;
- •participated in the IMARA-SA adaptation process. AGYW and FC must agree to participate as a dyad. AGYW refusal will supersede FC consent.
Outcomes
Primary Outcomes
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)
Time Frame: 8-17 months post baseline
A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Number of AGYW Completing HIV Testing and Counseling (HTC)
Time Frame: 8-17 months post baseline
Completion of HIV Testing and Counseling (HTC)
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)
Time Frame: 8-17 months post baseline
Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.
Secondary Outcomes
- AGYW Condom Use at Last Sex(6-10 months post baseline)
- AGYW Consistency of Condom Use(6-10 months post baseline)
- AGYW Substance Use During Sex in the Past 6 Months(6-10 months post baseline)
- Number of Partners in the Past 6 Months(6-10 months post baseline)
- AGYW's Report of Adherence to PrEP(6-10 months post baseline)