A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA
- Conditions
- HivSexually Transmitted Infection
- Interventions
- Behavioral: IMARA-SA (intervention group)Behavioral: Health promotion control group
- Registration Number
- NCT05504954
- Lead Sponsor
- University of Illinois at Chicago
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 120
Not provided
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IMARA-SA intervention arm IMARA-SA (intervention group) Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group). Health promotion control arm Health promotion control group Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).
- Primary Outcome Measures
Name Time Method Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and follow-up ~6 months (from baseline to follow-up) Completion of HTC
Proportion of adolescent girls and young women (AGYW) with a sexually transmitted infection (STI) at baseline and follow-up ~6 months (from baseline to follow-up) A positive test for at least one of two STIs: chlamydia and/or gonorrhea
Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and follow-up ~6 months (from baseline to follow-up) Uptake of PrEP
- Secondary Outcome Measures
Name Time Method Proportion of AGYW who report adherence to PrEP at baseline and follow-up ~6 months (from baseline to follow-up) Adherence to PrEP (where appropriate) will be measured via self-report using items from the Wilson scale (2017)
Proportion of AGYW who report risky sexual behavior at baseline and follow-up ~6 months (from baseline to follow-up) Sexual behavior (e.g., condom use, substance use during sex, number of partners, concurrent partners) will be measured via self-report using the AIDS Risk Behavior Assessment (ARBA) (Donenberg, 2001)
Trial Locations
- Locations (1)
Desmond Tutu HIV Centre
πΏπ¦Cape Town, Western Cape, South Africa