A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA

Not Applicable

Completed

• Conditions: Hiv; Sexually Transmitted Infection

• 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

Study Timeline

• Study Start: 2019-10-26
• Primary Completion: 2021-05-15
• Study Completion: 2021-05-15
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-17
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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:

1. are unable to understand the consent/assent process and provide written informed consent;
2. are currently enrolled in another research study addressing HIV/STIs/PrEP;
3. 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

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; 🇿🇦 Cape Town, Western Cape, South Africa