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

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)	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)	8-17 months post baseline	Completion of HIV Testing and Counseling (HTC)
Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)	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 Outcome Measures

Name	Time	Method
AGYW Condom Use at Last Sex	6-10 months post baseline	Self-reported condom use at last vaginal or anal sex using the AIDS Risk Behavior Assessment (ARBA).
AGYW Consistency of Condom Use	6-10 months post baseline	Self-reported consistency of condom use during vaginal and anal sex in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
AGYW Substance Use During Sex in the Past 6 Months	6-10 months post baseline	Self-reported number of times had vaginal or anal sex while drinking or taking drugs in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
Number of Partners in the Past 6 Months	6-10 months post baseline	Self-reported number of vaginal or anal sex partners in the past 6-months using the AIDS Risk Behavior Assessment (ARBA).
AGYW's Report of Adherence to PrEP	6-10 months post baseline	Adherence to PrEP is measured using an adapted version of the Wilson scale (2017). Measure Description: (0=low adherence to 100=high adherence) Scale is comprised of 3 items: number of days dose missed, how often did you take PrEP in the way you were supposed to, how good a job did you do at taking PrEP. Items were transformed to a 0-100 scale and averaged. Thirty was subtracted from number of days missed and multiplied by 3.33. Responses for remaining 2 items: never/very poor=0, rarely/poor=20, sometimes/fair=40, usually/good=60, almost always/very good=80, always/excellent=100.