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

University of Illinois at Chicago61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Sexually Transmitted Infection

Interventions

IMARA-SA (intervention group)BEHAVIORAL

The IMARA-SA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA-SA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA-SA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.

Health promotion control groupBEHAVIORAL

The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria for AGYW include: 1. Black or mixed race; 2. 15-19 years-old; 3. residing in Klipfontein/Mitchells Plain (K/MP); 4. speak isiXhosa or English or a combination of these languages. Inclusion criteria for FC include: 1. identified by AGYW as a FC; 2. 24 years and older; 3. living with or in daily contact with the AGYW; 4. speak isiXhosa or English or a combination of these languages. 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.

Outcomes

Primary Outcomes

Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI)

A positive test for at least one of two STIs: chlamydia and/or gonorrhea

Time frame: 8-17 months post baseline

Number of AGYW Completing HIV Testing and Counseling (HTC)

Completion of HIV Testing and Counseling (HTC)

Time frame: 8-17 months post baseline

Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP)

Uptake of Pre-Exposure Prophylaxis (PrEP) assessed as receipt of PrEP prescription from research team or other care provider after the baseline survey.

Time frame: 8-17 months post baseline

Secondary Outcomes

AGYW's Report of Adherence to PrEP

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.