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

Study Overview
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Brief Summary
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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.

Official Title
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Multilevel Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women

Conditions
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Sexually Transmitted Infection, Hiv

Intervention / Treatment
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* Behavioral: IMARA-SA (intervention group)
* Behavioral: Health promotion control group


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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Adolescent girl and young women-female caregiver (AGYW-FC) dyads will be randomized to the IMARA-SA intervention arm or a health promotion control arm matched in time and intensity. IMARA-SA and the health promotion program will be delivered as group interventions.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMARA-SA intervention arm<br>Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group). | Behavioral: IMARA-SA (intervention group)<br>* 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.<br>|
| Experimental: Health promotion control arm<br>Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group). | Behavioral: Health promotion control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of adolescent girls and young women (AGYW) with a sexually transmitted infection (STI) at baseline and follow-up | A positive test for at least one of two STIs: chlamydia and/or gonorrhea |  6 months (from baseline to follow-up) | 
| Proportion of AGYW who complete HIV testing and counseling (HTC) at baseline and follow-up | Completion of HTC |  6 months (from baseline to follow-up) | 
| Proportion of AGYW who elect to take pre-exposure prophylaxis (PrEP) at baseline and follow-up | Uptake of PrEP |  6 months (from baseline to follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of AGYW who report risky sexual behavior at baseline and 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) |  6 months (from baseline to follow-up) | 
| Proportion of AGYW who report adherence to PrEP at baseline and follow-up | Adherence to PrEP (where appropriate) will be measured via self-report using items from the Wilson scale (2017) |  6 months (from baseline to follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV prevention, Adolescent girls and young women, South Africa, Mother-daughter intervention