A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women
NCT04758390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1290
Last updated 2025-01-20
Summary
To achieve an AIDS-free generation, there is a critical need for programs which go beyond individual-level behavior change to reduce HIV and STI infections among adolescent girls and young women in sub-Saharan Africa. Informed, Motivated, Aware, and Responsible Adolescents and Adults (IMARA) 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. The study will test whether AGYW receiving IMARA will have fewer sexually-transmitted infections (STI) and greater acceptance of HIV testing and counseling (HTC) and pre-exposure prophylaxis (PrEP) at 6-month follow-up compared to AGYW assigned to the health-promotion control intervention.
Conditions
- Sexually Transmitted Infections
- HIV Infections
Interventions
- BEHAVIORAL
-
IMARA (intervention group)
The IMARA 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'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 is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.
- BEHAVIORAL
-
Health promotion control group
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.
Sponsors & Collaborators
-
Desmond Tutu Health Foundation
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
collaborator NIH -
University of Illinois at Chicago
lead OTHER
Principal Investigators
-
Geri R Donenberg, PhD · University of Illinois at Chicago
-
Linda-Gail Bekker, MBChB, PhD · Desmond Tutu Health Foundation
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 15 Years
- Max Age
- 19 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-10-02
- Primary Completion
- 2024-04-07
- Completion
- 2024-10-04
Countries
- South Africa
Study Locations
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