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

Sponsor
University of Illinois at Chicago
Study ID
NCT05504954
Status
Completed

Conditions

  • Hiv
  • Sexually Transmitted Infection

Eligibility Criteria

Sex
FEMALE
Age
15 Years - 19 Years
Healthy Volunteers
Accepted

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 group — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Oct 26, 2019
Status verified
Aug 2025
Primary completion
May 15, 2021
Completion
May 15, 2021

Study Design

Enrollment
61 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: IMARA-SA intervention arm
    Participants randomized to the IMARA-SA arm will receive the IMARA-SA intervention (i.e., the intervention group).
  • Experimental: Health promotion control arm
    Participants randomized to the health promotion control arm will receive the health promotion intervention (i.e., the control group).

Primary Outcome Measure

Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI) [ Time Frame: 8-17 months post baseline ]

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