N/A
N=59
A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA
Sexually Transmitted Infection · Hiv
Bottom Line
View on ClinicalTrials.gov: NCT05504954 ↗Enrolled (actual)
59
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI) — 4; 6 Participants — p=0.15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IMARA-SA (intervention group) (Behavioral); Health promotion control group (Behavioral)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI) |
4; 6 | 0.15 |
| PRIMARY Number of AGYW Completing HIV Testing and Counseling (HTC) |
20; 17 | — |
| PRIMARY Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP) |
17; 9 | 0.10 |
| SECONDARY AGYW's Report of Adherence to PrEP |
60.7; 54.4 | 0.65 |
| SECONDARY AGYW Condom Use at Last Sex |
10; 4; 8; 5 | 0.70 |
| SECONDARY AGYW Consistency of Condom Use |
10; 4; 8; 5 | .70 |
| SECONDARY AGYW Substance Use During Sex in the Past 6 Months |
9; 4; 9; 5 | 1.00 |
| SECONDARY Number of Partners in the Past 6 Months |
14; 8; 4; 1 | 0.64 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT05504954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.