Trial results for the IMARA-SA pilot study, focused on HIV prevention for South African adolescent girls and young women, were posted on ClinicalTrials.gov on 2025-08-22, with a total enrollment of 61 participants.
Background
HIV and sexually transmitted infections (STIs) continue to pose significant public health challenges, particularly among adolescent girls and young women (AGYW) in sub-Saharan Africa. Addressing these challenges requires comprehensive prevention strategies that extend beyond individual-level behavior modification. The IMARA-SA (Informed, Motivated, Aware and Responsible Adolescents and Adults- South Africa) program is an evidence-based HIV prevention intervention designed for AGYW and their female caregivers. This pilot study aimed to assess the feasibility of the IMARA-SA intervention in a South African context, in preparation for a larger randomized controlled trial.
Trial design
This completed pilot study, designated as Phase NA, enrolled 61 participants to investigate conditions including Sexually Transmitted Infection and Hiv. The trial compared the IMARA-SA intervention arm, which delivered a comprehensive HIV prevention package, against a health promotion control arm. The study's primary objective was to assess feasibility for a future randomized controlled trial.
Key results
The pilot study reported several key measurements and analyses:
- Number of AGYW Who Tested Positive for a Sexually Transmitted Infection (STI):
- IMARA-SA Intervention Arm: 4 participants
- Health Promotion Control Arm: 6 participants
- Number of AGYW Completing HIV Testing and Counseling (HTC):
- IMARA-SA Intervention Arm: 20 participants
- Health Promotion Control Arm: 17 participants
- Number of AGYW Who Elected to Take Pre-Exposure Prophylaxis (PrEP):
- IMARA-SA Intervention Arm: 17 participants
- Health Promotion Control Arm: 9 participants
- AGYW's Report of Adherence to PrEP (score on a scale):
- IMARA-SA Intervention Arm: Mean 60.7 (Standard Deviation 19.5)
- Health Promotion Control Arm: Mean 54.4 (Standard Deviation 30.8)
- AGYW Condom Use at Last Sex:
- IMARA-SA Intervention Arm: 10 participants
- Health Promotion Control Arm: 4 participants
- IMARA-SA Intervention Arm: 8 participants
- Health Promotion Control Arm: 5 participants
Key analyses included:
- A Logistic Regression analysis reported an Odds Ratio (OR) of 0.26 (95.0% CI 0.04 to 1.59) with a p-value of 0.15.
- Another Logistic Regression analysis reported an Odds Ratio (OR) of 2.83 (95.0% CI 0.81 to 9.89) with a p-value of 0.1.
- A Linear Regression analysis reported a beta coefficient of 5.0 (95.0% CI -17.78 to 27.78) with a p-value of 0.65.
- Fisher Exact tests reported p-values of 0.7, 0.7, and 1.
What this means
The results from this pilot study suggest potential trends for the IMARA-SA intervention in HIV and STI prevention among South African AGYW. The intervention arm reported fewer participants testing positive for STIs, higher rates of HIV Testing and Counseling completion, and a greater number of participants electing to take Pre-Exposure Prophylaxis (PrEP) compared to the health promotion control arm. Reported PrEP adherence was also numerically higher in the intervention group. While the statistical analyses did not show significant p-values, which is common in pilot and feasibility studies, these preliminary findings can inform the design and power calculations for a larger randomized controlled trial to further evaluate the efficacy of the IMARA-SA program.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05504954, titled "A Comprehensive HIV Prevention Package for South African Adolescent Girls and Young Women: IMARA SA", were posted on 2025-08-22 on clinicaltrials.gov.