Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial.

Family-based interventions may help reduce the risk of HIV and other sexually transmitted infections (STI) among adolescent girls and young women (AGYW) in sub-Saharan Africa but few have been tested. We examined the preliminary effectiveness and implementation outcomes of Informed, Motivated, Aware, and Responsible Adolescents and Adults-South Africa (IMARA-SA), an evidence-based intervention for South African AGYW (15-19 years) and their female caregivers. We piloted IMARA-SA in the Western Cape using an individually randomized experimental design and average follow-up at 11 months. Primary outcomes were HIV Testing and Counselling (HTC) uptake, STI incidence (gonorrhea, chlamydia), and pre-exposure prophylaxis (PrEP) uptake. Secondary outcomes were self-reported sexual risk behavior (condom use at last sex, consistency of condom use, substance use during sex, and number of sexual partners) and PrEP adherence. We examined four implementation outcomes: reach, feasibility, acceptability, and fidelity. Data from 59 AGYW (mean = 17.2 years) were analyzed at baseline (n = 29 from IMARA-SA, 30 from a health promotion control group). At follow-up, 51 (86%) completed surveys and 39 (66%) presented for HTC, STI testing, and/or PrEP. Compared to controls, fewer IMARA-SA participants tested positive for an STI (22% versus 38%), more IMARA-SA participants took up PrEP (68% versus 45%), and four of five secondary outcomes favored the IMARA-SA group at follow-up. These differences did not reach statistical significance. HTC uptake at follow-up was 100% in both groups. All AGYW-FC dyads agreed to participate in the study (reach). In the IMARA-SA group, 76% of dyads completed the intervention (feasibility), and over 76% of acceptability ratings from AGYW and their FC had the highest Likert rating. Fidelity of intervention delivery was 95%. IMARA-SA is a promising strategy for reducing HIV/STI risk among South African AGYW. We found strong evidence of reach, feasibility, acceptability, and fidelity. A fully powered randomized controlled trial is warranted. Trial registration: Clinical trials.gov registration number: NCT05504954.