PMID- 36962830 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20230327 IS - 2767-3375 (Electronic) IS - 2767-3375 (Linking) VI - 3 IP - 2 DP - 2023 TI - Preliminary effectiveness and implementation outcomes of the IMARA-South Africa sexual health intervention on adolescent girls and young women: A pilot randomized trial. PG - e0001092 LID - 10.1371/journal.pgph.0001092 [doi] LID - e0001092 AB - 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. CI - Copyright: This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication. FAU - Merrill, Katherine G AU - Merrill KG AUID- ORCID: 0000-0001-5308-4154 AD - Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago, Chicago, IL United States of America. FAU - Atujuna, Millicent AU - Atujuna M AD - Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa. FAU - Emerson, Erin AU - Emerson E AD - Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago, Chicago, IL United States of America. FAU - Blachman-Demner, Dara AU - Blachman-Demner D AD - Office of Behavioural and Social Sciences, National Institutes of Health, Bethesda, MD, United States of America. FAU - Bray, Bethany C AU - Bray BC AD - Institute for Health Research and Policy, University of Illinois Chicago, Chicago, IL, United States of America. FAU - Bekker, Linda-Gail AU - Bekker LG AD - Desmond Tutu HIV Centre, University of Cape Town, Cape Town, South Africa. FAU - Donenberg, Geri R AU - Donenberg GR AD - Department of Medicine, Center for Dissemination and Implementation Science, University of Illinois Chicago, Chicago, IL United States of America. LA - eng SI - ClinicalTrials.gov/NCT05504954 PT - Journal Article DEP - 20230215 PL - United States TA - PLOS Glob Public Health JT - PLOS global public health JID - 9918283779606676 PMC - PMC10022073 COIS- The authors have declared that no competing interests exist. EDAT- 2023/03/25 06:00 MHDA- 2023/03/25 06:01 PMCR- 2023/02/15 CRDT- 2023/03/24 18:19 PHST- 2022/08/16 00:00 [received] PHST- 2023/01/16 00:00 [accepted] PHST- 2023/03/24 18:19 [entrez] PHST- 2023/03/25 06:00 [pubmed] PHST- 2023/03/25 06:01 [medline] PHST- 2023/02/15 00:00 [pmc-release] AID - PGPH-D-22-01037 [pii] AID - 10.1371/journal.pgph.0001092 [doi] PST - epublish SO - PLOS Glob Public Health. 2023 Feb 15;3(2):e0001092. doi: 10.1371/journal.pgph.0001092. eCollection 2023.