Protocol for the Kisoboka Mukwano pilot randomized controlled trial in Uganda: A couples-based intervention to reduce intimate partner violence and alcohol use among adolescent girls and young women living with HIV and their male partners - PubMed (original) (raw)

doi: 10.1016/j.cct.2025.108136. Epub 2025 Nov 7.

Janet Nakigudde 2, Rose Naigino 3, Jamila K Stockman 4, Yunro Chung 5, Molly Nantongo 6, Flavio F Marsiglia 6, Judith A Hahn 7, Wendee M Wechsberg 8, Abel Mwebembezi 9, Rhoda K Wanyenze 10, Susan M Kiene 11

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Protocol for the Kisoboka Mukwano pilot randomized controlled trial in Uganda: A couples-based intervention to reduce intimate partner violence and alcohol use among adolescent girls and young women living with HIV and their male partners

Ijeoma Nwabuzor Ogbonnaya et al. Contemp Clin Trials. 2025 Dec.

Abstract

Background: Adolescent girls and young women living with HIV (AGYWLHIV) with intimate partner violence (IPV) have worse HIV care outcomes than those without IPV. The Kisoboka Mukwano intervention aims to improve AGYW's HIV care engagement through reducing IPV associated with male partner alcohol use. The primary objectives of this pilot randomized controlled trial (RCT) are to assess safety, acceptability, feasibility, and preliminary efficacy.

Methods: This 6-month parallel two-arm pilot RCT will occur in Wakiso District, Uganda. Participants are AGYWLHIV (aged 15-24) who are married/cohabiting with a male partner, non-engaged in HIV care, and report IPV. Male partners must report past 30-day hazardous alcohol use. Couples will be recruited through HIV clinics and nearby communities and randomized using a pre-programmed allocation sequence. The six-session intervention arm promotes strategies for reducing alcohol use, coping with relationship conflict and stress, changing norms that reduce IPV, and engaging in HIV care. The control arm involves brief counseling and referrals. The primary outcomes include safety, acceptability, feasibility, and the likelihood of changes in HIV care, alcohol use, and IPV. At 3-and-6-month follow-ups, we anticipate reduced IPV among couples, improved ART adherence in AGYW, and decreased hazardous alcohol use in male partners in the intervention arm compared to controls. Outcome assessors will be blind to the study arm.

Results: We screened 194 couples; 59 (30.4 %) were eligible, and 44 remain eligible. We aim to enroll 40 couples.

Conclusions: If feasible, safe, and acceptable, Kisoboka Mukwano can improve HIV care engagement among Ugandan AGYWLHIV by reducing IPV.

Trial registration: ClinicalTrials.gov identifier: NCT05947539.

Keywords: Alcohol use; Couples-based intervention; Gender-based violence; HIV intervention; Sub-Saharan Africa; Youth.

Copyright © 2024. Published by Elsevier Inc.

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Conflict of interest statement

Declaration of competing interest The authors declared no potential conflicts of interest concerning the research, authorship, and/or publication of this article.

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