Contemporary clinical trials · 2025
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.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Nwabuzor Ogbonnaya Ijeoma, Nakigudde Janet, Naigino Rose, Stockman Jamila K, Chung Yunro, Nantongo Molly, Marsiglia Flavio F, Hahn Judith A, Wechsberg Wendee M, Mwebembezi Abel, Wanyenze Rhoda K, Kiene Susan M
Аннотация
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.
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.