NCT05947539|Enrolling By InvitationDMC
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Sponsor study identifier
NIH
Secondary identifiers
NIH
interventional
80
1 country
1
Study Start
July 1, 2023
Actual (reported)Primary Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study will develop and pilot test a couples-based intervention to help adolescent girls and young women living with HIV (WLHIV (15-24 years) living in Uganda access HIV care and improve the outcomes of their HIV treatment by targeting male partner alcohol use to reduce IPV risk.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 22, 2023
Actual (reported)July 1, 2023
Actual (reported)July 17, 2023
Actual (reported)October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine
3 and 6 month follow up
change from baseline in self-reported antiretroviral therapy (ART) adherence (females and HIV+ male partners)
Self- report of missed ART using the AIDS Clinical Trials Group Adherence (AACTG) measures
3 and 6 month follow up
change from baseline in HIV care engagement (females and HIV+ male partners)
HIV clinic visit adherence
3 months, 6 months
change from baseline in phosphatidylethanol (PEth) (male partners)
alcohol biomarker (PEth) levels
6 months
Fear of intimate partner violence (males and females)
6 month follow up
change from baseline in HIV viral load (females and HIV+ males)
6 months
change from baseline in PrEP adherence (male partners taking PrEP)
3 and 6 month follow up
PrEP uptake
through 6 month follow-up
A brief couples-based intervention using motivational interviewing, peer navigation, and behavioral economic approaches to target intimate partner violence, alcohol use, and HIV care engagement.
Brief feedback on intimate partner violence and alcohol use (males), referrals for these conditions, and briefly discuss the importance of HIV care engagement and adherence.
The intervention consists of 5 bi-weekly sessions each lasting 60 to 90 minutes. It uses motivational interviewing, peer navigation, and behavioral economics to promote strategies for economic strengthening, reductions in male partner alcohol use, coping with relationship conflict and stress, changing norms that reduce intimate partner violence and support engagement in HIV care and antiretroviral therapy (ART) adherence among adolescent girls and young women living with HIV, and, thereby, enhances future sustained viral suppression and benefits of treatment as prevention.
Makerere Univerisity School of Public Health
Kampala, Uganda
Nwabuzor Ogbonnaya I, Nakigudde J, Naigino R, Stockman JK, Chung Y, Nantongo M, Marsiglia FF, Hahn JA, Wechsberg WM, Mwebembezi A, Wanyenze RK, Kiene SM. 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. Contemp Clin Trials. 2025 Dec;159:108136. doi: 10.1016/j.cct.2025.108136. Epub 2025 Nov 7.
Ijeoma Nwabuzor Ogbonnaya, PhD
Arizona State University
Susan M Kiene, PhD
San Diego State University
First Submitted
March 22, 2023
First Posted
July 17, 2023
Study Start
July 1, 2023
Actual (reported)Primary Completion
October 30, 2026
Estimated (date passed)change from baseline in heavy drinking (male partners)
assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)
3 months, 6 months
Intimate partner violence (IPV) occurence (males and females)
Any incident of IPV perpetration and victimization: physical, sexual, verbal/emotional, intimidation and/or controlling behavior measured using the World Health Organization (WHO) Instrument/ Demographic and Health Data (DHS) Domestic Violence Modules.
6 months
Intimate partner violence screening, alcohol screening, and referral
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
October 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 26, 2025
Record last verified: 2025-08
All collected individual participant data (IPD) that underlie the 6-month clinical trial, excluding qualitative data and data collected for formative research.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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