Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention

Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women Through Reductions in Male Partner Alcohol Use and Intimate Partner Violence Risk: The Kisoboka Mukwano Intervention

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alcohol Use Disorder; Domestic Violence; Intimate Partner Violence; HIV-infection/Aids
• Intervention / Treatment: Behavioral: Kisoboka Mukwano ("It is possible, my love!") Intervention; Behavioral: Screening and Referral

Detailed Description

In Uganda, adolescent girls and young women (AGYW) are disproportionately affected by HIV and have poor viral suppression rates, increasing their risk of onward transmission. Intimate partner violence (IPV) is a major barrier to mitigating the impact of HIV among AGYW. AGYW living with HIV (AGYWLHIV) in sub-Saharan Africa (SSA) who have experienced IPV have worse medication adherence, viral suppression, and care engagement than those without IPV. Further, male partner alcohol use directly and indirectly increases IPV risk among AGYW in SSA. Thus, an intervention with components that address heavy alcohol use among male partners could decrease AGYW's IPV risk, especially in Uganda, which has the highest alcohol use per capita in SSA. Couples- based interventions have effectively reduced male partner alcohol use, relationship conflict IPV, and improved viral suppression and HIV care engagement; yet, none have been tailored to AGYWLHIV in SSA. The investigators propose to develop and pilot a couples-based intervention that focuses on improving HIV care engagement and ART adherence among AGYWLHIV by reducing heavy alcohol use among male partners and couple IPV risk. Additionally, the investigators will explore the intervention's effects on AGYW viral load for the additional key benefit of treatment as prevention. The study aims are to: 1) Adapt the behavioral components of a brief Motivational Interviewing (MI)-based alcohol intervention to create the proposed Kisoboka Mukwano ("It is possible, my love!") intervention. The intervention will promote strategies for reductions in male partner alcohol use, coping with relationship conflict and stress, changing norms that reduce IPV and support engagement in HIV care and ART adherence among AGYWLHIV, and, thereby, enhance future sustained viral suppression and benefits of treatment as prevention. The intervention will be adapted and tailored to be delivered with heterosexual couples, involve peer navigators, address IPV, and be developmentally appropriate for AGYWLHIV in Uganda. The investigators will develop and refine the intervention in collaboration with an intervention steering committee through: qualitative research with married/cohabiting AGYWLHIV, married/cohabiting men, and key informants and an initial pilot test with 6 couples. 2) The investigators will assess safety, acceptability, feasibility, and preliminary estimates of the potential for the intervention, as compared to the control group, to improve HIV, alcohol, and IPV outcomes. The investigators will examine preliminary effects on AGYW HIV care engagement, AGYW ART adherence, heavy alcohol use among male partners, and couple IPV risk and explore effects on AGYW viral load as well as intermediate outcomes related to intervention components. The investigators will assess these outcomes at baseline and then at 3- and 6-month follow-up. Study findings will be used to guide a subsequent R01 proposal to test the intervention in a larger clinical trial.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Kampala, Uganda
    • Makerere Univerisity School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

Adolescent girls and young women (AGYW)/Female:

• aged 18-24 or self-reported as emancipated minors aged 15-17,
• HIV+
• meets one or more of the following non-engagement criteria: not currently enrolled in an HIV clinic (e.g., never enrolled, dropped out); not currently taking ART; missed 1 or more scheduled HIV care appointments requiring physical presence (e.g., viral load [VL] testing) in the last 12 months; < 90% ART adherence in the last 2 weeks; most recent VL>1000 or expected recent VL test results absent in clinic records despite initiating ART >6 months ago
• self-report a history of at least one incident of IPV (physical, sexual, and/or emotional) and/or controlling behavior ever perpetrated by their current male partner
• agree to let research staff contact their male partner.

Male Partners of AGYW/Male:

• aged 18+ years or emancipated minors
• report consuming ≥ 6 drinks per occasion at least once or more in the prior 30 days or scores 4 or more on the AUDIT (Alcohol Use Disorders Identification Test)-C

Couples (each partner (male and female) must independently report):

• married or living together as if married for ≥6 months
• planning to stay together for at least another 2 months (intervention period)
• lived in the Wakiso District area ≥3 months
• not planning to move from the area within the next 6 months
• respond similarly (not exact but close) to questions on the study-developed Couple Verification Screening

Exclusion Criteria

AGYW (female):

• reporting any severe physical IPV experienced in prior 3 months.

Couples (male and female):

• do not speak Luganda or English
• do not feel they cannot safely participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kisoboka Mukwano Intervention (treatment); 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.	Behavioral: Kisoboka Mukwano ("It is possible, my love!") Intervention; 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.
Active Comparator: Screening & Referral (control); 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.	Behavioral: Screening and Referral; Intimate partner violence screening, alcohol screening, and referral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of intimate partner violence (males and females)	Rating of how often one is afraid of their current spouse/partner measured using the WHO Instrument/ DHS Domestic Violence Modules.	6 month follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in HIV viral load (females and HIV+ males)	(1) Biomarker testing using blood (females) and (2) clinic records (males).	6 months
change from baseline in PrEP adherence (male partners taking PrEP)	self- report of missed PrEP using an adapted version of the AIDS Clinical Trials Group Adherence (AACTG) measures	3 and 6 month follow up
PrEP uptake	Initiation of PrEP	through 6 month follow-up

Collaborators and Investigators

• Sponsor: Arizona State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); San Diego State University; University of California, San Diego; Makerere University; Reach the Youth Uganda
• Investigators: Principal Investigator: Susan M Kiene, PhD, San Diego State University; Principal Investigator: Ijeoma Nwabuzor Ogbonnaya, PhD, Arizona State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: July 9, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Slow Virus Diseases; HIV Infections; Alcoholism; Acquired Immunodeficiency Syndrome; Professional Practice; Organization and Administration; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Diagnostic Techniques and Procedures; Diagnosis; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Diagnostic Services; Health Surveys; Surveys and Questionnaires; Public Health Practice; Methods; Referral and Consultation; Mass Screening
• Other Study ID Numbers: R34AA030489 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected individual participant data (IPD) that underlie the 6-month clinical trial, excluding qualitative data and data collected for formative research.
• IPD Sharing Time Frame: Two years after the grant end date specified on the first Notice of Award (08-31-2025). Any subject-level data and the associated analyzed data used in a journal publication will be shared at the time of publication, even if the publication occurs before the two-year automatic share date.
• IPD Sharing Access Criteria: Access to data for research purposes will be provided through the National Institute of Mental Health (NIMH) Data Archive (NDA) Data Access Committee (DAC). Investigators and institutions seeking data from NDA will be expected to meet data security measures and will be asked to submit a Data Use Certification, which is cosigned by the investigator and the designated Institutional Official(s) at the NIH-recognized sponsoring institution with a current Federal Wide Assurance (FWA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No