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

NCT05947539 | Enrolling By Invitation DMC

• 1 other identifier: R34AA030489
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HIV-infection/Aids; Intimate Partner Violence; Domestic Violence; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Fear of intimate partner violence (males and females)

  6 month follow up

Other Outcomes (3)

• 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

Study Arms (2)

Kisoboka Mukwano Intervention (treatment)

EXPERIMENTAL

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

Screening & Referral (control)

ACTIVE COMPARATOR

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

Interventions

Kisoboka Mukwano ("It is possible, my love!") Intervention BEHAVIORAL

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.

Kisoboka Mukwano Intervention (treatment)

Screening and Referral BEHAVIORAL

Intimate partner violence screening, alcohol screening, and referral

Screening & Referral (control)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• San Diego State University: collaborator
• Makerere University: collaborator
• University of California, San Diego: collaborator
• Reach the Youth Uganda: collaborator

Study Sites (1)

Makerere Univerisity School of Public Health

Kampala, Uganda

Location

Related Publications (1)

• 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.

  PMID: 41207472 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Alcoholism

Interventions

Methods; Mass Screening; Referral and Consultation

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Ijeoma Nwabuzor Ogbonnaya, PhD

  Arizona State University

  PRINCIPAL INVESTIGATOR

• Susan M Kiene, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: July 17, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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).

Locations

UG (1)