HIV-infection/AidsNCT05947539
Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention
A study testing Kisoboka Mukwano ("It is possible, my love!") Intervention and Screening and Referral in people with HIV-infection/Aids and Intimate Partner Violence, run by Arizona State University at 1 site in Uganda.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- HIV-infection/Aids, Intimate Partner Violence, Domestic Violence
- What is being tested?
- Kisoboka Mukwano ("It is possible, my love!") Intervention and Screening and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUganda
- Study dates
- 1 Jul 2023to 30 Oct 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Kisoboka Mukwano ("It is possible, my love!") Intervention, Screening and Referral
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kisoboka Mukwano ("It is possible, my love!") InterventionBehavioural
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.
Screening and ReferralBehavioural
Intimate partner violence screening, alcohol screening, and referral
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Screening and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine
Measured: 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
Measured: 3 and 6 month follow up
change from baseline in HIV care engagement (females and HIV+ male partners)
HIV clinic visit adherence
Measured: 3 months, 6 months
change from baseline in phosphatidylethanol (PEth) (male partners)
alcohol biomarker (PEth) levels
Measured: 6 months
change from baseline in heavy drinking (male partners)
assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Jul 2023
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-infection/AidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), San Diego State University, Makerere University, University of California, San Diego, Reach the Youth Uganda
- Responsible party
- Principal investigator, Ijeoma Ogbonnaya, Arizona State University
- Investigators
- Ijeoma Nwabuzor Ogbonnaya, PhD, Principal investigator, Arizona State UniversitySusan M Kiene, PhD, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947539
- Sponsor's protocol ID
- R34AA030489
- Other IDs
- R34AA030489
- Status last verified
- Aug 2025
- First submitted
- 22 Mar 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual participant data (IPD) that underlie the 6-month clinical trial, excluding qualitative data and data collected for formative research.
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.
PubMed 41207472