Couples-based intervention to improve HIV care for young women in Uganda
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 is testing a new program that helps young women with HIV in Uganda by involving their male partners to reduce alcohol use and improve their health care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Arizona State University Academic / other |
| Locations | 1 site (Kampala) |
| Trial ID | NCT05947539 on ClinicalTrials.gov |
What this trial studies
This intervention aims to develop and pilot test a couples-based approach to enhance HIV care engagement among adolescent girls and young women living with HIV in Uganda. The program focuses on addressing male partner alcohol use, which is linked to intimate partner violence (IPV) and poor health outcomes for these women. By utilizing motivational interviewing techniques, the intervention seeks to reduce alcohol consumption among male partners and improve adherence to HIV treatment for their female partners. The study will also assess the impact of this intervention on viral load and overall health outcomes for the participants.
Who should consider this trial
Good fit: Ideal candidates include adolescent girls and young women aged 15-24 who are HIV positive and have experienced intimate partner violence.
Not a fit: Patients who are not currently engaged in HIV care or do not have a male partner may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve HIV treatment adherence and health outcomes for young women living with HIV in Uganda.
How similar studies have performed: Previous studies have shown success with couples-based interventions targeting alcohol use and IPV, but this specific approach tailored for AGYW living with HIV in sub-Saharan Africa is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kampala
- Makerere Univerisity School of Public Health — Kampala, Uganda (Recruiting)
Study contacts
- Principal investigator: Ijeoma Nwabuzor Ogbonnaya, PhD — Arizona State University
- Study coordinator: Janet Nakigudde, PhD
- Email: janet.nakigudde@mak.ac.ug
- Phone: +256772407885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.