Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwan… (NCT05947539) | Clinical Trial Compass
By InvitationNot Applicable
Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention
Uganda80 participantsStarted 2023-07-01
Plain-language 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.
Who can participate
Age range
15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Criter…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
Timeframe: 3 and 6 month follow up
2
change from baseline in self-reported antiretroviral therapy (ART) adherence (females and HIV+ male partners)
Timeframe: 3 and 6 month follow up
3
change from baseline in HIV care engagement (females and HIV+ male partners)
Timeframe: 3 months, 6 months
4
change from baseline in phosphatidylethanol (PEth) (male partners)
Timeframe: 6 months
5
change from baseline in heavy drinking (male partners)
Timeframe: 3 months, 6 months
6
Intimate partner violence (IPV) occurence (males and females)