Clinical trial NCT05947539: Improving HIV Care Engagement Among Ugandan Adolescent Girls and Young Women: The Kisoboka Mukwano Intervention
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV-infection/Aids
Intimate Partner Violence
Domestic Violence
Alcohol Use Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: San Diego State University
name: Makerere University
name: University of California, San Diego
name: Reach the Youth Uganda
First posted: 2023-07-17
Enrollment: 80
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: change from baseline in antiretroviral therapy (ART) adherence biomarker (females and HIV+ male partners)
timeFrame: 3 and 6 month follow up
measure: change from baseline in self-reported antiretroviral therapy (ART) adherence (females and HIV+ male partners)
timeFrame: 3 and 6 month follow up
measure: change from baseline in HIV care engagement (females and HIV+ male partners)
timeFrame: 3 months, 6 months
measure: change from baseline in phosphatidylethanol (PEth) (male partners)
timeFrame: 6 months
measure: change from baseline in heavy drinking (male partners)
timeFrame: 3 months, 6 months
measure: Intimate partner violence (IPV) occurence (males and females)
timeFrame: 6 months
Secondary outcomes:
measure: Fear of intimate partner violence (males and females)
timeFrame: 6 month follow up
Other outcomes:
measure: change from baseline in HIV viral load (females and HIV+ males)
timeFrame: 6 months
measure: change from baseline in PrEP adherence (male partners taking PrEP)
timeFrame: 3 and 6 month follow up
measure: PrEP uptake
timeFrame: through 6 month follow-up
Locations:
city: Kampala
country: Uganda
facility: Makerere Univerisity School of Public Health
Study officials:
affiliation: Arizona State University
name: Ijeoma Nwabuzor Ogbonnaya, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: San Diego State University
name: Susan M Kiene, PhD
role: PRINCIPAL_INVESTIGATOR
References: