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

Alcohol Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05947539
• Other study ID #: R34AA030489
• Secondary ID: R34AA030489
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: August 2025

Study information

• Verified date: August 2023
• Source: Arizona State University
• Contact: Janet Nakigudde, PhD
• Phone: +256772407885
• Email: janet.nakigudde[@]mak.ac.ug
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Domestic Violence
• HIV Infections
• HIV-infection/Aids
• Intimate Partner Violence

Intervention

Behavioral:
• Kisoboka Mukwano ("It is possible, my love!") Intervention
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 Referral
Intimate partner violence screening, alcohol screening, and referral

Locations

Country	Name	City	State
Uganda	Makerere Univerisity School of Public Health	Kampala

Sponsors (6)

Lead Sponsor	Collaborator
Arizona State University	Makerere University, National Institute on Alcohol Abuse and Alcoholism (NIAAA), Reach the Youth Uganda, San Diego State University, University of California, San Diego

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change from baseline in HIV viral load (females and HIV+ males)	(1) Biomarker testing using blood (females) and (2) clinic records (males).	6 months
Other	change from baseline in PrEP adherence (male partners taking PrEP)	self- report of missed PrEP using an adapted version of the AIDS Clinical Trials Group Adherence (AACTG) measures	3 and 6 month follow up
Other	PrEP uptake	Initiation of PrEP	through 6 month follow-up
Primary	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
Primary	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
Primary	change from baseline in HIV care engagement (females and HIV+ male partners)	HIV clinic visit adherence	3 months, 6 months
Primary	change from baseline in phosphatidylethanol (PEth) (male partners)	alcohol biomarker (PEth) levels	6 months
Primary	change from baseline in heavy drinking (male partners)	assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)	3 months, 6 months
Primary	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	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.	6 month follow up