Makerere Univerisity School of Public Health
Kampala, Uganda
NCT Number: NCT05947539
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.
Interested in participating?
Request Info15 year and older
All sexes
Interventional
Not applicable
Kampala, Uganda
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adolescent girls and young women (AGYW)/Female:
Male Partners of AGYW/Male:
Couples (each partner (male and female) must independently report):
Exclusion criteria
AGYW (female):
Couples (male and female):
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.
Intimate partner violence screening, alcohol screening, and referral
Time frame: 3 and 6 month follow up
presence of Tenofoivir Disoproxil Fumarate (TDF) detected in urine
Time frame: 3 and 6 month follow up
Self- report of missed ART using the AIDS Clinical Trials Group Adherence (AACTG) measures
Time frame: 3 months, 6 months
HIV clinic visit adherence
Time frame: 6 months
alcohol biomarker (PEth) levels
Time frame: 3 months, 6 months
assessed with the Alcohol Use Disorders Identification Test (AUDIT-C)
Time frame: 6 months
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.
Time frame: 6 month follow up
Rating of how often one is afraid of their current spouse/partner measured using the WHO Instrument/ DHS Domestic Violence Modules.
Time frame: 6 months
(1) Biomarker testing using blood (females) and (2) clinic records (males).
Time frame: 3 and 6 month follow up
self- report of missed PrEP using an adapted version of the AIDS Clinical Trials Group Adherence (AACTG) measures
Time frame: through 6 month follow-up
Initiation of PrEP
Arizona State University
Other
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
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