Clinical trial NCT03919695: Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Official title: Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
HIV-infection/Aids
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: Makerere University
name: Mildmay Uganda Limited
name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: University of California, San Francisco
First posted: 2019-04-18
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.

Detailed description: The investigators propose to develop and pilot a brief combination intervention which addresses the key drivers of alcohol use and barriers to HIV care engagement and ART adherence in this population. This study addresses these multi-level factors in an intervention which combines a structural component of changing the mode of work payments from cash to mobile money, to reduce "cash in the pocket," and increase the accessibility of savings through mobile phone-based banking services, with behavioral components to change behavior. For the behavioral components, the study combines and adapt two efficacious Motivational Interviewing (MI)-based alcohol interventions to the cultural and situational context of this population: a brief intervention tested in Kenya and an intervention rooted in behavioral economics which focuses on increasing the extent to which individuals' behavior is motivated by and consistent with their long-term goals such as saving money for the future-in which the structural component of the intervention is interwoven. The aims of the project are to: 1) Combine a promising structural (e.g., reducing "cash in the pocket") and behavioral intervention to promote reductions in heavy alcohol use, engagement in HIV care, and ART adherence among HIV+ male fisherfolk. These interventions will be adapted and tailored to the population to create the proposed KISOBOKA ("It is possible!") intervention. The investigators will refine the combination intervention through qualitative research with HIV+ male fisherfolk and community stakeholders and an initial pilot test with 15 participants examining acceptability and feasibility; 2) Pilot the intervention, randomizing to the KISOBOKA intervention arm (n=80) or to the control arm (n=80, alcohol screening and referral). The investigators will assess feasibility, acceptability, and preliminary estimates of the potential for the intervention, as compared to control, to decrease heavy drinking frequency and improve HIV care engagement and ART adherence through 6 month follow up.

Eligibility criteria: Inclusion Criteria:

* occupation of working in the fishing industry or industry supporting the fishing industry; HIV+; on ART for at least 1 month; missed one or more dose of ART in the prior 2 weeks; consume 5 or more drinks per occasion 2 or more times in the prior month or have an AUDIT-C score of 4 or greater; not planning to move from the area within the next 6 weeks; have their own mobile phone and can be reached via phone

Exclusion Criteria:

* currently receiving a majority of income for work via mobile money, does not speak Luganda or English, unable to read basic Luganda or English, occupation of boat or engine owner.

Primary outcomes:
measure: Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
timeFrame: 3 and 6 month follow up
measure: Change in Phosphatidylethanol (PEth) From Baseline
timeFrame: 6 month follow up
measure: Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
timeFrame: 3 and 6 month follow up
Secondary outcomes:
measure: Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
timeFrame: 3 and 6 month follow up
measure: Number of Participants With an HIV Viral Load Value <839 at Baseline and Follow-up, From Clinic Records Viral Load Tests for Routine Clinical Monitoring
timeFrame: approximately 6 month follow up
measure: HIV Care Engagement
timeFrame: 6 month follow up
Other outcomes:
Locations:
city: Multiple Locations
country: Uganda
facility: selected Wakiso District HIV clinics
state: Wakiso District
Study officials:
affiliation: San Diego State University
name: Susan M Kiene
role: PRINCIPAL_INVESTIGATOR
References: