Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Primary Purpose
Alcohol Use Disorder, HIV-infection/Aids
Status
Unknown status
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Behavioral and Structural Intervention
Screening and Referral
Sponsored by
About this trial
This is an interventional supportive care trial for Alcohol Use Disorder
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.
Sites / Locations
- Wakiso District HIV clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
structural and behavioral intervention
Screening and Referral
Arm Description
The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Outcomes
Primary Outcome Measures
change from baseline in frequency of heavy/binge drinking
≥ 5 drinks per occasion
HIV care engagement
missed visit count, visit adherence, 3 month visit constancy
ART adherence
AACTG measure. The AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG).
Secondary Outcome Measures
phosphatidylethanol (PEth)
alcohol biomarker
change from baseline in HIV viral load
HIV viral load
Full Information
NCT ID
NCT03919695
First Posted
April 7, 2019
Last Updated
June 22, 2021
Sponsor
San Diego State University
Collaborators
Makerere University, Mildmay Uganda Limited, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03919695
Brief Title
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 7, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University
Collaborators
Makerere University, Mildmay Uganda Limited, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, HIV-infection/Aids
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
structural and behavioral intervention
Arm Type
Experimental
Arm Description
The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money.
Arm Title
Screening and Referral
Arm Type
Active Comparator
Arm Description
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral and Structural Intervention
Other Intervention Name(s)
KISOBOKA
Intervention Description
The intervention has two components; a structural component and a behavioral component.
Structural component: This component is about receiving work payments via mobile money instead of cash.
Behavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.
Intervention Type
Behavioral
Intervention Name(s)
Screening and Referral
Intervention Description
Alcohol screening and referral
Primary Outcome Measure Information:
Title
change from baseline in frequency of heavy/binge drinking
Description
≥ 5 drinks per occasion
Time Frame
3 and 6 month follow up
Title
HIV care engagement
Description
missed visit count, visit adherence, 3 month visit constancy
Time Frame
6 month follow up
Title
ART adherence
Description
AACTG measure. The AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG).
Time Frame
6 month follow up
Secondary Outcome Measure Information:
Title
phosphatidylethanol (PEth)
Description
alcohol biomarker
Time Frame
6 month follow up
Title
change from baseline in HIV viral load
Description
HIV viral load
Time Frame
6 month follow up
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M Kiene
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wakiso District HIV clinics
City
Multiple Locations
State/Province
Wakiso District
Country
Uganda
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
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