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Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03919695
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Makerere University
Mildmay Uganda
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, San Francisco
Information provided by (Responsible Party):
Susan M. Kiene, San Diego State University

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder HIV-infection/Aids Behavioral: Behavioral and Structural Intervention Behavioral: Screening and Referral Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: structural and behavioral intervention
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.
Behavioral: Behavioral and Structural Intervention

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.

Other Name: KISOBOKA

Active Comparator: Screening and Referral
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Behavioral: Screening and Referral
Alcohol screening and referral

Primary Outcome Measures :
  1. change from baseline in frequency of heavy/binge drinking [ Time Frame: 3 and 6 month follow up ]
    ≥ 5 drinks per occasion

  2. HIV care engagement [ Time Frame: 6 month follow up ]
    missed visit count, visit adherence, 3 month visit constancy

  3. ART adherence [ Time Frame: 6 month follow up ]
    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 :
  1. phosphatidylethanol (PEth) [ Time Frame: 6 month follow up ]
    alcohol biomarker

  2. change from baseline in HIV viral load [ Time Frame: 6 month follow up ]
    HIV viral load

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • occupation of working in the fishing industry, HIV+, on ART for at least 6 months, have an HIV VL >200 or <90% adherence in past 2 weeks, consume 5 or more drinks per occasion 2 or more times in the prior month, 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 work payments via mobile money, does not speak Luganda or English, unable to read basic Luganda or English, occupation of boat or engine owner.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03919695

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Contact: Susan M Kiene 6195941314

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Wakiso District HIV clinics Not yet recruiting
Multiple Locations, Wakiso District, Uganda
Contact: Harriet Chemusto   
Principal Investigator: Nazarius M Tumwesigye, PhD         
Sub-Investigator: Barbara Mukasa, MPH         
Sub-Investigator: Rhoda K Wanyenze, PhD         
Sponsors and Collaborators
San Diego State University
Makerere University
Mildmay Uganda
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, San Francisco
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Principal Investigator: Susan M Kiene San Diego State University

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Responsible Party: Susan M. Kiene, Professor, San Diego State University Identifier: NCT03919695     History of Changes
Other Study ID Numbers: R34AA025891 ( U.S. NIH Grant/Contract )
R34AA025891 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs