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

Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Alcohol Use Disorder; HIV-infection/Aids
• Intervention / Treatment: Behavioral: Behavioral and Structural Intervention; Behavioral: Screening and Referral

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.

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Uganda
  • Wakiso District
    • Multiple Locations, Wakiso District, Uganda
      • Wakiso District HIV clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change from baseline in frequency of heavy/binge drinking	≥ 5 drinks per occasion	3 and 6 month follow up
HIV care engagement	missed visit count, visit adherence, 3 month visit constancy	6 month follow up
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).	6 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phosphatidylethanol (PEth)	alcohol biomarker	6 month follow up
change from baseline in HIV viral load	HIV viral load	6 month follow up

Collaborators and Investigators

• Sponsor: San Diego State University
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); University of California, San Francisco; Makerere University; Mildmay Uganda Limited
• Investigators: Principal Investigator: Susan M Kiene, San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: April 7, 2019
• First Submitted That Met QC Criteria: April 17, 2019
• First Posted (Actual): April 18, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; Alcoholism; HIV Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: R34AA025891 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No