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

NCT03919695 | Completed Results DMC

• 1 other identifier: R34AA025891
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; HIV-infection/Aids

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up

  hazardous alcohol use as assessed with the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure using a cutpoint of 9 to indicate hazardous alcohol use in this population

  3 and 6 month follow up

• Change in Phosphatidylethanol (PEth) From Baseline

  alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks

  6 month follow up

• Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up

  Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence \>=90%.

  3 and 6 month follow up

Secondary Outcomes (3)

• Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days

  3 and 6 month follow up

• 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

  approximately 6 month follow up

• HIV Care Engagement

  6 month follow up

Study Arms (2)

Kisoboka: structural and behavioral intervention

EXPERIMENTAL

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: Kisoboka: Behavioral and Structural Intervention

Screening and Referral

ACTIVE COMPARATOR

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

Interventions

Kisoboka: Behavioral and Structural Intervention BEHAVIORAL

The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing. 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.

Also known as: KISOBOKA

Kisoboka: structural and behavioral intervention

Screening and Referral BEHAVIORAL

Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence

Screening and Referral

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mildmay Uganda Limited: collaborator
• University of California, San Francisco: collaborator
• San Diego State University: lead
• Makerere University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

selected Wakiso District HIV clinics

Multiple Locations, Wakiso District, Uganda

Location

MeSH Terms

Conditions

Alcoholism; Acquired Immunodeficiency Syndrome

Interventions

Mass Screening; Referral and Consultation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Assist. Vice President Research Support Services
• Organization: San Diego State University

rgulizia@sdsu.edu

619-594-5938

Study Officials

• Susan M Kiene

  San Diego State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2019
• First Posted: April 18, 2019
• Study Start: January 11, 2021
• Primary Completion: October 31, 2022
• Study Completion: April 27, 2023
• Last Updated: March 27, 2026
• Results First Posted: October 2, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)