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N/A N=160 Randomized Double-blind Supportive Care

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

Alcohol Use Disorder · HIV-infection/Aids

Enrolled (actual)
160
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up — 41; 26; 18; 27 Participants — p=.002

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Kisoboka: Behavioral and Structural Intervention (Behavioral); Screening and Referral (Behavioral)
Age
Adult · 18+ yrs
Sex
Male
Sponsor
San Diego State University
Primary completion
Oct 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
41; 26; 18; 27; 15; 20 .002 sig
PRIMARY
Change in Phosphatidylethanol (PEth) From Baseline
554.30; 518.34; 479.95; 595.65
PRIMARY
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
55; 57; 55; 40; 49; 37
SECONDARY
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
7.77; 8.45; 6.87; 8.52; 7.85; 8.46
SECONDARY
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
42; 44; 24; 18
SECONDARY
HIV Care Engagement

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03919695). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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