Reducing Hazardous Alcohol Use and Optimizing Treatment As Prevention Among Men Living with HIV in Risk Environments

Not Applicable

Not yet recruiting

• Conditions: HIV Antiretroviral Therapy (ART) Adherence; Alcohol Abuse; HIV Infection; Alcohol Use Disorder; HIV Infections

• Registration Number: NCT06771843
• Lead Sponsor: San Diego State University

Brief Summary

The investigators developed the Kisoboka ("It is possible") Intervention to address limitations of existing evidence-based interventions to optimize treatment as prevention among men living with HIV who drink alcohol at hazardous levels in "risk environments" such as fishing communities through reductions in hazardous alcohol use, improved adherence to HIV medications and achieving undetectable HIV viral loads.

Social and structural determinants unique to fishing communities interact to create a risk environment where hazardous drinking impedes adherence to HIV medications among men living with HIV, including prevalent social norms of drinking, drinking as a way of experiencing "reward" and connecting with others (e.g. in the context of transactional sex), stressful work conditions, a "live for today" outlook, and a cash-based economy with no traditional savings infrastructure leading to ease of daily expenditure on drinking and sex work. These social and environmental conditions result in high levels of alcohol misuse and HIV risk, poor HIV outcomes, and exacerbation of HIV-associated wellness comorbidities such as poor mental and subjective physical health and food insecurity.

The goal of this study is to learn if the intervention called Kisoboka works to help men in fishing communities reduce hazardous alcohol use, be better able to take the participants HIV medication as prescribed, and have undetectable HIV viral loads. The investigators will compare the Kisoboka intervention to a brief alcohol screening, adherence counseling, and referrals, and to components of the Kisoboka intervention.

Participants will attend intervention counseling sessions according to the study arm to which the participants are randomly assigned. The number of sessions ranges from 1 to 6 over 1 to 16 weeks and are individual only or both individual and group sessions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Study First Posted: 2025-01-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Study Start: 2025-04
• Primary Completion: 2028-10
• Study Completion: 2029-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 716

Inclusion Criteria

1. living with HIV;
2. residing in a fishing community (on most days/nights);
3. AUDIT-C positive (≥4) indicating potential hazardous drinking;
4. >6 months since initial antiretroviral treatment (ART) initiation;
5. an indicator of potential suboptimal treatment as prevention (TasP) either:

(i) last HIV viral load test (within 6 months) was detectable (>20) or (ii) last viral load test between 6 and 13 months ago was detectable (>20) and reports missing ≥2 ART doses in the past 2 weeks or (iii) a lack of viral load test results for the prior 13 months in clinic records and reports missing ≥2 ART doses in the past 2 weeks; (f) not planning to move from the area within the next 6 months; (g) have their own mobile phone and can be reached via phone.

Exclusion Criteria

1. visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
2. does not speak Luganda or English;
3. currently receiving a majority of work payments via mobile money/digital payments;
4. participated in the Kisoboka pilot RCT;
5. unable to read basic Luganda or English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in Phosphatidylethanol (PEth) From Baseline	6 and 12 month follow up	alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up	6 and 12 month follow up	Combined biomarker self-report outcome. Number of participants with phosphatidylethanol values ≥400ng/mL OR AUDIT-C scores ≥9. AUDIT-C is the Alcohol Use Disorder Identification Test - Concise.
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up	6 and 12 month follow up	ART levels tested using blood biomarkers with cut points indicating 6 or more doses per week
Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up	6 and 12 month follow up	HIV viral load laboratory test results showing undetectable viral load per the assay used (e.g., \<20, \<40 copies/ml)

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms from baseline	6 and 12 month follow up	self-reported symptoms of depression using a shortened version of the "Center for Epidemiologic Studies Depression Scale" adapted for the population based on prior scale adaptation and validation. Minimum and maximum expected values are 0- 39 with higher scores indicating more depressive symptoms.
Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months	6 and 12 month follow up	Self-reported adherence to antiretroviral treatment using the Instrument for Retrospective Adherence which includes an estimate of the number of doses missed over the previous 30-days and two subjective ratings of adherence
Change in subjective physical health from baseline	6 and 12 month follow up	Physical health summary score from the "HIV Medical Outcomes Survey" scale (MOS-HIV) including subscales of physical function, pain, role function, as well as energy/fatigue, overall health, and social function. Values for each subscale are transformed to 0 to 100 scale to permit comparisons with higher scores indicating better subjective physical health.
Number of participants who are food secure at baseline, 6 months, and 12 months	6 and 12 month follow up	Food insecurity is assessed using the "Household Food Insecurity Access" scale which assesses the degree of food insecurity/security in resource-limited settings. Scale scores are categorized into 4 categories ranging from Food Secure to Severely Food Insecure.

Trial Locations

Locations (1)

Makerere University Walter Reed Program; 🇺🇬 Kampala, Uganda