Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

716 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-16

Study Completion Date

2029-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV Antiretroviral Therapy (ART) Adherence Alcohol Abuse HIV Infection Alcohol Use Disorder HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

The study design is a 2x2 factorial randomized controlled trial (RCT); however, the investigators hypothesize an interaction between behavioral economics (BE) and motivational interviewing (MI), and therefore power the study to detect this interaction within the factorial design. With a statistically significant interaction between BE and MI the data would be analyzed as a 4-arm trial. Without a significant nor meaningful interaction the investigators would have additional power to examine effects for BE and MI vs S\&R via a traditional factorial analysis. While a factorial design is often used when no interaction between interventions is expected, it is also especially useful to evaluate a hypothesized interaction.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Kisoboka (BE + MI and synergy)

Group Type EXPERIMENTAL

Kisoboka

Intervention Type BEHAVIORAL

Intervention activities:

Financial goal setting (developing delayed rewards), Text message reminders of savings goals (increase salience of delayed rewards), Substance-free activities (alternative reinforcers), Mobile money savings and work payments (constraints on buying alcohol), Social support \& role models for financial goals and substance-free activities (delayed rewards, alternative reinforcers), Financial literacy, Develop motivation \& confidence for change, Goal setting for alcohol reduction \& ART adherence, Alcohol harms \& defining low risk drinking Discuss challenges to change and maintain alcohol risk reduction and improved adherence, Developing \& reinforcing discrepancy between savings/life goals and drinking/poor adherence, Developing discrepancy activity: goals for savings and healthy living and weekly, monthly, yearly spending on alcohol Self-monitoring of savings \& spending Text message reminders to reinforce discrepancy between unhealthy behavior \& goals

Behavioral Economics (BE)

Group Type EXPERIMENTAL

Behavioral Economics

Intervention Type BEHAVIORAL

Intervention activities:

Financial goal setting (developing delayed rewards), Text message reminders of savings goals (increase salience of delayed rewards), Substance free activities (alternative reinforcers), Mobile money savings and work payments (constraints on buying alcohol/ decrease reward value of alcohol), Social support \& role models for financial goals and substance free activities (delayed rewards, alternative reinforcers), Financial literacy

Motivational Interviewing (MI)

Group Type EXPERIMENTAL

Motivational Interviewing

Intervention Type BEHAVIORAL

Intervention activities:

Develop motivation and confidence for change, Specific goal setting for alcohol reduction and ART adherence, Alcohol harms \& defining low risk drinking, Discuss challenges to change and to maintain alcohol risk reduction and improved adherence/care engagement

Screening and Referral (S&R)

Group Type ACTIVE_COMPARATOR

Screening and Referral

Intervention Type BEHAVIORAL

Brief feedback on their Alcohol Use Disorders Identification Test (AUDIT) score per the AUDIT brief intervention manual, a referral for alcohol counseling, and brief guidance on the importance of HIV care engagement and adherence following the Ugandan Ministry of Health protocol. A referral coupon with details of the clinic name and location will be provided to each participant and participants will be asked to submit the referral note to the "alcohol and/or HIV counselor".

Interventions

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Kisoboka

Intervention activities:

Financial goal setting (developing delayed rewards), Text message reminders of savings goals (increase salience of delayed rewards), Substance-free activities (alternative reinforcers), Mobile money savings and work payments (constraints on buying alcohol), Social support \& role models for financial goals and substance-free activities (delayed rewards, alternative reinforcers), Financial literacy, Develop motivation \& confidence for change, Goal setting for alcohol reduction \& ART adherence, Alcohol harms \& defining low risk drinking Discuss challenges to change and maintain alcohol risk reduction and improved adherence, Developing \& reinforcing discrepancy between savings/life goals and drinking/poor adherence, Developing discrepancy activity: goals for savings and healthy living and weekly, monthly, yearly spending on alcohol Self-monitoring of savings \& spending Text message reminders to reinforce discrepancy between unhealthy behavior \& goals

Intervention Type BEHAVIORAL

Behavioral Economics

Intervention activities:

Financial goal setting (developing delayed rewards), Text message reminders of savings goals (increase salience of delayed rewards), Substance free activities (alternative reinforcers), Mobile money savings and work payments (constraints on buying alcohol/ decrease reward value of alcohol), Social support \& role models for financial goals and substance free activities (delayed rewards, alternative reinforcers), Financial literacy

Intervention Type BEHAVIORAL

Motivational Interviewing

Intervention activities:

Develop motivation and confidence for change, Specific goal setting for alcohol reduction and ART adherence, Alcohol harms \& defining low risk drinking, Discuss challenges to change and to maintain alcohol risk reduction and improved adherence/care engagement

Intervention Type BEHAVIORAL

Screening and Referral

Brief feedback on their Alcohol Use Disorders Identification Test (AUDIT) score per the AUDIT brief intervention manual, a referral for alcohol counseling, and brief guidance on the importance of HIV care engagement and adherence following the Ugandan Ministry of Health protocol. A referral coupon with details of the clinic name and location will be provided to each participant and participants will be asked to submit the referral note to the "alcohol and/or HIV counselor".

Intervention Type BEHAVIORAL

Eligibility Criteria

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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. not planning to move from the area within the next 6 months;
6. have their own mobile phone and can be reached via phone.
7. 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;

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No