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

San Diego State University

Status: Enrolling

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

Treatments: Behavioral: Screening and Referral; Behavioral: Behavioral Economics; Behavioral: Kisoboka; Behavioral: Motivational Interviewing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06771843

R01AA031650 (U.S. NIH Grant/Contract)

HS-2024-0086

Details and patient eligibility

About

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.

Enrollment: 716 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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716 participants in 4 patient groups

Kisoboka (BE + MI and synergy)

Experimental group

Treatment:

Behavioral: Kisoboka

Behavioral Economics (BE)

Experimental group

Treatment:

Behavioral: Behavioral Economics

Motivational Interviewing (MI)

Experimental group

Treatment:

Behavioral: Motivational Interviewing

Screening and Referral (S&R)

Active Comparator group

Treatment:

Behavioral: Screening and Referral