Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kisoboka, Behavioral Economics, Motivational Interviewing, Screening and Referral.
- Who it may be relevant to
- Registry conditions: HIV Antiretroviral Therapy (ART) Adherence, Alcohol Abuse, HIV Infection, Alcohol Use Disorder. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Uganda
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Overview
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.
Interventions
- Behavioral 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 re - 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 - 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 - 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".
Primary outcome measures
- Change in Phosphatidylethanol (PEth) From Baseline [Time frame: 6 and 12 month follow up]
- Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up [Time frame: 6 and 12 month follow up]
- Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up [Time frame: 6 and 12 month follow up]
- Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up [Time frame: 6 and 12 month follow up]
Secondary outcome measures (4)
- Change in depressive symptoms from baseline [Time frame: 6 and 12 month follow up]
- Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months [Time frame: 6 and 12 month follow up]
- Change in subjective physical health from baseline [Time frame: 6 and 12 month follow up]
- Number of participants who are food secure at baseline, 6 months, and 12 months [Time frame: 6 and 12 month follow up]
Eligibility criteria
Inclusion criteria
- living with HIV;
- residing in a fishing community (on most days/nights);
- AUDIT-C positive (≥4) indicating potential hazardous drinking;
- >6 months since initial antiretroviral treatment (ART) initiation;
- not planning to move from the area within the next 6 months;
- have their own mobile phone and can be reached via phone.
- 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
- visibly intoxicated at enrollment (eligible to enroll when not intoxicated);
- does not speak Luganda or English;
- currently receiving a majority of work payments via mobile money/digital payments;
- participated in the Kisoboka pilot RCT;
- unable to read basic Luganda or English
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Factorial
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
Uganda · 1 center
- Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, a — Kampala
Identifiers
NCT: NCT06771843 · HS-2024-0086 · R01AA031650