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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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
• Поведенческое 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
• Поведенческое 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".

Первичные конечные точки

• Change in Phosphatidylethanol (PEth) From Baseline [Срок оценки: 6 and 12 month follow up]
• Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up [Срок оценки: 6 and 12 month follow up]
• Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up [Срок оценки: 6 and 12 month follow up]
• Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up [Срок оценки: 6 and 12 month follow up]

Вторичные конечные точки (4)

• Change in depressive symptoms from baseline [Срок оценки: 6 and 12 month follow up]
• Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months [Срок оценки: 6 and 12 month follow up]
• Change in subjective physical health from baseline [Срок оценки: 6 and 12 month follow up]
• Number of participants who are food secure at baseline, 6 months, and 12 months [Срок оценки: 6 and 12 month follow up]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Uganda · 1 центр

• Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, a — Kampala

Идентификаторы

NCT: NCT06771843 · HS-2024-0086 · R01AA031650

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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