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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
716
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 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 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
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".
Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, and Kayunga Districts
Kampala, Uganda
RECRUITINGChange in Phosphatidylethanol (PEth) From Baseline
alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Time frame: 6 and 12 month follow up
Number of Participants with very Hazardous Alcohol Use at Baseline, 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.
Time frame: 6 and 12 month follow up
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up
ART levels tested using blood biomarkers with cut points indicating 6 or more doses per week
Time frame: 6 and 12 month follow up
Number of Participants with Undetectable HIV Viral Loads at baseline, 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)
Time frame: 6 and 12 month follow up
Change in depressive symptoms from baseline
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.
Time frame: 6 and 12 month follow up
Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months
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
Time frame: 6 and 12 month follow up
Change in subjective physical health from baseline
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.
Time frame: 6 and 12 month follow up
Number of participants who are food secure at baseline, 6 months, and 12 months
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.
Time frame: 6 and 12 month follow up
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