Alcohol Abuse, Alcohol Use Disorder, HIV Antiretroviral Therapy (ART) Adherence, HIV Infection, HIV Infections
Conditions
Keywords
behavioral economics, motivational interviewing
Brief summary
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
BEHAVIORALScreening 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".
BEHAVIORALKisoboka
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
BEHAVIORALBehavioral 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
BEHAVIORALMotivational 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
Sponsors
San Diego State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Makerere University Walter Reed Program
Makerere University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Phosphatidylethanol (PEth) From Baseline | 6 and 12 month follow up | alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks |
| Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up | 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. |
| Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up | 6 and 12 month follow up | ART levels tested using blood biomarkers with cut points indicating 6 or more doses per week |
| Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in depressive symptoms from baseline | 6 and 12 month follow up | 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. |
| Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months | 6 and 12 month follow up | 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 |
| Change in subjective physical health from baseline | 6 and 12 month follow up | 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. |
| Number of participants who are food secure at baseline, 6 months, and 12 months | 6 and 12 month follow up | 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. |
Countries
Uganda
Contacts
CONTACTJoseph Matovu, PhD, MHS
PRINCIPAL_INVESTIGATORSusan M Kiene, PhD, MPH
San Diego State University
PRINCIPAL_INVESTIGATORJoseph KB Matovu, PhD, MHS
Makerere University
Outcome results
None listed