Clinical trial NCT06771843: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Official title: Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Antiretroviral Therapy (ART) Adherence
Alcohol Abuse
HIV Infection
Alcohol Use Disorder
HIV Infections
Keywords: behavioral economics
motivational interviewing
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Makerere University Walter Reed Program
name: Makerere University
First posted: 2025-01-13
Enrollment: 716
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Phosphatidylethanol (PEth) From Baseline
timeFrame: 6 and 12 month follow up
measure: Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up
timeFrame: 6 and 12 month follow up
measure: Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up
timeFrame: 6 and 12 month follow up
measure: Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up
timeFrame: 6 and 12 month follow up
Secondary outcomes:
measure: Change in depressive symptoms from baseline
timeFrame: 6 and 12 month follow up
measure: Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months
timeFrame: 6 and 12 month follow up
measure: Change in subjective physical health from baseline
timeFrame: 6 and 12 month follow up
measure: Number of participants who are food secure at baseline, 6 months, and 12 months
timeFrame: 6 and 12 month follow up
Other outcomes:
measure: Change in delayed reward discounting from baseline
timeFrame: 6 and 12 month follow up
measure: Change in endorsement of alternative reinforcers from baseline
timeFrame: 6 and 12 month follow up
measure: Change from baseline in endorsement of the reward value of alcohol
timeFrame: 6 and 12 month follow up
measure: Change from baseline in motivation to change behavior
timeFrame: 6 and 12 month follow up
Locations:
city: Kampala
country: Uganda
facility: Makerere University Walter Reed Program
Study officials:
affiliation: San Diego State University
name: Susan M Kiene, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Makerere University
name: Joseph KB Matovu, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
References: