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

NCT06771843 | Recruiting DMC

• 2 other identifiers: HS-2024-0086R01AA031650
• Study Type: interventional
• Target: 716
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Antiretroviral Therapy (ART) Adherence; Alcohol Abuse; HIV Infection; Alcohol Use Disorder; HIV Infections

Keywords

behavioral economics; motivational interviewing

Outcome Measures

Primary Outcomes (4)

• Change in Phosphatidylethanol (PEth) From Baseline

  alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks

  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.

  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

  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)

  6 and 12 month follow up

Secondary Outcomes (4)

• Change in depressive symptoms from baseline

  6 and 12 month follow up

• Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months

  6 and 12 month follow up

• Change in subjective physical health from baseline

  6 and 12 month follow up

• Number of participants who are food secure at baseline, 6 months, and 12 months

  6 and 12 month follow up

Other Outcomes (4)

• Change in delayed reward discounting from baseline

  6 and 12 month follow up

• Change in endorsement of alternative reinforcers from baseline

  6 and 12 month follow up

• Change from baseline in endorsement of the reward value of alcohol

  6 and 12 month follow up

Study Arms (4)

Kisoboka (BE + MI and synergy)

EXPERIMENTAL

Behavioral: Kisoboka

Behavioral Economics (BE)

EXPERIMENTAL

Behavioral: Behavioral Economics

Motivational Interviewing (MI)

EXPERIMENTAL

Behavioral: Motivational Interviewing

Screening and Referral (S&R)

ACTIVE COMPARATOR

Behavioral: Screening and Referral

Interventions

Kisoboka BEHAVIORAL

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

Kisoboka (BE + MI and synergy)

Behavioral Economics BEHAVIORAL

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 Economics (BE)

Motivational Interviewing BEHAVIORAL

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

Motivational Interviewing (MI)

Screening and Referral BEHAVIORAL

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".

Screening and Referral (S&R)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Makerere University Walter Reed Program: collaborator
• Makerere University: collaborator

Study Sites (1)

Makerere University Walter Reed Program

Kampala, Uganda

RECRUITING

MeSH Terms

Conditions

Alcoholism; HIV Infections

Interventions

Economics, Behavioral; Motivational Interviewing; Mass Screening; Referral and Consultation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Psychology; Behavioral Sciences; Behavioral Disciplines and Activities; Economics; Health Care Economics and Organizations; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Susan M Kiene, PhD, MPH

  San Diego State University

  PRINCIPAL INVESTIGATOR

• Joseph KB Matovu, PhD, MHS

  Makerere University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph Matovu, PhD, MHS

CONTACT

+256 414 543872; jmatovu@musph.ac.ug

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 13, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Baseline data, such as demographics and self-reported data, that require no additional analyses will be submitted to the NIAAA Data Archive repository within 4 months after enrollment. Baseline laboratory test data will be added as it becomes available. After the study is complete and unmasked, the study team will submit all remaining data (follow-up data). Data will be shared with the general research community at the time of an associated publication, or the end of the award/support period, whichever comes first. As required by NIAAA Data Archive repository, for each publication developed, the investigators will also create studies that contain the data used in that analysis and include the digital object identifiers (DOI) for that study (from NIAAA Data Archive repository) in the manuscript to aid in findability. NIAAA Data Archive repository makes determinations regarding how long to preserve the data; to date files have been preserved in perpetuity.
• Access Criteria: Data will be findable for the research community through the NIMH Data Archive (NIAAA Data Archive specifically) which is established at the time of study funding. For all publications, an NIAAA Data Archive study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication. Investigators at institutions with a Federal Wide Assurance (FWA) will be able to gain access to NIAAA Data Archive repository data by submitting a data access request in accordance with applicable NIAAA Data Archive repository policies. Data requests will be reviewed and granted by an NIMH/NIAAA Data Archive Data Access Committee.

Locations

UG (1)