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NCT Number: NCT06771843

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

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.

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Key information

Conditions

HIV Antiretroviral Therapy (ART) Adherence Alcohol Abuse Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Blood-Borne Infections Chemically-Induced Disorders Communicable Diseases Genital Diseases HIV Infection HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Mental Disorders RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Substance-Related Disorders Urogenital Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, and Kayunga Districts

Kampala, Uganda

Location status: Recruiting

Location contact

Fred Magala

SUB_INVESTIGATOR

Program Director

CONTACT

[email protected]

+256312330400

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;

Exclusion criteria

  • 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

Treatment and study plan

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

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

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

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".

Primary outcomes

  1. Change in Phosphatidylethanol (PEth) From Baseline

    Time frame: 6 and 12 month follow up

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

  2. Number of Participants with very Hazardous Alcohol Use at Baseline, 6, and 12 Month Follow up

    Time frame: 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.

  3. Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 6 and 12 Month Follow up

    Time frame: 6 and 12 month follow up

    ART levels tested using blood biomarkers with cut points indicating 6 or more doses per week

  4. Number of Participants with Undetectable HIV Viral Loads at baseline, 6, and 12 month follow up

    Time frame: 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 outcomes

  1. Change in depressive symptoms from baseline

    Time frame: 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.

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

    Time frame: 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

  3. Change in subjective physical health from baseline

    Time frame: 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.

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

    Time frame: 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.

Other outcomes

  1. Change in delayed reward discounting from baseline

    Time frame: 6 and 12 month follow up

    Delay discounting to assess the extent to which participants respond to immediate vs. delayed rewards using a context-adapted version of the "Monetary Choice Questionnaire" (MCQ). The most frequently reported index from the MCQ is the k value, which reflects the hyperbolic discounting function most consistent across a given participant's choices. Higher K scores are indicative of greater delayed reward discounting.

  2. Change in endorsement of alternative reinforcers from baseline

    Time frame: 6 and 12 month follow up

    Measures the reinforcement from alcohol-free vs alcohol-involved activities incorporating availability using a context-adapted version of the Reinforcement-Survey Substance Use Version

  3. Change from baseline in endorsement of the reward value of alcohol

    Time frame: 6 and 12 month follow up

    The hypothetical Alcohol Purchase Task self-report measure adapted to Ugandan prices used to generate indices of the reward value of alcohol.

  4. Change from baseline in motivation to change behavior

    Time frame: 6 and 12 month follow up

    Items adapted from Information, Motivation, Behavioral Skills measures of motivation for antiretroviral adherence, and items adapted from the Theory of Planned Behavior (attitudes, subjective norms, perceived behavioral control, and intentions) measures for reducing hazardous alcohol consumption

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Matovu, PhD, MHS

CONTACT

[email protected]

+256 414 543872

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Collaborators

  • Makerere University
  • Makerere University Walter Reed Program
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

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

Acronym: Kisoboka

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jan 13, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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