HIV Antiretroviral Therapy (ART) AdherenceKisobokaNCT06771843
Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
A study testing Kisoboka, Behavioral Economics and Motivational Interviewing in people with HIV Antiretroviral Therapy (ART) Adherence and Alcohol Abuse, run by San Diego State University at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- HIV Antiretroviral Therapy (ART) Adherence, Alcohol Abuse, HIV Infection
- What is being tested?
- Kisoboka, Behavioral Economics and Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 716 participants
- Where
- 1 siteUganda
- Study dates
- 16 Jun 2025to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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;
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Makerere University Walter Reed Program affiliated sites in Buikwe, Nakasongola, Mukono, and Kayunga Districts
Kampala
Program Director, +256312330400, muwrp@muwrp.org
Fred Magala
About this study
Official title: Kisoboka: 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.
Read more
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
- Being tested
- Kisoboka, Behavioral Economics, Motivational Interviewing, Screening and Referral
- Keywords
- behavioral economics, motivational interviewing
- Medical subject headings
- Alcoholism, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KisobokaBehavioural
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 EconomicsBehavioural
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 InterviewingBehavioural
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 ReferralBehavioural
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".
| Study group | Role | What they receive |
|---|---|---|
| Kisoboka (BE + MI and synergy) | Experimental | Not described Receives: Behavioral: Kisoboka |
| Behavioral Economics (BE) | Experimental | Not described Receives: Behavioral: Behavioral Economics |
| Motivational Interviewing (MI) | Experimental | Not described Receives: Behavioral: Motivational Interviewing |
| Screening and Referral (S&R) | Active comparator | Not described Receives: Behavioral: Screening and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Phosphatidylethanol (PEth) From Baseline
alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Measured: 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.
Measured: 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
Measured: 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)
Measured: 6 and 12 month follow up
Secondary outcomes (4)
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 and 12 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start16 Jun 2025
- Primary completionOct 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV Antiretroviral Therapy (ART) AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 716 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Makerere University Walter Reed Program, Makerere University
- Responsible party
- Sponsor
- Investigators
- Susan M Kiene, PhD, MPH, Principal investigator, San Diego State UniversityJoseph KB Matovu, PhD, MHS, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771843
- Sponsor's protocol ID
- HS-2024-0086
- Other IDs
- R01AA031650
- Acronym
- Kisoboka
- Status last verified
- May 2026
- First submitted
- 9 Jan 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share raw questionnaire data. For all data, all identifiable information will be removed and maintained in a secure file for future contact purposes, but Global Unique Identifiers (GUIDs) or pseudoGUIDs will be assigned through the National Institute of Mental Health (NIMH) Data Archive. All other de-identified scientific data (questionnaire datasets, results from biological specimens testing, will be both preserved and shared through NIAAA Data Archive repository. Study protocol for the randomized controlled trial and survey questionnaires will be made available through NIAAA Data Archive repository. This documentation will be provided in portable document format (PDF). Scientific data will be processed and analyzed in standard statistical analysis software (e.g., SPSS, MPLUS, SAS, and R).
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kisoboka: Reducing Hazardous Alcohol Use and Optimizing Treatment as Prevention Among Men Living With HIV in Risk Environments
- ClinicalTrials.gov ID
- NCT06771843
- Acronym / sponsor ID
- Kisoboka / HS-2024-0086
- Conditions
- HIV Antiretroviral Therapy (ART) Adherence, Alcohol Abuse, HIV Infection, Alcohol Use Disorder, HIV Infections
- Keywords
- behavioral economics, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 716 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Makerere University Walter Reed Program, Makerere University
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KisobokaIntervention 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 | Behavioural | Kisoboka (BE + MI and synergy) |
| Behavioral EconomicsIntervention 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 | Behavioural | Behavioral Economics (BE) |
| Motivational InterviewingIntervention 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 | Behavioural | Motivational Interviewing (MI) |
| Screening and ReferralBrief 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". | Behavioural | Screening and Referral (S&R) |
Primary outcome
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
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.
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
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)
4 secondary outcomes
Change in depressive symptoms from baseline
Time frame: 6 and 12 month follow up
Number of participants with optimal self-reported Antiretroviral Adherence at Baseline, 6 and 12 months
Time frame: 6 and 12 month follow up
Change in subjective physical health from baseline
Time frame: 6 and 12 month follow up
Number of participants who are food secure at baseline, 6 months, and 12 months
Time frame: 6 and 12 month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: Yes. The investigators will share raw questionnaire data. For all data, all identifiable information will be removed and maintained in a secure file for future contact purposes, but Global Unique Identifiers (GUIDs) or pseudoGUIDs will be assigned through the National Institute of Mental Health (NIMH) Data Archive. All other de-identified scientific data (questionnaire datasets, results from biological specimens testing, will be both preserved and shared through NIAAA Data Archive repository. Study protocol for the randomized controlled trial and survey questionnaires will be made available through NIAAA Data Archive repository. This documentation will be provided in portable document format (PDF). Scientific data will be processed and analyzed in standard statistical analysis software (e.g., SPSS, MPLUS, SAS, and R).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Susan M Kiene, PhD, MPH principal investigator
San Diego State University
Joseph KB Matovu, PhD, MHS principal investigator
Makerere University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kisoboka, Behavioral Economics and Motivational Interviewing in people with HIV Antiretroviral Therapy (ART) Adherence and Alcohol Abuse, run by San Diego State University at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Matovu, PhD, MHS (+256 414 543872, jmatovu@musph.ac.ug), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Phosphatidylethanol (PEth) From Baseline (time frame: 6 and 12 month follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.