Alcohol Use DisorderNCT03919695
Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
A study testing Kisoboka: Behavioral and Structural Intervention and Screening and Referral in people with Alcohol Use Disorder and HIV-infection/Aids, run by San Diego State University at 1 site in Uganda.
Trial summary
Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation… Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Alcohol Use Disorder, HIV-infection/Aids
- What is being tested?
- Kisoboka: Behavioral and Structural Intervention and Screening and Referral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUganda
- Study dates
- 11 Jan 2021to 27 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- occupation of working in the fishing industry or industry supporting the fishing industry; HIV+; on ART for at least 1 month; missed one or more dose of ART in the prior 2 weeks; consume 5 or more drinks per occasion 2 or more times in the prior month or have an AUDIT-C score of 4 or greater; not planning to move from the area within the next 6 weeks; have their own mobile phone and can be reached via phone
Who cannot join
- currently receiving a majority of income for work via mobile money, does not speak Luganda or English, unable to read basic Luganda or English, occupation of boat or engine owner.
Trial locations and contacts
1 site in 1 country.
Uganda1 site
selected Wakiso District HIV clinics
Multiple Locations, Wakiso District
About this study
Official title: Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.
Read the detailed description
The investigators propose to develop and pilot a brief combination intervention which addresses the key drivers of alcohol use and barriers to HIV care engagement and ART adherence in this population. This study addresses these multi-level factors in an intervention which combines a structural component of changing the mode of work payments from cash to mobile money, to reduce "cash in the pocket," and increase the accessibility of savings through mobile phone-based banking services, with behavioral components to change behavior. For the behavioral components, the study combines and adapt two efficacious Motivational Interviewing (MI)-based alcohol interventions to the cultural and situational context of this population: a brief intervention tested in Kenya and an intervention rooted in behavioral economics which focuses on increasing the extent to which individuals' behavior is motivated by and consistent with their long-term goals such as saving money for the future-in which the structural component of the intervention is interwoven. The aims of the project are to: 1) Combine a promising structural (e.g., reducing "cash in the pocket") and behavioral intervention to promote reductions in heavy alcohol use, engagement in HIV care, and ART adherence among HIV+ male fisherfolk. These interventions will be adapted and tailored to the population to create the proposed KISOBOKA ("It is possible!") intervention. The investigators will refine the combination intervention through qualitative research with HIV+ male fisherfolk and community stakeholders and an initial pilot test with 15 participants examining acceptability and feasibility; 2) Pilot the intervention, randomizing to the KISOBOKA intervention arm (n=80) or to the control arm (n=80, alcohol screening and referral). The investigators will assess feasibility, acceptability, and preliminary estimates of the potential for the intervention, as compared to control, to decrease heavy drinking frequency and improve HIV care engagement and ART adherence through 6 month follow up.
- Conditions
- Alcohol Use Disorder, HIV-infection/Aids
- Being tested
- Kisoboka: Behavioral and Structural Intervention, Screening and Referral
- Medical subject headings
- Alcoholism, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kisoboka: Behavioral and Structural InterventionBehavioural
Also called KISOBOKA
The intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing.
Structural component: This component is about receiving work payments via mobile money instead of cash.
Behavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals.
Screening and ReferralBehavioural
Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
| Study group | Role | What they receive |
|---|---|---|
| Kisoboka: structural and behavioral intervention | Experimental | The KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money. Receives: Behavioral: Kisoboka: Behavioral and Structural Intervention |
| Screening and Referral | Active comparator | Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence. Receives: Behavioral: Screening and Referral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
hazardous alcohol use as assessed with the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure using a cutpoint of 9 to indicate hazardous alcohol use in this population
Measured: 3 and 6 month follow up
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 month follow up
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence >=90%.
Measured: 3 and 6 month follow up
Secondary outcomes (3)
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
number of days consumed ≥ 5 standard drinks/occasion in the 28 days prior to the assessment. 1 drink = 10g pure alcohol. Self-reported
Measured: 3 and 6 month follow up
Number of Participants With an HIV Viral Load Value <839 at Baseline and Follow-up, From Clinic Records Viral Load Tests for Routine Clinical Monitoring
The proportion of participants with an HIV viral load test value of <839 using clinical data among those with viral load tests available. Viral load tests were PCR-based assays. These clinics used a value of <839 to indicate a suppressed HIV viral load. The use of clinic records data relied on participants having routine viral load tests at intervals corresponding to the measurement intervals of baseline or before and near follow-up. Baseline: sample taken before baseline (up to 294 days before) and follow-up includes samples taken between 126-330 days after baseline.
Measured: approximately 6 month follow up
HIV Care Engagement
missed visit count, visit adherence, 3 month visit constancy
Measured: 6 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 posted18 Apr 2019
- Study start11 Jan 2021
- Primary completion31 Oct 2022
- Study completion27 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University, Mildmay Uganda Limited, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Susan M Kiene, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03919695
- Sponsor's protocol ID
- R34AA025891
- Other IDs
- R34AA025891
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2019
- Last updated
- 27 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
- ClinicalTrials.gov ID
- NCT03919695
- Acronym / sponsor ID
- R34AA025891
- Conditions
- Alcohol Use Disorder, HIV-infection/Aids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- Makerere University, Mildmay Uganda Limited, National Institute on Alcohol Abuse and Alcoholism (NIAAA), University of California, San Francisco
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 27 Apr 2023 (actual)
- First posted
- 18 Apr 2019 (actual)
- Results
- Posted 2 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fisherfolk are a high risk population for HIV and are prioritized to receive antiretroviral treatment (ART) in Uganda, but risky alcohol use among fisherfolk is a barrier to HIV care engagement; multilevel factors influence alcohol use and poor access to HIV care in fishing villages, including a lack of motivation, social support, access to savings accounts, and access to HIV clinics. This project aims to address these barriers, and subsequently reduce heavy alcohol use and increase engagement in HIV care, through an intervention in which counselors provide individual and group counseling to increase motivation, while also addressing structural barriers to care through increased opportunities for savings and increased social support. This may be a feasible approach to help this hard-to-reach population reduce drinking and increase access care, which could ultimately reduce mortality rates, improve treatment outcomes, and through its effect on HIV viral load, decrease the likelihood of transmitting HIV to others.
Detailed description
The investigators propose to develop and pilot a brief combination intervention which addresses the key drivers of alcohol use and barriers to HIV care engagement and ART adherence in this population. This study addresses these multi-level factors in an intervention which combines a structural component of changing the mode of work payments from cash to mobile money, to reduce "cash in the pocket," and increase the accessibility of savings through mobile phone-based banking services, with behavioral components to change behavior. For the behavioral components, the study combines and adapt two efficacious Motivational Interviewing (MI)-based alcohol interventions to the cultural and situational context of this population: a brief intervention tested in Kenya and an intervention rooted in behavioral economics which focuses on increasing the extent to which individuals' behavior is motivated by and consistent with their long-term goals such as saving money for the future-in which the structural component of the intervention is interwoven. The aims of the project are to: 1) Combine a promising structural (e.g., reducing "cash in the pocket") and behavioral intervention to promote reductions in heavy alcohol use, engagement in HIV care, and ART adherence among HIV+ male fisherfolk. These interventions will be adapted and tailored to the population to create the proposed KISOBOKA ("It is possible!") intervention. The investigators will refine the combination intervention through qualitative research with HIV+ male fisherfolk and community stakeholders and an initial pilot test with 15 participants examining acceptability and feasibility; 2) Pilot the intervention, randomizing to the KISOBOKA intervention arm (n=80) or to the control arm (n=80, alcohol screening and referral). The investigators will assess feasibility, acceptability, and preliminary estimates of the potential for the intervention, as compared to control, to decrease heavy drinking frequency and improve HIV care engagement and ART adherence through 6 month follow up.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kisoboka: structural and behavioral intervention | Experimental | Behavioral: Kisoboka: Behavioral and Structural InterventionThe KISOBOKA intervention adapts and combines a behavioral intervention with a structural component. The behavioral intervention component includes, alcohol screening, financial literacy training, and counseling and goal setting related to savings, alcohol use, and HIV care engagement. The structural intervention component changes the mode of work payment from cash to mobile money. |
| Screening and Referral | Active comparator | Behavioral: Screening and ReferralBrief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- occupation of working in the fishing industry or industry supporting the fishing industry; HIV+; on ART for at least 1 month; missed one or more dose of ART in the prior 2 weeks; consume 5 or more drinks per occasion 2 or more times in the prior month or have an AUDIT-C score of 4 or greater; not planning to move from the area within the next 6 weeks; have their own mobile phone and can be reached via phone
Key exclusion criteria (1 listed)
- currently receiving a majority of income for work via mobile money, does not speak Luganda or English, unable to read basic Luganda or English, occupation of boat or engine owner.
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 |
|---|---|---|
| Kisoboka: Behavioral and Structural InterventionAlso: KISOBOKAThe intervention has two components; a structural component and a behavioral component. The intervention draws from behavioral economics and motivational interviewing. Structural component: This component is about receiving work payments via mobile money instead of cash. Behavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals. | Behavioural | Kisoboka: structural and behavioral intervention |
| Screening and ReferralAlcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence | Behavioural | Screening and Referral |
Primary outcome
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
Time frame: 3 and 6 month follow up
hazardous alcohol use as assessed with the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) measure using a cutpoint of 9 to indicate hazardous alcohol use in this population
Change in Phosphatidylethanol (PEth) From Baseline
Time frame: 6 month follow up
alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
Time frame: 3 and 6 month follow up
Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence >=90%.
3 secondary outcomes
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
Time frame: 3 and 6 month follow up
Number of Participants With an HIV Viral Load Value <839 at Baseline and Follow-up, From Clinic Records Viral Load Tests for Routine Clinical Monitoring
Time frame: approximately 6 month follow up
HIV Care Engagement
Time frame: 6 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Susan M Kiene principal investigator
San Diego State 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 and Structural Intervention and Screening and Referral in people with Alcohol Use Disorder and HIV-infection/Aids, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 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?
Yes. Results are posted in the registry (first posted 2 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up (time frame: 3 and 6 month follow up). The study lists 3 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 27 Mar 2026.