Trial Outcomes & Findings for Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda (NCT NCT03919695)
NCT ID: NCT03919695
Last Updated: 2026-03-27
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
160 participants
Primary outcome timeframe
3 and 6 month follow up
Results posted on
2026-03-27
Participant Flow
Participants were recruited from HIV clinics and enrolled in the trial between January 2021 and March 2022.
Participant milestones
| Measure |
Structural and Behavioral Intervention
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.
Behavioral and Structural Intervention: 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 Referral
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral
|
|---|---|---|
|
3-month Follow-up
STARTED
|
80
|
80
|
|
3-month Follow-up
COMPLETED
|
79
|
75
|
|
3-month Follow-up
NOT COMPLETED
|
1
|
5
|
|
6-month Follow-up
STARTED
|
79
|
79
|
|
6-month Follow-up
COMPLETED
|
78
|
74
|
|
6-month Follow-up
NOT COMPLETED
|
1
|
5
|
|
Any Follow-up (3 and/or 6 Month)
STARTED
|
80
|
80
|
|
Any Follow-up (3 and/or 6 Month)
COMPLETED
|
79
|
77
|
|
Any Follow-up (3 and/or 6 Month)
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
Structural and Behavioral Intervention
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.
Behavioral and Structural Intervention: 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 Referral
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral
|
|---|---|---|
|
3-month Follow-up
Death
|
1
|
1
|
|
3-month Follow-up
unable to contact
|
0
|
3
|
|
3-month Follow-up
in prison
|
0
|
1
|
|
6-month Follow-up
Death
|
0
|
1
|
|
6-month Follow-up
Lost to Follow-up
|
1
|
2
|
|
6-month Follow-up
in prison
|
0
|
2
|
|
Any Follow-up (3 and/or 6 Month)
Death
|
1
|
1
|
|
Any Follow-up (3 and/or 6 Month)
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
Baseline characteristics by cohort
| Measure |
Structural and Behavioral Intervention
n=80 Participants
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.
Behavioral and Structural Intervention: 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 Referral
n=80 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral
|
Total
n=160 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.26 years
STANDARD_DEVIATION 6.29 • n=56 Participants
|
39.01 years
STANDARD_DEVIATION 6.70 • n=62 Participants
|
38.14 years
STANDARD_DEVIATION 6.54 • n=123 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=56 Participants
|
80 Participants
n=62 Participants
|
160 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=56 Participants
|
80 Participants
n=62 Participants
|
160 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Black or African American
|
80 Participants
n=56 Participants
|
80 Participants
n=62 Participants
|
160 Participants
n=123 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=56 Participants
|
0 Participants
n=62 Participants
|
0 Participants
n=123 Participants
|
|
Region of Enrollment
Uganda
|
80 participants
n=56 Participants
|
80 participants
n=62 Participants
|
160 participants
n=123 Participants
|
|
Occupation
Fishing
|
51 Participants
n=56 Participants
|
50 Participants
n=62 Participants
|
101 Participants
n=123 Participants
|
|
Occupation
Other
|
29 Participants
n=56 Participants
|
30 Participants
n=62 Participants
|
59 Participants
n=123 Participants
|
|
Education
Greater than grade 7
|
18 Participants
n=56 Participants
|
24 Participants
n=62 Participants
|
42 Participants
n=123 Participants
|
|
Education
Grade 7 or less
|
62 Participants
n=56 Participants
|
56 Participants
n=62 Participants
|
118 Participants
n=123 Participants
|
PRIMARY outcome
Timeframe: 3 and 6 month follow upPopulation: Participants completing baseline and at least one follow-up are included in the analysis.
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
Outcome measures
| Measure |
Kisoboka: Structural and Behavioral Intervention
n=79 Participants
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.
Kisoboka: Behavioral and Structural Intervention: 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 Referral
n=77 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
|
|---|---|---|
|
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
Baseline, AUDIT-C greater than/equal to 9
|
41 Participants
|
26 Participants
|
|
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
3-month follow-up, AUDIT-C greater than/equal to 9
|
18 Participants
|
27 Participants
|
|
Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up
6-month follow-up, AUDIT-C greater than/equal to 9
|
15 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: 6 month follow upPopulation: Participants who completed the 6-month follow-up
alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Outcome measures
| Measure |
Kisoboka: Structural and Behavioral Intervention
n=78 Participants
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.
Kisoboka: Behavioral and Structural Intervention: 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 Referral
n=74 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
|
|---|---|---|
|
Change in Phosphatidylethanol (PEth) From Baseline
baseline
|
554.30 ng/mL
Standard Deviation 607.15
|
518.34 ng/mL
Standard Deviation 521.77
|
|
Change in Phosphatidylethanol (PEth) From Baseline
6-month follow-up
|
479.95 ng/mL
Standard Deviation 459.63
|
595.65 ng/mL
Standard Deviation 656.93
|
PRIMARY outcome
Timeframe: 3 and 6 month follow upPopulation: Participants completing baseline and at least one follow-up.
Adult AIDS Clinical Trials Group (AACTG) measure. Self-reported ART adherence for the past 4 days. Optimal adherence \>=90%.
Outcome measures
| Measure |
Kisoboka: Structural and Behavioral Intervention
n=79 Participants
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.
Kisoboka: Behavioral and Structural Intervention: 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 Referral
n=77 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
|
|---|---|---|
|
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
baseline
|
55 Participants
|
57 Participants
|
|
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
3-months
|
55 Participants
|
40 Participants
|
|
Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up
6-months
|
49 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 3 and 6 month follow upPopulation: Participants completing baseline and at least one follow-up assessment
number of days consumed ≥ 5 standard drinks/occasion in the 28 days prior to the assessment. 1 drink = 10g pure alcohol. Self-reported
Outcome measures
| Measure |
Kisoboka: Structural and Behavioral Intervention
n=79 Participants
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.
Kisoboka: Behavioral and Structural Intervention: 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 Referral
n=77 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
|
|---|---|---|
|
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
baseline
|
7.77 days
Standard Deviation 6.31
|
8.45 days
Standard Deviation 7.47
|
|
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
3 months
|
6.87 days
Standard Deviation 6.81
|
8.52 days
Standard Deviation 7.63
|
|
Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days
6 months
|
7.85 days
Standard Deviation 7.25
|
8.46 days
Standard Deviation 7.52
|
SECONDARY outcome
Timeframe: approximately 6 month follow upPopulation: Participants with a routine clinic viral load assessment taken within one of the study measurement time windows (baseline or follow-up) - thus a participant with a viral load test recorded in the clinic record at either time point is included. It is expected that not all participants contribute data for this outcome nor have data at both time points. A participant is included if they have data at either time point, resulting in a larger overall number analyzed than the number at baseline.
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.
Outcome measures
| Measure |
Kisoboka: Structural and Behavioral Intervention
n=63 Participants
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.
Kisoboka: Behavioral and Structural Intervention: 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 Referral
n=59 Participants
Brief feedback on AUDIT-C score, referral for alcohol counseling, and briefly discussion of the importance of HIV care engagement and adherence.
Screening and Referral: Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
|
|---|---|---|
|
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
baseline HIV viral load <839 (from clinic records)
|
42 Participants
|
44 Participants
|
|
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
follow-up HIV viral load <839 (from clinic records)
|
24 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 6 month follow upmissed visit count, visit adherence, 3 month visit constancy
Outcome measures
Outcome data not reported
Adverse Events
Structural and Behavioral Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Screening and Referral
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Assist. Vice President Research Support Services
San Diego State University
Phone: 619-594-5938
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place