Alcohol Use Disorder, HIV-infection/Aids
Conditions
Brief 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, 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.
Interventions
BEHAVIORALKisoboka: 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.
BEHAVIORALScreening and Referral
Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence
Sponsors
San Diego State University
Makerere University
Mildmay Uganda Limited
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up | 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 | 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 | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | 3 and 6 month follow up | number of days consumed ≥ 5 standard drinks/occasion in the 28 days prior to the assessment. 1 drink = 10g pure alcohol. Self-reported |
| 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 | approximately 6 month follow up | 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. |
| HIV Care Engagement | 6 month follow up | missed visit count, visit adherence, 3 month visit constancy |
Countries
Uganda
Contacts
PRINCIPAL_INVESTIGATORSusan M Kiene
San Diego State University
Participant flow
Recruitment details
Participants were recruited from HIV clinics and enrolled in the trial between January 2021 and March 2022.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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 | 80 |
| Total | 160 |
Baseline characteristics
| Characteristic | Structural and Behavioral Intervention | Screening and Referral | Total |
|---|---|---|---|
| Age, Continuous | 37.26 years STANDARD_DEVIATION 6.29 | 39.01 years STANDARD_DEVIATION 6.7 | 38.14 years STANDARD_DEVIATION 6.54 |
| Education Grade 7 or less | 62 Participants | 56 Participants | 118 Participants |
| Education Greater than grade 7 | 18 Participants | 24 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 80 Participants | 80 Participants | 160 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Occupation Fishing | 51 Participants | 50 Participants | 101 Participants |
| Occupation Other | 29 Participants | 30 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 80 Participants | 80 Participants | 160 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Uganda | 80 participants | 80 participants | 160 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 80 Participants | 80 Participants | 160 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 80 | 2 / 80 |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Change in Phosphatidylethanol (PEth) From Baseline
alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks
Time frame: 6 month follow up
Population: Participants who completed the 6-month follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kisoboka: Structural and Behavioral Intervention | Change in Phosphatidylethanol (PEth) From Baseline | baseline | 554.30 ng/mL | Standard Deviation 607.15 |
| Kisoboka: Structural and Behavioral Intervention | Change in Phosphatidylethanol (PEth) From Baseline | 6-month follow-up | 479.95 ng/mL | Standard Deviation 459.63 |
| Screening and Referral | Change in Phosphatidylethanol (PEth) From Baseline | baseline | 518.34 ng/mL | Standard Deviation 521.77 |
| Screening and Referral | Change in Phosphatidylethanol (PEth) From Baseline | 6-month follow-up | 595.65 ng/mL | Standard Deviation 656.93 |
Primary
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
Time frame: 3 and 6 month follow up
Population: Participants completing baseline and at least one follow-up are included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kisoboka: Structural and Behavioral Intervention | 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 |
| Kisoboka: Structural and Behavioral Intervention | 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 |
| Kisoboka: Structural and Behavioral Intervention | 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 |
| Screening and Referral | Number of Participants With Hazardous Alcohol Use at Baseline, 3 and 6 Month Follow up | Baseline, AUDIT-C greater than/equal to 9 | 26 Participants |
| Screening and Referral | 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 | 27 Participants |
| Screening and Referral | 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 | 20 Participants |
Comparison: Generalized Estimating Equations (GEE) model specifying a logistic distribution examining the time x arm interactionp-value: 0.00295% CI: [0.11, 0.73]GEE model specifying a logistic distribu
Primary
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%.
Time frame: 3 and 6 month follow up
Population: Participants completing baseline and at least one follow-up.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kisoboka: Structural and Behavioral Intervention | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | baseline | 55 Participants |
| Kisoboka: Structural and Behavioral Intervention | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | 3-months | 55 Participants |
| Kisoboka: Structural and Behavioral Intervention | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | 6-months | 49 Participants |
| Screening and Referral | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | baseline | 57 Participants |
| Screening and Referral | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | 3-months | 40 Participants |
| Screening and Referral | Number of Participants With Optimal Antiretroviral (ART) Adherence at Baseline, 3 and 6 Month Follow up | 6-months | 37 Participants |
Secondary
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
Time frame: 3 and 6 month follow up
Population: Participants completing baseline and at least one follow-up assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Kisoboka: Structural and Behavioral Intervention | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | baseline | 7.77 days | Standard Deviation 6.31 |
| Kisoboka: Structural and Behavioral Intervention | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | 3 months | 6.87 days | Standard Deviation 6.81 |
| Kisoboka: Structural and Behavioral Intervention | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | 6 months | 7.85 days | Standard Deviation 7.25 |
| Screening and Referral | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | baseline | 8.45 days | Standard Deviation 7.47 |
| Screening and Referral | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | 3 months | 8.52 days | Standard Deviation 7.63 |
| Screening and Referral | Change From Baseline in Frequency of Consuming ≥ 5 Drinks/Occasion in the Prior 28 Days | 6 months | 8.46 days | Standard Deviation 7.52 |
Secondary
HIV Care Engagement
missed visit count, visit adherence, 3 month visit constancy
Time frame: 6 month follow up
Secondary
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.
Time frame: approximately 6 month follow up
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Kisoboka: Structural and Behavioral Intervention | 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 |
| Kisoboka: Structural and Behavioral Intervention | 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 |
| Screening and Referral | 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) | 44 Participants |
| Screening and Referral | 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) | 18 Participants |