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| ID | Type | Description | Link |
|---|---|---|---|
| R34AA025891 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Makerere University | OTHER |
| Mildmay Uganda Limited | OTHER |
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
| University of California, San Francisco |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kisoboka: Behavioral and Structural Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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%. | 3 and 6 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susan M Kiene | San Diego State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| selected Wakiso District HIV clinics | Multiple Locations | Wakiso District | Uganda |
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Participants were recruited from HIV clinics and enrolled in the trial between January 2021 and March 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| 3-month Follow-up |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 |
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| OTHER |
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| Screening and Referral | Behavioral | Alcohol screening and referral and emphasizing the importance of HIV care engagement and ART adherence |
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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. |
| approximately 6 month follow up |
| HIV Care Engagement | missed visit count, visit adherence, 3 month visit constancy | 6 month follow up |
| FG001 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| 6-month Follow-up |
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| Any Follow-up (3 and/or 6 Month) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Occupation | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Participants completing baseline and at least one follow-up are included in the analysis. | Posted | Count of Participants | Participants | 3 and 6 month follow up |
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| Primary | Change in Phosphatidylethanol (PEth) From Baseline | alcohol biomarker which correlates well with the volume of alcohol consumed over the prior 2-4 weeks | Participants who completed the 6-month follow-up | Posted | Mean | Standard Deviation | ng/mL | 6 month follow up |
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| 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%. | Participants completing baseline and at least one follow-up. | Posted | Count of Participants | Participants | 3 and 6 month follow up |
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| 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 | Participants completing baseline and at least one follow-up assessment | Posted | Mean | Standard Deviation | days | 3 and 6 month follow up |
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| 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. | 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. | Posted | Count of Participants | Participants | approximately 6 month follow up |
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| Secondary | HIV Care Engagement | missed visit count, visit adherence, 3 month visit constancy | Not Posted | 6 month follow up | Participants |
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 80 | 0 | 80 | 0 | 80 |
| EG001 | 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 | 2 | 80 | 0 | 80 | 0 | 80 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assist. Vice President Research Support Services | San Diego State University | 619-594-5938 | rgulizia@sdsu.edu |
| Aug 26, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 23, 2020 | Aug 23, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| D012017 | Referral and Consultation |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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| in prison |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Other |
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| Grade 7 or less |
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| 3-month follow-up, AUDIT-C greater than/equal to 9 |
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| 6-month follow-up, AUDIT-C greater than/equal to 9 |
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| OG001 | 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 and emphasizing the importance of HIV care engagement and ART adherence |
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