Development of an Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda
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|ClinicalTrials.gov Identifier: NCT03919695|
Recruitment Status : Not yet recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder HIV-infection/Aids||Behavioral: Behavioral and Structural Intervention Behavioral: Screening and Referral||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development and Pilot Testing of a Combination Intervention to Reduce Heavy Drinking and Improve HIV Care Engagement Among Fisherfolk in Uganda|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: 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: Behavioral and Structural Intervention
The intervention has two components; a structural component and a behavioral component.
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.
Other Name: KISOBOKA
Active Comparator: 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.
Behavioral: Screening and Referral
Alcohol screening and referral
- change from baseline in frequency of heavy/binge drinking [ Time Frame: 3 and 6 month follow up ]≥ 5 drinks per occasion
- HIV care engagement [ Time Frame: 6 month follow up ]missed visit count, visit adherence, 3 month visit constancy
- ART adherence [ Time Frame: 6 month follow up ]AACTG measure. The AACTG Adherence Instruments, which are comprised of two self-report questionnaires for use in clinical trials conducted by the Adult AIDS Clinical Trials Group (AACTG).
- phosphatidylethanol (PEth) [ Time Frame: 6 month follow up ]alcohol biomarker
- change from baseline in HIV viral load [ Time Frame: 6 month follow up ]HIV viral load
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919695
|Contact: Susan M Kienefirstname.lastname@example.org|
|Wakiso District HIV clinics||Not yet recruiting|
|Multiple Locations, Wakiso District, Uganda|
|Contact: Harriet Chemusto email@example.com|
|Principal Investigator: Nazarius M Tumwesigye, PhD|
|Sub-Investigator: Barbara Mukasa, MPH|
|Sub-Investigator: Rhoda K Wanyenze, PhD|
|Principal Investigator:||Susan M Kiene||San Diego State University|