Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)
Primary Purpose
Binge Drinking, Alcohol Abuse, Alcohol Dependence
Status
Completed
Phase
Phase 1
Locations
Kenya
Study Type
Interventional
Intervention
HIV support group
CBT
Sponsored by
About this trial
This is an interventional treatment trial for Binge Drinking focused on measuring alcohol use, HIV, cognitive behavioral treatment, Kenya, hazardous/binge drinking, alcohol abuse/dependence
Eligibility Criteria
Inclusion Criteria:
- HIV outpatient
- hazardous or binge drinker
- drank any alcohol in past month
- ARV-eligible or initiated on ARVs in past 12 months
- within 1 hour travel distance of Eldoret, Kenya HIV clinic
- speak Kiswahili
Exclusion Criteria:
- active psychosis or suicidality
- plans to move within next 6 months > 1 hr travel distance from Eldoret HIV clinic
- physically unable to attend sessions
- ever attended AMPATH alcohol support group
Sites / Locations
- AMPATH Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
CBT
HIV support group
Arm Description
group cognitive behavioral treatment
group support
Outcomes
Primary Outcome Measures
quantity and frequency of alcohol use
Secondary Outcome Measures
Full Information
NCT ID
NCT00792519
First Posted
November 17, 2008
Last Updated
June 20, 2011
Sponsor
Brown University
Collaborators
Moi Univeristy, Indiana University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT00792519
Brief Title
Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
Acronym
KHBS
Official Title
Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brown University
Collaborators
Moi Univeristy, Indiana University School of Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will determine whether a cognitive behavioral intervention that demonstrates strong evidence in the U.S. of reducing alcohol use is effective when delivered by paraprofessionals in Kenya and compared against a usual care support group.
Detailed Description
Alcohol use and abuse have been associated with increased risky sexual behavior, poor adherence to antiretroviral therapy (ARVs) and toxicity from ARVs among those with HIV infection. As such, alcohol use and abuse have a major impact on HIV transmission and disease progression. Because alcohol abuse is widespread in Kenya, with estimates of hazardous drinking as high as 68% in general medicine clinics and 53% in HIV clinics, this Stage 1 pilot project will develop and evaluate a paraprofessionally led group cognitive behavioral treatment (CBT) targeting alcohol use among HIV infected Kenyans who were initiated on ARV therapy in the past year. Although CBT is well-suited to the Kenyan setting because it is comparatively structured and consistent with the Kenyan conceptual model of drinking behavior, it requires adaptation for group paraprofessional delivery due to the extremely limited supply of Kenyan mental health professionals. The goal of this 24-month capacity-building R21 study is to evaluate the efficacy of a novel application of CBT, a 6-session paraprofessionally led group in Eldoret, Kenya, when compared against a usual care support group, to reduce hazardous and binge drinking among adult persons infected with HIV. This work will be conducted via the Kenya-U.S. HIV and Alcohol Research and Prevention Partnership-an experienced team of Kenyan and U.S. physicians, behavioral scientists, recovered substance users and persons infected with HIV. The team expands on well-established ties between the Academic Model for Providing Access to Health Care (AMPATH) and the Veterans Aging Cohort Study (VACS), a longitudinal clinical study of HIV and alcohol. AMPATH treats more than 65,000 HIV patients in 19 clinics in western Kenya. Our goals are to: 1) train Kenyan staff and investigators in research methods and train paraprofessionals in group CBT delivery; 2) pilot the CBT adaptation; and 3) evaluate the feasibility of the paraprofessionally led group CBT via a Stage 1 trial in which 56 HIV infected Kenyans are randomized to same-sex CBT or usual care HIV support groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Drinking, Alcohol Abuse, Alcohol Dependence, HIV Infections
Keywords
alcohol use, HIV, cognitive behavioral treatment, Kenya, hazardous/binge drinking, alcohol abuse/dependence
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CBT
Arm Type
Experimental
Arm Description
group cognitive behavioral treatment
Arm Title
HIV support group
Arm Type
Active Comparator
Arm Description
group support
Intervention Type
Behavioral
Intervention Name(s)
HIV support group
Intervention Description
group support
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
group cognitive behavioral treatment
Primary Outcome Measure Information:
Title
quantity and frequency of alcohol use
Time Frame
30 days post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
HIV outpatient
hazardous or binge drinker
drank any alcohol in past month
ARV-eligible or initiated on ARVs in past 12 months
within 1 hour travel distance of Eldoret, Kenya HIV clinic
speak Kiswahili
Exclusion Criteria:
active psychosis or suicidality
plans to move within next 6 months > 1 hr travel distance from Eldoret HIV clinic
physically unable to attend sessions
ever attended AMPATH alcohol support group
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca K Papas, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMPATH Centre
City
Eldoret
State/Province
Rift Valley
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
19967441
Citation
Papas RK, Sidle JE, Martino S, Baliddawa JB, Songole R, Omolo OE, Gakinya BN, Mwaniki MM, Adina JO, Nafula T, Owino-Ong'or WD, Bryant KJ, Carroll KM, Goulet JL, Justice AC, Maisto SA. Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya. AIDS Behav. 2010 Jun;14(3):669-78. doi: 10.1007/s10461-009-9647-6.
Results Reference
background
PubMed Identifier
19015972
Citation
Papas RK, Sidle JE, Wamalwa ES, Okumu TO, Bryant KL, Goulet JL, Maisto SA, Braithwaite RS, Justice AC. Estimating alcohol content of traditional brew in Western Kenya using culturally relevant methods: the case for cost over volume. AIDS Behav. 2010 Aug;14(4):836-44. doi: 10.1007/s10461-008-9492-z. Epub 2008 Nov 18.
Results Reference
background
PubMed Identifier
21631622
Citation
Papas RK, Sidle JE, Gakinya BN, Baliddawa JB, Martino S, Mwaniki MM, Songole R, Omolo OE, Kamanda AM, Ayuku DO, Ojwang C, Owino-Ong'or WD, Harrington M, Bryant KJ, Carroll KM, Justice AC, Hogan JW, Maisto SA. Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya. Addiction. 2011 Dec;106(12):2156-66. doi: 10.1111/j.1360-0443.2011.03518.x. Epub 2011 Aug 18.
Results Reference
result
PubMed Identifier
28351364
Citation
Galarraga O, Gao B, Gakinya BN, Klein DA, Wamai RG, Sidle JE, Papas RK. Task-shifting alcohol interventions for HIV+ persons in Kenya: a cost-benefit analysis. BMC Health Serv Res. 2017 Mar 28;17(1):239. doi: 10.1186/s12913-017-2169-4.
Results Reference
derived
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Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
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