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Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00792519
Recruitment Status : Completed
First Posted : November 18, 2008
Last Update Posted : June 22, 2011
Sponsor:
Collaborators:
Moi Univeristy
Indiana University School of Medicine
Information provided by:
Brown University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Binge Drinking Alcohol Abuse Alcohol Dependence HIV Infections Behavioral: HIV support group Behavioral: CBT Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention
Study Start Date : February 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
Experimental: CBT
group cognitive behavioral treatment
 Behavioral: CBT
group cognitive behavioral treatment
Active Comparator: HIV support group
group support
 Behavioral: HIV support group
group support


Outcome Measures
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Primary Outcome Measures :
  1. quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00792519


Locations
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Kenya
AMPATH Centre
Eldoret, Rift Valley, Kenya
Sponsors and Collaborators
Brown University
Moi Univeristy
Indiana University School of Medicine
Investigators
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Principal Investigator: Rebecca K Papas, PhD Brown University
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rebecca K Papas, PhD, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT00792519    
Other Study ID Numbers: 0703002442
R21AA016884 ( U.S. NIH Grant/Contract )
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: January 2011
Keywords provided by Brown University:
alcohol use
HIV
cognitive behavioral treatment
 Kenya
hazardous/binge drinking
alcohol abuse/dependence
Additional relevant MeSH terms:
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Alcoholism
Binge Drinking
Alcohol-Related Disorders
Substance-Related Disorders
 Chemically-Induced Disorders
Mental Disorders
Alcohol Drinking
Drinking Behavior