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

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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

Tracking Information
First Submitted Date  ICMJE November 17, 2008
First Posted Date  ICMJE November 18, 2008
Last Update Posted Date June 22, 2011
Study Start Date  ICMJE February 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2008)
quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00792519 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
Official Title  ICMJE Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge Drinking
  • Alcohol Abuse
  • Alcohol Dependence
  • HIV Infections
Intervention  ICMJE
  • Behavioral: HIV support group
    group support
  • Behavioral: CBT
    group cognitive behavioral treatment
Study Arms  ICMJE
  • Experimental: CBT
    group cognitive behavioral treatment
    Intervention: Behavioral: CBT
  • Active Comparator: HIV support group
    group support
    Intervention: Behavioral: HIV support group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2011)
75
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2008)
56
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kenya
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00792519
Other Study ID Numbers  ICMJE 0703002442
R21AA016884 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rebecca K Papas, PhD, Assistant Professor (Research), Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE
  • Moi Univeristy
  • Indiana University School of Medicine
Investigators  ICMJE
Principal Investigator: Rebecca K Papas, PhD Brown University
PRS Account Brown University
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP