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

This study has been completed.
Sponsor:
Collaborators:
Moi Univeristy
Indiana University School of Medicine
Information provided by:
Brown University
ClinicalTrials.gov Identifier:
NCT00792519
First received: November 17, 2008
Last updated: June 20, 2011
Last verified: January 2011
  Purpose

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 Intervention Phase
Binge Drinking
Alcohol Abuse
Alcohol Dependence
HIV Infections
Behavioral: HIV support group
Behavioral: CBT
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: February 2009
Study Completion Date: December 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792519

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

Publications:
Responsible Party: Rebecca K Papas, PhD, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT00792519     History of Changes
Other Study ID Numbers: 0703002442, R21AA016884
Study First Received: November 17, 2008
Last Updated: June 20, 2011
Health Authority: United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by Brown University:
alcohol use
HIV
cognitive behavioral treatment
Kenya
hazardous/binge drinking
alcohol abuse/dependence

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Alcoholism
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014