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

November 17, 2008
June 20, 2011
February 2009
December 2009   (final data collection date for primary outcome measure)
quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792519 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Binge Drinking
  • Alcohol Abuse
  • Alcohol Dependence
  • HIV Infections
  • Behavioral: HIV support group
    group support
  • Behavioral: CBT
    group cognitive behavioral treatment
  • Experimental: CBT
    group cognitive behavioral treatment
    Intervention: Behavioral: CBT
  • Active Comparator: HIV support group
    group support
    Intervention: Behavioral: HIV support group

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
December 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Kenya
 
NCT00792519
0703002442, R21AA016884
Yes
Rebecca K Papas, PhD, Assistant Professor (Research), Brown University
Brown University
  • Moi Univeristy
  • Indiana University School of Medicine
Principal Investigator: Rebecca K Papas, PhD Brown University
Brown University
January 2011

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