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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 17, 2008

Last Updated Date

June 20, 2011

Start Date ^ICMJE

February 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

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 Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Arm (s)

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

Enrollment ^ICMJE

Completion Date

December 2010

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Kenya

Administrative Information

NCT Number ^ICMJE

NCT00792519

Other Study ID Numbers ^ICMJE

0703002442, R21AA016884

Has Data Monitoring Committee

Yes

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

Information Provided By

Brown University

Verification Date

January 2011

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

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