Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)
June 20, 2011 updated by: Brown University
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Interventional
Enrollment (Actual)
75
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rift Valley
-
Eldoret, Rift Valley, Kenya
- AMPATH Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CBT
group cognitive behavioral treatment
|
group cognitive behavioral treatment
|
|
Active Comparator: HIV support group
group support
|
group support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
quantity and frequency of alcohol use
Time Frame: 30 days post-treatment
|
30 days post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca K Papas, PhD, Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Papas RK, Sidle JE, Martino S, Baliddawa JB, Songole R, Omolo OE, Gakinya BN, Mwaniki MM, Adina JO, Nafula T, Owino-Ong'or WD, Bryant KJ, Carroll KM, Goulet JL, Justice AC, Maisto SA. Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya. AIDS Behav. 2010 Jun;14(3):669-78. doi: 10.1007/s10461-009-9647-6.
- Papas RK, Sidle JE, Wamalwa ES, Okumu TO, Bryant KL, Goulet JL, Maisto SA, Braithwaite RS, Justice AC. Estimating alcohol content of traditional brew in Western Kenya using culturally relevant methods: the case for cost over volume. AIDS Behav. 2010 Aug;14(4):836-44. doi: 10.1007/s10461-008-9492-z. Epub 2008 Nov 18.
- Papas RK, Sidle JE, Gakinya BN, Baliddawa JB, Martino S, Mwaniki MM, Songole R, Omolo OE, Kamanda AM, Ayuku DO, Ojwang C, Owino-Ong'or WD, Harrington M, Bryant KJ, Carroll KM, Justice AC, Hogan JW, Maisto SA. Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya. Addiction. 2011 Dec;106(12):2156-66. doi: 10.1111/j.1360-0443.2011.03518.x. Epub 2011 Aug 18.
- Galarraga O, Gao B, Gakinya BN, Klein DA, Wamai RG, Sidle JE, Papas RK. Task-shifting alcohol interventions for HIV+ persons in Kenya: a cost-benefit analysis. BMC Health Serv Res. 2017 Mar 28;17(1):239. doi: 10.1186/s12913-017-2169-4.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
November 17, 2008
First Submitted That Met QC Criteria
November 17, 2008
First Posted (Estimate)
November 18, 2008
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 20, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0703002442
- R21AA016884 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.