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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Binge Drinking Alcohol Abuse Alcohol Dependence HIV Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CBT

group cognitive behavioral treatment

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

group cognitive behavioral treatment

HIV support group

group support

Group Type ACTIVE_COMPARATOR

HIV support group

Intervention Type BEHAVIORAL

group support

Interventions

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HIV support group

group support

Intervention Type BEHAVIORAL

CBT

group cognitive behavioral treatment

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No