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

Study Overview
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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.

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.

Official Title
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Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention

Conditions
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Binge Drinking, Alcohol Abuse, Alcohol Dependence, HIV Infections

Intervention / Treatment
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* Behavioral: HIV support group
* Behavioral: CBT


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>group cognitive behavioral treatment | Behavioral: CBT<br>* group cognitive behavioral treatment<br>|
| Active Comparator: HIV support group<br>group support | Behavioral: HIV support group<br>* group support<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantity and frequency of alcohol use |  | 30 days post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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alcohol use, HIV, cognitive behavioral treatment, Kenya, hazardous/binge drinking, alcohol abuse/dependence