Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Binge Drinking Alcohol Abuse Alcohol Dependence HIV Infections |
Behavioral: HIV support group Behavioral: CBT |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention |
- quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | February 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT
group cognitive behavioral treatment
|
Behavioral: CBT
group cognitive behavioral treatment
|
|
Active Comparator: HIV support group
group support
|
Behavioral: HIV support group
group support
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Kenya | |
| AMPATH Centre | |
| Eldoret, Rift Valley, Kenya | |
| Principal Investigator: | Rebecca K Papas, PhD | Brown University |
More Information
Publications:
| Responsible Party: | Rebecca K Papas, PhD, Assistant Professor (Research), Brown University |
| ClinicalTrials.gov Identifier: | NCT00792519 History of Changes |
| Other Study ID Numbers: | 0703002442, R21AA016884 |
| Study First Received: | November 17, 2008 |
| Last Updated: | June 20, 2011 |
| Health Authority: | United States: Institutional Review Board Kenya: Institutional Review Board |
Keywords provided by Brown University:
|
alcohol use HIV cognitive behavioral treatment |
Kenya hazardous/binge drinking alcohol abuse/dependence |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Alcoholism Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Alcohol-Related Disorders Substance-Related Disorders Mental Disorders Ethanol Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Central Nervous System Depressants Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013