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A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention (RAFIKI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01503255
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : July 14, 2017
Moi University
Syracuse University
Indiana University
Yale University
Information provided by (Responsible Party):
Rebecca Papas, Brown University

Brief Summary:
This study will determine whether a group cognitive-behavioral therapy intervention that demonstrates preliminary evidence of reducing alcohol use among HIV-infected outpatients in western Kenya is effective when compared against a group health education intervention in a large sample over a longer period of time. It will be delivered by paraprofessionals, individuals with limited formal education and little or no relevant professional experience. This approach is consistent with successful cost-effective models of service delivery in resource-limited settings in which paraprofessionals (e.g., clinical officers, traditional birth attendants and peer counselors) are trained.

Condition or disease Intervention/treatment Phase
Hazardous Drinking Binge Drinking HIV-infected Behavioral: cognitive behavioral group therapy Behavioral: health education group Phase 1

Detailed Description:
Hazardous and binge drinking 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, hazardous and binge drinking (score of e3 on the Alcohol Use Disorders Test - Consumption (AUDIT-C), or e6 drinks per occasion at least monthly) have a major impact on HIV transmission and disease progression. Prevalence rates of hazardous drinking are particularly high among HIV (53%) and general medicine (68%) outpatients in western Kenya, in part due to the wide availability of potent traditional brew. Growing evidence suggests that heavy drinking is an obstacle to successful sexual risk reduction approaches. This team recently completed a Stage 1 trial of a group cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among 74 HIV-infected Kenyans (R21AA017884). Results demonstrated feasibility, acceptability and estimated a large treatment effect at post-treatment. Investigators now propose a large Stage 2 efficacy trial of the CBT alcohol intervention. The goal is to evaluate the efficacy of the Reduce Alcohol First in Kenya Intervention (RAFIKI) in its ability to reduce alcohol use within a larger Stage 2 trial that includes an active control and a longer follow-up period. Rafiki means friend in Kiswahili, the national language of Kenya. The trial will be conducted by the Kenya Health Behavior Study (KHBS) team, an experienced group of Kenyan and U.S. behavioral scientists, physicians, substance users in recovery and persons infected with HIV. KHBS expands on well-established ties between the Academic Model for Providing Access to Healthcare (AMPATH) and the Brown University Medical School, which has been an active AMPATH partner since 1997. AMPATH currently treats more than 75,000 HIV-infected patients in 25 clinics in western Kenya. As part of these efforts, investigators have ready locally adapted training, treatment and fidelity rating manuals, a successful paraprofessional intervention delivery model, clinical assessment tools, and an experienced local team of trainers and supervisors. The specific aims are to: 1) To examine the efficacy of a same-sex group CBT intervention in a randomized clinical trial of 336 HIV-infected Kenyan outpatients who report hazardous or binge drinking, when compared to a time-matched group Healthy Lifestyles education intervention; 2) To conduct analyses to examine the mechanisms of intervention effects; and 3) To conduct exploratory analyses to examine the relationship between intervention condition and sexual risk behaviors. Completion of these objectives, which are consistent with NIAAA's mission to reduce both alcohol use and HIV risk in vulnerable populations, will provide a robust test of efficacy of the paraprofessionally led group CBT and potentially provide a sustainable and transportable intervention for other settings in sub-Saharan Africa.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 614 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
Study Start Date : July 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: cognitive behavioral group therapy Behavioral: cognitive behavioral group therapy
6 weekly 90-minute group sessions

Active Comparator: health education group Behavioral: health education group
6 weekly 90-minute group sessions

Primary Outcome Measures :
  1. Timeline Followback alcohol use (percent drinking days) [ Time Frame: longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up ]
    The Timeline Followback is a well-established, reliable and valid retrospective calendar-based measure employing memory cues to assess alcohol use. The primary hypothesis is that CBT will be more effective than HL in reducing alcohol use (percent drinking days) from baseline (past 30 days) through the 6-week active treatment phase. The secondary hypothesis is that CBT will be more effective than HL in reducing alcohol use (percent drinking days) from baseline through the 9-month post-intervention follow-up. Results will be analyzed in a longitudinal model.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • minimum age 18
  • HIV infected outpatient enrolled in 1 of 5 AMPATH clinics
  • drank alcohol in past month
  • hazardous or binge drinker (AUDIT-C)
  • lives within an hour of Eldoret HIV clinic
  • verbal working knowledge of Kiswahili

Exclusion Criteria:

  • active psychosis, suicidality or severe cognitive impairment
  • physically unable to attend session
  • previous participation in CBT study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01503255

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Moi University
Eldoret, Kenya
Sponsors and Collaborators
Brown University
Moi University
Syracuse University
Indiana University
Yale University
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Principal Investigator: Rebecca Papas, PhD Brown University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Rebecca Papas, Assistant Professor (Research), Brown University Identifier: NCT01503255    
Other Study ID Numbers: R01AA020805 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Keywords provided by Rebecca Papas, Brown University:
Additional relevant MeSH terms:
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Binge Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders