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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Brown University
Sponsor:
Collaborators:
Moi University
Syracuse University
Indiana University
Yale University
Information provided by (Responsible Party):
Rebecca Papas, Brown University
ClinicalTrials.gov Identifier:
NCT01503255
First received: December 16, 2011
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Hazardous Drinking
Binge Drinking
HIV-infected
Behavioral: cognitive behavioral group therapy
Behavioral: health education group
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: A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention

Resource links provided by NLM:


Further study details as provided by Brown University:

Primary Outcome Measures:
  • Timeline Followback alcohol use (percent drinking days) [ Time Frame: longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 336
Study Start Date: July 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01503255

Contacts
Contact: Rebecca Papas, PhD 401-273-7100 rebecca_papas@brown.edu
Contact: Benson Gakinya, MD 0112540721587353 gakinyandegwa@yahoo.co.uk

Locations
Kenya
Moi University Recruiting
Eldoret, Kenya
Principal Investigator: Benson Gakinya, MD         
Sponsors and Collaborators
Brown University
Moi University
Syracuse University
Indiana University
Yale University
Investigators
Principal Investigator: Rebecca Papas, PhD Brown University
  More Information

No publications provided

Responsible Party: Rebecca Papas, Assistant Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT01503255     History of Changes
Other Study ID Numbers: R01AA020805
Study First Received: December 16, 2011
Last Updated: September 7, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
Kenya: Institutional Review Board

Keywords provided by Brown University:
CBT
alcohol
HIV
Kenya
paraprofessional

Additional relevant MeSH terms:
Binge Drinking
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Alcohol Drinking
Drinking Behavior
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014