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

This study is currently recruiting participants.
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

December 16, 2011
September 7, 2012
July 2012
May 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01503255 on ClinicalTrials.gov Archive Site
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A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hazardous Drinking
  • Binge Drinking
  • HIV-infected
  • Behavioral: cognitive behavioral group therapy
    6 weekly 90-minute group sessions
  • Behavioral: health education group
    6 weekly 90-minute group sessions
  • Experimental: cognitive behavioral group therapy
    Intervention: Behavioral: cognitive behavioral group therapy
  • Active Comparator: health education group
    Intervention: Behavioral: health education group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
336
May 2016
May 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Rebecca Papas, PhD 401-273-7100 rebecca_papas@brown.edu
Contact: Benson Gakinya, MD 0112540721587353 gakinyandegwa@yahoo.co.uk
Kenya
 
NCT01503255
R01AA020805
Yes
Rebecca Papas, Brown University
Brown University
  • Moi University
  • Syracuse University
  • Indiana University
  • Yale University
Principal Investigator: Rebecca Papas, PhD Brown University
Brown University
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP