- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503255
A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention (RAFIKI)
July 13, 2017 updated by: Rebecca Papas, Brown University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
614
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Eldoret, Kenya
- Moi University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cognitive behavioral group therapy
|
6 weekly 90-minute group sessions
|
Active Comparator: health education group
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6 weekly 90-minute group sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
longitudinal alcohol use from baseline (past 30 days) to 9 month post-intervention follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rebecca Papas, PhD, Brown University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
December 16, 2011
First Submitted That Met QC Criteria
December 30, 2011
First Posted (Estimate)
January 4, 2012
Study Record Updates
Last Update Posted (Actual)
July 14, 2017
Last Update Submitted That Met QC Criteria
July 13, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AA020805 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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