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

NCT01503255 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 614

Last updated 2017-07-14

No results posted yet for this study

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.

Conditions

  • Hazardous Drinking
  • Binge Drinking
  • HIV-infected

Interventions

BEHAVIORAL

cognitive behavioral group therapy

6 weekly 90-minute group sessions

BEHAVIORAL

health education group

6 weekly 90-minute group sessions

Sponsors & Collaborators

  • Moi University

    collaborator OTHER

  • Syracuse University

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Rebecca Papas, PhD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • Kenya

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01503255 on ClinicalTrials.gov