NCT01503255

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
614

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

July 14, 2017

Status Verified

July 1, 2017

Enrollment Period

4.1 years

First QC Date

December 16, 2011

Last Update Submit

July 13, 2017

Conditions

Hazardous DrinkingBinge DrinkingHIV-infected

Keywords

CBTalcoholHIVKenyaparaprofessional

Outcome Measures

Primary Outcomes (1)

  • Timeline Followback alcohol use (percent drinking days)

    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

Study Arms (2)

cognitive behavioral group therapy

EXPERIMENTAL
Behavioral: cognitive behavioral group therapy

health education group

ACTIVE COMPARATOR
Behavioral: health education group

Interventions

cognitive behavioral group therapyBEHAVIORAL

6 weekly 90-minute group sessions

cognitive behavioral group therapy
health education groupBEHAVIORAL

6 weekly 90-minute group sessions

health education group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moi University

Eldoret, Kenya

Location

Related Publications (1)

  • Galarraga O, Gao B, Gakinya BN, Klein DA, Wamai RG, Sidle JE, Papas RK. Task-shifting alcohol interventions for HIV+ persons in Kenya: a cost-benefit analysis. BMC Health Serv Res. 2017 Mar 28;17(1):239. doi: 10.1186/s12913-017-2169-4.

    PMID: 28351364DERIVED

MeSH Terms

Conditions

Binge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersAlcohol DrinkingDrinking BehaviorBehaviorMental Disorders

Study Officials

  • Rebecca Papas, PhD

    Brown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor (Research)

Study Record Dates

First Submitted

December 16, 2011

First Posted

January 4, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

July 14, 2017

Record last verified: 2017-07

Locations

KE(1)