NCT00792519

Brief Summary

This study will determine whether a cognitive behavioral intervention that demonstrates strong evidence in the U.S. of reducing alcohol use is effective when delivered by paraprofessionals in Kenya and compared against a usual care support group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2009

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

November 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 18, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

June 22, 2011

Status Verified

January 1, 2011

Enrollment Period

10 months

First QC Date

November 17, 2008

Last Update Submit

June 20, 2011

Conditions

Binge DrinkingAlcohol AbuseAlcohol DependenceHIV Infections

Keywords

alcohol useHIVcognitive behavioral treatmentKenyahazardous/binge drinkingalcohol abuse/dependence

Outcome Measures

Primary Outcomes (1)

  • quantity and frequency of alcohol use

    30 days post-treatment

Study Arms (2)

CBT

EXPERIMENTAL

group cognitive behavioral treatment

Behavioral: CBT

HIV support group

ACTIVE COMPARATOR

group support

Behavioral: HIV support group

Interventions

HIV support groupBEHAVIORAL

group support

HIV support group
CBTBEHAVIORAL

group cognitive behavioral treatment

CBT

Eligibility Criteria

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

You may qualify if:

  • HIV outpatient
  • hazardous or binge drinker
  • drank any alcohol in past month
  • ARV-eligible or initiated on ARVs in past 12 months
  • within 1 hour travel distance of Eldoret, Kenya HIV clinic
  • speak Kiswahili

You may not qualify if:

  • active psychosis or suicidality
  • plans to move within next 6 months \> 1 hr travel distance from Eldoret HIV clinic
  • physically unable to attend sessions
  • ever attended AMPATH alcohol support group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AMPATH Centre

Eldoret, Rift Valley, Kenya

Location

Related Publications (4)

  • Papas RK, Sidle JE, Martino S, Baliddawa JB, Songole R, Omolo OE, Gakinya BN, Mwaniki MM, Adina JO, Nafula T, Owino-Ong'or WD, Bryant KJ, Carroll KM, Goulet JL, Justice AC, Maisto SA. Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya. AIDS Behav. 2010 Jun;14(3):669-78. doi: 10.1007/s10461-009-9647-6.

    PMID: 19967441BACKGROUND

  • Papas RK, Sidle JE, Wamalwa ES, Okumu TO, Bryant KL, Goulet JL, Maisto SA, Braithwaite RS, Justice AC. Estimating alcohol content of traditional brew in Western Kenya using culturally relevant methods: the case for cost over volume. AIDS Behav. 2010 Aug;14(4):836-44. doi: 10.1007/s10461-008-9492-z. Epub 2008 Nov 18.

    PMID: 19015972BACKGROUND

  • Papas RK, Sidle JE, Gakinya BN, Baliddawa JB, Martino S, Mwaniki MM, Songole R, Omolo OE, Kamanda AM, Ayuku DO, Ojwang C, Owino-Ong'or WD, Harrington M, Bryant KJ, Carroll KM, Justice AC, Hogan JW, Maisto SA. Treatment outcomes of a stage 1 cognitive-behavioral trial to reduce alcohol use among human immunodeficiency virus-infected out-patients in western Kenya. Addiction. 2011 Dec;106(12):2156-66. doi: 10.1111/j.1360-0443.2011.03518.x. Epub 2011 Aug 18.

    PMID: 21631622RESULT

  • 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 DrinkingAlcoholismHIV InfectionsAlcohol Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersDrinking BehaviorBehaviorMental DisordersBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Rebecca K 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

Study Record Dates

First Submitted

November 17, 2008

First Posted

November 18, 2008

Study Start

February 1, 2009

Primary Completion

December 1, 2009

Study Completion

December 1, 2010

Last Updated

June 22, 2011

Record last verified: 2011-01

Locations

KE(1)