Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans (KHBS)

• ClinicalTrials.gov Identifier: NCT00792519
• Recruitment Status: Completed
• First Posted: November 18, 2008
• Last Update Posted: June 22, 2011
• Sponsor: Brown University
• Collaborators: Moi Univeristy; Indiana University School of Medicine
• Information provided by: Brown University

Tracking Information

• First Submitted Date: November 17, 2008
• First Posted Date: November 18, 2008
• Last Update Posted Date: June 22, 2011
• Study Start Date: February 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 17, 2008): quantity and frequency of alcohol use [ Time Frame: 30 days post-treatment ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cognitive Behavioral Treatment to Reduce Alcohol Use Among HIV-Infected Kenyans
• Official Title: Alcohol & HIV in Kenya: Stage 1 Trial of a Peer-Led Alcohol Behavior Intervention
• 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.
• Detailed Description: Alcohol use and abuse 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, alcohol use and abuse have a major impact on HIV transmission and disease progression. Because alcohol abuse is widespread in Kenya, with estimates of hazardous drinking as high as 68% in general medicine clinics and 53% in HIV clinics, this Stage 1 pilot project will develop and evaluate a paraprofessionally led group cognitive behavioral treatment (CBT) targeting alcohol use among HIV infected Kenyans who were initiated on ARV therapy in the past year. Although CBT is well-suited to the Kenyan setting because it is comparatively structured and consistent with the Kenyan conceptual model of drinking behavior, it requires adaptation for group paraprofessional delivery due to the extremely limited supply of Kenyan mental health professionals. The goal of this 24-month capacity-building R21 study is to evaluate the efficacy of a novel application of CBT, a 6-session paraprofessionally led group in Eldoret, Kenya, when compared against a usual care support group, to reduce hazardous and binge drinking among adult persons infected with HIV. This work will be conducted via the Kenya-U.S. HIV and Alcohol Research and Prevention Partnership-an experienced team of Kenyan and U.S. physicians, behavioral scientists, recovered substance users and persons infected with HIV. The team expands on well-established ties between the Academic Model for Providing Access to Health Care (AMPATH) and the Veterans Aging Cohort Study (VACS), a longitudinal clinical study of HIV and alcohol. AMPATH treats more than 65,000 HIV patients in 19 clinics in western Kenya. Our goals are to: 1) train Kenyan staff and investigators in research methods and train paraprofessionals in group CBT delivery; 2) pilot the CBT adaptation; and 3) evaluate the feasibility of the paraprofessionally led group CBT via a Stage 1 trial in which 56 HIV infected Kenyans are randomized to same-sex CBT or usual care HIV support groups.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Binge Drinking
• Alcohol Abuse
• Alcohol Dependence
• HIV Infections

Intervention

• Behavioral: HIV support group
  group support
• Behavioral: CBT
  group cognitive behavioral treatment

Study Arms

• Experimental: CBT
  group cognitive behavioral treatment
  Intervention: Behavioral: CBT
• Active Comparator: HIV support group
  group support
  Intervention: Behavioral: HIV support group

Publications *

• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2011): 75
• Original Estimated Enrollment (submitted: November 17, 2008): 56
• Actual Study Completion Date: December 2010
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Kenya

Administrative Information

• NCT Number: NCT00792519
• Other Study ID Numbers: 0703002442; R21AA016884 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Rebecca K Papas, PhD, Assistant Professor (Research), Brown University
• Original Responsible Party: Rebecca K Papas, PhD, Associate Research Scientist, Yale University
• Current Study Sponsor: Brown University
• Original Study Sponsor: Yale University

Collaborators

• Moi Univeristy
• Indiana University School of Medicine

Investigators

• Principal Investigator: Rebecca K Papas, PhD; Brown University

• PRS Account: Brown University
• Verification Date: January 2011