A Stage 2 Cognitive-behavioral Trial: Reduce Alcohol First in Kenya Intervention
Condition: Hazardous Drinking; Binge Drinking; HIV-infected
MeSH terms: Binge Drinking
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): cognitive behavioral group therapy; health education group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 6 weekly 90-minute group sessions; 6 weekly 90-minute group sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CBT; alcohol; HIV; Kenya; paraprofessional