Rebecca K. Papas, Ph.D. - US grants

[unreadable] DESCRIPTION (provided by applicant): 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, we propose a Stage 1 pilot project to develop and evaluate a peer-led group cognitive behavioral treatment (CBT) targeting alcohol use among HIV infected Kenyans who are eligible for ARV therapy. 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 peer 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 peer-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 (KHARPP)-an experienced team of Kenyan and U.S. physicians, behavioral scientists, recovered substance users and persons infected with HIV. KHARPP expands on well- established ties between the Academic Model for Prevention and Treatment of HIV/AIDS (AMPATH) and the Veterans Aging Cohort Study (VACS), a longitudinal clinical study of HIV and alcohol. AMPATH treats more than 25,000 patients in 15 clinics in western Kenya. As a part of these efforts, we have already completed translation to Kiswahili and adaptation of the CBT protocol, translation of the screening and outcome instruments, and the quantification of types and serving sizes of locally brewed drinks. Our specific aims are to: 1) train 2 Kenyan psychologists to provide ongoing quality/fidelity monitoring of the peer-led CBT model using standardized adherence/quality rating scales; 2) train 4 Kenyan peer facilitators in the standardized CBT intervention to reduce alcohol use; and 3) evaluate the feasibility of the peer-led group CBT intervention via a small, 6-week trial in which 56 HIV infected Kenyans are randomized to same-sex CBT or usual care HIV support groups. Completion of our objectives, which are consistent with NIAAA's mission to reduce both alcohol use and HIV risk in vulnerable populations, will result in the following products: (1) a complete manual for the CBT intervention in both English and Kiswahili, (2) clinician training materials and process rating forms, (3) preliminary indicators of effect size from the pilot study, and well as adapted alcohol-related assessment instruments for this setting and population. If the CBT intervention is demonstrated to have promise in this Stage 1 study, these materials should be sufficient to develop a full "Stage 2" randomized trial with this population to be implemented at additional HIV clinics in Kenya. This study will determine whether a cognitive behavioral intervention that demonstrates strong evidence in the U.S. of reducing alcohol use is effective in Kenya, when compared against a usual care support group. It will be delivered by individuals who are infected with HIV and may have little formal education but who are trained in standardized intervention methods and keenly aware of the needs of their peers with HIV infection and alcohol problems. This approach is consistent with successful cost-effective models of service delivery in resource-poor settings in which lay individuals (e.g., clinical officers, traditional birth attendants and peer counselors) are trained. [unreadable] [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): 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. We now propose a large Stage 2 efficacy trial of the CBT alcohol intervention. Our 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, we 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. Our 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 our 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. PUBLIC HEALTH RELEVANCE: 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.