CART STUDY 3: PRE-PILOT TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This study is a pilot trial proposing that people completing the CART intervention will show more improvements in medication adherence behavior as measured by time-line follow-back procedures, and greater reduction in cocaine problem severity as measured on the ASI than the participants completing the informational video intervention. Also, that people completing the CART condition will show greater improvements on clinical markers of immune health. Many studies have found substance use to be associated with decreased HIV medication adherence. Unfortunately, many providers may assume that substance using individuals cannot be adherent to their medication, leading to a risk of withholding treatment universally from substance abusers. In addition, despite the effectiveness of drug treatment, substance abusers often choose not to use available treatment resources. Interventions that improve adherence to antiviral medications among people with HIV are urgently needed. Cocaine users, especially crack users, are at increased risk of contracting HIV and the prevalence of HIV in this group of drug users is high. Once infected with HIV, crack users are likely to be under-treated for HIV. HIV and cocaine use are two factors that reduce the likelihood of obtaining adequate healthcare. This project is a Stage 1 study; therefore, the final protocol for the pilot trial will evolve throughout the project phases following three preliminary studies. The goal of Stage 1 research is to develop novel interventions and assess their feasibility prior to proposing a Stage 2 efficacy trial. The proposed study is well suited to a Stage 1 project because there is a dearth of validated treatments for the combined problems of non-adherence and cocaine use among patients with HIV, requiring the development and testing of novel interventions in a small number of patients. This stage 1 study will yield important clinical innovations to improve the health of cocaine abusers with HIV. It will provide direction and methods for future research on improving adherence and reducing cocaine use in people with HIV, and will provide the materials needed before implementing a Stage 2 trial.