Preparing Patients to Start Antiretroviral Therapy: A Randomized Controlled Trial

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DESCRIPTION (provided by applicant): Despite the widespread availability and effectiveness of antiretroviral therapy (ART) for HIV disease, there is a substantial population with advanced disease who are not on therapy, and an alarming number of HIV+ people die due to failure to access ART. The purpose of the proposed research is to develop and test an intervention to prepare HIV+ men and women who, based on current treatment guidelines, should be but are not currently taking ART. The overarching goal of this line of research is to prevent unnecessary death due to failure to access ART, and the immediate goal of the proposed intervention is to address obstacles to ART uptake/initiation. The proposed work is based in the Information, Motivation, Behavioral Skills ((MB) Model and the intervention will be designed to actively enhance information (e.g. where and how to access care), motivation (e.g. benefits of treatment), and behavioral skills (e.g. problem solving, communication with providers) to increase ART uptake and adherence. Our team has conducted extensive formative research on the topic of treatment expectancies and readiness, including interviews with patients, providers, and the piloting of a preliminary intervention. We now propose to extend this work through the development of a mixed mode intervention based on the content outlined above to be tested in a RCT compared to a lagged intervention condition. The population of interest, those with HIV and low CD4 counts but not taking ART, are more likely to be ethnic and racial minorities, have higher rates of mental illness, substance use, and other barriers to successful management of their HIV. However, they are most likely to die from AIDS-related illness and are at risk of transmitting HIV to others if they do not engage in effective treatment. Our team has experience with such populations and we plan to use recruitment, retention, and assessment protocols demonstrated effective in this context. We will enroll 300 HIV-infected persons not on ART with CD4 <= 250 who will be randomized to immediate or lagged intervention. The intervention will consist of a combination of one-on-one meetings and a single small group session led by cross-disciplinary experts and peers. Booster sessions are proposed to reinforce the intervention. The primary outcome will be initiation (uptake) of ART and secondary outcomes will be ART adherence, CD4, viral load, health status, and morbidity. Follow-up assessments will be conducted at 3, 6, and 12 months with CD4 and viral load at months 0, 6 and 12.