Over the past several years, programs of directly observed therapy (DOT) of antiretroviral therapy (ART) have been implemented to improve the adherence of HIV-positive individuals who fail standard care and traditional outpatient adherence support. Many of these individuals are marginalized by poverty, ethnicity, substance abuse, and/or mental illness and suffer disproportionately high rates of AIDS morbidity and mortality. Results of preliminary HIV DOT adherence interventions among these populations have been promising, with at least three programs demonstrating at least a 30% increase in adherence rates as well as increasing CD4 counts and decreasing HIV viral loads. DOT, however, is highly costly and may not be a practical long-term intervention for ART treatment of HIV-infected individuals. In addition, as presently structured, short-term DOT interventions may not lead to sustained self-adherence, as demonstrated in one study where the benefit of DOT was lost within six months of its cessation. It is therefore imperative that programs be developed which can successfully facilitate transition from DOT to self-administration for these populations. There is a critical need for the development of tools for post-DOT self-administration readiness assessment as well as adherence maintenance interventions tailored to address the specific needs of these marginalized individuals. Thus, the overall goal of this proposed study is to create a transitional program to successfully bridge the gap between DOT and self-administration of ART. Study results will add to the existing repertoire of readiness tools and adherence interventions and will be the first evaluation of a post- DOT transition and maintenance intervention among challenging HIV-positive patients. Goals for future research include a full-scale clinical trial studying a multi-tiered adherence intervention that includes short-term DOT for high-risk patients.
