Pre-Exposure Prophylaxis for at-Risk HIV Individuals

Pre-exposure prophylaxis, or PrEP, is a relatively new HIV prevention method where individuals who are at risk for HIV but do not currently have it take a daily pill (Truvada). PrEP has been proven medically effective and could help to reduce the rate of new HIV incidence in the United States, but in five large, randomized and controlled studies, many prospective PrEP patients chose not to take PrEP, and those that did often did not adhere to it consistently. How do we increase PrEP uptake and adherence amongst those most at risk for HIV? Also, will taking PrEP increase or decrease high-risk individual sexual behavior and HIV incidence? Here, the investigators propose a parallel group randomized, controlled clinical trial to test the effectiveness of a behavioral intervention designed to buffer individuals against stigma-related feelings, and to increase their connection to their selves twenty years in the future. The primary objective of the study is to increase PrEP adherence, as measured by the concentration of tenofovir diphosphate (TFV-DP) in dried blood spot samples (DBS). The secondary objectives are to decrease the incidence of STIs and increase safe sexual practices, as measured by clinic diagnoses and self-reported practices at 3, 6, 9 and 12 months. This 12-month outpatient study will take place at four PrEP clinics in Pittsburgh and will enroll 170 subjects across 4 sites, with an expectation of retaining 80%, or 135 subjects. Eligibility includes male and female adults, ages 18-65, who are at risk of contracting HIV. Efforts will be made to recruit 33% of subjects from each of the following strata: 1) young, minority LGBT adults age 18-30 years of age; 2) Caucasian adults (MSM and heterosexual females) age 18-65 years of age; and 3) IDU adults, age 18-65, of any ethnic background.