Widespread diversion of antiretroviral medications (ARVs), which are used to treat HIV infection, has recently been documented in South Florida. Diversion refers to the unlawful channeling of regulated pharmaceuticals from legal sources to the informal marketplace. The recent approval of ARVs for HIV prevention, or pre-exposure prophylaxis (PrEP), has the potential to broaden these informal markets, as high risk individuals seek ARVs without a prescription or medical supervision. Non-adherence of prescribed ARV regimens among ARV diverters and unsupervised use of informally-obtained ARVs for PrEP increase risks of treatment failure, drug resistance, and disease transmission.
The proposed study is grounded in prior work and pilot data documenting: 1) the diversion of ARVs to informal markets in South Florida; 2) high rates of sexual risk behaviors among substance-using men who have sex with men (MSM); and 3) preliminary evidence of substance-using MSM obtaining and using diverted ARVs for HIV prevention. Building on this work, the proposed study will utilize a social ecology theory-driven design to collect qualitative data from substance-using MSM buying, selling, sharing and/or trading ARVs in the informal market (N=50) and from key informants (N=8) who have in-depth knowledge of PrEP and it's use and diversion in the informal market. Based on these data, the study will identify targets for the prevention of ARV diversion and intervention strategies that encourage substance-using MSM to obtain and use PrEP as prescribed, as well as inform public policy initiatives, and health and service provider education. The significant public health impact of the study is indicated by the high rates of HIV incidence and infection among MSM in South Florida and the needs to reduce non-adherence of ARVs among infected patients and improve MSM's correct use of PrEP as a new and effective HIV prevention strategy.