California's "Bridge to Reform": identifying challenges and defining strategies for providers and policymakers implementing the Affordable Care Act in low-income HIV/AIDS care and treatment settings.

BACKGROUND: In preparation for full Affordable Care Act implementation, California has instituted two healthcare initiatives that provide comprehensive coverage for previously uninsured or underinsured individuals. For many people living with HIV, this has required transition either from the HIV-specific coverage of the Ryan White program to the more comprehensive coverage provided by the county-run Low-Income Health Programs or from Medicaid fee-for-service to Medicaid managed care. Patient advocates have expressed concern that these transitions may present implementation challenges that will need to be addressed if ambitious HIV prevention and treatment goals are to be achieved. METHODS: 30 semi-structured, in-depth interviews were conducted between October, 2012, and February, 2013, with policymakers and providers in 10 urban, suburban, and rural California counties. Interview topics included: continuity of patient care, capacity to handle payer source transitions, and preparations for healthcare reform implementation. Study team members reviewed interview transcripts to produce emergent themes, develop a codebook, build inter-rater reliability, and conduct analyses. RESULTS: Respondents supported the goals of the ACA, but reported clinic and policy-level challenges to maintaining patient continuity of care during the payer source transitions. They also identified strategies for addressing these challenges. Areas of focus included: gaps in communication to reach patients and develop partnerships between providers and policymakers, perceived inadequacy in new provider networks for delivering quality HIV care, the potential for clinics to become financially insolvent due to lower reimbursement rates, and increased administrative burdens for clinic staff and patients. CONCLUSIONS: California's new healthcare initiatives represent ambitious attempts to expand and improve health coverage for low-income individuals. The state's challenges in maintaining quality care and treatment for people living with HIV experiencing these transitions demonstrate the importance of setting effective policies in anticipation of full ACA implementation in 2014.

Community member perspectives from transgender women and men who have sex with men on pre-exposure prophylaxis as an HIV prevention strategy: implications for implementation.

BACKGROUND: An international randomized clinical trial (RCT) on pre-exposure prophylaxis (PrEP) as an human immunodeficiency virus (HIV)-prevention intervention found that taken on a daily basis, PrEP was safe and effective among men who have sex with men (MSM) and male-to-female transgender women. Within the context of the HIV epidemic in the United States (US), MSM and transgender women are the most appropriate groups to target for PrEP implementation at the population level; however, their perspectives on evidenced-based biomedical research and the results of this large trial remain virtually unknown. In this study, we examined the acceptability of individual daily use of PrEP and assessed potential barriers to community uptake. METHODS: We conducted semi-structured interviews with an ethnoracially diverse sample of thirty HIV-negative and unknown status MSM (n = 24) and transgender women (n = 6) in three California metropolitan areas. Given the burden of disease among ethnoracial minorities in the US, we purposefully oversampled for these groups. Thematic coding and analysis of data was conducted utilizing an approach rooted in grounded theory. RESULTS: While participants expressed general interest in PrEP availability, results demonstrate: a lack of community awareness and confusion about PrEP; reservations about PrEP utilization, even when informed of efficacious RCT results; and concerns regarding equity and the manner in which a PrEP intervention could be packaged and marketed in their communities. CONCLUSIONS: In order to effectively reduce HIV health disparities at the population level, PrEP implementation must take into account the uptake concerns of those groups who would actually access and use this biomedical intervention as a prevention strategy. Recommendations addressing these concerns are provided.

A qualitative study of provider thoughts on implementing pre-exposure prophylaxis (PrEP) in clinical settings to prevent HIV infection.

BACKGROUND: A recent clinical trial demonstrated that a daily dose tenofovir disoproxil fumarate and emtricitabrine (TDF-FTC) can reduce HIV acquisition among men who have sex with men (MSM) and transgender (TG) women by 44%, and up to 90% if taken daily. We explored how medical and service providers understand research results and plan to develop clinical protocols to prescribe, support and monitor adherence for patients on PrEP in the United States. METHODS: Using referrals from our community collaborators and snowball sampling, we recruited 22 healthcare providers in San Francisco, Oakland, and Los Angeles for in-depth interviews from May-December 2011. The providers included primary care physicians seeing high numbers of MSM and TG women, HIV specialists, community health clinic providers, and public health officials. We analyzed interviews thematically to produce recommendations for setting policy around implementing PrEP. Interview topics included: assessing clinician impressions of PrEP and CDC guidance, considerations of cost, office capacity, dosing schedules, and following patients over time. RESULTS: Little or no demand for PrEP from patients was reported at the time of the interviews. Providers did not agree on the most appropriate patients for PrEP and believed that current models of care, which do not involve routine frequent office visits, were not well suited for prescribing PrEP. Providers detailed the need to build capacity and were concerned about monitoring side effects and adherence. PrEP was seen as potentially having impact on the epidemic but providers also noted that community education campaigns needed to be tailored to effectively reach specific vulnerable populations. CONCLUSIONS: While PrEP may be a novel and clinically compelling prevention intervention for MSM and TG women, it raises a number of important implementation challenges that would need to be addressed. Nonetheless, most providers expressed optimism that they eventually could prescribe and monitor PrEP in their practice.