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Progress and Challenges in “Getting to Zero” New HIV Infections in Miami, Florida

Objectives: Miami has the highest rate of new HIV diagnoses in the United States. We examined the early successes and challenges in fulfilling recommendations made by the Miami-Dade County HIV/AIDS Getting to Zero Task Force, formed by local experts in 2016. Methods: We used a host of surveillance data, published empirical studies, public reports, and unpublished data from partners of the Task Force to evaluate progress and challenges in meeting the recommendations. Results: Improvements in prevention and care included routinized HIV testing in emergency departments, moving the linkage-to-care benchmark from 90 to 30 days, increased viral suppression, and awareness of pre-exposure prophylaxis. However, treatment enrollment, viral suppression, and pre-exposure prophylaxis uptake remained low. Conclusions: Recommendations from the Task Force provide excellent guidance for implementing evidence-based HIV prevention in Miami, yet success in achieving the recommendations will require continued or increased support in many public health sectors in South Florida.


Introduction
In 2017, Miami-Dade County in Florida had the highest annual rate of newly diagnosed HIV infections (42.9 cases per 100 000 residents) of all cities and counties monitored by the Centers for Disease Control and Prevention in the United States. 1 This rate was more than twice as high as New York City (17.9), San Francisco (18.5), Los Angeles (15.0), and Washington, DC

What Do We Already Know About This Topic?
A Getting to Zero plan has been established, but we do not know the broad progress and challenges in fulfilling the recommendations put forth in the plan.

How Does Your Research Contribute to the Field?
We provide an overview of important accomplishments and challenges facing HIV prevention efforts in Miami, which continues to have the highest HIV incidence in the United States.
How Does Your Research Contribute to the Field? (18.0). 1 The Miami rate was highest for all but 2 such surveillance reports in the United States since 2004. 2 Since 2004, HIV incidence has decreased in Miami in all major transmission categories: injection drug use, heterosexual, and sex among men who have sex with men (MSM). 3 These reductions have, however, lagged behind substantial progress in other metropolitan areas. 2 Additionally, although the HIV epidemic in Miami is driven primarily by MSM transmission, other groups, particularly heterosexual non-Hispanic black men and women and persons who inject drugs, are at increased risk. 3,4 The complex nature of the HIV epidemic in Miami (many racial, ethnic, and sexually diverse risk groups and geographic diversity of HIV risk) is an example of local challenges surrounding HIV prevention: no single pharmacological, behavioral, or structural intervention is sufficient to eliminate HIV transmission. [5][6][7][8] For example, although condoms have been effective in preventing sexual HIV transmission, 9 they have not been used to the extent necessary to eliminate HIV infections in Miami or elsewhere in the United States. 10,11 More recently, promoted pharmacological interventions, such as secondary prevention through antiretroviral therapy and preexposure prophylaxis (PrEP), have also had real-world limitations in Miami and elsewhere, despite promising results in trial settings. [12][13][14][15][16] These antiretroviral-based prevention strategies have encountered hurdles in their implementation with respect to early HIV diagnosis, 17,18 drug adherence, 18,19 and access to antiretroviral treatment or prophylaxis. 14,18 To address the limitations of any single HIV prevention strategy, various jurisdictions have developed a combination of approaches to prevention, such as structural and individuallevel prevention strategies that tailor program priorities to local epidemics for maximum effect. 5

Evaluation of Progress and Challenges
The recommendations made by the Task Force were developed and approved by a consortium of policy-makers and HIV prevention stakeholders, yet they are not supported by any specific local legislation or budgetary allocation. The implementation of these recommendations should be-and are being-carefully monitored. [20][21][22] We examine the early successes and challenges in fulfilling the Task Force recommendations and describe recent epidemiologic trends in Miami. The objective of this evaluation is to broadly characterize improvements in HIV prevention efforts recommended by the Task Force and summarize relevant outcomes. We focus on key areas: HIV incidence and risks for infection, the HIV continuum of care, PrEP, harm reduction, research data sharing, and legislative progress. We provide generalized summaries of efforts that have achieved notable progress or encountered substantial barriers.

Methods
We used the recommendations made by the Task Force as a guide to HIV prevention priorities for the Miami HIV epidemic, yet the progress and challenges in achieving these recommendations did not manifest only after the Task Force's final report, so our evaluation extends to before their release, where possible. Specifically, we used surveillance data from FDOH from 1998 to 2017 to summarize epidemiologic trends in the prevalence and incidence of HIV infection in Miami-Dade County. We used published empirical studies, public reports, and unpublished data from partners of the Task Force to evaluate progress and challenges in meeting the proposed recommendations. These sources included public reports on the HIV care continuum, empirical studies of PrEP awareness and use, unpublished data from HIV testing and harm reduction services, and publicly available data on state and local legislation. For

Ethical and Informed Consent
Ethics approval and informed consent were not required for this study since all data obtained were publicly available or anonymized by the source; no direct contact with human participants was conducted.   3 ; about 80% of all new infections were reported among men (71.2 per 100 000 residents), of whom 84% reported a history of sex with men. 3 The ratio of newly diagnosed HIV infections among men and women in Miami increased from 1.7:1.0 in 1998 to 2.7:1.0  HIV testing has increased considerably in the past 20 years in Miami, yet it is difficult to obtain estimates for the proportion of the HIV-infected population in Miami that is unaware of its HIV status. Sparse data are available for some high-risk groups: in the 2014 MSM cycle of the National HIV Behavioral Surveillance (NHBS) system, the most recent year for which data are available, 32.6% of HIV-positive MSM in Miami reported that they were previously unaware of their HIVpositive status. 24 In the 2013 cycle of the NHBS, 35% of HIV-positive heterosexual men and women at increased risk of infection in Miami were unaware of their status. 25

Pre-Exposure Prophylaxis
In 2017, FDOH committed to providing up to a 90-day free supply of medication for PrEP among all eligible patients visiting county health department sexually transmitted disease and family planning clinics. 27 This commitment marks a positive step in scaling up PrEP delivery, yet many high-risk persons in this setting lack knowledge of or access to PrEP. A study conducted in 2014 among MSM recruited for the NHBS system found that only 41% of MSM in Miami had ever heard of PrEP as a means to prevent HIV infection, and <2% reported taking PrEP in the previous 12 months, despite reports of frequent risk-taking behaviors in the sample. 28 Awareness of PrEP among MSM in Miami doubled from the 2011 (20% aware) to the 2014 (41%) NHBS surveys (P < .001). 28,29 Research among sheltered women in Miami conducted in 2014 suggested a low awareness of PrEP, with 21% (15/74) reporting knowledge before being enrolled in the study. 30 In 2017, Doblecki-Lewis et al published data on the continued use of PrEP among MSM who participated in the PrEP Demonstration Project. 15 Of 99 MSM in Miami who participated in the PrEP Demonstration Project, 90% (89/99) reported interest in receiving PrEP after study completion. 15 Yet, access to PrEP among project participants remained limited, with only 18% (18/99) reporting receiving a prescription since they left the original study. 15 Researchers published evidence in 2018 of informal, or nonprescriptive, use of antiretroviral medication to prevent HIV acquisition among MSM in Miami and elsewhere in South Florida. 31 Data from this research were first reported in 2017 when it was also found that of 24 MSMs who had a history of substance use, 2 had recently seroconverted while engaging in unsupervised and sporadic PrEP usage. 32 Lack of access to medically supervised PrEP can lead to inappropriate usage of antiretroviral medication for primary prevention. Illicit sales and sharing of the medication should be monitored because these practices interfere with the effectiveness of interventions designed to interrupt HIV transmissions in the community. 33 Lack of access may be due in part to the underuse of PrEP by medical providers. A study conducted during 2012 to 2013 among HIV care and infectious disease physicians in Washington, DC, and Miami found that only 17% had ever prescribed PrEP to 1 of their patients. 16 Although provider characteristics have been identified as a perceived barrier to PrEP, a 2017 study among MSM in San Francisco and Miami found drug expense and lack of insurance to be the most common obstacles to adoption by prospective enrollees. 15 Referring and linking persons at high risk of HIV infection to knowledgeable practitioners is a central component of delivering PrEP in Miami-Dade County. The quality of medical referral (eg, active versus passive) may have a substantial effect on responses and follow-up for HIV-related services. 33 In early 2018, FDOH in Miami-Dade County released a draft protocol for an active referral system for PrEP (PrEPLink) that had 3 primary objectives: (1) increase community outreach activities to HIV-negative persons at high risk of infection, (2) establish a referral network for PrEP providers, and (3) track the linkage of care for persons who receive a PrEP referral. 34 PrEPLink is currently advertised and described in materials being distributed by FDOH (Figure 2). It has proposed a 48 business-hour timetable for receipt of referrals for all major PrEP providers in Miami. The development of a comprehensive referral system represents a positive step toward enhanced centralization and tracking of PrEP services in Miami-Dade. A Miami PrEP workgroup, organized by FDOH in Miami-Dade County, has been convened to explore pathways to increased access to PrEP for high-risk populations and remove locally relevant barriers experienced by patients and at-risk persons in Miami.

Harm Reduction
HIV transmission through injection drug use has decreased dramatically in Miami in recent decades 3 ; however, a substantial risk remains among people who inject drugs (PWID). In 2016, the University of Miami's IDEA Exchange began providing syringe exchange services to PWID in Miami. 35 Infectious Disease Elimination Act Exchange provides evidence-based HIV prevention through harm reduction among a population with a highly elevated risk of HIV acquisition. 36 Administered through the University of Miami and centrally located (Figure 3), IDEA Exchange also provides other services, such as HIV and HCV testing, naloxone, and linkage to addiction treatment providers. As of August 2018, IDEA Exchange reported having provided services to 845 PWID (with 6899 total visits), exchanged 184 322 clean needles, and delivered 1416 doses of naloxone, which resulted in 724 overdose reversals (written communication, August 2018). Recently, local officials addressed publicly an investigation into a potentially large number of new cases of HIV and HCV among homeless PWID in the Overtown area of Miami. Despite widespread media attention, this investigation has yet to uncover an identified outbreak or changing risk dynamics in this community.

Research Data Sharing
An important Task Force recommendation focuses on data sharing among care providers and researchers interested in secondary analyses. Florida Department of Health in Miami-Dade County has partnered with Florida International University to identify research opportunities and future collaboration; these institutions plan to develop a 5-year strategic plan outlining these goals. 20 Similarly, a data-sharing agreement has been established between the Ryan White Part A/Minority AIDS Initiative program in Miami-Dade County and public health researchers at Florida International University. According to researchers at the Behavioral Science Research Corporation (written communication, June 2018), the data-sharing agreement permits researchers at Florida International University to access deidentified client-level data from almost 50 000 records, which include data on hundreds of clinical end points and demographic characteristics, including results of viral load testing, antiretroviral therapy regimens, behavioral risk factors, and client retention in care.

Legislative Progress
Several Florida state senators championed a bipartisan, bicameral anticriminalization of disclosure bill, the HIV Prevention Justice Act, in the 2017-2018 legislative session of the Florida State Congress. Identical bills, SB546 and H719, were filed in fall 2017 for spring 2018 legislative consideration. The Act sought to modernize Florida's laws on the transfer of disease through bodily fluids by decreasing the severity of punishment for transfer of disease from a felony to a first-degree misdemeanor and to clarify the definition of "intent" in the transfer of disease through bodily fluids. In March 2018, both bills were indefinitely postponed and, ultimately, withdrawn from consideration.
The Task Force recommendations call for comprehensive, age-appropriate sexual education in Miami-Dade schools. These recommendations are supported by strong indications of sexual risk behavior in Miami-Dade adolescents: 56.8% of Miami-Dade high school students in 2017 reported sexual experience (slightly higher than the national average of 52.2%), and only 18.6% had ever been tested for HIV. 37 Furthermore, Miami-Dade County has the most cases of bacterial sexually transmitted infections among 13-to 19-yearolds in Florida. 38   system have been introduced. 39 Legislative failures demonstrate the difficulty in aligning local public health priorities with the statewide political environment in the implementation of the Task Force's recommendations, particularly reliable sexual education for at-risk young persons.

Conclusion
Recommendations of the Task Force have established a multifaceted plan for eliminating new HIV infections in the Miami-Dade County. These recommendations provide guidance for implementing evidence-based HIV prevention and treatment strategies in a highly diverse setting. Although progress has been noted in some areas, such as routine HIV testing, linkage to care, and eliminating barriers to access to PrEP, much work remains, particularly in achieving population-level antiretroviral therapy enrollment, HIV suppression, and PrEP uptake. Furthermore, because the recommendations proposed by the Task Force were not accompanied by any budgetary commitments, it is difficult to estimate the effect of the proposed prevention plan. Despite recent reductions in new HIV diagnoses, continued efforts must be made to ensure that all risk groups, including non-Hispanic black women, who have had an increase in new diagnoses, benefit from enhanced HIV prevention efforts. Further research is needed to determine the number of undiagnosed infections in various segments of the at-risk population; the most recent data available suggest that a substantial portion of HIV-infected persons may still be unaware of their HIV status. Success in achieving all of the evidencebased recommendations made by the Task Force will require continued or increased support throughout many sectors of the public health apparatus in South Florida.