Preexposure Prophylaxis Monitoring in New York City: A Public Health Approach

Julie E. Myers, Zoe R. Edelstein, Anisha D. Gandhi, Kavita Misra, Alexis V. Rivera, Paul M. Salcuni, Kathleen Scanlin, Chi-Chi Udeagu, and Sarah L. Braunstein are with the Bureau of HIV/AIDS Prevention and Control, New York City Department of Health and Mental Hygiene (DOHMH), Queens, NY. Demetre C. Daskalakis is with the Division of Disease Control, New York City Department of Health and Mental Hygiene.

Correspondence should be sent to Julie E. Myers, 42-09 28th St, 2284, Queens, NY 11101 (e-mail: vog.cyn.htlaeh@sreymj). Reprints can be ordered at http://www.ajph.org by clicking the “Reprints” link.

J. E. Myers, Z. R. Edelstein, and S. L. Braunstein conceptualized, drafted, and critically revised the article. A. D. Gandhi, K. Misra, A. V. Rivera, P. M. Salcuni, K. Scanlin, and C.-C. Udeagu drafted and critically revised the article. D. C. Daskalakis critically revised the essay. All authors approved the final article.

Abstract

The scale-up of preexposure prophylaxis (PrEP) represents a paradigm shift in HIV prevention that poses unique challenges for public health programs. Monitoring of PrEP implementation at the population level is a national priority, with particular significance in New York City (NYC) given the substantial HIV burden and the prominence of PrEP in state and local Ending the Epidemic program plans.

We highlight the importance of local monitoring and evaluation of PrEP implementation outcomes and describe the experience at the NYC Health Department, which includes engaging communities, triangulating a variety of data sources regarding PrEP implementation, and leveraging those data to help guide programming. In NYC, we used data from national surveillance systems and incorporated PrEP-related indicators into existing local data collection systems to help illustrate gaps in PrEP awareness and use.

Ultimately, ensuring that PrEP achieves the desired impact at the population level depends on identifying disparities through appropriate and accurate measurement, and addressing them through evidence-based programs.

As we approach the fifth decade of the HIV epidemic, jurisdictions worldwide are working to accelerate progress in “Ending the Epidemic” 1 while also addressing HIV-related disparities. The Ending the Epidemic Blueprint for New York State features scale-up of preexposure prophylaxis (PrEP)—the use of antiretroviral medications for HIV prevention—as 1 of its 3 pillars. 2 PrEP and its scale-up represent a paradigm shift in HIV prevention that poses unique challenges for public health; as a biomedical intervention, receipt of PrEP involves ongoing engagement with the health care system, whereas earlier interventions focused on access to condoms and behavior change alone. However, some populations affected by HIV have also historically experienced poorer access to health care that affirms their race/ethnicity, gender identity, and sexual orientation. 3 These systemic barriers need to be addressed to achieve successful PrEP implementation.

The New York City (NYC) Health Department has multiyear experience in PrEP implementation. Beginning in 2014, following the 2012 Food and Drug Administration’s approval of tenofovir–emtricitabine for a prevention indication, NYC implemented a 4-point plan 4 to support PrEP, including (1) promoting PrEP to potential users (e.g., social marketing and media, and an online directory of PrEP providers citywide), (2) promoting PrEP to potential providers (e.g., public health detailing to clinicians, clinic transformation courses, all-staff trainings), (3) supporting PrEP provision in diverse practice models through navigation by patients and establishing intersite referral networks, and (4) comprehensive PrEP-related monitoring and evaluation. There is now evidence from national-level analyses to suggest that, on the state level, the scale-up of PrEP in New York State has been relatively successful, with the 2016 rate of prescriptions (prescriptions per 100 000 population) outpacing that of all other states and territories other than the District of Columbia, 5 and with parallel, historical declines in new diagnoses among men who have sex with men (MSM), 6 the population presumed to have the strongest and earliest adoption of PrEP.

Local monitoring and evaluation has been an important part of NYC’s efforts toward PrEP implementation. Here, we describe the case for monitoring and the experience of engaging communities, triangulating a variety of data sources, and leveraging those data to help guide programming. All of these have been done with an eye toward identifying and addressing disparities related to this important new prevention strategy.

THE CASE FOR MONITORING

The monitoring of PrEP implementation at the population level is a national priority, 7,8 with particular significance in NYC given the prominence of PrEP in local Ending the Epidemic plans. Identifying priority populations disproportionately affected by HIV, who historically have had less access to high-impact prevention and treatment options, is essential; in NYC, priority populations include MSM, transgender persons, and Black and Latina cisgender women, especially those residing in high-prevalence neighborhoods or with recently diagnosed gonorrhea or syphilis. The NYC monitoring strategy for PrEP implementation has included assessment of disparities across the domains of race/ethnicity, gender, age, geography, access to health care, socioeconomic status, and changes in the magnitude of these disparities over time. To achieve the desired impact at the population level, identifying disparities in outcomes and mitigating them through evidence-based programs is imperative; this can only be achieved through appropriate and accurate measurement.

HOW TO MONITOR PREP IMPLEMENTATION

Experts and community activists have called for a concerted effort to follow PrEP implementation, 9 including integrating PrEP monitoring into existing national monitoring and evaluation systems. The Centers for Disease Control and Prevention (CDC) previously proposed a comprehensive framework for PrEP monitoring and evaluation, applying the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, maintenance). 8 Subsequently, the White House Office of National AIDS Policy proposed a “developmental” indicator related to PrEP monitoring: to increase the number of adults prescribed PrEP by 500% between 2014 and 2020 as measured by prescription data among commercially insured persons. 10 In parallel, jurisdictions are developing their own strategies for monitoring and evaluation, and they can likely be more creative and nimble in harnessing local data sources. The NYC approach hewed to the CDC’s framework but focused almost exclusively on “reach” and “adoption”; such an approach would likely make sense for other jurisdictions as well, leaving the monitoring of “effectiveness,” “implementation,” and “maintenance” for entities with more comprehensive access to clinical data. Further, resource limitations prevented local adoption of the Office of National AIDS Policy indicator, which relies on access to prescription data that, until recently, were only available through purchase. Additionally, some have questioned the wisdom of relying on a database of commercially insured persons to track implementation, as it is not nationally representative and does not capture uptake among individuals who are publicly insured or underinsured; many who might benefit from PrEP may fall into these latter categories (although some prescription data sources do include Medicaid claims).

Local innovation notwithstanding, the field of PrEP monitoring remains in a relatively nascent stage and is beset by specific challenges, some of which are not observed when monitoring HIV treatment at the population level. First, identifying who should be offered PrEP is challenging 11 ; it may require a thorough sexual and drug use history and rely on patients’ reports of sensitive or potentially stigmatizing behaviors. For some groups, refined screening tools do not exist, but they may be useful given that only a relatively small proportion are likely to benefit from PrEP. 12 Even if we were able to identify all those with indications for PrEP, uptake would probably not be 100%; initiating PrEP is one of many choices for HIV prevention. Second, surveillance of pharmaceutical use is complex, as pharmacy claims data have only recently become publicly available and the collection of those data are not typically within the purview of public health departments (although this is changing, with New York State 13 and the CDC 7 having conducted analyses to date). Further, analyses of adherence to PrEP are complicated because voluntary discontinuation and reinitiation are expected, off-label use of on-demand PrEP 14 complicates interpretation of pharmacy refill rates, 15 measurement of tenofovir drug levels has limited availability in clinical care, 16 and a direct adherence proxy measure does not yet exist (as it does for HIV treatment with viral load suppression). One innovative way to address some of these challenges is the PrEP-to-need ratio, which estimates the distribution of PrEP prescriptions relative to the burden of new diagnoses. 17

A NEW YORK CITY APPROACH TO MONITORING

Discussion about how best to monitor and evaluate PrEP use in NYC began in 2012 with the formation of a cross-bureau work group within the NYC Health Department. In tandem, a citywide taskforce was convened by a leading community-based organization. Early NYC Health Department activities included reviewing local evidence to support PrEP implementation, conducting a needs assessment in public sexual health clinics, 18 and planning PrEP-related data collection. As relevant information emerged from these efforts in the context of Ending the Epidemic–related activities launched in New York State, 2 a community consultation was convened on the subject of PrEP monitoring in February 2016. The consultation focused on discussing possible indicators and data sources for monitoring. The resulting indicators were primarily PrEP awareness and use, as well as PrEP “coverage”: the concept of estimating PrEP use among those with indications for PrEP. The NYC Health Department continues to engage with community stakeholders through discussions with planning bodies and contribution of data to a public, interactive online dashboard that displays trends in key HIV-related indicators. 19

Although there is work being conducted on a number of outcomes, including all of those that compose a PrEP continuum 20 and a related integrated care and prevention (“status-neutral”) continuum, 21 population-level monitoring of PrEP implementation in NYC focuses primarily on PrEP awareness and PrEP use among priority populations.

AN OVERVIEW OF NEW YORK CITY DATA SOURCES

A comprehensive overview of NYC data sources for PrEP monitoring follows. Table 1 proposes a framework used to conceptualize the various data sources and support completeness of our inventory process. Table 2 presents a systematic review of the population, frequency, and PrEP-related outcomes for each data source. Table A (available as a supplement to the online version of this article at http://www.ajph.org) provides more detail about definitions for each outcome and which covariates are available. In the following paragraphs, we briefly introduce each source, share some baseline data (as well as data trends where available), and discuss opportunities afforded and challenges presented by each, particularly with respect to measuring disparities.

TABLE 1—

A New York City (NYC) Framework of Data Sources for Preexposure Prophylaxis (PrEP) Monitoring

Note. MMP = Medical Monitoring Project; NHBS = National HIV Behavioral Survey.

TABLE 2—

Selected Data Sources Used in Monitoring Preexposure Prophylaxis (PrEP) in New York City (NYC)

Note. CI = confidence interval; DOHMH = Department of Health and Mental Hygiene; HET = heterosexual women; MSM = men who have sex with men; PLWH = people living with HIV; PrEP = preexposure prophylaxis; YMSM = young men who have sex with men.

Sexual Health Survey

The Sexual Health Survey (SHS) is a local survey modeled on National HIV Behavioral Surveillance (NHBS) 33 but conducted at least annually among priority populations: MSM and Black and Latina women. MSM are recruited at venues and online 34 ; Black and Latina women are recruited in person at transportation hubs and shopping centers in high-burden neighborhoods. Launched in 2009, with PrEP questions added in 2011 and 2012, the SHS is central to efforts to monitor trends and explore disparities in NYC among priority populations. Benefits include the opportunity to measure the most local and relevant covariates in a timely manner. Limitations include the potential for sampling and selection bias due to the recruitment strategy and survey content, and the possibility of social desirability bias that may lead to under- or overreporting of PrEP-related outcomes or behaviors that are considered indications for PrEP. Published data to date reveal a dramatic increase in both PrEP awareness (from 35% in spring 2012 to 95% in spring 2016) and use (from 2% in spring 2012 to 28% in spring 2016) among MSM recruited online, across age groups and races/ethnicities. In 2016, use among MSM was associated with education, insurance status, and risk behavior but not age, race/ethnicity, income, or country of birth. 20,22 Among Black and Latina women recruited in person, both relative and absolute increases in PrEP awareness were smaller in this time (awareness: from 15% in fall 2012 to 24% in fall 2016; use: < 1% at both time points).23,35 In 2016, higher income was associated with PrEP awareness; PrEP use remained too low to identify correlates. 23

National HIV Behavioral Surveillance

NHBS is a national, comprehensive behavioral surveillance system conducted with varying methodologies among priority populations in select jurisdictions; local tailoring of the instrument is allowed. 33 The demographically diverse samples approximate populations likely to benefit from PrEP and allow disparity measurement. One limitation is the possibility of social desirability bias. Second, the triennial surveying by risk group (i.e., surveys every 3 years among MSM, people who inject drugs, and heterosexually active persons at high risk for HIV) diminishes NHBS’s utility for trend analysis given the pace of PrEP scale-up. Third, questions have changed since they were first added in round 2 (2008–2010), limiting year-to-year comparability. Recent cycles among MSM, 24 young MSM, 25 and cisgender women who exchange sex 26 support the finding that awareness and use are markedly higher among MSM aged 18 to 40 years (awareness = 71%, use = 4%) compared with adolescent MSM (awareness = 43%, use not available) and cisgender women who exchange sex (awareness = 29%, use = 2%).

Medical Monitoring Project

The Medical Monitoring Project is a surveillance system designed to collect nationally and locally representative data on the behaviors and health of people living with HIV; it comprises both interviews and medical chart abstraction. 36 Medical Monitoring Project data can describe disparities in awareness of PrEP among HIV-positive partners in sero-different relationships or among those who have not achieved an undetectable viral load. Analyses of trends are possible, as PrEP-related questions have been included annually since 2013 and 2014, respectively. The large number of covariates allows for exploration of disparities. Prior to 2015, the sample was limited to people living with HIV in care. In the 2013–2014 cycle, 39% of Medical Monitoring Project participants reported being aware of PrEP (C. -C. U., unpublished data, 2018).

Community Health Survey

The Community Health Survey is a telephone survey conducted annually by the NYC Health Department using a stratified random sample to provide population-based estimates about chronic diseases and behavioral risk factors. 37 Since 2016, the survey has provided population-level estimates of PrEP awareness and use among noninstitutionalized NYC adults, thus providing an understanding of the impact of programs and messaging in the general population; disparities and time trends can also be explored, although behavioral covariates that are indications for PrEP are limited. In 2016, PrEP awareness among sexually active Community Health Survey respondents was 25% (95% confidence interval = 23%, 26%), substantially lower than detected in surveys among MSM (e.g., the SHS) despite their overrepresentation among incident and prevalent infections in NYC 6 (Z. R. E., unpublished data, 2018).

NYC Health Department HIV Partner Services

Through its Field Services Unit, the NYC Department of Health provides partner services—the process of eliciting HIV-exposed partner names, notifying them of HIV exposure, and providing HIV testing and linkage to care if they are diagnosed with HIV. Current and previous PrEP use questions (including PrEP initiation and discontinuation dates, and reasons for discontinuation) were added to the program’s interviews in 2015. Data from the Field Services Unit help explore disparities in PrEP awareness and use among index patients and their partners. Specifically, data from the former group are potentially useful in identifying missed opportunities for HIV prevention and in characterizing incident diagnoses among those with previous antiretroviral exposure; data from the latter group are important because the population surveyed is extremely likely to benefit from PrEP. (PrEP use data elicited through interview of index patients are verified through medical chart review and the provider report form, where available.) Limitations include the possibility of social desirability bias; selection bias (related to which index patients name partners, who they name, and which named partners accept assistance from the Field Services Unit); and possible incompletion of data collection because of refusals to answer questions. Among index patients interviewed in 2016, ever PrEP use (2% overall) was more common among transgender people, men, Whites, younger people, MSM, and transgender people with sexual contact. 6 Among notified partners interviewed from May 2015 to April 2017, PrEP awareness (44% overall) was more common among Whites than among Black and Hispanic partners and more common among MSM than among heterosexual sex partners; disparities in PrEP use (14% overall) were not identified by partner characteristics because of the small sample size of PrEP users. 29

Public Health Detailing Program

Since 2014, the NYC Department of Health has implemented a large-scale provider education initiative, using Public Health Detailing to conduct brief visits with prescribing providers to increase the capacity to provide sexual health care, including the discussion and provision of PrEP. 30,38,39 Public Health Detailing data identify trends and disparities in prescribing behavior among a large sample of clinicians practicing in prioritized ambulatory care settings (approximately 2500 providers to date). However, the sample is limited by lack of generalizability to all NYC providers, irregular intervals between campaigns, social desirability bias that may inflate estimates, and limited covariates in the data set (due to the brief nature of the detailing encounter). Public Health Detailing results (25% of providers reported having ever prescribed PrEP at their follow-up visit in 2014–2015) point to potential geographic disparities, with providers practicing in Manhattan more likely to be early adopters of PrEP prescribing than those in other boroughs. 30

Hub Population Health System

A unique clinical surveillance system, the Hub Population Health System (“the Hub”) allows ad hoc queries of aggregate patient counts from a convenience sample of over 700 ambulatory care practices and over 2500 NYC providers, with overrepresentation of primary care. All use a particular electronic medical record product, described in more detail elsewhere. 40 Hub data can describe real-time trends and explore disparities in PrEP prescribing rates among a large patient population (about 2.1 million) who are receiving care under usual conditions. However, the Hub may not be representative of all ambulatory care practices in NYC, and PrEP prescriptions are identified on the basis of electronic medical record data elements, which can be incomplete or inaccurate. Furthermore, data on sexual behavior, used to determine whether a patient has indications for PrEP, are not available. A recent analysis of these data revealed that the PrEP prescription rate rose from 38.9 per 100 000 in the first quarter of 2014 to 418.5 per 100 000 in the second quarter of 2016, a 976% increase. Increases were significant for both reported sexes. In multivariate analysis, disparities were observed by age, race/ethnicity, and geography. Although practices with a greater proportion of patients from high-poverty neighborhoods were less likely to prescribe PrEP initially, this association weakened over time. 31

Medicaid Claims Data

The Medicaid Data Warehouse contains comprehensive information on the utilization of services funded by New York State Medicaid. Medicaid data can be used to describe trends and explore some disparities in PrEP use among Medicaid recipients since PrEP was added to the Medicaid formulary in January 2013. To date, these data have been analyzed at the state level, with some description of NYC-level trends. 19 The sample is robust and includes diverse priority populations, especially those with low income, although it is limited to Medicaid recipients. As with the Hub, covariates do not include risk behavior, meaning that whether individuals have indications for PrEP cannot be ascertained; the covariates present are subject to data submission efforts and omissions. 13 A recent analysis revealed that, among recipients residing in NYC, there were 2732 Medicaid enrollees with at least 1 PrEP prescription in the period July to December 2016, which marked a 1226% increase from January to June 2014, dramatically exceeding the target of the indicator proposed by the Office of National AIDS Policy (albeit using Medicaid claims data rather than a commercial claims and encounter database containing employed individuals only). 10,19

Other Data Sources

HIV/AIDS surveillance data can serve as a population-based means of monitoring a potential unintended consequence of PrEP scale-up: the emergence of resistance to the medications used for PrEP among persons with incident infections while on PrEP (i.e., the proportion of persons with newly diagnosed HIV who have transmitted drug resistance using HIV genotypes reported to the registry). This indicator can be monitored prospectively, both overall and among subpopulations (e.g., MSM, Black and Latina women). Data from publicly funded programs serving individuals who might benefit from PrEP are another possible source of information. In NYC, the electronic medical records of citywide, publicly funded Sexual Health Clinics help estimate PrEP use among persons at high risk of HIV; these clinics diagnose approximately 10% of people newly diagnosed with HIV in NYC. Limitations include the fact that it is still a convenience sample of those who seek services there, albeit one that likely overrepresents underserved communities who preferentially seek free or low-cost services at publicly funded clinics. And finally, NYC has created a collaborative of clinical and nonclinical providers (The PlaySure Network) 21 ; these funded entities serve persons likely to benefit from PrEP, navigating them from testing and community sites to clinical PrEP care. Data from these programs can help measure trends among client populations who have been identified as possibly benefiting from PrEP.

ANALYSIS

This overview of NYC data sources for monitoring PrEP implementation reveals successes and challenges in scale-up of this important new HIV prevention intervention. Although PrEP awareness appears to be high in some priority populations (MSM and people living with HIV), it remains low among the general population, notified partners of persons newly diagnosed with HIV, and Black and Latina women from high-burden neighborhoods. These disparities appear to be amplified in measures of PrEP use 31 and reflect the differential impact of public health programming, as well as the inherent difficulty of effective messaging given the range of needs of disparate priority populations and the varied structural barriers that limit their access to PrEP.

Comparisons across data sources to date reveal that disparities observed in national-level analyses (e.g., by gender, race/ethnicity, and geography) are observed in NYC, but not necessarily across all data sources. For example, SHS data collected about PrEP use among MSM do not reveal disparities by race/ethnicity, but the Hub data do. These observed differences likely reflect some of the limitations of each data source; both are, fundamentally, convenience samples. Data in the Hub likely underrepresent practices affiliated with larger academic medical centers and community health centers that provide specialized services for lesbian, gay, bisexual, and transgender patients. By contrast, despite special efforts to recruit Black and Latino MSM, the SHS conducted among MSM still fundamentally relies on participation of those frequenting specific social venues and dating and hookup Web sites. Using a variety of data sources supports a proactive approach; evidence of disparities in even one of them instigates exploration of those findings and actions to address them.

As described under “A New York City Approach to Monitoring,” our focus to date has been on PrEP awareness and use. Fully applying the CDC’s proposed RE-AIM framework to monitoring PrEP implementation remains difficult at the population level. In addition to lack of access to clinical data sources, valid and reliable indicators of PrEP adherence and retention in care are challenging to construct, both at the individual and population levels; there is no gold standard, further complicated by PrEP’s potentially selective utility during intermittent “seasons of risk.” Thus, “perfect use” for PrEP will likely reflect a different pattern than treatments for HIV or other diseases, or even most other prophylactic regimens. 8,15

LESSONS LEARNED

Use of all available data sources to measure PrEP implementation is key; no single source is sufficient for all outcomes of interest or for all different disparities because some data sources lack certain measures or covariates, and each has its limitations. Collaboration (across programs, bureaus, and agencies) has been necessary and valuable, as some essential data sources of interest are not specific to HIV. Leveraging CDC-supported surveillance systems, such as NHBS, has been important; however, the relative infrequency of NHBS—every 3 years among each population of interest—motivated us to identify or develop other sources with more frequent data collection among priority populations (e.g., the SHS) given the pace of scale-up. Even a modest investment in other jurisdictions would allow the creation of an analogous survey, which can be more broadly useful and timely for measuring the implementation of other HIV prevention activities. Incorporating PrEP-related questions into established local health surveys (in NYC, the Community Health Survey) is another way to leverage existing resources to obtain more data about disparities in awareness more broadly.

Despite an interest in understanding the PrEP coverage of a given priority population for the purposes of estimating impact (an interest that emerged in our initial community consultation and that has persisted), 12 such an estimate has proven complicated. Estimating coverage implies 2 things: that the denominator is known, and that the numerator is derived from the denominator. In both cases, we have learned that these assumptions can be problematic. First of all, it is difficult to know how generalizable program clients or survey samples are compared with the overall priority population. Secondly, individuals may initiate PrEP without actually having indications for PrEP as defined by clinical guidelines and therefore may not be counted in the hypothetical denominator. A related challenge is that the denominator (i.e., the persons who would benefit from PrEP) is not static. With changing behaviors related to HIV risk come changing prevention needs. The new “PrEP-to-need” ratio as an epidemiological proxy for PrEP need fills a gap 17 ; however, the prescription data recently made publically available contain only sex and age covariates, 5 limiting local authorities’ exploration of other disparities of interest, especially race/ethnicity and factors related to health care access (e.g., insurance status).

CONCLUSIONS

The dramatic increase in PrEP uptake in NYC, likely the result of tremendous investment and policy change, paired with the unfortunate apparent emergence of disparities in awareness and use, continue to motivate and inform intervention activities. Efforts are currently under way to improve PrEP implementation through refining geographic focus and developing new, evidence-based programs or policy change. For example, the NYC Health Department has increasingly focused public health detailing visits on providers in geographic areas where PrEP is prescribed at lower rates; it is also conducting efforts to promote PrEP to women and to providers of care to women citywide. In parallel, with support from federal demonstration project funding, we are enhancing the routine identification in Sexual Health Clinics of persons who might benefit from PrEP and focusing efforts to improve navigation of Black and Latino MSM clients to prevention and care services in a discrete geographic area, Brooklyn.

Nationwide, even with PrEP monitoring at its early stages, incorporating PrEP-related indicators into existing, local data collection systems must be conducted without further delay. PrEP has a crucial role to play in curbing new infections. It is our obligation to ensure that our march toward this end is enacted equitably, which depends on reducing disparities in access and use. Early, appropriate, and accurate measurement of potential gaps in access is the key to our success.

ACKNOWLEDGMENTS

This work was supported by the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP) of the Centers for Disease Control and Prevention (grant 5U62PS00369-05).

We thank Davida Farhat, MPH, for assistance with article preparation; the attendees of the February 2016 Community Consultation on PrEP Metrics for the robust dialogue on this subject; other DOHMH colleagues who were instrumental to data collection, management, and interpretation; and the participants of the various surveys described herein.

HUMAN PARTICIPANT PROTECTION

The New York City Department of Health’s institutional review board reviewed some analyses and determined that they were nonresearch; for other analyses, they reviewed and approved the protocol, methodology, and questionnaire.

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