Design of the HPTN 065 (TLC-Plus) study: A study to evaluate the feasibility of an enhanced test, link-to-care, plus treat approach for HIV prevention in the United States.

Background/Aims HIV continues to be a major public health threat in the United States, and mathematical modeling has demonstrated that the universal effective use of antiretroviral therapy among all HIV-positive individuals (i.e. the "test and treat" approach) has the potential to control HIV. However, to accomplish this, all the steps that define the HIV care continuum must be achieved at high levels, including HIV testing and diagnosis, linkage to and retention in clinical care, antiretroviral medication initiation, and adherence to achieve and maintain viral suppression. The HPTN 065 (Test, Link-to-Care Plus Treat [TLC-Plus]) study was designed to determine the feasibility of the "test and treat" approach in the United States. Methods HPTN 065 was conducted in two intervention communities, Bronx, NY, and Washington, DC, along with four non-intervention communities, Chicago, IL; Houston, TX; Miami, FL; and Philadelphia, PA. The study consisted of five components: (1) exploring the feasibility of expanded HIV testing via social mobilization and the universal offer of testing in hospital settings, (2) evaluating the effectiveness of financial incentives to increase linkage to care, (3) evaluating the effectiveness of financial incentives to increase viral suppression, (4) evaluating the effectiveness of a computer-delivered intervention to decrease risk behavior in HIV-positive patients in healthcare settings, and (5) administering provider and patient surveys to assess knowledge and attitudes regarding the use of antiretroviral therapy for prevention and the use of financial incentives to improve health outcomes. The study used observational cohorts, cluster and individual randomization, and made novel use of the existing national HIV surveillance data infrastructure. All components were developed with input from a community advisory board, and pragmatic methods were used to implement and assess the outcomes for each study component. Results A total of 76 sites in Washington, DC, and the Bronx, NY, participated in the study: 37 HIV test sites, including 16 hospitals, and 39 HIV care sites. Between September 2010 and December 2014, all study components were successfully implemented at these sites and resulted in valid outcomes. Our pragmatic approach to the study design, implementation, and the assessment of study outcomes allowed the study to be conducted within established programmatic structures and processes. In addition, it was successfully layered on the ongoing standard of care and existing data infrastructure without disrupting health services. Conclusion The HPTN 065 study demonstrated the feasibility of implementing and evaluating a multi-component "test and treat" trial that included a large number of community sites and involved pragmatic approaches to study implementation and evaluation.

Acceptability of home self-tests for HIV in New York City, 2006.

Data from a 2006 telephone survey representative of New York City adults showed that more than half (56.2%) of those aged 18 to 64 years responded favorably to a question about acceptability of a rapid home HIV test. More than two thirds of certain subpopulations at high risk for HIV reported that they would use a rapid home HIV test, but approximately half who expressed interest had indications of financial hardship. The match of acceptability and HIV risk bodes well for self-testing utility, but cost might impede uptake.

Geography should not be destiny: focusing HIV/AIDS implementation research and programs on microepidemics in US neighborhoods.

African Americans and Hispanics are disproportionately affected by the HIV/AIDS epidemic. Within the most heavily affected cities, a few neighborhoods account for a large share of new HIV infections. Addressing racial and economic disparities in HIV infection requires an implementation program and research agenda that assess the impact of HIV prevention interventions focused on increasing HIV testing, treatment, and retention in care in the most heavily affected neighborhoods in urban areas of the United States. Neighborhood-based implementation research should evaluate programs that focus on community mobilization, media campaigns, routine testing, linkage to and retention in care, and block-by-block outreach strategies.

Knowledge and use of pre-exposure prophylaxis among an online sample of young men who have sex with men in New York City.

Understanding prior knowledge and experience with pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) is critical to its implementation. In fall 2011, NYC MSM were recruited via banner advertisements on six popular dating websites and asked questions about their knowledge and use of PrEP (n = 329). Overall, 123 (38%) respondents reported knowledge of PrEP, of whom two (1.5%) reported PrEP use in the past 6 months. Knowledge of PrEP was associated with high educational attainment, gay identity and recent HIV testing, suggesting an uneven dissemination of information about PrEP and missed opportunities for education. To avoid disparities in use during scale-up, MSM should be provided with additional information about PrEP.

Preparing for the next outbreak: A review of indices measuring outbreak preparedness, vulnerability, and resilience.

The COVID-19 pandemic has highlighted the need for relevant metrics describing the resources and community attributes that affect the impact of communicable disease outbreaks. Such tools can help inform policy, assess change, and identify gaps to potentially reduce the negative outcomes of future outbreaks. The present review was designed to identify available indices to assess communicable disease outbreak preparedness, vulnerability, or resilience, including articles describing an index or scale developed to address disasters or emergencies which could be applied to addressing a future outbreak. This review assesses the landscape of indices available, with a particular focus on tools assessing local-level attributes. This systematic review yielded 59 unique indices applicable to assessing communicable disease outbreaks through the lens of preparedness, vulnerability, or resilience. However, despite the large number of tools identified, only 3 of these indices assessed factors at the local level and were generalizable to different types of outbreaks. Given the influence of local resources and community attributes on a wide range of communicable disease outcomes, there is a need for local-level tools that can be applied broadly to various types of outbreaks. Such tools should assess both current and long-term changes in outbreak preparedness with the intent to identify gaps, inform local-level decision makers, public policy, and future response to current and novel outbreaks.

NYC condom use and satisfaction and demand for alternative condom products in New York City sexually transmitted disease clinics.

In 2007, via a high-profile media campaign, the New York City Department of Health and Mental Hygiene (NYC DOHMH) introduced the "NYC Condom," the first specially packaged condom unique to a municipality. We conducted a survey to measure NYC Condom awareness of and experience with NYC Condoms and demand for alternative male condoms to be distributed by the DOHMH. Trained interviewers administered short, in-person surveys at five DOHMH-operated sexually transmitted disease (STD) clinics in Spring 2008. We systematically sampled eligible patients: NYC residents aged ≥18 years waiting to see a physician. We approached 539; 532 agreed to be screened (98.7% response rate); 462 completed the survey and provided NYC zip codes. Most respondents were male (56%), non-Hispanic black (64%), aged 18-24 years (43%) or 25-44 years (45%), employed (65%), and had a high school degree/general equivalency diploma or less (53%). Of those surveyed, 86% were aware of the NYC Condom, and 81% of those who obtained the condoms used them. NYC Condom users were more likely to have four or more sexual partners in the past 12 months (adjusted odds ratio [AOR] = 2.0, 95% confidence interval [CI] = 1.0-3.8), use condoms frequently (AOR = 2.1, 95% CI = 1.3-3.6), and name an alternative condom for distribution (AOR = 2.2, 95% CI = 1.3-3.9). The most frequently requested condom types respondents wanted DOHMH to provide were larger size (28%), ultra thin/extra sensitive (21%), and extra strength (16%). We found high rates of NYC Condom use. NYC Condom users reported more sexual partners than others, suggesting the condom initiative successfully reached higher-risk persons within the STD clinic population. Study results document the condom social marketing campaign's success.

The NYC Condom: use and acceptability of New York City's branded condom.

We assessed awareness and experience with the NYC Condom via surveys at 7 public events targeting priority condom distribution populations during 2007. Most respondents (76%) were aware of NYC Condoms. Of those that had obtained them, 69% had used them. Most (80%) wanted alternative condoms offered for free: 22% wanted ultra-thin, 18% extra-strength, and 14% larger-size. Six months after the NYC Condom launch, we found high levels of awareness and use. Because many wanted alternative condoms, the Department of Health and Mental Hygiene began distributing the 3 most-requested alternatives.

Vaginal microbicides and the prevention of HIV transmission.

Worldwide, nearly half of all individuals living with HIV are now women, who acquire the virus largely by heterosexual exposure. With an HIV vaccine likely to be years away, topical microbicide formulations applied vaginally or rectally are being investigated as another strategy for HIV prevention. A review of preclinical and clinical research on the development of microbicides formulated to prevent vaginal HIV transmission yielded 118 studies: 73 preclinical and 45 clinical. Preclinical research included in-vitro assays and cervical explant models, as well as animal models. Clinical research included phase I and II/IIb safety studies, and phase III efficacy studies. Whereas most phase I and phase II clinical trials have found microbicide compounds to be safe and well tolerated, phase III trials completed to date have not demonstrated efficacy in preventing HIV transmission. Topical microbicides are grouped into five classes of agents, based on where they disrupt the pathway of sexual transmission of HIV. These classes include surfactants/membrane disruptors, vaginal milieu protectors, viral entry inhibitors, reverse transcriptase inhibitors, and a fifth group whose mechanism is unknown. The trajectory of microbicide development has been toward agents that block more specific virus-host cell interactions. Microbicide clinical trials face scientifically and ethically complex issues, such as the choice of placebo gel, the potential for viral resistance, and the inclusion of HIV-infected participants. Assessment of combination agents will most likely advance this field of research.

Cost-Effectiveness of Meningococcal Vaccination Among Men Who Have Sex With Men in New York City.

BACKGROUND: To control an outbreak of invasive meningococcal disease (IMD) among men who have sex with men (MSM) in New York City, the New York City Department of Health and Mental Hygiene recommended vaccination of all HIV-infected MSM and at-risk HIV-uninfected MSM in October 2012. METHODS: A decision-analytic model estimated the cost-effectiveness of meningococcal vaccination compared with no vaccination. Model inputs, including IMD incidence of 20.5 per 100,000 HIV-positive MSM (42% fatal) and 7.6 per 100,000 HIV-negative MSM (20% fatal), were from Department of Health and Mental Hygiene reported data and published sources. Outcomes included costs (2012 US dollars), IMD cases averted, IMD deaths averted, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs; $/QALY). Scenarios with and without herd immunity were considered, and sensitivity analyses were performed on key inputs. RESULTS: Compared with no vaccination, the targeted vaccination campaign averted an estimated 2.7 IMD cases, 1.0 IMD deaths, with an ICER of $66,000/QALY when herd immunity was assumed. Without herd immunity, vaccination prevented 1.1 IMD cases, 0.4 IMD deaths, with an ICER of $177,000/QALY. In one-way sensitivity analyses, variables that exerted the greatest influence on results in order of effect were the magnitude of herd immunity, IMD case fatality ratio, and IMD incidence. In probabilistic sensitivity analyses, at a cost-effectiveness threshold of $100,000/QALY, vaccination was preferred in 97% of simulations with herd immunity and 20% of simulations without herd immunity. CONCLUSIONS: Vaccination during an IMD outbreak among MSM with and without HIV infection was projected to avert IMD cases and deaths and could be cost-effective depending on IMD incidence, case fatality, and herd immunity.

It's Never Just HIV: Exposure to an HIV Prevention Media Campaign and Behavior Change Among Men Who Have Sex with Men Participating in the National HIV Behavioral Surveillance System in New York City.

PURPOSE: The aim of this study was to assess the exposure to and impact of the It's Never Just HIV mass media campaign aimed at HIV negative men who have sex with men (MSM) in New York City. METHODS: Questions about the campaign were included in the local questionnaire of the Centers for Disease Control and Prevention (CDC)-sponsored National HIV Behavioral Surveillance (NHBS) study of MSM in NYC conducted in 2011. Participants in this cross-sectional study were recruited using venue-based sampling. RESULTS: Among 447 NYC National HIV Behavioral Surveillance study participants who self-reported HIV negative or unknown status and answered questions about the NYC Department of Health and Mental Hygiene's It's Never Just HIV campaign, more than one-third (n = 173, 38.7%) reported having seen the campaign. Latinos (34.8%) and blacks (34.4%) were less likely to report seeing the campaign compared to whites (47.7%). Most of those who reported seeing the campaign saw it on the subway (80.1%). Only 9.4% of those who saw the campaign reported having changed their sexual or health behaviors in response to the campaign. CONCLUSIONS: These data suggest that thousands of HIV-uninfected MSM in NYC have been reached by the campaign and recalled its message.

HIV testing experience in New York City: offer of and willingness to test in the context of new legal support of routine testing.

BACKGROUND: In the United States, routine HIV testing is recommended for persons aged 13-64 years. In 2010, New York State passed a law mandating offer of testing in most health-care settings. We report on the consumer perspective in New York City (NYC) shortly after the law's enactment. METHODS: We analyzed data from a 2011 telephone survey representative of NYC adults aged 18-64 years (n = 1,846). This analysis focused on respondents' report of HIV test offer at last clinical visit and of willingness to test if recommended by their doctor. Offer and willingness were estimated by age, gender, race/ethnicity, education, income, marital status, sexual identity, partner number, and HIV testing history; associations were examined using multivariable regression. RESULTS: Among NYC adults, 35.7% reported an HIV test in the past year and 31.8% had never tested. Among 86.7% with a clinical visit in the past year, 31.4% reported being offered a test at last visit. Offer was associated with younger age, race/ethnicity other than white, non-Hispanic, lower income, and previous testing. Only 6.7% of never-testers were offered a test at last clinical visit. Willingness to test if recommended was high overall (90.2%) and across factors examined. CONCLUSIONS: After a new law was enacted in support of routine HIV testing, approximately 1 in 3 New Yorkers aged 18-64 years were offered a test at last clinical visit; 9 in 10 were willing to test if recommended by their doctor. This suggests that patient attitudes will not be a barrier to complete implementation of the law.

The evolution of HIV testing requirements in New York State, 1989-2013.

In 2010, New York State (NYS) made major changes to its HIV testing law to come more closely into compliance with 2006 recommendations of the Centers for Disease Control and Prevention. Because of the size and severity of the epidemic in NYS, the strong public health response, and powerful advocacy community, the state had early on enacted strict rules around all aspects of HIV testing. Between 2006 and 2010, 12 distinct legislative proposals were advanced to modernize NYS's approach, leading ultimately to the bill that became law and went into effect on September 10, 2010. The approved changes included oral consent for rapid HIV tests, streamlined provision of pretest information, and most notably a mandated offer of HIV testing to all persons between 13 and 64 years of age. In 2014, NYS finally removed the requirement for written informed consent (except in criminal justice settings). In a separate legislative action and in tacit acknowledgment to the success of the 2010 HIV testing law, a mandate for hepatitis C testing for persons born between 1945 and 1965 was adopted. For a variety of reasons, HIV-related statutes have sometimes been difficult to change, but once the initial inertia is overcome, additional changes may come more quickly.

Evaluating the 2010 New York State HIV testing law in NYC ambulatory practices using electronic health records.

INTRODUCTION: In 2010, the New York State Legislature made it mandatory to offer an HIV test to people aged 13-64 years receiving hospital or primary care services, with limited exceptions. In this study, we used data from New York City practices to evaluate the impact of the law on HIV testing rates in ambulatory care. METHODS: We collected quarterly testing data from the electronic health records of 218 practices. We calculated overall and stratified crude testing rates. Using univariate and multivariate generalized estimating equation models, we assessed the odds of testing in the year before the law (baseline) versus the first and second year after the law's implementation (year 1 and year 2). RESULTS: During baseline, the odds of testing did not increase significantly. During year 1, the odds of testing significantly increased by 50% in the univariate model and 200% after adjusting for confounders. During year 2, the odds of testing increased 10%. This was only significant in the univariate model. The crude quarterly testing rate increased from 2.8% to 5.7% from baseline to year 2. CONCLUSIONS: Our evaluation showed that after the implementation of the HIV testing law, there was an increase in HIV testing among NYC ambulatory practices. Testing rates remained modest, but considerable improvement was seen in community health centers, in age ranges targeted by the law and in practices that were screening for HIV at baseline. This study suggests that legislation may be effective when used in a comprehensive prevention strategy.

Barriers and facilitators to engagement of vulnerable populations in HIV primary care in New York City.

BACKGROUND: Engagement in HIV care helps to maximize viral suppression, which in turn, reduces morbidity and mortality and prevents further HIV transmission. With more HIV cases than any other US city, New York City reported in 2012 that only 41% of all persons estimated to be living with HIV (PLWH) had a suppressed viral load, whereas nearly three-quarters of those in clinical care achieved viral suppression. Thus, retaining PLWH in HIV care addresses this central goal of both the US National HIV/AIDS Strategy and Governor Cuomo's plan to end the AIDS epidemic in New York State. METHODS: We conducted 80 in-depth qualitative interviews with PLWH in 4 New York City populations that were identified as being inconsistently engaged in HIV medical care: African immigrants, previously incarcerated adults, transgender women, and young men who have sex with men. RESULTS: Barriers to and facilitators of HIV care engagement fell into 3 domains: (1) system factors (eg, patient-provider relationship, social service agencies, transitions between penal system and community), (2) social factors (eg, family and other social support; stigma related to HIV, substance use, sexual orientation, gender identity, and incarceration), and (3) individual factors (eg, mental illness, substance use, resilience). Similarities and differences in these themes across the 4 populations as well as research and public health implications were identified. CONCLUSIONS: Engagement in care is maximized when the social challenges confronted by vulnerable groups are addressed, patient-provider communication is strong, and coordinated services are available, including housing, mental health and substance use treatment, and peer navigation.

What is health communication and how does it affect the HIV/AIDS continuum of care? A brief primer and case study from New York City.

This article responds to key questions related to health communication that are commonly asked in the HIV/AIDS arena: "What is health communication?"; "What is its role beyond HIV prevention?"; and "How can it be used to achieve better HIV/AIDS outcomes?" We review how communication scientists think about their own discipline and build on a basic definition of communication as a fundamental human process without which most individual, group, organizational, and societal activities could not happen, including how people think about and respond to health issues such as HIV and AIDS. Diverse factors and processes that drive human behavior are reviewed, including the concept of ideation (what people know, think, and feel about particular behaviors) and the influence of communication at multiple levels of a social ecological system. Four main functions of communication-information seeking and delivery, persuasion, social connection and structural/cultural expression and maintenance-are linked to a modified version of the Department of Health and Human Services Continuum of Care and are used to conceptualize ways in which communication can achieve better HIV/AIDS outcomes. The article provides examples of how communication complements other types of interventions across the HIV/AIDS continuum of care and has effects on HIV-related knowledge, attitudes, social norms, risk perceptions, service delivery quality, and behavioral decisions that affect if and when the virus is transmitted, when and where testing and care are sought, and how well adherence to antiretroviral therapy is maintained. We illustrate this approach with a case study of HIV/AIDS communication conducted by the New York City Health Department during 2005-2013.

Evaluating the impact of prioritization of antiretroviral pre-exposure prophylaxis in New York.

OBJECTIVE: To compare the value and effectiveness of different prioritization strategies of pre-exposure prophylaxis (PrEP) in New York City (NYC). DESIGN: Mathematical modelling utilized as clinical trial is not feasible. METHODS: Using a model accounting for both sexual and parenteral transmission of HIV, we compare different PrEP prioritization strategies (PPS) with two scenarios ­ no PrEP and PrEP for all susceptible at-risk individuals. The PPS included PrEP for all MSM,only high-risk MSM, high-risk heterosexuals, and IDUs, and all combinations of these four strategies. Outcomes included HIV infections averted, and incremental cost effectiveness(per-infection averted) ratios. Initial assumptions regarding PrEP included a 44% reduction in HIV transmission, 50% uptake in the prioritized population and an annual cost per person of $9762. Sensitivity analyses on key parameters were conducted. RESULTS: Prioritization to all MSM results in a 19% reduction in new HIV infections. Compared with PrEP for all persons at-risk, this PPS retains 79% of the preventive effect at 15% of the total cost. PrEP prioritized to only high-risk MSM results in a reduction in new HIV infections of 15%. This PPS retains 60% of the preventive effect at 6% of the total cost. There are diminishing returns when PrEP utilization is expanded beyond this group. CONCLUSION: PrEP implementation is relatively cost-inefficient under our initial assumptions. Our results suggest that PrEP should first be promoted among MSM who are at particularly high risk of HIV acquisition. Further expansion beyond this group may be cost-effective, but is unlikely to be cost-saving.

Barriers and facilitators of linkage to HIV primary care in New York City.

One in 5 people living with HIV are unaware of their status; they account for an estimated 51% of new infections. HIV transmission can be reduced through a "Test and Treat" strategy, which can decrease both viral load and risk behaviors. However, linkage of newly diagnosed HIV-positive persons to care has proved challenging. We report quantitative and qualitative data on linkage to care from HIV testing sites that partnered with the New York City Department of Health and Mental Hygiene to implement "The Bronx Knows" (TBK), an initiative that tested 607,570 residents over 3 years. During TBK, partner agencies reported the aggregate number of HIV tests conducted, the number of confirmed positives (overall and new), and the number of confirmed positives linked to medical care. We conducted qualitative interviews with directors of 24 of 30 TBK HIV testing agencies to identify linkage barriers and selected 9 for case studies. Barriers to linkage fell into 3 domains: (1) health care system factors (long wait for provider appointments, requirement of a positive confirmatory test before scheduling an appointment, system navigation, and disrespect to patients); (2) social factors (HIV stigma); and (3) characteristics of risk populations (eg, mental illness, homelessness, substance use, and immigrant). Best practices for linkage included networking among community organizations, individualized care plans, team approach, comprehensive and coordinated care services, and patient peer navigation. Research and public health implications are discussed.

Averting HIV infections in New York City: a modeling approach estimating the future impact of additional behavioral and biomedical HIV prevention strategies.

BACKGROUND: New York City (NYC) remains an epicenter of the HIV epidemic in the United States. Given the variety of evidence-based HIV prevention strategies available and the significant resources required to implement each of them, comparative studies are needed to identify how to maximize the number of HIV cases prevented most economically. METHODS: A new model of HIV disease transmission was developed integrating information from a previously validated micro-simulation HIV disease progression model. Specification and parameterization of the model and its inputs, including the intervention portfolio, intervention effects and costs were conducted through a collaborative process between the academic modeling team and the NYC Department of Health and Mental Hygiene. The model projects the impact of different prevention strategies, or portfolios of prevention strategies, on the HIV epidemic in NYC. RESULTS: Ten unique interventions were able to provide a prevention benefit at an annual program cost of less than $360,000, the threshold for consideration as a cost-saving intervention (because of offsets by future HIV treatment costs averted). An optimized portfolio of these specific interventions could result in up to a 34% reduction in new HIV infections over the next 20 years. The cost-per-infection averted of the portfolio was estimated to be $106,378; the total cost was in excess of $2 billion (over the 20 year period, or approximately $100 million per year, on average). The cost-savings of prevented infections was estimated at more than $5 billion (or approximately $250 million per year, on average). CONCLUSIONS: Optimal implementation of a portfolio of evidence-based interventions can have a substantial, favorable impact on the ongoing HIV epidemic in NYC and provide future cost-saving despite significant initial costs.

Assessing the impact of a community-wide HIV testing scale-up initiative in a major urban epidemic.

BACKGROUND: The Bronx, one of 5 boroughs in New York City (NYC), bears a high burden of HIV. We evaluated the impact of HIV testing initiatives in the Bronx, including the 2008 The Bronx Knows campaign. METHODS: We used data from an annual telephone survey representative of NYC adults to compare 2005 and 2009 estimates of HIV testing prevalence among Bronx residents and to identify correlates of testing. We used NYC HIV surveillance data to evaluate changes in the percentage of persons concurrently being diagnosed with HIV and AIDS, an indicator of delayed HIV diagnosis. RESULTS: Between 2005 and 2009, relative increases of 14% and 32% were found in the proportion of Bronx adults who have ever been HIV tested and who have been tested in the past year, respectively (P < 0.001). The largest increases were among those aged 24-44 years, men, non-Hispanic blacks and Hispanics, and those with low income or education, nonheterosexual identity, a personal doctor/provider, or health insurance. Factors independently associated with being recently tested included black or other race, Hispanic ethnicity, and bisexual identity. The proportion concurrently diagnosed with HIV and AIDS fell 22% from 2005 to 2009, and decreases generally occurred among subgroups experiencing increases in testing. CONCLUSION: Community-wide testing in the Bronx increased the proportion of people with known HIV status and reduced the proportion with delayed diagnoses.