Achieving the "Ending the HIV Epidemic in the U.S." incidence reduction goals among at-risk populations in the South.

INTRODUCTION: Antiretroviral medication coverage remains sub-optimal in much of the United States, particularly the Sothern region, and Non-Hispanic Black or African American persons (NHB) continue to be disproportionately impacted by the HIV epidemic. The "Ending the HIV Epidemic in the U.S." (EHE) initiative seeks to reduce HIV incidence nationally by focusing resources towards the most highly impacted localities and populations. This study evaluates the impact of hypothetical improvements in ART and PrEP coverage to estimate the levels of coverage needed to achieve EHE goals in the South. METHODS: We developed a stochastic, agent-based network model of 500,000 individuals to simulate the HIV epidemic and hypothetical improvements in ART and PrEP coverage. RESULTS: New infections declined by 78.6% at 90%/40% ART/PrEP and 94.3% at 100%/50% ART/PrEP. Declines in annual incidence rates surpassed 75% by 2025 with 90%/40% ART/PrEP and 90% by 2030 with 100%/50% ART/PrEP coverage. Increased ART coverage among NHB MSM was associated with a linear decline in incidence among all MSM. Declines in incidence among Hispanic/Latino and White/Other MSM were similar regardless of which MSM race group increased their ART coverage, while the benefit to NHB MSM was greatest when their own ART coverage increased. The incidence rate among NHB women declined by over a third when either NHB heterosexual men or NHB MSM increased their ART use respectively. Increased use of PrEP was associated with a decline in incidence for the groups using PrEP. MSM experienced the largest absolute declines in incidence with increasing PrEP coverage, followed by NHB women. CONCLUSIONS: Our analysis indicates that it is possible to reach EHE goals. The largest reductions in HIV incidence can be achieved by increasing ART coverage among MSM and all race groups benefit regardless of differences in ART initiation by race. Improving ART coverage to > 90% should be prioritized with a particular emphasis on reaching NHB MSM. Such a focus will reduce the largest number of incident cases, reduce racial HIV incidence disparities among both MSM and women, and reduce racial health disparities among persons with HIV. NHB women should also be prioritized for PrEP outreach.

Estimated Uncovered Costs For HIV Preexposure Prophylaxis In The US, 2018.

The cost of HIV preexposure prophylaxis (PrEP) medication and care is a key barrier to PrEP use. Using population-based surveys and published information, we estimated the number of people with uncovered costs for PrEP care among US adults with PrEP indications, stratified by HIV transmission risk group, insurance status, and income. Accounting for existing PrEP payer mechanisms, we estimated annual uncovered costs for PrEP medication, clinical visits, and laboratory testing based on the 2021 PrEP clinical practice guideline. Of 1.2 million US adults with PrEP indications in 2018, we estimated that 49,860 (4 percent) of them had PrEP-related uncovered costs, including 32,350 men who have sex with men, 7,600 heterosexual women, 5,070 heterosexual men, and 4,840 people who inject drugs. Of those 49,860 people with uncovered costs, 3,160 (6 percent) incurred $18.9 million in uncovered costs for PrEP medication, clinical visits, and lab testing, and 46,700 (94 percent) incurred $83.5 million in uncovered costs for only clinical visits and lab testing. The total annual uncovered costs for adults with PrEP indications were $102.4 million in 2018. The proportion of people with uncovered costs for PrEP is less than 5 percent among adults with PrEP indications, but the magnitude of costs is significant.

Costs of Providing Preexposure Prophylaxis for HIV Prevention at Community Health Centers in the United States.

OBJECTIVE: Preexposure prophylaxis (PrEP) is recommended for people at risk of acquiring HIV. We assessed billable costs associated with PrEP delivery at community health centers. METHODS: The Sustainable Health Center Implementation PrEP Pilot (SHIPP) study is an observational cohort of people receiving daily oral PrEP at participating federally qualified health centers and other community health centers. We assessed health care utilization and billable costs of providing PrEP at 2 health centers, 1 in Chicago, Illinois, and 1 in Washington, DC, from 2014 to 2018. The health centers followed the clinical practice guidelines for PrEP provision, including regular visits with health care providers and ongoing laboratory monitoring. Using clinic billing records and Current Procedural Terminology (CPT) coding, we retrospectively extracted data on the frequency and costs (in 2017 US dollars) of PrEP clinic visits and laboratory screening, for each patient, for 12 months since first PrEP prescription. RESULTS: The average annual number of PrEP clinic visits and associated laboratory screens per patient was 5.1 visits and 25.2 screens in Chicago (n = 482 patients) and 5.4 visits and 24.8 screens in Washington, DC (n = 56 patients). The average annual PrEP billable cost per patient was $583 for clinic visits and $1070 for laboratory screens in Chicago and $923 for clinic visits and $1018 for laboratory screens in Washington, DC. The average annual total cost per patient was $1653 (95% CI, $1639-$1668) in Chicago and $1941 (95% CI, $1811-$2071) in Washington, DC. CONCLUSIONS: Our analysis, which provides PrEP billable cost estimates based on empirical data, may help inform health care providers who are considering implementing this HIV prevention strategy.

Toward Greater Pre-exposure Prophylaxis Equity: Increasing Provision and Uptake for Black and Hispanic/Latino Individuals in the U.S.

Pre-exposure prophylaxis (PrEP) is highly effective at preventing HIV acquisition and is a critical tool in the Ending the HIV Epidemic in the U.S. initiative. However, major racial and ethnic disparities across the pre-exposure prophylaxis continuum, secondary to structural inequities and systemic racism, threaten progress. Many barriers, operating at the individual, network, healthcare, and structural levels, impede PrEP access and uptake within Black and Hispanic/Latino communities. This review provides an overview of those barriers and the innovative and collaborative solutions that health departments, healthcare organizations, and community partners have implemented to increase PrEP provision and uptake among disproportionately affected communities. Promising strategies at the individual and network levels focus on increasing patient support throughout the PrEP continuum, positioning and training community members to expand knowledge of and interest in PrEP, and leveraging mobile technologies to support PrEP uptake. Healthcare-level solutions include expanding the venues and types of healthcare professionals that can provide PrEP, and structural- and policy-level options focus on financial assistance programs and health insurance expansion. Key research gaps include demonstrating that pilot studies and interventions remain effective at scale and across varied contexts. Although the last 2 decades have provided effective tools to end the HIV epidemic, realizing this vision for the U.S. will require addressing persistent and pervasive HIV-related disparities in Black and Hispanic/Latino communities. Federal, state, and local partners should expand efforts to address longstanding health and structural inequities and partner with disproportionately affected communities to rapidly expand PrEP scale-up.

Racial and ethnic disparities in HIV diagnoses among heterosexually active persons in the United States nationally and by state, 2018.

BACKGROUND: Despite declining HIV infection rates, persistent racial and ethnic disparities remain. Appropriate calculations of diagnosis rates by HIV transmission category, race and ethnicity, and geography are needed to monitor progress towards reducing systematic disparities in health outcomes. We estimated the number of heterosexually active adults (HAAs) by sex and state to calculate appropriate HIV diagnosis rates and disparity measures within subnational regions. METHODS: The analysis included all HIV diagnoses attributed to heterosexual transmission in 2018 in the United States, in 50 states and the District of Columbia. Logistic regression models estimated the probability of past-year heterosexual activity among adults in three national health surveys, by sex, age group, race and ethnicity, education category, and marital status. Model-based probabilities were applied to estimated counts of HAAs by state, which were synthesized through meta-analysis. HIV diagnoses were overlaid to calculate racial- and ethnic-specific rates, rate differences (RDs), and rate ratios (RRs) among HAAs by sex and state. RESULTS: Nationally, HAA women have a two-fold higher HIV diagnosis rate than HAA men (rate per 100,000 HAAs, women: 6.57; men: 3.09). Compared to White non-Hispanic HAAs, Black HAAs have a 20-fold higher HIV diagnosis rate (RR, men: 21.28, women: 19.55; RD, men: 15.40, women: 31.78) and Hispanic HAAs have a 4-fold higher HIV diagnosis rate (RR, men: 4.68, RD, women: 4.15; RD, men: 2.79, RD, women: 5.39). Disparities were ubiquitous across regions, with >75% of states in each region having Black-to-White RR ≥10. CONCLUSION: The racial and ethnic disparities across regions suggests a system-wide failure particularly with respect to preventing HIV among Black and Hispanic women. Pervasive disparities emphasize the role for coordinated federal responses such as the current Ending the HIV Epidemic (EHE) initiative.

A decision analytics model to optimize investment in interventions targeting the HIV preexposure prophylaxis cascade of care.

OBJECTIVES: Gaps between recommended and actual levels of HIV preexposure prophylaxis (PrEP) use remain among MSM. Interventions can address these gaps but it is unknown how public health initiatives should invest prevention funds into these interventions to maximize their population impact. DESIGN: We used a stochastic network-based HIV transmission model for MSM in the Atlanta area paired with an economic budget optimization model. METHODS: The model simulated MSM participating in up to three real-world PrEP cascade interventions designed to improve initiation, adherence, or persistence. The primary outcome was infections averted over 10 years. The budget optimization model identified the investment combination under different budgets that maximized this outcome, given intervention costs from a payer perspective. RESULTS: From the base 15% PrEP coverage level, the three interventions could increase coverage to 27%, resulting in 12.3% of infections averted over 10 years. Uptake of each intervention was interdependent: maximal use of the adherence and persistence interventions depended on new PrEP users generated by the initiation intervention. As the budget increased, optimal investment involved a mixture of the initiation and persistence interventions but not the adherence intervention. If adherence intervention costs were halved, the optimal investment was roughly equal across interventions. CONCLUSION: Investments into the PrEP cascade through initiatives should account for the interactions of the interventions as they are collectively deployed. Given current intervention efficacy estimates, the total population impact of each intervention may be improved with greater total budgets or reduced intervention costs.

Assessment of PrEP Awareness, PrEP Discussion with a Provider, and PrEP Use by Transmission Risk Group with an Emphasis on the Southern United States.

The number of new HIV diagnoses is highest in the South. Many persons who might benefit from pre-exposure prophylaxis (PrEP) are not engaged in the HIV PrEP continuum of care. We analyzed National HIV Behavioral Surveillance data to assess engagement in the PrEP continuum of care among persons with increased HIV risk. We compared PrEP awareness, discussion with a clinical provider, and use among persons living in the South to those living elsewhere in the United States. PrEP awareness was lowest among heterosexual persons (7%), highest among men who have sex with men (85%), and 26% among persons who inject drugs. PrEP use was low among each population (≤ 35% for all cycles). There was limited evidence of differences in PrEP use between persons in southern and non-southern U.S. Efforts are needed to increase use of PrEP among each of the groups with increased HIV risk.

RESUMEN: El número de nuevos diagnósticos de virus de la inmunodeficiencia humana (VIH) es más alto en el sur. Muchas personas que podrían beneficiarse de la profilaxis preexposición (PrEP) no participan en la VIH-PrEP continuidad de la atención. Analizamos datos del Sistema Nacional de Vigilancia del Comportamiento Relacionado con el VIH (conocido en inglés como National HIV Behavioral Surveillance System) para evaluar la participación en la PrEP continuidad de la atención en personas con mayor riesgo de contraer el VIH. Comparamos concientización de PrEP, discusión con un proveedor clínico, y uso entre personas que viven en el sur con las personas que viven en otras partes de los Estados Unidos. Concientización de PrEP fue más baja entre personas heterosexuales (7%), más alta entre hombres que tienen relaciones sexuales con hombres (91%), y 26% entre personas que se inyectan drogas. Utilización de PrEP fue baja para todas las poblaciones (≤35% para todos los ciclos). La evidencia de diferencias en el uso de PrEP entre personas que viven en el sur con personas que no viven en el sur de los Estados Unidos fue limitada. Se necesitan esfuerzos para aumentar el uso de PrEP entre estos grupos con más riesgo de contraer el VIH.

Out-of-pocket costs and HIV pre-exposure prophylaxis persistence in a US multicity demonstration project.

OBJECTIVE: To evaluate whether out-of-pocket (OOP) costs reduced HIV pre-exposure prophylaxis (PrEP) persistence. DATA SOURCE: Participants from five urban community health centers (CHCs) in four US cities enrolled in a PrEP demonstration project from September 2014 to August 2017. STUDY DESIGN: Patients initiating PrEP were followed quarterly until they withdrew from PrEP care or the study ended. Self-reported OOP medication and clinic visit costs were assessed by semiannual questionnaires. Persistence was defined as the time from study enrollment to the last visit after which two subsequent 3-month visits were missed. Multivariable Cox proportional hazard regression was used to assess the effect of demographics, insurance, and OOP costs on PrEP persistence. PRINCIPAL FINDINGS: Among 918 participants with OOP cost data, the average quarterly OOP cost was $34 (median: $5, IQR: $0-$25). Participants who were men, White, employed, completed college, and had commercial insurance had higher OOP costs. Higher OOP costs were not associated with lower PrEP persistence by Cox proportional hazards regression (adjusted hazard ratio = 1.00 per $50 increase, 95% CI = 0.97, 1.02). CONCLUSION: Among patients receiving care from these urban CHCs, OOP costs were low and did not undermine PrEP persistence.

Addressing Gaps in HIV Preexposure Prophylaxis Care to Reduce Racial Disparities in HIV Incidence in the United States.

The potential for human immunodeficiency virus (HIV) preexposure prophylaxis (PrEP) to reduce the racial disparities in HIV incidence in the United States might be limited by racial gaps in PrEP care. We used a network-based mathematical model of HIV transmission for younger black and white men who have sex with men (BMSM and WMSM) in the Atlanta, Georgia, area to evaluate how race-stratified transitions through the PrEP care continuum from initiation to adherence and retention could affect HIV incidence overall and disparities in incidence between races, using current empirical estimates of BMSM continuum parameters. Relative to a no-PrEP scenario, implementing PrEP according to observed BMSM parameters was projected to yield a 23% decline in HIV incidence (hazard ratio = 0.77) among BMSM at year 10. The racial disparity in incidence in this observed scenario was 4.95 per 100 person-years at risk (PYAR), a 19% decline from the 6.08 per 100 PYAR disparity in the no-PrEP scenario. If BMSM parameters were increased to WMSM values, incidence would decline by 47% (hazard ratio = 0.53), with an associated disparity of 3.30 per 100 PYAR (a 46% decline in the disparity). PrEP could simultaneously lower HIV incidence overall and reduce racial disparities despite current gaps in PrEP care. Interventions addressing these gaps will be needed to substantially decrease disparities.

PrEP implementation by local health departments in US cities and counties: Findings from a 2015 assessment of local health departments.

OBJECTIVE: The United States Public Health Service released clinical practice guidelines for daily oral preexposure prophylaxis (PrEP) in May 2014. Local health departments (LHDs) are expected to play a critical role in PrEP implementation. We surveyed LHDs to assess awareness of and interest in supporting PrEP implementation, what roles they were taking, or believed they should take, in supporting PrEP, and what resources would be required to do so. METHODS: LHDs were surveyed in 2015 to assess their engagement in PrEP implementation (n = 500). The study employed a cross-sectional survey design with a randomly selected stratified sample. RESULTS: Among responding LHDs (n = 284), 109 (29%, weighted proportion) reported engagement in PrEP implementation. LHDs serving large jurisdictions (population 500,000+) and located in the West were more likely to be engaged in PrEP implementation. Making referrals for PrEP (74%) and conducting education and outreach to community members (51%) were the activities most frequently reported by LHDs engaged in PrEP implementation; 45% anticipated expanding their level of engagement. Among LHDs not engaged in PrEP implementation, 13% expected to become engaged over the next four years, 46% were undecided, and 41% reported it was unlikely. Information about PrEP for health care providers and information about PrEP for health department staff were the most frequently reported resource needs for LHDs engaged and not engaged in PrEP implementation, respectively. CONCLUSIONS: PrEP implementation by LHDs was limited in 2015, three years after Food and Drug Administration approval and one year after the U.S. Public Health Service issued clinical practice guidelines. PrEP is a recently available intervention that is requiring LHDs to adjust existing HIV prevention efforts and service delivery models. Additional resources and implementation research is needed to effectively support PrEP scale-up by LHDs. Efforts must also be undertaken to increase PrEP awareness, knowledge, and implementation capacity among LHDs.

Estimated Coverage to Address Financial Barriers to HIV Preexposure Prophylaxis Among Persons With Indications for Its Use, United States, 2015.

BACKGROUND: An estimated 1.2 million American adults engage in sexual and drug use behaviors that place them at significant risk of acquiring HIV infection. Engagement in health care for the provision of daily oral antiretroviral medication as preexposure prophylaxis (PrEP), when clinically indicated, could substantially reduce the number of new HIV infections in these persons. However, resources to cover the financial cost of PrEP care are anticipated barriers for many of the populations with high numbers of new HIV infections. METHODS: Using nationally representative data, we estimated the current national met and unmet need for financial assistance with covering the cost of PrEP medication, clinical visits, and laboratory tests among adults with indications for its use, overall and by transmission risk population. RESULTS: This study found that of the 1.2 million adults estimated to have indications for PrEP use, <1% (∼7300) are in need of financial assistance for both PrEP medication and clinical care, at an estimated annual cost of $89 million. An additional 7% (∼86,300) are in need of financial assistance only for PrEP clinical care at an estimated annual cost of $119 million. CONCLUSIONS: This information on PrEP care costs, insurance coverage, and unmet financial need among persons in key HIV transmission risk subpopulations can inform policy makers at all levels as they consider how to address remaining financial barriers to the use of PrEP and accommodate any changes in eligibility for various insurance and financial assistance programs that may occur in coming years.

Uptake of HIV Preexposure Prophylaxis Among Commercially Insured Persons-United States, 2010-2014.

BACKGROUND: Daily, oral use of tenofovir disoproxil fumarate and emtricitabine (TDF-FTC) for preexposure prophylaxis (PrEP) is an effective strategy to prevent acquisition of human immunodeficiency virus (HIV) infection. It is important to monitor PrEP uptake at the national level to increase our understanding of trends in its utilization, but national HIV surveillance data do not include PrEP uptake. Our objective was to develop feasible methods to estimate PrEP uptake and to estimate uptake each year among commercially insured persons during 2010-2014. METHODS: We conducted a retrospective analysis of the 2010-2014 MarketScan database, a national sample of persons with commercial health insurance in the United States. We developed an algorithm to identify persons aged ≥16 years who were prescribed TDF-FTC for PrEP each year. We generated nationally representative estimates of prevalence of persons prescribed PrEP. RESULTS: We found a significantly increasing trend in the proportion of persons prescribed TDF-FTC for PrEP during the study period, with 417 users in 2010 and 9375 in 2014 (P < .001); 97% of PrEP users were male and 98% lived in metropolitan areas in 2014. During the study period, the numbers of women prescribed PrEP were low. CONCLUSIONS: Our analytic method provides the only feasible means to monitor PrEP uptake in the United States. Although a marked increasing trend in uptake was observed for men, the number of women who used PrEP remained very low during the study period. Interventions are needed to increase PrEP use by women at substantial risk of acquiring HIV infection.

Acceptability and willingness among men who have sex with men (MSM) to use a tablet-based HIV risk assessment in a clinical setting.

We developed an iPad-based application to administer an HIV risk assessment tool in a clinical setting. We conducted focus group discussions (FGDs) with gay, bisexual and other men who have sex with men (MSM) to assess their opinions about using such a device to share risk behavior information in a clinical setting. Participants were asked about their current assessment of their risk or any risk reduction strategies that they discussed with their healthcare providers. Participants were then asked to provide feedback about the iPad-based risk assessment, their opinions about using it in a clinic setting, and suggestions on how the assessment could be improved. FGD participants were generally receptive to the idea of using an iPad-based risk assessment during healthcare visits. Based on the results of the FGDs, an iPad-based risk assessment is a promising method for identifying those patients at highest risk for HIV transmission.

Knowledge of and interest in using preexposure prophylaxis for HIV prevention among men who have sex with men in Thailand.

Little is known about HIV preexposure prophylaxis (PrEP) acceptability among men who have sex with men (MSM) in Thailand. The authors recruited an online convenience sample of Thai MSM (n = 404) to assess the knowledge of and interest in PrEP. Less than 7% had heard of PrEP; however, 35% indicated interest in PrEP after an explanation of its possible efficacy. Regression modeling demonstrated that HIV knowledge and risk behavior, but not demographics, are significant predictors of PrEP interest. More information and education about PrEP is necessary and more research is needed to examine PrEP acceptability and to inform the message for PrEP uptake.

Attitudes and program preferences of African-American urban young adults about pre-exposure prophylaxis (PrEP).

We elicited attitudes about, and service access preferences for, daily oral antiretroviral pre-exposure prophylaxis (PrEP) from urban, African-American young men and women, ages 18-24 years, at risk for HIV transmission through their sexual and drug-related behaviors participating in eight mixed-gender and two MSM-only focus groups in Atlanta, Georgia. Participants reported substantial interest in PrEP associated with its perceived cost, effectiveness, and ease of accessing services and medication near to their homes or by public transportation. Frequent HIV testing was a perceived benefit. Participants differed about whether risk-reduction behaviors would change, and in which direction; and whether PrEP use would be associated with HIV stigma or would enhance the reputation for PrEP users. This provides the first information about the interests, concerns, and preferences of young adult African Americans that can be used to inform the introduction of PrEP services into HIV prevention efforts for this critical population group.

Antiretroviral postexposure prophylaxis after sexual, injection-drug use, or other nonoccupational exposure to HIV in the United States: recommendations from the U.S. Department of Health and Human Services.

The most effective means of preventing human immunodeficiency virus (HIV) infection is preventing exposure. The provision of antiretroviral drugs to prevent HIV infection after unanticipated sexual or injection-drug--use exposure might be beneficial. The U.S. Department of Health and Human Services (DHHS) Working Group on Nonoccupational Postexposure Prophylaxis (nPEP) made the following recommendations for the United States. For persons seeking care < or =72 hours after nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person known to be HIV infected, when that exposure represents a substantial risk for transmission, a 28-day course of highly active antiretroviral therapy (HAART) is recommended. Antiretroviral medications should be initiated as soon as possible after exposure. For persons seeking care < or =72 hours after nonoccupational exposure to blood, genital secretions, or other potentially infectious body fluids of a person of unknown HIV status, when such exposure would represent a substantial risk for transmission if the source were HIV infected, no recommendations are made for the use of nPEP. Clinicians should evaluate risks and benefits of nPEP on a case-by-case basis. For persons with exposure histories that represent no substantial risk for HIV transmission or who seek care >72 hours after exposure, DHHS does not recommend the use of nPEP. Clinicians might consider prescribing nPEP for exposures conferring a serious risk for transmission, even if the person seeks care >72 hours after exposure if, in their judgment, the diminished potential benefit of nPEP outweighs the risks for transmission and adverse events. For all exposures, other health risks resulting from the exposure should be considered and prophylaxis administered when indicated. Risk-reduction counseling and indicated intervention services should be provided to reduce the risk for recurrent exposures.

Use of highly active antiretroviral therapy in HIV-infected women: impact of HIV specialist care.

OBJECTIVES: To evaluate factors associated with use of HIV specialist care by women, and to determine whether medical indications for therapy validate lower rates of antiretroviral use in women not using HIV specialty care. DESIGN: Cross-sectional analysis of the 1998 interview from the HIV Epidemiology Research Study (HERS) cohort. METHODS: Data from 273 HIV-infected women in the HERS were analyzed by multiple logistic regression to calculate predictors of the use of HIV specialist care providers. Variables included study site, age, education, insurance status, income, substance abuse, depression, AIDS diagnosis, CD4 + lymphocyte count, and HIV-1 viral load. In addition, medical indications for therapy and medical advice to begin antiretroviral therapy were assessed. RESULTS: Of 273 women, 222 (81%) used HIV specialists and 51 (19%) did not. Having health insurance, not being an injection drug user, and being depressed were predictive of using HIV specialist care (all p < or = .05). Although medical indications for therapy in the two groups were comparable, the rate of highly active antiretroviral therapy (HAART) use was significantly higher in women using HIV specialist care (27%) compared with those not using HIV specialists (7.8%). Women using HIV specialists received significantly more advice to begin antiretroviral therapy (ART) in the 6 months prior to the interview compared with those not using specialists (relative risk, 2.4; 95% CI = 1.3-4.6). CONCLUSIONS: Having insurance, not being an injection drug user, and being depressed all increased the likelihood of women receiving HIV specialty care, which, in turn, increased the likelihood of receiving recommended therapies. The level of HAART use (23%) and any ART use (47%) in these HIV-infected women was disturbingly low. Despite comparable medical indications, fewer women obtaining care from other than HIV specialists received HAART. These data indicate substantial gaps in access to HIV specialist care and thereby to currently recommended antiretroviral treatment.