BACKGROUND: The "Ending the HIV Epidemic" (EHE) initiative seeks to reduce new HIV infections in the U.S. by prioritizing federal resources towards highly impacted populations. Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are essential for reaching EHE goals. Adolescents are often at increased risk for HIV because they may lack agency in negotiating their sexual partnerships and may not have the same access to treatment and prevention as adults. This study estimates the potential contribution of expanded PrEP coverage among adolescents ages 15-17 to achieving the EHE goals in the South. METHODS: An HIV-transmission model was built to simulate the HIV epidemic in the South. Increased ART and PrEP uptake were systematically varied with and without PrEP eligibility including individuals age<18. RESULTS: Prioritizing PrEP for adolescents had a negligible impact on incidence. At 50% uptake among eligible adolescents and 90% ART coverage, including adolescents only improved the percentage of infections averted from 80.1% to 80.3%. In 10 of 15 scenarios explored, there was no reduction in new infections when PrEP eligibility was expanded to include adolescents age<18. At 95% ART coverage at the population-level incidence among adolescents declined by over 80%, but PrEP uptake among adolescents did not contribute to additional declines in incidence among adolescents. CONCLUSIONS: Prioritizing PrEP for adolescents did not significantly contribute to reaching EHE incidence reductions goal. Focusing resources to specific adolescent populations at risk, such sexual minority males in high incidence settings, will remain an important public health goal outside the context of EHE.

Objectives Gaps between recommended and actual levels of HIV preexposure prophylaxis (PrEP) use remain among men who have sex with men (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.Conclusions 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.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by Centers for Disease Control and Prevention cooperative agreement number U38 PS004646 and National Institutes of Health grant R01 AI138783. Dr. Marcus is supported in part by National Institutes of Health grant K01 AI122853.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Emory University Institutional Review Board approved the study protocols for the primary empirical data collection yielding model parameters for the current study.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe model code and parameters are all open and availability at the Github repository linked below. https://github.com/EpiModel/PrEP-Optimize

Objective We sought to evaluate which combinations of HIV prevention and care activities would have the greatest impact towards reaching the US Ending the HIV Epidemic (EHE) plan goals of reducing HIV incidence at least 75% by 2025 and 90% by 2030.Design A stochastic HIV transmission model for men who have sex with men (MSM), calibrated to local surveillance estimates in the Atlanta area, a focal EHE target jurisdiction.Methods Model scenarios varied HIV screening rates relative to current levels, under different assumptions of how HIV-negative MSM would be linked to PrEP initiation, and also considered improvements to HIV care linkage and retention for those screening positive.Results A 10-fold relative increase in HIV screening rates (to approximately biannual screening for black and Hispanic MSM and quarterly for white MSM) would lead to 43% of infections averted if integrated with PrEP initiation. Improvements to HIV care retention would avert 41% of infections if retention rates were improved 10-fold. If both screening and retention were jointly improved 10-fold, up to 74% of cumulative infections would be averted. Under this scenario, it would take 4 years to meet the 75% EHE goal and 12 years to meet the 90% goal for MSM in Atlanta.Conclusions Interventions to improve HIV screening linked with PrEP for those screening negative, and HIV care retention would have a substantial impact on HIV prevention. However, additional interventions may be necessary to reach the EHE goal of a 90% reduction in incidence for Atlanta MSM by 2030.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by Centers for Disease Control and Prevention cooperative agreement number U38 PS004646 and National Institutes of Health grants R21 MH112449 and R01 AI138783.Author DeclarationsAll relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.YesAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesModel data and analysis scripts are available on our Github repository linked below. https://github.com/EpiModel/CombPrev

Background HIV preexposure prophylaxis (PrEP) could reduce the disparities in HIV incidence among black men who have sex with men (BMSM) compared to white MSM (WMSM), but this may depend on progression through the PrEP care continuum.Methods We expanded our network-based mathematical model of HIV transmission for MSM, which simulates PrEP based on CDC’s clinical practice guidelines, to include race-stratified transitions through the PrEP continuum steps of awareness, access, prescription, adherence, and retention. Continuum parameters were estimated based on published incidence cohorts and PrEP open-label studies. Counterfactuals included a no-PrEP reference scenario, and intervention scenarios in which the BMSM continuum step parameters were modified.Results Implementing PrEP according to the observed BMSM continuum was projected to result in 8.4% of all BMSM on PrEP at year 10, yielding a 23% decline in incidence (HR = 0.77). On an absolute scale, the racial disparity in incidence in this scenario was 4.95 per 100 person-years at risk (PYAR), a 19% decline from the 6.08 per 100 PYAR disparity in the reference scenario. If BMSM continuum parameters were equal to WMSM values, 17.7% of BMSM would be on PrEP, yielding a 47% decline in incidence (HR = 0.53) and a disparity of 3.30 per 100 PYAR (a 46% decline in the disparity).Conclusions PrEP could lower HIV incidence overall and reduce absolute racial disparities between BMSM and WMSM. Interventions addressing the racial gaps in the PrEP continuum will be needed to further decrease these HIV disparities.

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.

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.

The COVID-19 pandemic has disrupted HIV prevention, care, and transmission opportunities. This likely varies by geography, given differences in COVID-19 burden and mandates over time, and by age, given different likelihoods of severe COVID-19 consequences. We consider changes in sexual behavior, HIV testing, pre-exposure prophylaxis (PrEP) use and antiretroviral therapy (ART) use among men who have sex with men (MSM) over the first year of the COVID-19 epidemic, comparing the Atlanta metropolitan area and New York City (NYC). We use two continuous time-series datasets and one panel dataset, assessing changes over time within city and comparing across cities, and disaggregate major findings by age. For clinical results, ART use showed by far the smallest reductions, and testing the largest. Disruptions occurred concurrently between cities, despite the major wave of COVID-19, and government mandates, occurring later in Atlanta. Test positivity increased in NYC only. In both cities, younger MSM saw the greatest reductions in testing and PrEP use, but the smallest in sexual behavior. Reduced clinical service usage would be unconcerning if stemming solely from reductions in exposure; however, the patterns for young MSM suggest that the COVID-19 epidemic likely generated new conditions for increased HIV transmission, especially in this cohort.

OBJECTIVE: To estimate trends in the proportion of sexually active U.S. adults with HIV (PWH) reporting an HIV-discordant sexual partner taking preexposure prophylaxis (PrEP) and proportion of partners taking PrEP. DESIGN: The Medical Monitoring Project is a complex sample survey of U.S. adults with diagnosed HIV. METHODS: We used annual cross-sectional data collected during June 2015-May 2020 to estimate the annual percentage change (EAPC), overall and by selected characteristics, in reported partner PrEP use among PWH with HIV-discordant partners (N = 8707) and reported PrEP use among these partners (N = 15 844). RESULTS: The proportion of PWH reporting PrEP use by one or more HIV-discordant sex partner rose 19.5% annually (11.3 to 24.4%). The prevalence rose from 6.0 to 17.4% (EAPC, 25.8%) among Black PWH, 10.1 to 26.0% (EAPC, 19.5%) among Hispanic/Latino PWH, and 20.8 to 34.6% (EAPC, 16.3%) among White PWH. Among MSM with HIV, the prevalence increased from 9.6 to 32.6% (EAPC, 28.2%) among Black MSM, 16.6 to 36.0% (EAPC, 15.6%) among Hispanic/Latino MSM, and 24.9 to 44.1% (EAPC, 17.9%) among White MSM. Among HIV-discordant sex partners, the proportion reported to be taking PrEP increased 21.1% annually (7.8 to 18.8%). Reported PrEP use rose from 4.9 to 14.2% (EAPC, 29.9%) among Black partners, 6.5 to 16.8% (EAPC, 20.3%) among Hispanic/Latino partners, and 12.7 to 26.1% (EAPC, 17.0%) among White partners. CONCLUSIONS: One in five HIV-discordant sexual partners of PWH was reported to be taking PrEP. PrEP use rose among all examined populations, although the increases did not eliminate disparities in PrEP use.

On May 17, 2022, the Massachusetts Department of Health announced the first suspected case of monkeypox associated with the global outbreak in a U.S. resident. On May 23, 2022, CDC launched an emergency response (1,2). CDC's emergency response focused on surveillance, laboratory testing, medical countermeasures, and education. Medical countermeasures included rollout of a national JYNNEOS vaccination strategy, Food and Drug Administration (FDA) issuance of an emergency use authorization to allow for intradermal administration of JYNNEOS, and use of tecovirimat for patients with, or at risk for, severe monkeypox. During May 17-October 6, 2022, a total of 26,384 probable and confirmed* U.S. monkeypox cases were reported to CDC. Daily case counts peaked during mid-to-late August. Among 25,001 of 25,569 (98%) cases in adults with information on gender identity,(†) 23,683 (95%) occurred in cisgender men. Among 13,997 cisgender men with information on recent sexual or close intimate contact,(§) 10,440 (75%) reported male-to-male sexual contact (MMSC) ≤21 days preceding symptom onset. Among 21,211 (80%) cases in persons with information on race and ethnicity,(¶) 6,879 (32%), 6,628 (31%), and 6,330 (30%) occurred in non-Hispanic Black or African American (Black), Hispanic or Latino (Hispanic), and non-Hispanic White (White) persons, respectively. Among 5,017 (20%) cases in adults with information on HIV infection status, 2,876 (57%) had HIV infection. Prevention efforts, including vaccination, should be prioritized among persons at highest risk within groups most affected by the monkeypox outbreak, including gay, bisexual, and other men who have sex with men (MSM); transgender, nonbinary, and gender-diverse persons; racial and ethnic minority groups; and persons who are immunocompromised, including persons with advanced HIV infection or newly diagnosed HIV infection.

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.

Human monkeypox is caused by Monkeypox virus (MPXV), an Orthopoxvirus, previously rare in the United States (1). The first U.S. case of monkeypox during the current outbreak was identified on May 17, 2022 (2). As of September 28, 2022, a total of 25,341 monkeypox cases have been reported in the United States.* The outbreak has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) (3). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), administered subcutaneously as a 2-dose (0.5 mL per dose) series with doses administered 4 weeks apart, was approved by the Food and Drug Administration (FDA) in 2019 to prevent smallpox and monkeypox infection (4). U.S. distribution of JYNNEOS vaccine as postexposure prophylaxis (PEP) for persons with known exposures to MPXV began in May 2022. A U.S. national vaccination strategy(†) for expanded PEP, announced on June 28, 2022, recommended subcutaneous vaccination of persons with known or presumed exposure to MPXV, broadening vaccination eligibility. FDA emergency use authorization (EUA) of intradermal administration of 0.1 mL of JYNNEOS on August 9, 2022, increased vaccine supply (5). As of September 28, 2022, most vaccine has been administered as PEP or expanded PEP. Because of the limited amount of time that has elapsed since administration of initial vaccine doses, as of September 28, 2022, relatively few persons in the current outbreak have completed the recommended 2-dose series.(§) To examine the incidence of monkeypox among persons who were unvaccinated and those who had received ≥1 JYNNEOS vaccine dose, 5,402 reported monkeypox cases occurring among males(¶) aged 18-49 years during July 31-September 3, 2022, were analyzed by vaccination status across 32 U.S. jurisdictions.** Average monkeypox incidence (cases per 100,000) among unvaccinated persons was 14.3 (95% CI = 5.0-41.0) times that among persons who received 1 dose of JYNNEOS vaccine ≥14 days earlier. Monitoring monkeypox incidence by vaccination status in timely surveillance data might provide early indications of vaccine-related protection that can be confirmed through other well-controlled vaccine effectiveness studies. This early finding suggests that a single dose of JYNNEOS vaccine provides some protection against monkeypox infection. The degree and durability of such protection is unknown, and it is recommended that people who are eligible for monkeypox vaccination receive the complete 2-dose series.

Few studies investigating daily oral preexposure prophylaxis (PrEP) focus on transgender persons. The Sustainable Health Center Implementation PrEP Pilot (SHIPP) Study included a large observational cohort of transgender persons with implications for PrEP in the United States. We examined data from SHIPP's observational cohort and its Medication Adherence Substudy (MAS) to understand adherence among transgender participants in Chicago, IL. We assessed adherence by the proportion of days covered (PDC) for PrEP medication prescriptions, self-reported interview data, and concentrations of intracellular tenofovir diphosphate (TFV-DP) in dried blood spot (DBS) samples. Between 2014 and 2018, there were 510 transgender participants, 349 (68.4%) transgender women and 152 (29.8%) transgender men. Forty-five of these participants were enrolled in the MAS, 31 (68.9%) transgender women and 9 (20.0%) transgender men. By the 3-month follow up, 100% of MAS participants who completed an interview reported taking 4 or more doses of PrEP in the previous week. At 6, 9, and 12 months, taking 4 or more doses in the past week was reported by 81.0%, 94.1%, and 83.3% of participants, respectively. Results from TFV-DP DBS indicated that fewer participants reached the same level of adherence (4 or more doses/week) at clinical visits compared to self-report and even fewer participants reached this level of adherence based on the calculated PDC. Among participants who remained on PrEP throughout the study, DBS adherence levels declined after the first three months. There remains a critical need to develop strategies to address barriers and interventions that support PrEP adherence among transgender people.

Black women are disproportionately affected by the U.S. human immunodeficiency virus (HIV) epidemic. Preexposure prophylaxis (PrEP) is a safe and effective intervention for HIV prevention. Increased PrEP implementation is a pillar of the U.S. Department of Health and Human Services' Ending the HIV Epidemic in the U.S. initiative. However, PrEP has been used by a smaller proportion of women with PrEP indications compared with men. The goals of the Ending the HIV Epidemic in the U.S. initiative can be achieved only by increasing PrEP use among Black women. Obstetricians and gynecologists are uniquely poised to provide PrEP services for women. We describe the need for community-to-clinic models to overcome the barriers to PrEP use by Black women and a roadmap for clinician and community organization collaboration to increase access to and use of PrEP by Black women.

Pre-exposure prophylaxis (PrEP) is highly effective in preventing new HIV infection, but uptake remains challenging among Black and Hispanic/Latino persons. The purpose of this review was to understand how studies have used electronic telecommunication technology to increase awareness, uptake, adherence, and persistence in PrEP care among Black and Hispanic/Latino persons and how it can reduce social and structural barriers that contribute to disparities in HIV infection. Of the 1114 articles identified, 10 studies were eligible. Forty percent (40%) of studies focused on Black or Hispanic/Latino persons and 80% addressed social and structural barriers related to PrEP use such as navigation or access to PrEP. Mobile health designs were more commonly used (50%) compared to telehealth (30%) and e-health (20%) designs. There is a need to increase the development of telecommunications interventions that address the needs of Black and Hispanic/Latino persons often challenged with uptake and adherent use of PrEP.

INTRODUCTION: We assessed reproductive intentions and associated characteristics among men enrolled in the Sustainable Health Center Implementation pre-exposure prophylaxis (PrEP) Pilot (SHIPP) Study. METHODS: We analyzed baseline data from 1275 men who self-identified as gay or bisexual and participated in the SHIPP study. SHIPP was a cohort study of PrEP implementation in five community health centers in Chicago, Jackson, Philadelphia, and Washington, D.C. conducted from 2014 to 2016. Participants completed audio computer-assisted self-interviews querying intentions to have a child in the future. We estimated the association between participants' reproductive intentions and their characteristics using Poisson regression models. RESULTS: Approximately 47% of participants indicated their intentions to have a child. Black/non-Hispanic (aPR = 1.40; 95% CI: 1.10-1.78) and other/non-Hispanic participants (aPR = 1.40; 95% CI: 1.01-1.93) were more likely to report intentions to have a child than white/non-Hispanic participants. Participants were less likely to report intentions to have children as age increased (18-29 years, reference group; 30-39 years, aPR = 0.80, 95% CI: 0.64-0.99; 40-49 years, aPR = 0.49, 95% CI: 0.33-0.72; 50+ years, aPR = 0.07, 95% CI: 0.02-0.21). CONCLUSIONS: Clinicians offering PrEP to black and other/non-Hispanic gay and bisexual men should assess their reproductive intentions as family-planning counseling may be an opportunity to introduce PrEP to HIV-negative gay and bisexual men.

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.

June 2021 marked 40 years since the first reported cases of AIDS.1 In the 30 years that followed its detection, there have been several critical successes2 (Figure 1): identifying HIV as the causative agent3; defining the sexual and injection drug use behaviors that lead to a high risk for HIV transmission or acquisition4; developing HIV antibody tests of increasing sensitivity and ease of use5,6 that allowed accurate monitoring of epidemic trends, provision of blood product transfusion safety, and identification of people in need of treatment; identifying a broad array of medications used in combinations to effectively treat HIV infection and prevent perinatal transmission7; and developing HIV nucleic acid tests that allow monitoring of treatment effectiveness.8,9 These accomplishments, along with behavioral counseling interventions10 to increase condom use; reduce injection equipment sharing; engage people in prevention, care, and treatment; and support medication adherence, were implemented by state and local public health partners and led to a marked reduction in the estimated number of new HIV infections from a high of 130,000 in 1984 to 50,000 in 2006,11 which stabilized at 47,500 from 2008 to 2010.12

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.

HIV (human immunodeficiency virus) preexposure prophylaxis (PrEP) is an effective biomedical HIV prevention tool. Increasing PrEP use among populations disproportionately affected by HIV is one of the key efforts in the United States' Ending the HIV Epidemic (EHE) initiative and the HIV National Strategic Plan for the United States. Given that PrEP is available only through prescription, it is important to explore structural, organizational, or environmental factors that could facilitate or impede health care provider's PrEP prescribing behavior. The purpose of this systematic review (PROSPERO [CRD: 42019138889]) is to identify qualitative studies that addressed this topic and conduct meta-synthesis using the thematic synthesis method to identify major themes on the characteristics of clinic infrastructure or clinic models that providers consider as facilitators of PrEP prescribing in the United States. Eighteen citations representing 15 studies were included in this review. Five overarching themes were identified: (1) routinized HIV risk assessment; (2) interdisciplinary/coordinated PrEP teams or services; (3) clinic capacity to provide essential PrEP-related services; (4) low out-of-pocket patient costs; and (5) access to the priority populations. Some of these themes are consistent with the recommendations of CDC's PrEP clinical guidelines and the EHE initiative. More recent studies that include perspectives of diverse providers, timely analysis of these studies, and implementation research to assess strategies to address the current practice gaps are needed to further promote PrEP prescribing among providers in the United States.

The prevention effectiveness of oral preexposure prophylaxis (PrEP) is highly dependent on medication adherence but no validated longer term PrEP adherence measures are readily available for use by primary care clinicians caring for diverse populations. We compared two self-report measures (number of doses missed in past 7 days and day-by-day past week pill taking) to results of tenofovir concentrations in dried blood spot (DBS) samples at quarterly visits over the first 12 months of PrEP use. 1420 men and women in five US community health centers enrolled in a medication adherence substudy. For 3, 6, 9 and 12 months, the respective percentages of persons with self-report vs DBS levels consistent having taken all 7 doses in the week prior were 71% (51%), 70% (47%), 71% (46%) and 69% (44%). Conversely, the percentage of participants reporting taking 0-1 doses in the week prior by self-report vs DBS drug levels at 3, 6, 9 and 12 months consistent with this level of nonadherence of 6% (9%), 5% (10%), 8% (9%), and 9% (15%). The estimated risk of low adherence (estimated 0-1 doses in the week prior) was higher for participants of Black (RR 1.60, CI 1.09-2.34) or "Other" race (RR 1.62, CI 0.99-2.65) compared with participants of White race; being a transgender female (RR 2.31, CI 1.33-4.02) compared to men who have sex with men; or enrollment at a study site with less experience in the provision of PrEP. The estimated risk of low adherence by DBS was lower for participants with a higher number of sex partners in the past 3 months and those having a bachelor's degree or higher. More work is needed to provide clinicians with measures to assess medication adherence in diverse US populations being prescribed PrEP to support its effective use in reducing HIV acquisition in individuals and at the community level.

OBJECTIVES: Gaps between recommended and actual levels of HIV preexposure prophylaxis (PrEP) use remain among men who have sex with men (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. CONCLUSIONS: 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.

From January 1, 2018, through October 9, 2019, 82 HIV diagnoses occurred among people who inject drugs (PWID) in Cabell County, West Virginia. Increasing the use of HIV preexposure prophylaxis (PrEP) among PWID was one of the goals of a joint federal, state, and local response to this HIV outbreak. Through partnerships with the local health department, a federally qualified health center, and an academic medical system, we integrated PrEP into medication-assisted treatment, syringe services program, and primary health care settings. During the initial PrEP implementation period (April 18-May 17, 2019), 110 health care providers and administrators received PrEP training, the number of clinics offering PrEP increased from 2 to 15, and PrEP referrals were integrated with partner services, outreach, and testing activities. The number of people on PrEP increased from 15 in the 6 months before PrEP expansion to 127 in the 6 months after PrEP implementation. Lessons learned included the importance of implementing PrEP within existing health care services, integrating PrEP with other HIV prevention response activities, adapting training and material to fit the local context, and customizing care to meet the needs of PWID. The delivery of PrEP to PWID is challenging but complements other HIV prevention interventions. The expansion of PrEP in response to this HIV outbreak in Cabell County provides a framework for expanding PrEP in other outbreak and non-outbreak settings.

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.

Few studies have assessed providers' intent of prescribing PrEP in the future. We analyzed cross-sectional web-based surveys to estimate trends from 2016 to 2020 in PrEP awareness and prescribing behaviors in the United States among primary care providers. Multivariable logistic regression was used to estimate prevalence of PrEP awareness, prescribing behaviors, and likelihood of prescribing PrEP in the next 12 months. The adjusted prevalence for PrEP awareness was significantly higher in 2019 (93.7%, 95% CI 91.9%, 95.2%) compared to 2018 (88.1%, 95% CI 85.5%, 90.3%). The adjusted prevalence for prescribing PrEP was significantly higher in 2019 (16.4%, 95% CI 13.6%, 19.6%) and 2020 (15.6%, 95% CI 13.0%, 18.7%) compared to 2018 (12.2%, 95% CI 10.0%, 14.7%). Practicing in the West and regularly screening for HIV were associated with higher PrEP awareness and provision. Studies should examine factors associated with PrEP provision for groups with increased risk for HIV.

Pre-exposure prophylaxis (PrEP) is highly effective in reducing HIV transmission but remains underutilised globally. Same-day PrEP prescribing and medication provision is an emerging implementation approach. The experiences of the three same-day PrEP programmes support the feasibility of the approach. Key elements of safe and effective same-day PrEP programmes include the ability to order laboratory tests at the time of the clinical visit and the ability to contact patients when laboratory results are available. Same-day PrEP has the potential to alleviate the attrition seen in usual care between initial evaluation and receipt of a PrEP prescription. A widespread application of same-day prescribing will be needed to assess its effect on PrEP usage.

OBJECTIVE: We sought to evaluate which combinations of HIV prevention and care activities would have the greatest impact towards reaching the US Ending the HIV Epidemic (EHE) plan goals of HIV incidence reduction. DESIGN: A stochastic network-based HIV transmission model for men who have sex with men (MSM), calibrated to surveillance estimates in the Atlanta area, a focal EHE jurisdiction. METHODS: Model scenarios varied HIV screening rates under different assumptions of how HIV-negative MSM would be linked to PrEP initiation, and rates of HIV care linkage and retention for those screening positive. RESULTS: A 10-fold relative increase in HIV screening rates (to approximately biannual screening for black and Hispanic MSM and quarterly for white MSM) would lead to 43% of infections averted if integrated with PrEP initiation. Improvements focused only on black MSM would achieve nearly the same outcome (37% of infections averted). Improvements to HIV care retention would avert 41% of infections if retention rates were improved 10-fold. If both screening and retention were jointly improved 10-fold, up to 74% of cumulative infections would be averted. Under this scenario, it would take 4 years to meet the 75% EHE goal and 12 years to meet the 90% goal for Atlanta MSM. CONCLUSIONS: Reaching the EHE 75% incidence reduction goals by their target dates will require immediate and substantial improvements in HIV screening, PrEP, and ART care retention. Meeting these EHE goals in target jurisdictions like Atlanta will be possible only by addressing the HIV service needs of black MSM.

When used appropriately, pre-exposure prophylaxis (PrEP) substantially reduces the risk of HIV acquisition. Early implementation outcomes often suggest poor PrEP adherence and persistence; however, this intervention is time-limited and the need for PrEP fluctuates as risk behaviours change. In this Viewpoint we examine the current guidelines and early programmatic outcomes after starting, stopping, and restarting PrEP, and we review the implications of PrEP in relation to HIV testing algorithms. Guidelines suggest to discontinue PrEP when a person is no longer at risk for HIV, but effectively implementing this strategy requires support tools to make the decision of stopping and restarting PrEP that considers the complex relationship between risk perceptions and risk behaviours. Safely discontinuing PrEP also requires greater understanding of the daily dosing duration that is needed to protect the person after their last HIV exposure. Additionally, clear strategies are needed to re-engage a person as their HIV exposure risk changes over time.

Cases of seroconversion on PrEP should be carefully investigated given their public health implications and rarity. We report a case of transmitted drug resistance causing seroconversion on PrEP in spite of high adherence, confirmed with dried blood spot and segmental hair drug-level testing and single-genome sequencing.

Men and women of color have had low pre-exposure prophylaxis (PrEP) uptake. How one's preferred source of health information shapes attitudes toward PrEP is unclear. We conducted cross-sectional surveys to assess changes in PrEP awareness, knowledge, and attitudes, trusted sources for PrEP information, and associations between trusted source of information and PrEP knowledge and attitudes. Participants were recruited from six areas served by community health centers in Chicago, IL (two health centers); Jackson, MS; Newark, NJ; Philadelphia, PA; and Washington, D.C. during June-September 2015 (n = 160) and June-September 2016 (n = 200). Participants were Black (74%), heterosexual (81%), and largely unaware of PrEP (72%). Participants who trusted health experts and community organizations for PrEP information had lower percentages of agreeing with statements indicative of negative PrEP attitudes. Interventions that increase PrEP awareness as well as knowledge and favorable attitudes might help increase PrEP use in communities with high HIV prevalence.

In Thailand, pre-exposure prophylaxis (PrEP) is recommended for human immunodeficiency virus (HIV) prevention among at-risk men who have sex with men (MSM). We modeled the impact of PrEP and condom use as independent and combined interventions on the estimated number of HIV infections among a hypothetical population of 10,000 MSM in Bangkok, Thailand. Our model demonstrated a 92% (95% confidence interval 89.7, 94.2) reduction in HIV infections among Thai MSM who took daily PrEP and self-reported using condoms correctly and consistently (100% condom use). Increased use of PrEP and condoms likely would have a substantial impact on the HIV epidemic in Thailand.