BACKGROUND: We assessed annual out-of-pocket (OOP) costs for HIV preexposure prophylaxis (PrEP)-related services among commercially insured individuals in the U.S. before and after the Affordable Care Act (ACA) mandated no cost-sharing in 2021. METHODS: Using data from a large commercial database, we identified persons aged ≥18 years who were prescribed PrEP from 2017-2022. Medical claims for PrEP-related services submitted within one week before each PrEP prescription were extracted using CPT codes. For each service, we calculated the annual proportion of persons incurring OOP costs and associated annual amounts, adjusted to 2022 U.S. dollars. We assessed trends in the proportion of persons with OOP costs for each service from 2019-2022. We also examined the association between OOP cost occurrence and patient demographic characteristics. RESULTS: Among 141,300 PrEP users, we observed decreasing trends in the proportion incurring OOP costs for PrEP ancillary services over the study period. In 2022, OOP costs were incurred by 65.6% for provider visits, 14.3% for HIV testing, and 32.5% for creatinine testing, with mean OOP costs of $54.18, $26.06, and $6.07, respectively. Rural users were more likely to incur costs than urban users. CONCLUSIONS: Despite ACA mandates, many persons received cost-sharing bills for PrEP services. Standardized billing and coding, along with enhanced monitoring and enforcement, could help protect access to evidence-based preventive care.

Preexposure prophylaxis (PrEP) is highly effective in preventing HIV infections and is recommended for people without HIV who are at ongoing risk of HIV acquisition. In 2019, the U.S. launched the "Ending the HIV Epidemic in the U.S." initiative, which aims to reduce by 90 % the number of annual new HIV infections. To monitor progress towards this goal, several national indicators have been established, one of which is PrEP coverage. Several ways to monitor PrEP use have been developed, each with its own advantages and disadvantages. We developed a method to estimate PrEP "need" in the U.S. that could be used as a denominator to estimate PrEP coverage. The "population need for PrEP" (PPN) is estimated based on the number of people needed to treat (NNT) with PrEP to prevent an additional HIV infection in subpopulations whose annual HIV incidence is ≥ 1 %. This is done in three steps: 1) calculating NNT for each transmission group using 1 % incidence threshold and clinical trial-and cohort-generated evidence of the degree of PrEP effectiveness in each transmission group, 2) estimating the proportion of new HIV infections in subpopulations with incidence at least 1 % from epidemiologic data, 3) multiplying estimates from steps 1 and 2 with the number of new HIV infections for each transmission group from Surveillance. The estimates for each transmission group are then added together, and the number of current PrEP users is finally added to this estimate to produce PPN. This method is relatively easy to calculate and can provide public health authorities at the national, state, or local level with pragmatic estimates of PrEP "need" among different demographic or transmission groups, which can help with planning, resource allocation, and monitoring progress.

BACKGROUND: The 2021 update of the CDC clinical guidelines for HIV preexposure prophylaxis (PrEP) recommended both antigen/antibody (Ag/Ab) and RNA testing at PrEP initiation and routine follow-up. We assessed real-world utilization and performance of HIV tests among oral PrEP users. METHODS: An oral PrEP user cohort was constructed using the HealthVerity database that included linked diagnoses, laboratory tests, and prescriptions from December 2018 to August 2023. Data was stratified by guideline pre- (2019-2021) and post-update (2022-2023) periods. For each period, we assessed the agreement between same-day HIV Ag/Ab and RNA results and calculated the false positive rate (FPR) and positive predictive values (PPV) of HIV Ag/Ab and RNA tests compared with adjudicated HIV status. RESULTS: The HIV RNA testing rate for follow-up increased from 16 per 100 person-years (PY) to 123 per 100 PYs after the guideline update. The positivity rate of HIV RNA tests decreased from 1.39% to 0.22%. Overall agreement between Ag/Ab and RNA results remained high. The FPRs of HIV Ag/Ab and RNA testing remained similar, but the PPV of HIV RNA testing for PrEP follow-up decreased from 100% to 67%. We estimated that 8,226 to 9,900 RNA tests would be needed for one HIV diagnosis earlier than would be detected with Ag/Ab testing alone. DISCUSSION: HIV RNA testing did not provide additional value to Ag/Ab testing during routine follow-up of oral PrEP users. Considering the cost and logistical complexity of HIV RNA testing, its use as a routine test during follow-up of oral PrEP users warrants reconsideration.

Objectives. HIV preexposure prophylaxis (PrEP) use has increased since its US Food and Drug Administration approval in 2012. Our objective was to describe trends in PrEP use by US women. Methods. Using national pharmacy and HIV surveillance data, we calculated the PrEP-to-diagnosis ratio (PDR), a measure of PrEP prescriptions each year compared with HIV diagnoses the previous year, for women from 2017 to 2023. We also calculated PDRs in 2023 for the 20 counties with the highest numbers of diagnosed HIV infections among women and reviewed reports of public health activities conducted by recipients of Centers for Disease Control and Prevention HIV prevention funding. Results. The PDR for women was 1.5 in 2017, and it increased to 5.8 by 2023. In the 20 counties with the highest number of diagnosed HIV infections among women, PDRs ranged from 2.2 to 16.9. Counties with the highest PDRs conducted PrEP activities designed for women. Conclusions. PrEP is a highly effective HIV prevention intervention that can empower women to protect their health, but its use has been low. Public health and clinical interventions designed for women can increase their PrEP use and support ending the US HIV epidemic. (Am J Public Health. Published online ahead of print April 24, 2025:e1-e4. https://doi.org/10.2105/AJPH.2025.308056).

INTRODUCTION: The Ending the HIV Epidemic in the U.S. (EHE) initiative was launched by the U.S. Department of Health and Human Services in 2019 with the goal of decreasing new HIV infections 90% by 2030. Increasing the use of HIV preexposure prophylaxis (PrEP) is one of the EHE strategies. We assessed the impact of EHE activities on PrEP use. METHODS: Using IQVIA Real-world longitudinal prescription data and the National HIV Surveillance System data, we calculated jurisdiction-level PrEP to diagnosis ratios (PDRs) in the United States from 2016-2023. We assessed impact of EHE with a difference-in-difference (DID) analysis. RESULTS: The PDR increased from 3.0 to 14.7 in EHE Jurisdictions; from 1.2 to 7.2 in EHE states; and from 2.5 to 13.4 in non-EHE jurisdictions. On average, no additional increase in the PDR was found for EHE counties compared with matched non-EHE counties, (adjusted DID: 0.2, 95% confidence interval [CI]: -1.0∼1.3), or for EHE states (adjusted DID: 0.4, 95% CI: -1.6∼2.4). CONCLUSIONS: Overall PrEP use increased markedly, with some EHE jurisdictions achieving greater increases than non-EHE jurisdictions with similar PDRs in 2019. The uneven increase in PrEP use in EHE jurisdictions underscores the need for jurisdiction-specific PrEP implementation strategies designed for the needs of each community. It also underscores the need for sufficient funding to accomplish EHE goals.

BACKGROUND: People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) can have ambiguous HIV test results if HIV is acquired during its use. The 2021 CDC PrEP guidelines recommend both HIV antigen/antibody (Ag/Ab) and RNA testing at CAB-LA initiation and follow-up. METHODS: We conducted a cohort study using the HealthVerity database to evaluate the utilization of HIV testing among people who use CAB-LA PrEP. We identified and adjudicated HIV Ag/Ab and RNA tests with a positive result, and estimated the incidence of breakthrough HIV infection or long-acting early viral inhibition (LEVI) syndrome. Testing agreement, false positive test rates, and positive predictive value were explored. RESULTS: Among 384 people who use CAB-LA PrEP with both HIV Ag/Ab and RNA testing with a median follow-up time of 4.2 months, we found one discordant pair with Ag/Ab(-) and RNA(+), and one with Ag/Ab(+) and RNA(-). Among four users with a positive Ag/Ab or RNA test, we identified one who acquired HIV before CAB-LA initiation with both Ag/Ab(+) and RNA(+), one likely false RNA(+), one likely false Ag/Ab(+), and one inconclusive Ag/Ab(+) due to insufficient follow-up. We identified no persons with confirmed breakthrough HIV infection or LEVI syndrome, or with RNA testing resulting in an earlier HIV diagnosis compared with Ag/Ab testing alone. INTERPRETATION: The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted.

BACKGROUND: Previous studies have estimated preexposure prophylaxis (PrEP) use among persons with commercial health insurance and Medicaid. However, data are lacking regarding PrEP use among those with Medicare. METHODS: Using a previously developed algorithm, we estimated the number of Medicare beneficiaries (MBs) with fee-for-service (FFS) claims who were prescribed PrEP from 2014 to 2021. The analysis was stratified by age, sex, and race/ethnicity. We also examined trends in PrEP prevalence by U.S. state and demographic characteristics during 2014-2021. RESULTS: The number of Medicare PrEP users increased 11-fold, from 388 in 2014 to 4,685 in 2021. MBs prescribed PrEP were predominantly younger men, White persons, residing in the South or West regions, living with a disability, and dually eligible for both Medicare and Medicaid. The prevalence of PrEP prescriptions among MBs increased 12-fold, from 9.7 per million in 2014 to to 120.0 per million in 2021. Black/African American persons had the highest prevalence of PrEP use, followed by Hispanic/Latino and White persons in 2021. The District of Columbia had the highest prevalence of PrEP use compared with other U.S. states in 2021. Significant increasing trends in PrEP use were observed across sex, age groups, and race/ethnicity. CONCLUSIONS: Disparities in PrEP uptake existed across MB demographic subgroups from 2014 to 2021. Public health interventions are needed to increase PrEP access and utilization, particularly among women, younger MBs, Black persons, and Hispanic persons, including those with Medicare. Strategies and policies to expand PrEP use are essential for optimal HIV prevention in the United States.

OBJECTIVES: It is important to monitor national HIV preexposure prophylaxis (PrEP) use in the United States. However, PrEP use data in the Veterans Health Administration (VHA) system are not included in the current monitoring surveillance. To address this gap, we examined the trends in PrEP use among U.S. Veterans receiving health services in the VHA system. METHODS: We analyzed 2014-2022 VHA data to identify the annual number and prevalence of persons aged ≥18 years prescribed PrEP, stratified by sex, age, race/ethnicity, and region. We also assessed trends by calculating the estimated annual percent change and 95% confidence intervals using Poisson models. RESULTS: The number of Veterans prescribed PrEP increased from 361 in 2014 to 6050 in 2022 with an estimated annual percent change of 29.6% (95% CI: 22.6 to 37.1). Of 6050 Veterans with PrEP prescriptions in 2022, 95.2% were men, 4.8% were women, 50.4% were White, 24.5% Black or African American (Black), and 14.0% Hispanic or Latino. The prevalence of Black and Hispanic or Latino individuals prescribed PrEP increased significantly from 2014 to 2022. CONCLUSIONS: VHA data fill a gap in monitoring PrEP use in the United States. We observed an increasing trend in the number of Veterans prescribed PrEP similar to trends among persons with commercial or public health insurance.

This study examines the prescribing trends of 3 oral preexposure prophylaxis medications and a long-acting injectable option from 2013 to 2023. | eng

BACKGROUND: Male-to-male sexual transmission continues to account for the greatest proportion of new HIV diagnoses in the United States. However, calculating population-specific surveillance metrics for HIV and other sexually transmitted infections requires regularly updated estimates of the number and proportion of men who have sex with men (MSM) in the United States, which are not collected by census surveys. OBJECTIVE: The purpose of this analysis was to estimate the number and percentage of MSM in the United States from population-based surveys. METHODS: We used data from 5 population-based surveys to calculate weighted estimates of the proportion of MSM in the United States and pooled these estimates using meta-analytic procedures. We estimated the proportion of MSM using sexual behavior-based questions (encompassing anal or oral sex) for 3 recall periods-past 12 months, past 5 years, and lifetime. In addition, we estimated the proportion of MSM using self-reported identity and attraction survey responses. The total number of MSM and non-MSM in the United States were calculated from estimates of the percentage of MSM who reported sex with another man in the past 12 months. RESULTS: The percentage of MSM varied by recall period: 3.3% (95% CI 1.7%-4.9%) indicated sex with another male in the past 12 months, 4.7% (95% CI 0.0%-33.8%) in the past 5 years, and 6.2% (95% CI 2.9%-9.5%) in their lifetime. There were comparable percentages of men who identified as gay or bisexual (3.4%, 95% CI 2.2%-4.6%) or who indicated that they are attracted to other men (4.9%, 95% CI 3.1%-6.7%) based on pooled estimates. Our estimate of the total number of MSM in the United States is 4,230,000 (95% CI 2,179,000-6,281,000) based on the history of recent sexual behavior (sex with another man in the past 12 months). CONCLUSIONS: We calculated the pooled percentage and number of MSM in the United States from a meta-analysis of population-based surveys collected from 2017 to 2021. These estimates update and expand upon those derived from the Centers for Disease Control and Prevention in 2012 by including estimates of the percentage of MSM based on sexual identity and sexual attraction. The percentage and number of MSM in the United States is an important indicator for calculating population-specific disease rates and eligibility for preventive interventions such as pre-exposure prophylaxis.

BACKGROUND: People with HIV (PWH) have higher rates of cardiovascular disease than people without HIV. However, limited information exists about hypertension prevalence and associated risk factors in PWH. METHODS: This cross-sectional study included adult patients in the 2022 IQVIATM Ambulatory Electronic Medical Record - US data. HIV was identified based on ≥2 HIV diagnosis codes or a positive HIV test. Hypertension was identified by diagnosis codes, ≥2 blood pressure (BP) readings ≥130/80 mmHg, or an antihypertensive medication prescription. Among those with hypertension, control was defined as most recent BP <130/80 mmHg. Logistic models using marginal standardization method were used to estimate adjusted prevalence ratios (aPR) of hypertension and hypertension control among all patients and PWH specifically, controlling for covariates. RESULTS: Of 7,533,379 patients, 19,102 (0.3%) had HIV. PWH had higher hypertension prevalence (66% vs 54%, aPR:1.14, 95% CI: 1.13-1.15) compared with people without HIV. Among persons with hypertension, PWH were more likely to have controlled hypertension (aPR: 1.10, 95% CI: 1.07-1.13) compared with people without HIV. Among PWH, those from the South were more likely to have hypertension (aPR: 1.07, 95% CI: 1.02-1.12) than PWH from the Northeast, while Black PWH were less likely to have controlled hypertension (aPR: 0.72, 95% CI: 0.67-0.77) than White PWH. CONCLUSIONS: PWH were more likely to have hypertension than people without HIV. Geographic and racial disparities in hypertension prevalence and control were observed among PWH. Optimal care for PWH includes comprehensive strategies to screen for, prevent, and manage hypertension.

BACKGROUND: Transgender persons are disproportionately affected by HIV, but preexposure prophylaxis (PrEP) use has been low in this population. Clinical encounters for gender-affirming hormone therapy (GAHT) provide opportunities for HIV prevention. OBJECTIVE: To estimate the number of commercially insured transgender women (TGW) and transgender men (TGM) in the United States and their use of HIV prevention services. DESIGN: Retrospective analysis of secondary data. SETTING: Merative MarketScan commercial databases from 2014 to 2021. PARTICIPANTS: TGW and TGM, defined as those with transgender-related diagnoses and prescriptions for feminizing or masculinizing GAHT. MEASUREMENTS: HIV testing and PrEP use. RESULTS: A substantially increasing trend was observed in the prevalence of transgender-related diagnosis codes from 2014 to 2021 and in the proportion of persons who used GAHT. The increases were driven by persons aged 18 to 34 years. In 2021, among 10 613 TGW with a test for or a diagnosis of a sexually transmitted infection (STI) in the previous 12 months, 61.1% had an HIV test; among those, 20.2% were prescribed PrEP. Among 4184 TGM with STI risk, 48.3% had an HIV test; among those, 10.2% were prescribed PrEP. The prevalence of TGW and TGM who had a test for or a diagnosis of an STI, had an HIV test, and were prescribed PrEP increased substantially from 2014 to 2021. LIMITATION: The findings represent only persons with commercial health insurance who sought health care services for GAHT. CONCLUSION: It is important to identify transgender persons to monitor their receipt of HIV prevention services. Encounters for GAHT provide opportunities to offer HIV prevention and other prevention services. Many HIV prevention opportunities were likely missed at clinical encounters for GAHT. PRIMARY FUNDING SOURCE: None.

BACKGROUND AND OBJECTIVES: HIV preexposure prophylaxis (PrEP) is safe, effective, and was approved for adolescents in 2018. Adolescents and young adults make up 20% of HIV diagnoses in the United States. Our objective was to describe trends in adolescents prescribed PrEP during 2018 through 2021 and characteristics of these adolescents and their PrEP providers. METHODS: We identified adolescents aged 13 to 19 years with oral PrEP prescriptions during 2018 through 2021 in a national pharmacy database using a validated algorithm. We assessed trends by calculating the overall percentage change and estimated annual percentage change with 95% confidence intervals. We described characteristics of adolescents and their PrEP providers in 2021. We performed χ2 analyses to assess differences by sex and age group. RESULTS: The number of adolescents prescribed PrEP increased 76.2% from 2018 to 2021 (estimated annual percentage change: 18.0% [95% confidence interval: 16.6-19.5]), despite decreases in 2020. We observed increases among all sex and age groups, with larger increases among older adolescents aged 18 to 19 years. The majority of the 6444 adolescents prescribed PrEP in 2021 were male (82.6%) and aged 18 to 19 years (87.8%). Among 2455 physician PrEP providers, 29.6% were pediatricians, with varying specialty distributions by adolescent age group (P < .001). Among the 217 pediatricians who prescribed PrEP to adolescents aged 13 to 17 years, 67.7% were general pediatricians. CONCLUSIONS: PrEP provision for adolescents has increased, largely among older and male adolescents. The availability of PrEP provides an important opportunity for pediatric providers to take an active role in HIV prevention.

Hospitalizations involving fungal infections increased 8.5% each year in the United States during 2019-2021. During 2020-2021, patients hospitalized with COVID-19-associated fungal infections had higher (48.5%) in-hospital mortality rates than those with non-COVID-19-associated fungal infections (12.3%). Improved fungal disease surveillance is needed, particularly during respiratory virus pandemics.

BACKGROUND: A study from Botswana identified an increased risk of neural tube defects (NTDs) in infants of mothers with HIV who were treated with dolutegravir around the time of conception. We aimed to examine associations of dolutegravir use with NTDs and pregnancy loss using large health-care claims databases from the USA, a country with folic acid fortification of food. METHODS: In this cohort study, we analysed health-care claims data, recorded in the Merative MarketScan commercial database (MarketScan data) and Centers for Medicare & Medicaid Services Medicaid database (Medicaid data) from Jan 1, 2008, to Dec 31, 2020. We identified pregnancies with enrolment during their entire duration among women aged 15-49 years and we estimated time of conception. For each pregnancy, we determined HIV status and periconceptional exposure to dolutegravir or other antiretroviral agents. We estimated and compared the incidence rate of NTDs, stillbirths, and pregnancy loss (ie, spontaneous or induced abortions) by type of periconceptional antiretroviral exposure. We calculated adjusted risk ratios of the adverse outcomes using Poisson models adjusting for demographic and clinical factors. FINDINGS: Of 4 489 315 pregnancies in MarketScan data and 14 405 861 pregnancies in Medicaid data that had full enrolment, we identified 69 pregnancies in MarketScan data and 993 pregnancies in Medicaid data that were associated with HIV and periconceptional dolutegravir exposure. For women without HIV, the NTD rate was 4·1 per 10 000 live births (95% CI 3·9-4·3) in MarketScan and 5·7 per 10 000 live births (5·6-5·8) in Medicaid. No NTD cases were found among those with dolutegravir or non- dolutegravir antiretroviral drug exposure in the MarketScan data; only one NTD case was identified among women with dolutegravir, and three among women with non-dolutegravir antiretroviral exposure in Medicaid. After adjusting for covariates, there were no significant differences in risk ratios of NTD between groups with periconceptional dolutegravir or non-dolutegravir antiretroviral exposure and the group without HIV. However, compared with women without HIV, the risk of pregnancy loss was higher among women exposed to antiretroviral therapy: for dolutegravir exposure the adjusted risk ratio was 1·73 (95% CI 1·20-2·49) in MarketScan data and 1·41 (1·30-1·54) in Medicaid data; for non-dolutegravir antiretroviral exposure the adjusted risk ratio was 1·23 (1·10-1·37) in MarketScan data and 1·11 (1·07-1·15) in Medicaid data. INTERPRETATION: We studied the largest US cohort of women with periconceptional or early-pregnancy dolutegravir exposure. Our results do not show an increased risk of NTDs in exposed infants in the USA. Administrative databases can be used, with rigorous methodology, to study correlates of rare outcomes, such as NTDs, and to monitor for adverse pregnancy outcomes in women who receive antiretrovirals. FUNDING: US Centers for Disease Control and Prevention.

Pregnancy is a condition of broad interest across many medical and health services research domains, but one not easily identified in healthcare claims data. Our objective was to establish an algorithm to identify pregnant women and their pregnancies in claims data. We identified pregnancy-related diagnosis, procedure, and diagnosis-related group codes, accounting for the transition to International Statistical Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis and procedure codes, in health encounter reporting on 10/1/2015. We selected women in Merative MarketScan commercial databases aged 15-49 years with pregnancy-related claims, and their infants, during 2008-2019. Pregnancies, pregnancy outcomes, and gestational ages were assigned using the constellation of service dates, code types, pregnancy outcomes, and linkage to infant records. We describe pregnancy outcomes and gestational ages, as well as maternal age, census region, and health plan type. In a sensitivity analysis, we compared our algorithm-assigned date of last menstrual period (LMP) to fertility procedure-based LMP (date of procedure + 14 days) among women with embryo transfer or insemination procedures. Among 5,812,699 identified pregnancies, most (77.9%) were livebirths, followed by spontaneous abortions (16.2%); 3,274,353 (72.2%) livebirths could be linked to infants. Most pregnancies were among women 25-34 years (59.1%), living in the South (39.1%) and Midwest (22.4%), with large employer-sponsored insurance (52.0%). Outcome distributions were similar across ICD-9 and ICD-10 eras, with some variation in gestational age distribution observed. Sensitivity analyses supported our algorithm's framework; algorithm- and fertility procedure-derived LMP estimates were within a week of each other (mean difference: -4 days [IQR: -13 to 6 days]; n = 107,870). We have developed an algorithm to identify pregnancies, their gestational age, and outcomes, across ICD-9 and ICD-10 eras using administrative data. This algorithm may be useful to reproductive health researchers investigating a broad range of pregnancy and infant outcomes.

We developed an ad hoc method to estimate the number of excess deaths among persons with HIV (PWH) during the COVID-19 pandemic in the United States. Using this method, we estimated approximately 1,448 excess deaths from COVID-19 among PWH in 2020 in the United States. We also developed an Excel workbook for use as a tool to quickly assess excess deaths among PWH in settings with limited surveillance data.

The association between thromboembolic events (TE) and COVID-19 infection is not completely understood at the population level in the United States. We examined their association using a large US healthcare database. We analyzed data from the Premier Healthcare Database Special COVID-19 Release and conducted a case-control study. Thestudy population consisted of men and non-pregnant women aged18years with (cases) or without (controls) an inpatient ICD-10-CM diagnosis of TE between 3/1/2020 and 6/30/2021. Using multivariable logistic regression, we assessed the association between TE occurrence and COVID-19 diagnosis, adjusting for demographic factors and comorbidities. Among 227,343 cases, 15.2% had a concurrent or prior COVID-19 diagnosis within 30days of their index TE. Multivariable regression analysis showed a statistically significant association between a COVID-19 diagnosis and TE among cases when compared to controls (adjusted odds ratio [aOR]1.75, 95% CI 1.72-1.78). The association was more substantial if a COVID-19 diagnosis occurred 1-30days prior to index hospitalization (aOR3.00, 95% CI 2.88-3.13) compared to the same encounter as the index hospitalization. Our findings suggest an increased risk of TE among persons within 30days of beingdiagnosed COVID-19, highlighting the need for careful consideration of the thrombotic risk among COVID-19 patients, particularly during the first month following diagnosis.

Increasing HIV testing, preexposure prophylaxis (PrEP), and antiretroviral therapy (ART) are pillars of the federal Ending the HIV Epidemic in the U.S. (EHE) initiative, with a goal of decreasing new HIV infections by 90% by 2030.* In response to the COVID-19 pandemic, a national emergency was declared in the United States on March 13, 2020, resulting in the closure of nonessential businesses and most nonemergency health care venues; stay-at-home orders also limited movement within communities (1). As unemployment increased during the pandemic (2), many persons lost employer-sponsored health insurance (3). HIV testing and PrEP prescriptions declined early in the COVID-19 pandemic (4-6); however, the full impact of the pandemic on use of HIV prevention and care services and HIV outcomes is not known. To assess changes in these measures during 2019-2021, quarterly data from two large U.S. commercial laboratories, the IQVIA Real World Data - Longitudinal Prescription Database (IQVIA),(†) and the National HIV Surveillance System (NHSS)(§) were analyzed. During quarter 1 (Q1)(¶) 2020, a total of 2,471,614 HIV tests were performed, 190,955 persons were prescribed PrEP, and 8,438 persons received a diagnosis of HIV infection. Decreases were observed during quarter 2 (Q2), with 1,682,578 HIV tests performed (32% decrease), 179,280 persons prescribed PrEP (6% decrease), and 6,228 persons receiving an HIV diagnosis (26% decrease). Partial rebounds were observed during quarter 3 (Q3), with 2,325,554 HIV tests performed, 184,320 persons prescribed PrEP, and 7,905 persons receiving an HIV diagnosis. The proportion of persons linked to HIV care, the number who were prescribed ART, and proportion with a suppressed viral load test (<200 copies of HIV RNA per mL) among those tested were stable during the study period. During public health emergencies, delivery of HIV services outside of traditional clinical settings or that use nonclinical delivery models are needed to facilitate access to HIV testing, ART, and PrEP, as well as to support adherence to ART and PrEP medications.

OBJECTIVE: To access disruption in healthcare services for HIV treatment by national emergency in response to the coronavirus disease 2019 (COVID-19) pandemic in the United States. DESIGN: Time-series analysis. METHODS: We analyzed the IQVIA Real World Data-Longitudinal Prescriptions Database and calculated time trends in the weekly number of persons with active antiretroviral (ARV) prescriptions for HIV treatment, and of persons who obtained ARV prescriptions during January 2017-March 2021. We used interrupted time-series models to estimate the impact of the COVID-19 pandemic on antiretroviral therapy (ART) use between March 2020 and March 2021. RESULTS: We found that the weekly number of persons with active ARV prescriptions decreased by an average 2.5% (95% confidence interval [CI]: -3.8% to -1.1%), compared to predicted use, during March 2020 through March 2021. The weekly number of persons who obtained ARV prescriptions decreased 4.5% (95% CI: -6.0% to -3.0%), compared to the predicted number. Men, persons aged ≤34 years, privately insured persons, and persons in medication assistance programs had greater decreases than other groups. CONCLUSIONS: We demonstrated a decrease in the number of persons with active ARV prescriptions during the first year of the COVID-19 pandemic and the number did not return to levels expected in the absence of the pandemic. Disruptions in HIV care and decreased ART may lead to lower levels of viral suppression and immunologic control, and increased HIV transmission in the community.

BACKGROUND: Uptake of HIV preexposure prophylaxis (PrEP) has been increasing in the United States since its FDA approval in 2012; however, the COVID-19 pandemic may have affected this trend. Our objective was to assess the impact of the COVID-19 pandemic on PrEP prescriptions in the United States. METHODS: We analyzed data from a national pharmacy database from January 2017 through March 2021 to fit an interrupted time-series model that predicted PrEP prescriptions and new PrEP users had the pandemic not occurred. Observed PrEP prescriptions and new users were compared with those predicted by the model. Main outcomes were weekly numbers of PrEP prescriptions and new PrEP users based on a previously developed algorithm. The impact of the COVID-19 pandemic was quantified by computing rate ratios and percent decreases between the observed and predicted counts during 3/15/2020 - 3/31/2021. RESULTS: In the absence of the pandemic, our model predicted that there would have been 1,058,162 PrEP prescriptions during 3/15/2020 - 3/31/2021. We observed 825,239 PrEP prescriptions, a 22.0% reduction (95% CI: 19.1%-24.8%) after the emergency declaration. The model predicted 167,720 new PrEP users during the same period; we observed 125,793 new PrEP users, a 25.0% reduction (95% CI: 20.9%-28.9%). The COVID-19 impact was greater among younger persons and those with commercial insurance. The impact of the pandemic varied markedly across states. CONCLUSION: The COVID-19 pandemic disrupted an increasing trend in PrEP prescriptions in the United States, highlighting the need for innovative interventions to maintain access to HIV prevention services during similar emergencies.

We analyzed a national pharmacy database to estimate the annual number of persons who abandoned their PrEP prescription and assessed the associated factors. About 9% of persons prescribed PrEP abandoned it in 2019, and PrEP abandonment was associated with sex, age, insurance type, black race/ethnicity, and drug copayment amount.

BACKGROUND: The number and characteristics of pre-exposure prophylaxis (PrEP) health care providers in the United States have not been reported. METHODS: We analyzed a national pharmacy database that included >90% of all prescriptions dispensed by retail pharmacies and 60%-86% dispensed by mail-order outlets. We estimated the number of PrEP providers by year, provider type, physician specialty, and geographic location. We also measured the Gini coefficients for the distribution of PrEP patients among providers. RESULTS: The number of PrEP providers increased from 9621 in 2014 to 65,822 in 2019. In 2019, 68.1% of PrEP providers were physicians. The proportion of nurse practitioners or physician assistants increased from 18.0% in 2014 to 29.7% in 2019. Among all the US health care providers, those who prescribed PrEP increased from 0.7% in 2014 to 4.3% in 2019. Among all general practice/family medicine physicians, the percentage of who prescribed PrEP increased from 1.8% in 2014 to 13.6% in 2019 and from 14.2% to 34.2% among infectious disease physicians. The ratio of PrEP providers to 100 persons with PrEP indications was lowest in the South with 4.4. The Gini coefficient for the distribution of PrEP patients among providers was 0.75 in 2019, with 50% of the PrEP patients prescribed PrEP by 2.2% of PrEP providers. CONCLUSIONS: An increasing number of providers prescribed PrEP during 2014-2019. The South had the largest number of new HIV diagnoses and greatest need for HIV prevention but had less PrEP service capacity compared with other regions. Expanded access to PrEP services is needed in the United States.

HIV testing is a critical component of effective HIV prevention and care. CDC recommends routine opt-out HIV testing in health care settings for all sexually active persons aged 13-64 years at least once in their lifetime and risk-based testing regardless of age for those who report behaviors associated with HIV acquisition (1). However, recent studies show low HIV testing rates in clinical settings; HIV testing rates at visits to physician offices did not increase during 2009-2016 (2). The objective of the current study is to estimate temporal trends in HIV testing among persons with commercial insurance or Medicaid from 2014 through 2019 and describe their demographic characteristics in 2019. Weighted data from the IBM MarketScan Commercial Claims and Encounters database* (commercial insurance) and from the Centers for Medicare & Medicaid Services (CMS) claims database(†) (Medicaid) were analyzed to estimate the proportions of persons with commercial insurance or Medicaid who received testing for HIV. Testing rates increased among male and nonpregnant female persons aged ≥13 years with either type of coverage. In 2019, only 4.0% of those with commercial insurance and 5.5% of those with Medicaid received testing for HIV. Testing rates were higher among non-Hispanic Black or African American (Black) persons and Hispanic or Latino (Hispanic) persons. Based on mathematical modeling studies, these annual testing rates would need to increase at least threefold and be sustained over several years (3,4) to achieve the Ending the HIV Epidemic (EHE) in the U.S. initiative goal of ≥95% of persons with HIV being aware of their infection by 2025.(§) Interventions need to be implemented to increase routine and risk-based HIV testing in clinical settings to higher levels that can help reduce disparities in HIV diagnoses between Black and Hispanic persons compared with non-Hispanic White (White) persons (5). Increased HIV testing is essential to achieve the goals of the EHE initiative and reduce disparities in HIV diagnoses; public health should partner with health care systems to implement interventions that support increased testing.

To assess advanced practitioners' scope of practice laws (i.e., legal authority providers can prescribe regulated medications) as potential barriers to HIV pre-exposure prophylaxis (PrEP), we conducted an analysis using IQVIA Real World Data in association with scope of practice law classifications supplied by the American Association of Nurse Practitioners and scopeofpracticepolicy.org. Nurse practitioners in states that allowed independent scope of practice were 1.4 times more likely to have prescribed PrEP compared with nurse practitioners in states where their prescribing authority is determined by a supervising medical doctor (MD). Physician assistants in states where the law or a state board defined their prescribing authority were more than twice as likely to prescribe PrEP compared with those in states where a supervising MD oversaw prescribing rights. Our findings suggest that restricting scope of prescribing practice by requiring MD oversight limits PrEP access and poses a barrier to scaling up PrEP.

INTRODUCTION | Our primary objective was to estimate human immunodeficiency virus (HIV) testing rates among female patients with a gonorrhea or syphilis diagnosis. Our secondary objective was to estimate the rate of preexposure prophylaxis prescriptions among these patients. | | Go to: | METHODS | We analyzed data from both the IBM MarketScan commercial and Medicaid insurance databases. Nonpregnant female patients aged 15–64 years without a prior HIV diagnosis who had a diagnosis of gonorrhea or syphilis (Appendix 1, available online at http://links.lww.com/AOG/C94) in 2017 and who were continuously enrolled in their health insurance plans for at least 6 months before and 11 months after their first sexually transmitted infection (STI) diagnosis date were included in the analysis (Appendix 2, available online at http://links.lww.com/AOG/C94). To estimate associations between HIV testing (Appendix 3, available online at http://links.lww.com/AOG/C94) and female patients’ characteristics and STI diagnoses, we performed multivariate logistic regression analyses for those with commercial insurance and those with Medicaid insurance separately. In the commercial model, we included age, U.S. geographic region, and urban compared with rural location as covariates; in the Medicaid model, we included age and race–ethnicity. | | Go to: | RESULTS | Among female patients with commercial insurance, 3,709 were diagnosed with gonorrhea and 1,696 with syphilis (Table 1). Among female patients with Medicaid insurance, 6,172 were diagnosed with gonorrhea and 1,497 with syphilis (Table 1). HIV testing rates among female patients with Medicaid insurance who were diagnosed with gonorrhea (716/6,172, 11.6%) or syphilis (146/1,497, 9.8%) were higher than among those with commercial insurance (282/3,709, 7.6% and 102/1,696, 6.0%) (P<.001) (Table 1).

BACKGROUND: The suppression of viremia among persons with HIV (PWH) using antiretroviral therapy has been hypothesized to reduce HIV incidence at the population level. We investigated the impact of state level viral suppression among PWH in the United States on estimated HIV incidence between 2010 and 2015. METHODS: Viral suppression data and HIV incidence estimates from the National HIV Surveillance System were available from 29 states and the District of Columbia. We assumed a one year delay for viral suppression to impact incidence. Poisson regression models were used to calculate the estimated annual percent change (EAPC) in incidence rate. We employed a multivariable mixed-effects Poisson regression model to assess the effects of state level race/ethnicity, socioeconomic status, percent men who have sex with men (MSM) and hepatitis C virus prevalence as a proxy for injection drug use on HIV incidence. FINDINGS: Fitted HIV incidence for 30 jurisdictions declined from 11.5 in 2010 to 10.0 per 100,000 population by 2015 corresponding with an EAPC of -2.67 (95% confidence interval [95%CI] -2.95, -2.38). Southern states experienced the highest estimated incidence by far throughout this period but upon adjustment for viral suppression and demographics there was a 36% lower incidence rate than Northeast states (adjusted rate ratio [aRR] 0.64; 95%CI 0.42, 0.99). For every 10 percentage point (pp) increase in viral suppression there was an adjusted 4% decline in HIV incidence rate in the subsequent year (aRR 0.96; 95%CI 0.93, 0.99). While controlling for viral suppression, HIV incidence rate increased by 42% (aRR 1.42 95%CI 1.31, 1.54) for every 5 pp increase in percent Black race and by 27% (aRR 1.27 95%CI 1.10, 1.48) for every 1 pp increase in percent MSM in states. INTERPRETATION: A decline in estimated HIV incidence from 2010 to 2015 was associated with increasing viral suppression in the United States. Race and sexual orientation were important HIV acquisition risk factors.

BACKGROUND: Use of HIV preexposure prophylaxis (PrEP) has increased nationwide, but the magnitude and distribution of PrEP medication costs across the health care system are unknown. OBJECTIVE: To estimate out-of-pocket (OOP) and third-party payments using a large pharmacy database. DESIGN: Retrospective cohort study. SETTING: Prescriptions for tenofovir disoproxil fumarate with emtricitabine (TDF-FTC) for PrEP in the United States in the IQVIA Longitudinal Prescriptions database, which covers more than 90% of retail pharmacy prescriptions. MEASUREMENTS: Third-party, OOP, and total payments were compared by third-party payer, classified as commercial, Medicaid, Medicare, manufacturer assistance program, or other. Missing payment data were imputed using a generalized linear model to estimate overall PrEP medication payments. RESULTS: Annual PrEP prescriptions increased from 73 739 to 1 100 684 during 2014 to 2018. Over that period, the average total payment for 30 TDF-FTC tablets increased from $1350 to $1638 (5.0% compound annual growth rate) and the average OOP payment increased from $54 to $94 (14.9% compound annual growth rate). Of the $1638 in total payments per 30 TDF-FTC tablets in 2018, OOP payments accounted for $94 (5.7%) and third-party payments for $1544 (94.3%). Out-of-pocket payments per 30 tablets were lower among Medicaid recipients ($3) than among those with Medicare ($80) or commercial insurance ($107). Payments for PrEP medication in the IQVIA database in 2018 totaled $2.08 billion; $1.68 billion (80.7%) originated from prescriptions for persons with commercial insurance, $200 million (9.6%) for those with Medicaid, $48 million (2.3%) for those with Medicare, and $127 million (6.1%) for those with manufacturer assistance. LIMITATION: The IQVIA database does not capture every prescription nationwide. CONCLUSION: Third-party and OOP payments per 30 TDF-FTC tablets increased annually. The $2.08 billion in PrEP medication payments in 2018 is an underestimation of national costs. High costs to the health care system may hinder PrEP expansion. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention.

In 2019, the U.S. Department of Health and Human Services launched the Ending the HIV Epidemic: A Plan for America (EHE) initiative to end the U.S. human immunodeficiency virus (HIV) epidemic by 2030. A critical component of the EHE initiative involves early diagnosis of HIV infection, along with prevention of new transmissions, treatment of infections, and response to HIV outbreaks (1). HIV testing is the first step in identifying persons with HIV infection who need to be engaged in treatment and care as well as persons with a negative HIV test result and who are at high risk for infection and can benefit from HIV preexposure prophylaxis (PrEP) and other prevention services. These opportunities are often missed for persons receiving clinical services in ambulatory care settings (2). Data from the 2009-2016 National Ambulatory Medical Care Survey (NAMCS) and 2009-2017 National Hospital Ambulatory Medical Care Survey (NHAMCS) were analyzed to estimate trends in HIV testing at visits by males and nonpregnant females to physician offices, community health centers (CHCs), and emergency departments (EDs) in the United States. HIV tests were performed at 0.63% of 516 million visits to physician offices, 2.65% of 37 million visits to CHCs, and 0.55% of 87 million visits to EDs. The percentage of visits with an HIV test did not increase at visits to physician offices during 2009-2016, increased at visits to CHC physicians during 2009-2014, and increased slightly at visits to EDs during 2009-2017. All adolescents and adults should have at least one HIV test in their lifetime (3). Strategies that reduce clinical barriers to HIV testing (e.g., clinical decision supports that use information in electronic health records [EHRs] to order an HIV test for persons who require one or standing orders for routine opt-out testing) are needed to increase HIV testing at ambulatory care visits.

BACKGROUND: In 2015, there were approximately 40,000 new HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) is an effective strategy that reduces the risk of HIV acquisition; however, uptake among those who can benefit from it has lagged. In this study, we 1) compared the characteristics of patients who were prescribed PrEP with individuals newly diagnosed with HIV infection, 2) identified the specialties of practitioners prescribing PrEP, 3) identified metropolitan statistical areas (MSAs) within the US where there is relatively low uptake of PrEP, and 4) reported median amounts paid by patients and third-party payors for PrEP. METHODS AND FINDINGS: We analyzed prescription drug claims for individuals prescribed PrEP in the Integrated Dataverse (IDV) from Symphony Health for the period of September 2015 to August 2016 to describe PrEP patients, prescribers, relative uptake, and payment methods in the US. Data were available for 75,839 individuals prescribed PrEP, and findings were extrapolated to approximately 101,000 individuals, which is less than 10% of the 1.1 million adults for whom PrEP was indicated. Compared to individuals with newly diagnosed HIV infection, PrEP patients were more likely to be non-Hispanic white (45% versus 26.2%), older (25% versus 19% at ages 35-44), male (94% versus 81%), and not reside in the South (30% versus 52% reside in the South).Using a ratio of the number of PrEP patients within an MSA to the number of newly diagnosed individuals with HIV infection, we found MSAs with relatively low uptake of PrEP were concentrated in the South. Of the approximately 24,000 providers who prescribed PrEP, two-thirds reported primary care as their specialty. Compared to the types of payment methods that people living with diagnosed HIV (PLWH) used to pay for their antiretroviral treatment in 2015 to 2016 reported in the Centers for Disease Control and Prevention (CDC) HIV Surveillance Special Report, PrEP patients were more likely to have used commercial health insurance (80% versus 35%) and less likely to have used public healthcare coverage or a publicly sponsored assistance program to pay for PrEP (12% versus 45% for Medicaid). Third-party payors covered 95% of the costs of PrEP. Overall, we estimated the median annual per patient out-of-pocket spending on PrEP was approximately US$72. Limitations of this study include missing information on prescription claims of patients not included in the database, and for those included, some patients were missing information on patient diagnosis, race/ethnicity, educational attainment, and income (34%-36%). CONCLUSIONS: Our findings indicate that in 2015-2016, many individuals in the US who could benefit from being on PrEP were not receiving this HIV prevention medication, and those prescribed PrEP had a significantly different distribution of characteristics from the broader population that is at risk for acquiring HIV. PrEP patients were more likely to pay for PrEP using commercial or private insurance, whereas PLWH were more likely to pay for their antiretroviral treatment using publicly sponsored programs. Addressing the affordability of PrEP and otherwise promoting its use among those with indications for PrEP represents an important opportunity to help end the HIV epidemic.