Closing the Dissemination Gap: Accessible Toolkits for the Rapid Replication of Evidence-Informed Interventions to Improve Health Outcomes Among People with HIV.

Despite advances in HIV care and treatment in the U.S., disparities in outcomes along the HIV care continuum persist. The widespread replication of effective and sustainable interventions that prioritize the engagement of underserved populations has been identified as a promising path to ending the HIV epidemic in the U.S. Intervention dissemination products, however, rarely provide the comprehensive and accessible information needed to replicate interventions within community settings. To bridge the divide between research and community-based implementation, the Using Evidence-informed Interventions to Improve Health Outcomes among People Living with HIV (E2i) initiative-grounded in the HIV/AIDS Bureau Implementation Science Framework-created a suite of tools to promote the rapid replication of interventions focused on transgender women, Black men who have sex with men, behavioral health integration, and identifying and addressing trauma. The resulting dissemination products are detailed and digestible multimedia toolkits that follow adult learning theory principles and align with the Template for Intervention Description and Replication criteria for adapting non-pharmacological interventions. Each E2i toolkit consists of five components: implementation guides, narrative videos of site implementation, best practice demonstration videos, interactive learning modules, and recruitment posters and brochures. Over 2 years (2022-2024), the E2i toolkit webpages amassed 7703 unique users and 17,666 pageviews. These toolkits can serve as a blueprint for designing comprehensive and accessible dissemination products for replication of HIV interventions in care settings. Dissemination products that bridge the gap between intervention research and replication in community settings are a crucial missing tool for ending the HIV epidemic.

The health equity implications of the Health Resources and Services Administration's Ryan White HIV/AIDS Program.

OBJECTIVE: Investigate the role of the Ryan White HIV/AIDS Program (RWHAP) - which funds services for vulnerable and historically disadvantaged populations with HIV - in reducing health inequities among people with HIV over a 10-year horizon. DESIGN: We use an agent-based microsimulation model to incorporate the complexity of the program and long-time horizon. METHODS: We use a composite measure (the Theil index) to evaluate the health equity implications of the RWHAP for each of four subgroups (based on race and ethnicity, age, gender, and HIV transmission category) and two outcomes (probability of being in care and treatment and probability of being virally suppressed). We compare results with the RWHAP fully funded versus a counterfactual scenario, in which the medical and support services funded by the RWHAP are not available. RESULTS: The model indicates the RWHAP will improve health equity across all demographic subgroups and outcomes over a 10-year horizon. In Year 10, the Theil index for race and ethnicity is 99% lower for both outcomes under the RWHAP compared to the non-RWHAP scenario; 71-93% lower across HIV transmission categories; 31-44% lower for age; and 73-75% lower for gender. CONCLUSION: Given the large number of people served by the RWHAP and our findings on its impact on equity, the RWHAP represents an important vehicle for achieving the health equity goals of the National HIV/AIDS Strategy (2022-2025) and the Ending the HIV Epidemic Initiative goal of reducing new infections by 90% by 2030.

A Peer-to-Peer Collaborative Learning Approach for the Implementation of Evidence-Informed Interventions to Improve HIV-Related Health Outcomes.

The nationwide scale-up of evidence-based and evidence-informed interventions has been widely recognized as a crucial step in ending the HIV epidemic. Although the successful delivery of interventions may involve intensive expert training, technical assistance (TA), and dedicated funding, most organizations attempt to replicate interventions without access to focused expert guidance. Thus, there is a grave need for initiatives that meaningfully address HIV health disparities while addressing these inherent limitations. Here, the Health Resources and Services Administration HIV/AIDS Bureau (HRSA HAB) initiative Using Evidence-Informed Interventions to Improve HIV Health Outcomes among People Living with HIV (E2i) piloted an alternative approach to implementation that de-emphasized expert training to naturalistically simulate the experience of future HIV service organizations with limited access to TA. The E2i approach combined the HAB-adapted Institute for Healthcare Improvement's Breakthrough Series Collaborative Learning Model with HRSA HAB's Implementation Science Framework, to create an innovative multi-tiered system of peer-to-peer learning that was piloted across 11 evidence-informed interventions at 25 Ryan White HIV/AIDS Program sites. Four key types of peer-to-peer learning exchanges (i.e., intervention, site, staff role, and organization specific) took place at biannual peer learning sessions, while quarterly intervention cohort calls and E2i monthly calls with site staff occurred during the action periods between learning sessions. Peer-to-peer learning fostered both experiential learning and community building and allowed site staff to formulate robust site-specific action plans for rapid cycle testing between learning sessions. Strategies that increase the effectiveness of interventions while decreasing TA could provide a blueprint for the rapid uptake and integration of HIV interventions nationwide.

Assessing Health Care Utilization and Spending Among Older Medicare Beneficiaries With and Without HIV.

Improvements in treatment have made HIV a manageable chronic condition, leading to increased life expectancy and a growing share of people with HIV who are older. Older people with HIV have higher rates of many chronic conditions, yet little is known about differences in health care utilization and spending. This study compared health care utilization and spending for Medicare beneficiaries with and without HIV, accounting for differential mortality. The data included demographic characteristics and claims-based information. Estimated cumulative spending for beneficiaries with HIV aged 67 to 77 years was 26% higher for Medicare Part A and 39% higher for Medicare Part B compared with beneficiaries without HIV; most of these differences would be larger if not for greater mortality risk among people with HIV (and therefore fewer years to receive care). Future research should disentangle underlying causes for this increased need and describe potential responses by policymakers and health care providers.

Coordinating Care for People With HIV Who Have Lower Incomes and Alternative Sources of Health Care Coverage.

ABSTRACT: As people with HIV increasingly access affordable health care coverage-enabling them to obtain medical care from private providers-understanding how they use the Ryan White HIV/AIDS Program (RWHAP), and their unmet health care needs, can enhance their overall care. We analyzed RWHAP client-level data and interviewed staff and clients at 29 provider organizations to identify trends in health care coverage and service use for clients who received medical care from private providers. The RWHAP helps cover the cost of premiums and copays for these clients and provides medical and support services that help them stay engaged in care and virally suppressed. The RWHAP plays an important role in HIV care and treatment for clients with health care coverage. The growing number of people who receive a combination of services from RWHAP providers and private providers offers opportunities for greater care coordination through communication and data sharing between these settings.

HIV Care Continuum Interventions for Transgender Women: A Topical Review.

Transgender women experience a disproportionate prevalence of HIV and barriers to linkage to care, retention in care, medication adherence, and viral suppression. As part of a national cooperative agreement funded by the Health Resources and Services Administration's HIV/AIDS Bureau, we searched the literature from January 1, 2010, through June 1, 2020, for English-language articles on interventions designed to improve at least 1 HIV care continuum outcome or address 1 barrier to achieving HIV care continuum outcomes among transgender women diagnosed with HIV in the United States. To be included, articles needed to identify transgender women as a priority population for the intervention. We found 22 interventions, of which 15 reported quantitative or qualitative outcomes and 7 reported study protocols. Recent interventions have incorporated a range of strategies that show promise for addressing pervasive structural and individual barriers rooted in societal and cultural stigma and discrimination against transgender people. Cross-cutting themes found among the interventions included meaningful community participation in the design and implementation of the interventions; culturally affirming programs that serve as a gateway to HIV care and combine gender-affirming care and social services with HIV care; interventions to improve behavioral health outcomes; peer-led counseling, education, and navigation; and technology-based interventions to increase access to care management and online social support. Ongoing studies will further elucidate the efficacy and effectiveness of these interventions, with the goal of reducing disparities in the HIV care continuum and bringing us closer to ending the HIV epidemic among transgender women in the United States.

Interventions for Integrating Behavioral Health Services Into HIV Clinical Care: A Narrative Review.

The integration of behavioral health services within human immunodeficiency virus (HIV) care settings holds promise for improving substance use, mental health, and HIV-related health outcomes for people with HIV. As part of an initiative funded by the Health Resources and Services Administration's HIV/AIDS Bureau, we conducted a narrative review of interventions focused on behavioral health integration (BHI) in HIV care in the United States (US). Our literature search yielded 19 intervention studies published between 2010 and 2021. We categorized the interventions under 6 approaches: collaborative care; screening, brief intervention, and referral to treatment (SBIRT); patient-reported outcomes (PROs); onsite psychological consultation; integration of addiction specialists; and integration of buprenorphine/naloxone (BUP/NX) treatment. All intervention approaches appeared feasible to implement in diverse HIV care settings and most showed improvements in behavioral health outcomes; however, measurement of HIV outcomes was limited. Future research studies of BHI interventions should evaluate HIV outcomes and assess facilitators and barriers to intervention uptake.

Interventions for addressing trauma among people with HIV: a narrative review.

Traumatic experiences are disproportionately prevalent among people with HIV and adversely affect HIV-related health outcomes. As part of a national cooperative agreement funded by the Health Resources and Services Administration's HIV/AIDS Bureau, we searched the literature for interventions designed to address trauma among people with HIV in the U.S. Our search yielded 22 articles on 14 studies that fell into five intervention categories: expressive writing, prolonged exposure therapy, coping skills, cognitive-behavioral approaches integrated with other methods, and trauma-informed care. Thematic elements among the interventions included adaptating existing interventions for subpopulations with a high burden of trauma and HIV, such as transgender women and racial/ethnic minorities; addressing comorbid substance use disorders; and implementing organization-wide trauma-informed care approaches. Few studies measured the effect of the interventions on HIV-related health outcomes. To address the intersecting epidemics of HIV and trauma, it is critical to continue developing, piloting, and evaluating trauma interventions for people with HIV, with the goal of wide-scale replication of effective interventions in HIV settings.

HIV care continuum interventions for Black men who have sex with men in the USA.

Disparities persist along the HIV care continuum among Black men who have sex with men (MSM) in the USA. As part of an initiative funded by the Health Resources and Services Administration's HIV/AIDS Bureau (US Department of Health and Human Services), we searched for recently published interventions focused on improving HIV care continuum outcomes among Black MSM with HIV in the USA. Our search identified 14 interventions, all of which were associated with at least one statistically significant outcome. Medication adherence was the most common outcome of interest, and linkage to care was the least common. More than half of the interventions focused on younger populations and took place in the US South. Interventions used a range of strategies to increase cultural relevance and address common barriers to optimal HIV outcomes for Black MSM. Several interventions harnessed social media, text messaging, and smartphone apps to facilitate social support, deliver HIV education, and encourage medication adherence. Interventions were delivered mostly at the individual or interpersonal level, although three made system-level changes to address structural barriers. Notably missing were interventions focused on minimising behavioural health barriers, and interventions directly addressing social determinants of health such as housing. To accelerate the pace of implementation and scale-up of interventions for Black MSM with HIV, public health entities can pilot emerging interventions in real-world settings, and use an implementation science approach to evaluate outcomes and assess the implementation strategies that drive or hinder effectiveness.

Implementation Science Protocol: evaluating evidence-informed interventions to improve care for people with HIV seen in Ryan White HIV/AIDS program settings.

In 2017, the Health Resources and Services Administration's HIV/AIDS Bureau funded an Evaluation Center (EC) and a Coordinating Center for Technical Assistance (CCTA) to oversee the rapid implementation of 11 evidence-informed interventions at 26 HIV care and treatment providers across the U.S. This initiative aims to address persistent gaps in HIV-related health outcomes emerging from social determinants of health that negatively impact access to and retention in care. The EC adapted the Conceptual Model of Implementation Research to develop a Hybrid Type III, multi-site mixed-methods evaluation, described in this paper. The results of the evaluation will describe strategies associated with uptake, implementation outcomes, as well as HIV-related health outcomes for clients engaged in the evidence-informed interventions. This approach will allow us to understand in detail the processes that sites undergo to implement these important intervention strategies for high priority populations.

Cost-Effectiveness of HRSA's Ryan White HIV/AIDS Program?

BACKGROUND: With an annual budget of more than $2 billion, the Health Resources and Services Administration's Ryan White HIV/AIDS Program (RWHAP) is the third largest source of public funding for HIV care and treatment in the United States, yet little analysis has been done to quantify the long-term public health and economic impacts of the federal program. METHODS: Using an agent-based, stochastic model, we estimated health care costs and outcomes over a 50-year period in the presence of the RWHAP relative to those expected to prevail if the comprehensive and integrated system of medical and support services funded by the RWHAP were not available. We made a conservative assumption that, in the absence of the RWHAP, only uninsured clients would lose access to these medical and support services. RESULTS: The model predicts that the proportion of people with HIV who are virally suppressed would be 25.2 percentage points higher in the presence of the RWHAP (82.6 percent versus 57.4 percent without the RWHAP). The number of new HIV infections would be 18 percent (190,197) lower, the number of deaths among people with HIV would be 31 percent (267,886) lower, the number of quality-adjusted life years would be 2.7 percent (5.6 million) higher, and the cumulative health care costs would be 25 percent ($165 billion) higher in the presence of the RWHAP relative to the counterfactual. Based on these results, the RWHAP has an incremental cost-effectiveness ratio of $29,573 per quality-adjusted life year gained compared with the non-RWHAP scenario. Sensitivity analysis indicates that the probability of transmitting HIV via male-to-male sexual contact and the cost of antiretroviral medications have the largest effect on the cost-effectiveness of the program. CONCLUSIONS: The RWHAP would be considered very cost-effective when using standard guidelines of less than the per capita gross domestic product of the United States. The results suggest that the RWHAP plays a critical and cost-effective role in the United States' public health response to the HIV epidemic.

Development of a Mathematical Model to Estimate the Cost-Effectiveness of HRSA's Ryan White HIV/AIDS Program.

BACKGROUND: The Health Resources and Services Administration's Ryan White HIV/AIDS Program provides services to more than half of all people diagnosed with HIV in the United States. We present and validate a mathematical model that can be used to estimate the long-term public health and cost impact of the federal program. METHODS: We developed a stochastic, agent-based model that reflects the current HIV epidemic in the United States. The model simulates everyone's progression along the HIV care continuum, using 2 network-based mechanisms for HIV transmission: injection drug use and sexual contact. To test the validity of the model, we calculated HIV incidence, mortality, life expectancy, and lifetime care costs and compared the results with external benchmarks. RESULTS: The estimated HIV incidence rate for men who have sex with men (502 per 100,000 person years), mortality rate of all people diagnosed with HIV (1663 per 100,000 person years), average life expectancy for individuals with low CD4 counts not on antiretroviral therapy (1.52-3.78 years), and lifetime costs ($362,385) all met our validity criterion of within 15% of external benchmarks. CONCLUSIONS: The model represents a complex HIV care delivery system rather than a single intervention, which required developing solutions to several challenges, such as calculating need for and receipt of multiple services and estimating their impact on care retention and viral suppression. Our strategies to address these methodological challenges produced a valid model for assessing the cost-effectiveness of the Ryan White HIV/AIDS Program.

Implementation science and the Health Resources and Services Administration's Ryan White HIV/AIDS Program's work towards ending the HIV epidemic in the United States.

Demetrios Psihopaidas and co-authors discuss the implementation science framework of an HIV/AIDS program in the United States.

Assessing the health status and mortality of older people over 65 with HIV.

BACKGROUND: Nearly half of people with HIV in the United States are 50 years or older, and this proportion is growing. Between 2012 and 2016, the largest percent increase in the prevalence rate of HIV was among people aged 65 and older, the eligibility age for Medicare coverage for individuals without a disability or other qualifying condition. Previous work suggests that older people with HIV may have higher rates of chronic conditions and develop them more rapidly than older people who do not have HIV. This study compared the health status of older people with HIV with the older US population not living with HIV by comparing: (1) mortality; (2) prevalence of certain conditions, and (3) incidence of these conditions with increasing age. METHODS AND FINDINGS: We used a sample of Medicare beneficiaries aged 65 and older from the Medicare Master Beneficiary Summary File for the years 2011 to 2016, including 100% of individuals with HIV (N = 43,708), as well as a random 1% sample of individuals without diagnosed HIV (N = 1,029,518). We conducted a survival analysis using a Cox proportional hazards model to assess mortality and to determine the need to adjust for differential mortality in our analyses of the incidence of certain chronic conditions. These results showed that Medicare beneficiaries living with HIV have a significantly higher hazard of mortality compared to older people without diagnosed HIV (3.6 times the hazard). We examined the prevalence of these conditions using logistic regression analysis and found that people with HIV have a statistically significant higher odds of depression, chronic kidney disease, chronic obstructive pulmonary disease (COPD), osteoporosis, hypertension, ischemic heart disease, diabetes, chronic hepatitis, end-stage liver disease, lung cancer, and colorectal cancer. To look at the rate at which older people are diagnosed with conditions as they age, we used a Fine-Gray competing risk model and showed that for individuals without diagnosis of a given condition at age 65, the future incidence of that condition over the remaining study period was higher for people with HIV even after adjusting for differential hazard of mortality and for other demographic characteristics. Many of these results also varied by personal characteristics including Medicaid dual enrollment, sex, and race and ethnicity, as well as by condition. CONCLUSIONS: Increasing access to care and improving health outcomes for people with HIV is a critical goal of the National HIV/AIDS Strategy 2020. It is important for clinicians and policymakers to be aware that despite significant advances in the treatment and care of people with HIV, older people with HIV have a higher odds of having multiple chronic conditions at any point in time, a higher incidence of new diagnoses of these conditions over time, and a higher hazard of mortality than Medicare beneficiaries without HIV.

The Health Resources and Services Administration (HRSA) Ryan White HIV/AIDS Program's Response to the Opioid Epidemic.

BACKGROUND: The United States is in the midst of an unprecedented opioid crisis with increasing injection drug use (IDU)-related human immunodeficiency virus (HIV) outbreaks, particularly in rural areas. The Health Resources and Services Administration (HRSA)'s Ryan White HIV/AIDS Program (RWHAP) is well positioned to integrate treatment for IDU-associated HIV infections with treatment for drug use disorders. These activities will be crucial for the "Ending the HIV Epidemic: A Plan for America" (EHE) initiative, in which 7 southern states were identified with rural HIV epidemics. METHODS: The RWHAP Services Report data were used to assess the IDU population and substance use services utilization among RWHAP clients in 2017, nationally and in the 7 EHE-identified states. THe HRSA held a 1-day Technical Expert Panel (TEP) to explore how RWHAP can best respond to the growing opioid crisis. RESULTS: During the TEP, 8 key themes emerged and 11 best practices were identified to address opioid use disorder (OUD) among people with HIV. In 2017, among RWHAP clients with reported age and transmission category, 6.7% (31 683) had HIV attributed to IDU; among IDU clients, 6.3% (1988) accessed substance use services. CONCLUSIONS: The TEP results and RWHAP data were used to develop implementation science projects that focus on addressing OUD and integrating behavioral health in primary care. These activities are critical to ending the HIV epidemic.

A mathematical model to estimate the state-specific impact of the Health Resources and Services Administration's Ryan White HIV/AIDS Program.

BACKGROUND: Access to and engagement in high-quality HIV medical care and treatment is essential for ending the HIV epidemic. The Health Resources and Services Administration's (HRSA) Ryan White HIV/AIDS Program (RWHAP) plays a critical role in ensuring that people living with diagnosed HIV (PLWH) are linked to and consistently engaged in high quality care and receive HIV medication in a timely manner. State variation in HIV prevalence, the proportion of PLWH served by the RWHAP, and local health care environments could influence the state-specific impact of the RWHAP. This analysis sought to measure the state-specific impact of the RWHAP on the HIV service delivery system and health outcomes for PLWH, and presents template language to communicate this impact for state planning and stakeholder engagement. METHODS AND FINDINGS: The HRSA's HIV/AIDS Bureau (HAB) and the Centers for Disease Control and Prevention's Division of HIV/AIDS Prevention (CDC DHAP) have developed a mathematical model to estimate the state-specific impact of the RWHAP. This model was parameterized using RWHAP data, HIV surveillance data, an existing CDC model of HIV transmission and disease progression, and parameters from the literature. In this study, the model was used to analyze the hypothetical scenario of an absence of the RWHAP and to calculate the projected impact of this scenario on RWHAP clients, RWHAP-funded providers, mortality, new HIV cases, and costs compared with the current state inclusive of the RWHAP. To demonstrate the results of the model, we selected two states, representing high HIV prevalence and low HIV prevalence areas. These states serve to demonstrate the functionality of the model and how state-specific results can be translated into a state-specific impact statement using template language. CONCLUSIONS: In the example states presented, the RWHAP provides HIV care, treatment, and support services to a large proportion of PLWH in each state. The absence of the RWHAP in these states could result in substantially more deaths and HIV cases than currently observed, resulting in considerable lifetime HIV care and treatment costs associated with additional HIV cases. State-specific impact statements may be valuable in the development of state-level HIV prevention and care plans or for communications with planning bodies, state health department leadership, and other stakeholders. State-specific impact statements will be available to RWHAP Part B recipients upon request from HRSA's HIV/AIDS Bureau.

HIV-related outcome disparities between transgender women living with HIV and cisgender people living with HIV served by the Health Resources and Services Administration's Ryan White HIV/AIDS Program: A retrospective study.

BACKGROUND: In the United States, approximately one-fifth of transgender women are living with HIV-nearly one-half of Black/African American (Black) transgender women are living with HIV. Limited data are available on HIV-related clinical indicators among transgender women. This is because of a lack of robust transgender data collection and research, especially within demographic subgroups. The objective of this study was to examine retention in care and viral suppression among transgender women accessing the Health Resources and Services Administration's (HRSA) Ryan White HIV/AIDS Program (RWHAP)-supported HIV care, compared with cisgender women and cisgender men. METHODS AND FINDINGS: We assessed the association between gender (cisgender or transgender) and (1) retention in care and (2) viral suppression using 2016 client-level RWHAP Services Report data. Multivariable modified Poisson regression models adjusting for confounding by age, race, health care coverage, housing, and poverty level, overall and stratified by race/ethnicity, were used to calculate adjusted prevalence ratios (aPRs) and 95% confidence intervals (CIs). In 2016, the RWHAP served 6,534 transgender women (79.8% retained in care, 79.0% virally suppressed), 143,173 cisgender women (83.7% retained in care, 84.0% virally suppressed), and 382,591 cisgender men (81.0% retained in care, 85.9% virally suppressed). Black transgender women were less likely to be retained in care than Black cisgender women (aPR: 0.95, 95% CI: 0.92-0.97, p < 0.001). Black transgender women were also less likely to reach viral suppression than Black cisgender women (aPR: 0.55, 95%I CI: 0.41-0.73, p < 0.001) and Black cisgender men (aPR: 0.55, 95% CI: 0.42-0.73, p < 0.001). A limitation of the study is that RWHAP data are collected for administrative, not research, purposes, and clinical outcome measures, including retention and viral suppression, are only reported to the RWHAP for the approximately 60% of RWHAP clients engaged in RWHAP-supported outpatient medical care. CONCLUSIONS: In this study, we observed disparities in HIV clinical outcomes among Black transgender women. These results fill an important gap in national HIV data about transgender people with HIV. Reducing barriers to HIV medical care for transgender women is critical to decrease disparities among this population.

Pre-exposure prophylaxis for preventing acquisition of HIV: A cross-sectional study of patients, prescribers, uptake, and spending in the United States, 2015-2016.

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.