Disparities in Unmet Health Care Needs Among US Children During the COVID-19 Pandemic.

PURPOSE: The COVID-19 pandemic disrupted pediatric health care in the United States, and this disruption layered on existing barriers to health care. We sought to characterize disparities in unmet pediatric health care needs during this period. METHODS: We analyzed data from Wave 1 (October through November 2020) and Wave 2 (March through May 2021) of the COVID Experiences Survey, a national longitudinal survey delivered online or via telephone to parents of children aged 5 through 12 years using a probability-based sample representative of the US household population. We examined 3 indicators of unmet pediatric health care needs as outcomes: forgone care and forgone well-child visits during fall 2020 through spring 2021, and no well-child visit in the past year as of spring 2021. Multivariate models examined relationships of child-, parent-, household-, and county-level characteristics with these indicators, adjusting for child's age, sex, and race/ethnicity. RESULTS: On the basis of parent report, 16.3% of children aged 5 through 12 years had forgone care, 10.9% had forgone well-child visits, and 30.1% had no well-child visit in the past year. Adjusted analyses identified disparities in indicators of pediatric health care access by characteristics at the level of the child (eg, race/ethnicity, existing health conditions, mode of school instruction), parent (eg, childcare challenges), household (eg, income), and county (eg, urban-rural classification, availability of primary care physicians). Both child and parent experiences of racism were also associated with specific indicators of unmet health care needs. CONCLUSIONS: Our findings highlight the need for continued research examining unmet health care needs and for continued efforts to optimize the clinical experience to be culturally inclusive.

Alignment of PrEP use and sexual behavior over four months among men who have sex with men in the southern United States.

Unlike antiretrovirals for HIV treatment, pre-exposure prophylaxis (PrEP) does not require continual adherence to be fully effective; rather, PrEP adherence is important only in the context of episodes of sexual risk. Therefore, studies of PrEP adherence and persistence must incorporate contemporaneous measurement of sexual behavior. Short, frequent surveys of PrEP use and sexual behavior allow for the measurement of the alignment between PrEP use and sexual behavior. We assessed the feasibility of using biweekly PrEP use and sexual behavior questionnaires to measure adherence and persistence on PrEP over a period of four months. We also measured the alignment of PrEP use and condomless anal sex. PrEP-using MSM in the southern US were recruited using online advertisements. Participants completed a baseline survey followed by brief surveys every two weeks for 16 weeks to report their PrEP use and sexual behavior over the preceding two-week period. Study retention was high: 91% of participants completed the baseline and final survey and, overall, 86% of study surveys were completed. Self-reported PrEP adherence and persistence were high, but instances of PrEP non-adherence were observed to frequently overlap with episodes of condomless anal sex. The most prominent reasons cited for missing PrEP doses were being too busy, not having PrEP on hand, and not being sexually active. Completing short, biweekly surveys of PrEP use and sexual behavior is feasible and acceptable to MSM in the southern US. Future studies should investigate incorporating biomarker measurements to validate self-reported adherence.

Demographic and behavioral characteristics of urban and non-urban PrEP-using MSM in the South.

Pre-exposure prophylaxis (PrEP) is a highly effective HIV prevention intervention; however, most studies of PrEP adherence and persistence among men who have sex with men (MSM) have been conducted with MSM who live in urban areas. The experiences of PrEP-using MSM in non-urban areas might differ due to increased barriers to culturally competent care. We examined similarities and differences among urban and non-urban PrEP-using MSM in the southern United States, the region with the highest number of annual HIV diagnoses. We surveyed a total of 78 (n = 25 non-urban, n = 53 urban) PrEP-using MSM. Self-reported adherence was high across all participants. No differences were observed with respect to PrEP persistence, source of PrEP, or reasons for PrEP initiation. Fewer non-urban than urban men reported STI testing in the past 12 months. Overall, we observed few differences comparing urban and non-urban PrEP-using MSM. Additional studies are needed to describe differences in PrEP initiation comparing urban and non-urban MSM.

The Roles of Technology in Primary HIV Prevention for Men Who Have Sex with Men.

Men who have sex with men (MSM) are at disproportionate risk for HIV infection globally. The past 5 years have seen considerable advances in biomedical interventions to reduce the risk of HIV infection. To be impactful in reducing HIV incidence requires the rapid and expansive scale-up of prevention. One mechanism for achieving this is technology-based tools to improve knowledge, acceptability, and coverage of interventions and services. This review provides a summary of the current gap in coverage of primary prevention services, how technology-based interventions and services can address gaps in coverage, and the current trends in the development and availability of technology-based primary prevention tools for use by MSM. Results from agent-based models of HIV epidemics of MSM suggest that 40-50 % coverage of multiple primary HIV prevention interventions and services, including biomedical interventions like preexposure prophylaxis, will be needed to reduce HIV incidence among MSM. In the USA, current levels of coverage for all interventions, except HIV testing and condom distribution, fall well short of this target. Recent findings illustrate how technology-based HIV prevention tools can be used to provide certain kinds of services at much larger scale, with marginal incremental costs. A review of mobile apps for primary HIV prevention revealed that most are designed by nonacademic, nonpublic health developers, and only a small proportion of available mobile apps specifically address MSM populations. We are unlikely to reach the required scale of HIV prevention intervention coverage for MSM unless we can leverage technologies to bring key services to broad coverage for MSM. Despite an exciting pipeline of technology-based prevention tools, there are broader challenges with funding structures and sustainability that need to be addressed to realize the full potential of this emerging public health field.

Engaging Black or African American and Hispanic or Latino Men Who Have Sex With Men for HIV Testing and Prevention Services Through Technology: Protocol for the iSTAMP Comparative Effectiveness Trial.

BACKGROUND: Gay, bisexual, and other men who have sex with men (MSM), particularly Black or African American MSM (BMSM) and Hispanic or Latino MSM (HLMSM), continue to be disproportionately affected by the HIV epidemic in the United States. Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVSTs) nested within a randomized controlled trial designed to assess the benefit of a mobile phone app for increasing the uptake of HIV prevention and other social services. OBJECTIVE: This study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care. METHODS: Study development began with individual and group consultations that elicited feedback from 3 core groups: HIV care practitioners and researchers, HIV service organization leaders from study states, and BMSM and HLMSM living in the study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone apps. After eligibility was verified, participants consented and were randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone app to support linkage to posttest prevention services that included sexually transmitted infection testing, pre-exposure prophylaxis initiation, antiretroviral treatment, and acquisition of condoms and compatible lubricants has been planned. Data on these outcomes were obtained from several sources, including HIVST-reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot cards returned by the participant, and data obtained from the state health department surveillance systems. Where possible, relevant subgroup analyses were performed. RESULTS: During the formative development phase, 9 consultations were conducted: 6 in-depth individual discussions and 3 group consultations. From February 2020 through February 2021, we enrolled 2093 MSM in the randomized controlled trial from 11 states, 1149 BMSM and 944 HLMSM. CONCLUSIONS: This study was designed and implemented to evaluate the effectiveness of recruitment strategies to reach BMSM and HMSM and of a mobile app with regard to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04219878); https://clinicaltrials.gov/ct2/show/NCT04219878. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43414.

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

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

Policy- and county-level associations with HIV pre-exposure prophylaxis use, the United States, 2018.

PURPOSE: HIV pre-exposure prophylaxis (PrEP) is highly efficacious, and yet most individuals indicated for it are not currently using it. To provide guidance for health policymakers, researchers, and community advocates, we developed county-level PrEP use estimates and assessed locality and policy associations. METHODS: Using data from a national aggregator, we applied a validated crosswalk procedure to generate county-level estimates of PrEP users in 2018. A multilevel Poisson regression explored associations between PrEP use and (1) state policy variables of Medicaid expansion and state Drug Assistance Programs (PrEP-DAPs) and (2) county-level characteristics from the U.S. Census Bureau. Outcomes were PrEP per population (prevalence) and PrEP-to-need ratio (PnR), defined as the ratio of PrEP users per new HIV diagnosis. Higher levels of PrEP prevalence or PnR indicate more PrEP users relative to the total population or estimated need, respectively. RESULTS: Our 2018 county-level data set included a total of 188,546 PrEP users in the United States. Nationally, PrEP prevalence was 70.3/100,000 population and PnR was 4.9. In an adjusted model, counties with a 5% higher proportion of black residents had 5% lower PnR (rate ratio (RR): 0.95, 95% confidence interval (CI): 0.93, 0.96). Similarly, counties with higher concentration of residents uninsured or living in poverty had lower PnR. Relative to states without Medicaid expansion or PrEP-DAPs, states with only one of those programs had 25% higher PrEP prevalence (RR: 1.25, 95% CI: 1.09, 1.45), and states with both programs had 99% higher PrEP prevalence (RR: 1.99, 95% CI: 1.60, 2.48). There was a significant linear trend across the three policy groups, and similar findings for the relation between PnR and the policy groups. CONCLUSIONS: In a data set comprising approximately 80% of PrEP users in the United States, we found that Medicaid expansion and PrEP-DAPs were associated with higher PrEP use in states that adopted those policies, after controlling for potential confounders. Future research should identify which components of PrEP support programs have the most success and how to best promote PrEP among groups most impacted by the epidemic. States should support the admirable health decisions of their residents to get on PrEP by implementing policies that facilitate access.

Methods for county-level estimation of pre-exposure prophylaxis coverage and application to the U.S. Ending the HIV Epidemic jurisdictions.

PURPOSE: Pre-exposure prophylaxis (PrEP) is a pillar of the US Department of Health and Human Services "Ending the HIV Epidemic" (EHE) initiative in 50 EHE jurisdictions (48 U.S. counties and two U.S. cities) and seven U.S. states with high numbers of HIV diagnoses rates in rural areas. Current data systems do not provide data on PrEP uptake in counties or cities. METHODS: We report on PrEP users at the county level. Data from a large, commercial pharmacy database were used; we applied the U.S. Census Bureau's method to allocate PrEP users within a ZIP3 into counties and validated the results. We report counts and rates of PrEP users in 2018 for all EHE jurisdictions. We used joinpoint regression to model the estimated annual percent change in PrEP use for each jurisdiction and state. RESULTS: 93,156 people in the 50 EHE jurisdictions used PrEP in 2018; 94% were men and 39% were aged 25-34 years. There was more than an 80-fold difference in the range of rates of PrEP use per 100,000 population among the EHE jurisdictions (range: 8-644 per 100,000 population; median 93 per 100,000 population). PrEP use increased from 2012 to 2018 in all EHE counties and states. At current rates of growth of PrEP use, 94% of EHE counties and jurisdictions will reach their National HIV/AIDS Strategy goals of a 500% increase in PrEP use in 2020. EHE states had less variation in rates of PrEP use (range: 29-51/100,000 population; median 32/100,000 population). CONCLUSIONS: At the outset of a major U.S. government program to reduce HIV infections, rates of PrEP use are highly variable among the 50 EHE jurisdictions. Data from commercial prescription databases will be a useful public resource to understand progress in promoting use of PrEP as part of the EHE initiative and evaluating progress in PrEP use across health jurisdictions.

Trends in the use of oral emtricitabine/tenofovir disoproxil fumarate for pre-exposure prophylaxis against HIV infection, United States, 2012-2017.

PURPOSE: Pre-exposure prophylaxis (PrEP) with oral emtricitibine/tenofovir disoproxil fumarate (TDF/FTC) reduces the risk of HIV infection by >90% when taken as prescribed. Trends in prevalence of PrEP use, which account for persons who have stopped PrEP, increased through 2016, but have not been described since. METHODS: Annual prevalence estimates of unique, TDF/FTC PrEP users (individuals with ≥1 day of a filled PrEP prescription in a given year) in the United States (US) were generated for 2012-2017 from a national prescription database. A validated algorithm was used to distinguish users of TDF/FTC for HIV or chronic Hepatitis B treatment or postexposure prophylaxis from PrEP users. We calculated annual prevalence of PrEP use overall and by age, sex, and region. We used log-transformation to calculate estimated annual percent change (EAPC) in the prevalence of PrEP use. RESULTS: Annual prevalence of PrEP use increased from 3.3/100,000 population in 2012 to 36.7 in 2017 -a 56% annual increase from 2012 to 2017 (EAPC: +56%). Annual prevalence of PrEP use increased faster among men than among women (EAPC: +68% and +5%, respectively). By age group, annual prevalence of PrEP use increased fastest among 25- to 34-year olds (EAPC: +61%) and slowest among ≥55-year olds (EAPC: +52%) and ≤24-year olds (EAPC: +51%). In 2017, PrEP use was lowest in the South (29.8/100,000) and highest in the Northeast (62.3/100,000). CONCLUSIONS: Despite overall increases in the annual number of TDF/FTC PrEP users in the US from 2012 to 2017, the growth of PrEP coverage is inconsistent across groups. Efforts to optimize PrEP access are especially needed for women and for those living in the South.

Safety and acceptability of couples HIV testing and counseling for US men who have sex with men: a randomized prevention study.

We tested a couples HIV testing and counseling (CHTC) intervention with male couples in Atlanta by randomizing eligible couples to receive either CHTC or separate individual voluntary HIV counseling and testing (iVCT). To evaluate the acceptability and safety of CHTC, main outcomes were satisfaction with the intervention and the proportions of couples reporting intimate partner violence (IPV) and relationship dissolution after the service. The results indicated that the service was very acceptable to men (median 7-item index of satisfaction was 34 for CHTC and 35 for iVCT, P = .4). There was no difference in either incident IPV (22% versus 17% for CHTC and iVCT, respectively, P = .6) or relationship dissolution (42% versus 51% for CHTC and iVCT, respectively, P = .5). Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners.