Lack of Medicaid Coverage of Routine Newborn Circumcision Leads to Increased Operative Circumcisions, Chordee Procedures, and Balanitis.

OBJECTIVE: To compare proportions of newborn circumcisions, operative circumcisions, chordee procedures, and cases of balanitis in states where Medicaid covers newborn circumcision (covered states) versus states that do not (noncovered states) using the pediatric health information system database. METHODS: A retrospective review of pediatric health information system data was conducted from 2011 to 2020. The proportions and median ages of newborn circumcision current procedural terminology (CPT 54,150, 54,160), operative circumcision (CPT 54,161), chordee (CPT 54,360), and balanitis (ICD-9 607.1, ICD-10 N48.1, N47.6) were compared in covered versus noncovered states. RESULTS: A total of 118,530 circumcisions were reviewed. Covered states had significantly higher proportions of circumcision overall (9.7% vs 7.1%, P < 0.0001). Noncovered states had significantly higher proportions of Medicaid-covered operative circumcisions (54.9% vs 47.7%, P < 0.0001). Compared to covered states, noncovered states had significantly higher median ages of all types of circumcisions. Noncovered states also had higher numbers of balanitis cases and double the incidence of balanitis compared with covered states. The median age of chordee (1.07 vs 0.79 years, P < 0.0001) and proportion of chordee repairs (15.2% vs 12.9%, P < 0.0001) were also significantly higher in noncovered states. CONCLUSION: The lack of Medicaid coverage of circumcision increases the number of foreskin procedures done in the operating room. In addition, in states without Medicaid coverage of circumcision, there is an increased burden of disease related to the foreskin. These findings represent a need to further investigate the costs of healthcare associated with Medicaid coverage of circumcision or the lack thereof.

Racial differences in the association of undetectable HIV viral load and transportation to an HIV provider among men who have sex with men in Atlanta, Georgia: a health equity perspective.

There are inequities in HIV outcomes among Black gay, bisexual, and other sexual minority men who have sex with men (GBMSM) compared to GBMSM overall, including access to transportation to HIV care. It is unclear if the relationship between transportation and clinical outcomes extends to viral load. We assessed the relationship between transportation dependence to an HIV provider and undetectable viral load among Black and White GBMSM in Atlanta. We collected transportation and viral load information from GBMSM with HIV from 2016-2017 (n = 345). More Black than White GBMSM had a detectable viral load (25% vs. 15%) and took dependent (e.g. public) transportation (37% vs. 18%). Independent (e.g. car) transportation was associated with undetectable viral load for White GBMSM (cOR 3.61, 95% CI 1.45, 8.97) but was attenuated by income (aOR. 2.29, 95% CI 0.78, 6.71), and not associated for Black GBMSM (cOR 1.18, 95% CI 0.58, 2.24). One possible explanation for no association for Black GBMSM is that there are more competing barriers to HIV care for Black GBMSM than White GBMSM. Further investigation is needed to confirm whether 1) transportation is unimportant for Black GBMSM or 2) transportation interacts with additional factors not considered in this analysis.

Evidence-Based Interventions to Improve Opioid Prescribing in Primary Care: a Qualitative Assessment of Implementation in Two Studies.

BACKGROUND: The TOPCARE and TEACH randomized controlled trials demonstrated the efficacy of a multi-faceted intervention to promote guideline-adherent long-term opioid therapy (LTOT) in primary care settings. Intervention components included a full-time Nurse Care Manager (NCM), an electronic registry, and academic detailing sessions. OBJECTIVE: This study sought to identify barriers, facilitators, and other issues germane to the wider implementation of this intervention. DESIGN: We conducted a nested, qualitative study at 4 primary care clinics (TOPCARE) and 2 HIV primary care clinics (TEACH), where the trials had been conducted. APPROACH: We purposively sampled primary care physicians and advanced practice providers (hereafter: PCPs) who had received the intervention. Semi-structured interviews explored perceptions of the intervention to identify unanticipated barriers to and facilitators of implementation. Interview transcripts were analyzed through iterative deductive and inductive coding exercises. KEY RESULTS: We interviewed 32 intervention participants, 30 physicians and 2 advanced practice providers, who were majority White (66%) and female (63%). Acceptability of the intervention was high, with most PCPs valuing didactic and team-based intervention elements, especially co-management of LTOT patients with the NCM. Adoption of new prescribing practices was facilitated by proximity to expertise, available behavioral health care, and the NCM's support. Most participants were enthusiastic about the intervention, though a minority voiced concerns about the appropriateness in their particular clinical environments, threats to the patient-provider relationship, or long-term sustainability. CONCLUSION: TOPCARE/TEACH participants found the intervention generally acceptable, appropriate, and easy to adopt in a variety of primary care environments, though some challenges were identified. Careful attention to the practical challenges of implementation and the professional relationships affected by the intervention may facilitate implementation and sustainability.

A multinational Delphi consensus to end the COVID-19 public health threat.

Despite notable scientific and medical advances, broader political, socioeconomic and behavioural factors continue to undercut the response to the COVID-19 pandemic1,2. Here we convened, as part of this Delphi study, a diverse, multidisciplinary panel of 386 academic, health, non-governmental organization, government and other experts in COVID-19 response from 112 countries and territories to recommend specific actions to end this persistent global threat to public health. The panel developed a set of 41 consensus statements and 57 recommendations to governments, health systems, industry and other key stakeholders across six domains: communication; health systems; vaccination; prevention; treatment and care; and inequities. In the wake of nearly three years of fragmented global and national responses, it is instructive to note that three of the highest-ranked recommendations call for the adoption of whole-of-society and whole-of-government approaches1, while maintaining proven prevention measures using a vaccines-plus approach2 that employs a range of public health and financial support measures to complement vaccination. Other recommendations with at least 99% combined agreement advise governments and other stakeholders to improve communication, rebuild public trust and engage communities3 in the management of pandemic responses. The findings of the study, which have been further endorsed by 184 organizations globally, include points of unanimous agreement, as well as six recommendations with >5% disagreement, that provide health and social policy actions to address inadequacies in the pandemic response and help to bring this public health threat to an end.

Cost of Hepatitis C care facilitation for HIV/Hepatitis C Co-infected people who use drugs.

BACKGROUND: Using data from a randomized trial, we evaluated the cost of HCV care facilitation that supports moving along the continuum of care for HIV/HCV co-infected individuals with substance use disorder. METHODS: Participants were HIV patients residing in the community, initially recruited from eight US hospital sites. They received HCV care facilitation (n = 51) or treatment as usual (n = 62) for up to six months. We used micro-costing methods to evaluate costs from the healthcare sector and patient perspectives in 2017 USD. We conducted sensitivity analyses varying care facilitator caseloads and examined offsetting savings using participant self-reported healthcare utilization. RESULTS: The average site start-up cost was $6320 (site range: $4320-$7000), primarily consisting of training. The mean weekly cost per participant was $20 (site range: $4-$30) for care facilitation visits and contacts, $360 (site range: $130- $700) for supervision and client outreach, and $70 (site range: $20-$180) for overhead. In sensitivity analyses applying a weekly caseload of 10 participants per care facilitator (versus 1-6 observed in the trial), the total mean weekly care facilitation cost from the healthcare sector perspective decreased to $110. Weekly participant time and travel costs averaged $7. There were no significant differences in other healthcare service costs between participants in the intervention and control arms. CONCLUSION: Weekly HCV care facilitation costs were approximately $450 per participant, but approximately $110 at a real-world setting maximum caseload of 10 participants per week. No healthcare cost offsets were identified during the trial period, although future savings might result from successful HCV treatment.

American Medical Trainee Perspectives on Ethical Conflicts during a Short-Term Global Health Rotation in Ethiopia: A Qualitative Analysis of 30 Cases.

There has been a significant increase in the number of students, residents, and fellows from high-income settings participating in short-term global health experiences (STGHEs) during their medical training. This analysis explores a series of ethical conflicts reported by medical residents and fellows from Emory University School of Medicine in the United States who participated in a 1-month global health rotation in Ethiopia. A constant comparative analysis was conducted using 30 consecutive reflective essays to identify emerging categories and themes of ethical conflicts experienced by the trainees. Ethical conflicts were internal; based in the presence of the visiting trainee and their personal interactions; or external, occurring due to witnessed events. Themes within internal conflicts include issues around professional identity and insufficient preparation for the rotation. External experiences were further stratified by the trainee's perception that Ethiopian colleagues agreed that the scenario represented an ethical conflict (congruent) or disagreed with the visiting trainee's perspective (incongruent). Examples of congruent themes included recognizing opportunities for collaboration and witnessing ethical conflicts that are similar to those experienced in the United States. Incongruent themes included utilization of existing resources, issues surrounding informed consent, and differing expectations of clinical outcomes. By acknowledging the frequency and roots of ethical conflicts experienced during STGHEs, sponsors may better prepare visiting trainees and reframe these conflicts as collaborative educational experiences that benefit both the visiting trainee and host providers.

Harmonizing healthcare and other resource measures for evaluating economic costs in substance use disorder research.

BACKGROUND: Standardization and harmonization of healthcare resource utilization data can improve evaluations of the economic impact of treating people with substance use disorder (SUD), including reductions in use of expensive hospital and emergency department (ED) services, and can ensure consistency with current cost-effectiveness and cost-benefit analysis guidelines. METHODS: We examined self-reported healthcare and other resource utilization data collected at baseline from three National Institute on Drug Abuse (NIDA)-funded Seek, Test, Treat, and Retain intervention studies of individuals living with/at risk for HIV with SUD. Costs were calculated by multiplying mean healthcare resource utilization measures by monetary conversion factors reflecting cost per unit of care. We normalized baseline recall timeframes to past 30 days and evaluated for missing data. RESULTS: We identified measures that are feasible and appropriate for estimating healthcare sector costs including ED visits, inpatient hospital and residential facility stays, and outpatient encounters. We also identified two self-reported measures to inform societal costs (days experiencing SUD problems, participant spending on substances). Missingness was 8% or less for all study measures and was lower for single questions measuring utilization in a recall period. CONCLUSIONS: We recommend including measures representing units of service with specific recall periods (e.g., 6 months vs. lifetime), and collecting healthcare resource utilization data using single-question measures to reduce missingness.

Understanding disparities in viral suppression among Black MSM living with HIV in Atlanta Georgia.

INTRODUCTION: Due to factors associated with structural racism, Black men who have sex with men (MSM) living with HIV are less likely to be virally suppressed compared to white MSM. Most of these data come from clinical cohorts and modifiable reasons for these racial disparities need to be defined in order to intervene on these inequities. Therefore, we examined factors associated with racial disparities in baseline viral suppression in a community-based cohort of Black and white MSM living with HIV in Atlanta, GA. METHODS: We conducted an observational cohort of Black and white MSM living with HIV infection in Atlanta. Enrolment occurred from June 2016 to June 2017 and men were followed for 24 months; laboratory and behavioural survey data were collected at 12 and 24 months after enrolment. Explanatory factors for racial disparities in viral suppression included sociodemographics and psychosocial variables. Poisson regression models with robust error variance were used to estimate prevalence ratios (PR) for Black/white differences in viral suppression. Factors that diminished the PR for race by ≥5% were considered to meaningfully attenuate the racial disparity and were included in a multivariable model. RESULTS: Overall, 26% (104/398) of participants were not virally suppressed at baseline. Lack of viral suppression was significantly more prevalent among Black MSM (33%; 69/206) than white MSM (19%; 36/192) (crude Prevalence Ratio (PR) = 1.6; 95% CI: 1.1 to 2.5). The age-adjusted Black/white PR was diminished by controlling for: ART coverage (12% decrease), housing stability (7%), higher income (6%) and marijuana use (6%). In a multivariable model, these factors cumulatively mitigated the PR for race by 21% (adjusted PR = 1.1 [95% CI: 0.8 to 1.6]). CONCLUSIONS: Relative to white MSM, Black MSM living with HIV in Atlanta were less likely to be virally suppressed. This disparity was explained by several factors, many of which should be targeted for structural, policy and individual-level interventions to reduce racial disparities.

Self-efficacy as a mediator of patient navigation interventions to engage persons living with HIV and substance use.

BACKGROUND: People living with HIV who report substance use (PLWH-SU) face many barriers to care, resulting in an increased risk for poor health outcomes and the potential for ongoing disease transmission. This study evaluates the mechanisms by which Patient Navigation (PN) and Contingency Management (CM) interventions may work to address barriers to care and improve HIV outcomes in this population. METHODS: Mediation analysis was conducted using data from a randomized, multi-site trial testing PN interventions to improve HIV care outcomes among 801 hospitalized PLHW-SU. Direct and indirect effects of PN and PN + CM were evaluated through five potential mediators-psychosocial conditions, healthcare avoidance, financial hardship, system barriers, and self-efficacy for HIV treatment adherence-on engagement in HIV care and viral suppression. RESULTS: The PN + CM intervention had an indirect effect on improving engagement in HIV care at 6 months by increasing self-efficacy for HIV treatment adherence (ß = 0.042, 95% CI = 0.008, 0.086). PN + CM also led to increases in viral suppression at 6 months (ß = 0.090, 95% CI = 0.023, 0.168) and 12 months (ß = 0.069, 95% CI = 0.009, 0.129) via increases in self-efficacy, although the direct effects were not significant. No mediating effects were observed for PN alone. CONCLUSION: PN + CM interventions for PLWH-SU can increase an individual's self-efficacy for HIV treatment adherence, which in turn improves engagement in care at 6 months and may contribute to viral suppression over 12 months. Building self-efficacy may be a key factor in the success of such interventions and should be considered as a primary goal of PN + CM in practice.

Assessment of the Inclusion of Racial/Ethnic Minority, Female, and Older Individuals in Vaccine Clinical Trials.

Importance: Medical research has not equitably included members of racial/ethnic minority groups or female and older individuals. There are limited data on participant demographic characteristics in vaccine trials despite the importance of these data to current trials aimed at preventing coronavirus disease 2019. Objective: To investigate whether racial/ethnic minority groups and female and older adults are underrepresented among participants in vaccine clinical trials. Design, Setting, and Participants: This cross-sectional study examined data from completed US-based vaccine trials registered on ClinicalTrials.gov from July 1, 2011, through June 30, 2020. The terms vaccine, vaccination, immunization, and inoculation were used to identify trials. Only those addressing vaccine immunogenicity or efficacy of preventative vaccines were included. Main Outcomes and Measures: The numbers and percentages of racial/ethnic minority, female, and older individuals compared with US census data from 2011 and 2018. Secondary outcome measures were inclusion by trial phase and year of completion. Results: A total of 230 US-based trials with 219 555 participants were included in the study. Most trials were randomized (180 [78.3%]), included viral vaccinations (159 [69.1%]), and represented all trial phases. Every trial reported age and sex; 134 (58.3%) reported race and 79 (34.3%) reported ethnicity. Overall, among adult study participants, White individuals were overrepresented (77.9%; 95% CI, 77.4%-78.4%), and Black or African American individuals (10.6%; 95% CI, 10.2%-11.0%) and American Indian or Alaska Native individuals (0.4%; 95% CI, 0.3%-0.5%) were underrepresented compared with US census data; enrollment of Asian individuals was similar (5.7%; 95% CI, 5.5%-6.0%). Enrollment of Hispanic or Latino individuals (11.6%; 95% CI, 11.1%-12.0%) was also low even among the limited number of adult trials reporting ethnicity. Adult trials were composed of more female participants (75 325 [56.0%]), but among those reporting age as a percentage, enrollment of participants who were aged 65 years or older was low (12.1%; 95% CI, 12.0%-12.3%). Black or African American participants (10.1%; 95% CI, 9.7%-10.6%) and Hispanic or Latino participants (22.5%; 95% CI, 21.6%-23.4%) were also underrepresented in pediatric trials. Among trials reporting race/ethnicity, 65 (48.5%) did not include American Indian or Alaska Native participants and 81 (60.4%) did not include Hawaiian or Pacific Islander participants. Conclusions and Relevance: This cross-sectional study found that among US-based vaccine clinical trials, members of racial/ethnic minority groups and older adults were underrepresented, whereas female adults were overrepresented. These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections.

The Potential Epidemiological Impact of Coronavirus Disease 2019 (COVID-19) on the Human Immunodeficiency Virus (HIV) Epidemic and the Cost-effectiveness of Linked, Opt-out HIV Testing: A Modeling Study in 6 US Cities.

BACKGROUND: Widespread viral and serological testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) may present a unique opportunity to also test for human immunodeficiency virus (HIV) infection. We estimated the potential impact of adding linked, opt-out HIV testing alongside SARS-CoV-2 testing on the HIV incidence and the cost-effectiveness of this strategy in 6 US cities. METHODS: Using a previously calibrated dynamic HIV transmission model, we constructed 3 sets of scenarios for each city: (1) sustained current levels of HIV-related treatment and prevention services (status quo); (2) temporary disruptions in health services and changes in sexual and injection risk behaviors at discrete levels between 0%-50%; and (3) linked HIV and SARS-CoV-2 testing offered to 10%-90% of the adult population in addition to Scenario 2. We estimated the cumulative number of HIV infections between 2020-2025 and the incremental cost-effectiveness ratios of linked HIV testing over 20 years. RESULTS: In the absence of linked, opt-out HIV testing, we estimated a total of a 16.5% decrease in HIV infections between 2020-2025 in the best-case scenario (50% reduction in risk behaviors and no service disruptions), and a 9.0% increase in the worst-case scenario (no behavioral change and 50% reduction in service access). We estimated that HIV testing (offered at 10%-90% levels) could avert a total of 576-7225 (1.6%-17.2%) new infections. The intervention would require an initial investment of $20.6M-$220.7M across cities; however, the intervention would ultimately result in savings in health-care costs in each city. CONCLUSIONS: A campaign in which HIV testing is linked with SARS-CoV-2 testing could substantially reduce the HIV incidence and reduce direct and indirect health care costs attributable to HIV.

Dental Care Utilization of Hospitalized Persons Living with HIV and Substance Use.

People living with HIV (PLWH) who use drugs experience worse health outcomes than their non-using counterparts. Little is known about how often they seek dental care and the factors that influence their utilization. PLWH with substance use disorders who were inpatients at 11 urban hospitals (n = 801) participated in a National Institute on Drug Abuse Clinical Trials Network study to improve engagement in HIV outcomes. Dental care utilization at each time point during the study period (baseline, 6 months and/or 12 months) was assessed (n = 657). Univariate analysis and logistic regression were used to examine factors associated with dental care utilization. Over half (59.4%) reported not having received any dental care at any timepoint. Participants with less than high school education had lower odds of reporting dental care utilization than those with more than education (aOR = 0.60 [95% CI 0.37-0.99], p = 0.0382). Participants without health insurance also had lower odds of reporting dental care utilization than those with insurance (aOR = 0.50 [95% CI 0.331-0.76], p = 0.0012). Higher food insecurity was associated with having recent dental care utilization (OR = 1.03 [95% CI 1.00, 1.05], p = 0.0359). Additionally, those from Southern states were less likely to report dental care utilization (aOR = 0.55 [95% CI 0.38, 0.79], p = 0.0013). Having health insurance and education are key factors associated with use of dental care for PLWH with substance use disorders. The association between food insecurity and dental care utilization among this population suggests the need for further exploration.

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2020 Recommendations of the International Antiviral Society-USA Panel.

Importance: Data on the use of antiretroviral drugs, including new drugs and formulations, for the treatment and prevention of HIV infection continue to guide optimal practices. Objective: To evaluate new data and incorporate them into current recommendations for initiating HIV therapy, monitoring individuals starting on therapy, changing regimens, preventing HIV infection for those at risk, and special considerations for older people with HIV. Evidence Review: New evidence was collected since the previous International Antiviral (formerly AIDS) Society-USA recommendations in 2018, including data published or presented at peer-reviewed scientific conferences through August 22, 2020. A volunteer panel of 15 experts in HIV research and patient care considered these data and updated previous recommendations. Findings: From 5316 citations about antiretroviral drugs identified, 549 were included to form the evidence basis for these recommendations. Antiretroviral therapy is recommended as soon as possible for all individuals with HIV who have detectable viremia. Most patients can start with a 3-drug regimen or now a 2-drug regimen, which includes an integrase strand transfer inhibitor. Effective options are available for patients who may be pregnant, those who have specific clinical conditions, such as kidney, liver, or cardiovascular disease, those who have opportunistic diseases, or those who have health care access issues. Recommended for the first time, a long-acting antiretroviral regimen injected once every 4 weeks for treatment or every 8 weeks pending approval by regulatory bodies and availability. For individuals at risk for HIV, preexposure prophylaxis with an oral regimen is recommended or, pending approval by regulatory bodies and availability, with a long-acting injection given every 8 weeks. Monitoring before and during therapy for effectiveness and safety is recommended. Switching therapy for virological failure is relatively rare at this time, and the recommendations for switching therapies for convenience and for other reasons are included. With the survival benefits provided by therapy, recommendations are made for older individuals with HIV. The current coronavirus disease 2019 pandemic poses particular challenges for HIV research, care, and efforts to end the HIV epidemic. Conclusion and Relevance: Advances in HIV prevention and management with antiretroviral drugs continue to improve clinical care and outcomes among individuals at risk for and with HIV.

Ending the HIV Epidemic Among Persons Who Inject Drugs: A Cost-Effectiveness Analysis in Six US Cities.

BACKGROUND: Persons who inject drugs (PWID) are at a disproportionately high risk of HIV infection. We aimed to determine the highest-valued combination implementation strategies to reduce the burden of HIV among PWID in 6 US cities. METHODS: Using a dynamic HIV transmission model calibrated for Atlanta, Baltimore, Los Angeles, Miami, New York City, and Seattle, we assessed the value of implementing combinations of evidence-based interventions at optimistic (drawn from best available evidence) or ideal (90% coverage) scale-up. We estimated reduction in HIV incidence among PWID, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs) for each city (10-year implementation; 20-year horizon; 2018 $ US). RESULTS: Combinations that maximized health benefits contained between 6 (Atlanta and Seattle) and 12 (Miami) interventions with ICER values ranging from $94 069/QALY in Los Angeles to $146 256/QALY in Miami. These strategies reduced HIV incidence by 8.1% (credible interval [CI], 2.8%-13.2%) in Seattle and 54.4% (CI, 37.6%-73.9%) in Miami. Incidence reduction reached 16.1%-75.5% at ideal scale. CONCLUSIONS: Evidence-based interventions targeted to PWID can deliver considerable value; however, ending the HIV epidemic among PWID will require innovative implementation strategies and supporting programs to reduce social and structural barriers to care.

Federal and State Action Needed to End the Infectious Complications of Illicit Drug Use in the United States: IDSA and HIVMA's Advocacy Agenda.

In response to the opioid crisis, IDSA and HIVMA established a working group to drive an evidence- and human rights-based response to illicit drug use and associated infectious diseases. Infectious diseases and HIV physicians have an opportunity to intervene, addressing both conditions. IDSA and HIVMA have developed a policy agenda highlighting evidence-based practices that need further dissemination. This paper reviews (1) programs most relevant to infectious diseases in the 2018 SUPPORT Act; (2) opportunities offered by the "End the HIV Epidemic" initiative; and (3) policy changes necessary to affect the trajectory of the opioid epidemic and associated infections. Issues addressed include leveraging harm reduction tools and improving integrated prevention and treatment services for the infectious diseases and substance use disorder care continuum. By strengthening collaborations between infectious diseases and addiction specialists, including increasing training in substance use disorder treatment among infectious diseases and addiction specialists, we can decrease morbidity and mortality associated with these overlapping epidemics.

"Ending the Epidemic" Will Not Happen Without Addressing Racial/Ethnic Disparities in the United States Human Immunodeficiency Virus Epidemic.

We estimated human immunodeficiency virus incidence and incidence rate ratios (IRRs) for black and Hispanic vs white populations in 6 cities in the United States (2020-2030). Large reductions in incidence are possible, but without elimination of disparities in healthcare access, we found that wide disparities persisted for black compared with white populations in particular (lowest IRR, 1.69 [95% credible interval, 1.19-2.30]).