Efficacy and Safety of a Bivalent RSV Prefusion F Vaccine in Older Adults.

BACKGROUND: Respiratory syncytial virus (RSV) infection causes considerable illness in older adults. The efficacy and safety of an investigational bivalent RSV prefusion F protein-based (RSVpreF) vaccine in this population are unknown. METHODS: In this ongoing, phase 3 trial, we randomly assigned, in a 1:1 ratio, adults (≥60 years of age) to receive a single intramuscular injection of RSVpreF vaccine at a dose of 120 µg (RSV subgroups A and B, 60 µg each) or placebo. The two primary end points were vaccine efficacy against seasonal RSV-associated lower respiratory tract illness with at least two or at least three signs or symptoms. The secondary end point was vaccine efficacy against RSV-associated acute respiratory illness. RESULTS: At the interim analysis (data-cutoff date, July 14, 2022), 34,284 participants had received RSVpreF vaccine (17,215 participants) or placebo (17,069 participants). RSV-associated lower respiratory tract illness with at least two signs or symptoms occurred in 11 participants in the vaccine group (1.19 cases per 1000 person-years of observation) and 33 participants in the placebo group (3.58 cases per 1000 person-years of observation) (vaccine efficacy, 66.7%; 96.66% confidence interval [CI], 28.8 to 85.8); 2 cases (0.22 cases per 1000 person-years of observation) and 14 cases (1.52 cases per 1000 person-years of observation), respectively, occurred with at least three signs or symptoms (vaccine efficacy, 85.7%; 96.66% CI, 32.0 to 98.7). RSV-associated acute respiratory illness occurred in 22 participants in the vaccine group (2.38 cases per 1000 person-years of observation) and 58 participants in the placebo group (6.30 cases per 1000 person-years of observation) (vaccine efficacy, 62.1%; 95% CI, 37.1 to 77.9). The incidence of local reactions was higher with vaccine (12%) than with placebo (7%); the incidences of systemic events were similar (27% and 26%, respectively). Similar rates of adverse events through 1 month after injection were reported (vaccine, 9.0%; placebo, 8.5%), with 1.4% and 1.0%, respectively, considered by the investigators to be injection-related. Severe or life-threatening adverse events were reported in 0.5% of vaccine recipients and 0.4% of placebo recipients. Serious adverse events were reported in 2.3% of participants in each group through the data-cutoff date. CONCLUSIONS: RSVpreF vaccine prevented RSV-associated lower respiratory tract illness and RSV-associated acute respiratory illness in adults (≥60 years of age), without evident safety concerns. (Funded by Pfizer; RENOIR ClinicalTrials.gov number, NCT05035212; EudraCT number, 2021-003693-31.).

Two Models for Increasing the Scope and Activities of Human Immunodeficiency Virus Partner Services Programs: Preliminary Findings From the Fast Track Project.

BACKGROUND: We sought to develop a novel strategy for expanding an existing human immunodeficiency virus (HIV) partner services (PS) model to provide comprehensive sexual health services, including sexually transmitted infection testing, a virtual telemedicine visit, and access to immediate start medication (antiretroviral treatment, preexposure or postexposure prophylaxis). Fast Track was a National Institutes of Health-funded implementation science trial in New York City to pilot and refine the new strategy, and examine its feasibility, acceptability, and impact. METHODS: Over the course of 1 year, health department staff collaborated with the academic research team to develop Fast Track protocols and workflows, create a cloud-based database to interview and track patients, and train disease intervention specialists to deliver the new program. The initial field-based program (Fast Track 1.0) was piloted March to December 2019. A modified telephone-based program (Fast Track 2.0) was developed in response to COVID-19 pandemic constraints and was piloted August 2020 to March 2021. RESULTS: These 2 pilots demonstrate the feasibility and acceptability of integrating comprehensive sexual health services into HIV PS programs. Disease intervention specialists were successfully trained to conduct comprehensive sexual health visits, and clients reported that the availability of comprehensive sexual health services made them more willing to engage with PS. Key lessons for scale-up include managing collaboration with a licensed provider, navigating technical and technological issues, and challenges in client engagement and retention. CONCLUSIONS: The success of this integrated strategy suggests that telehealth visits may be a critical gateway to care engagement for PS clients. This model is an innovative strategy for increasing engagement with HIV testing, prevention, and treatment for underserved populations.

Prevalence and Correlates of Trichomonas vaginalis Infection Using the OSOM Rapid Point-of-Care Test Among Women Attending New York City Sexual Health Clinics, May-July 2016.

Using electronic medical record data and OSOM Trichomonas Rapid Tests, Trichomonas vaginalis prevalence was 9.3% among women attending New York City sexual health clinics in 2016. Positivity was associated with black race (adjusted odds ratios 3.73; 95% confidence interval, 1.9-7.1) and vaginal pH of 4.5 or greater (adjusted odds ratios, 1.9; 95% CI, 1.2-3.3).

The Change in Insurance Status Among Patients Seeking Care at Chicago Sexually Transmitted Disease Clinics After Affordable Care Act Implementation.

There was a 13% increase in the number of insured patients in Chicago sexually transmitted disease clinics 1 year after Affordable Care Act implementation. Major disparities in being insured persisted among those at higher risk for sexually transmitted diseases. ABSTRACT: There was a 13% increase in the number of insured patients in Chicago sexually transmitted disease clinics 1 year after Affordable Care Act implementation. Insured patients were more likely to report having access to preventive (65% vs. 36%, P < 0.01) and sick care (72% vs. 44%, P < 0.01). Major disparities in being insured persisted among men, those aged 26 to 45 years, and racial minorities.

Adherence to Centers for Disease Control and Prevention Gonococcal Treatment Guidelines Among Chicago Health Care Providers, 2011-2012.

BACKGROUND: Expansion of antimicrobial resistance in Neisseria gonorrhoeae requires rapid adaptation of treatment guidelines and responsive provider practice. We evaluated patient factors associated with provider adherence to the Centers for Disease Control and Prevention gonococcal treatment recommendations among Chicago providers in 2011 to 2012. METHODS: Laboratory-confirmed cases of uncomplicated urogenital gonorrhea were classified via surveillance data as originating from Chicago Department of Public Health (CDPH) or non-CDPH providers. Recommended treatment was determined according to the Centers for Disease Control and Prevention sexually transmitted disease treatment guidelines: April 2011-July 2012 (period 1) and August-December 2012 (period 2, after August 2012 revision). Multivariable log-binomial regression identified factors associated with recommended treatment over time, stratified by provider type. RESULTS: April 2011 through December 2012, 16,646 laboratory-confirmed gonorrhea cases were identified, of which 9597 (57.7%) had treatment information: 2169 CDPH cases and 7428 non-CDPH cases. Documented recommended treatment increased for CDPH (period 1: 71.3%, period 2: 80.8%; P < 0.01) and non-CDPH providers (period 1: 63.5%, period 2: 68.9%; P < 0.01). Among CDPH cases, statistically significant factors associated with recommended treatment were male sex (adjusted prevalence rate ratio [aPRR], 1.16) white versus black race (aPRR, 0.68), same-day treatment (aPRR, 1.07), and period 2 (aPRR, 1.11). Among non-CDPH cases, statistically significant factors were as follows: male sex (aPRR, 1.10), other versus black race (aPRR, 0.91), same-day treatment (aPRR, 1.31), greater number of within-facility reported cases (aPRRs ranging from 1.22 to 1.41), and at least 50% within-facility missing treatment data (aPRR, 0.84). CONCLUSIONS: Recommended treatment improved over time, yet remains suboptimal. Efforts to reduce variability and improve provider adherence to recommended treatment are urgently needed.

Initiating antiretroviral treatment for newly diagnosed HIV patients in sexual health clinics greatly improves timeliness of viral suppression.

OBJECTIVE: The 'JumpstART' program in New York City (NYC) public Sexual Health Clinics (SHC) provides patients newly diagnosed with human immunodeficiency virus (HIV) with antiretroviral medication (ART) (1-month supply) on day of diagnosis and active linkage to HIV care (LTC). We examined viral suppression (VS) among patients who did and did not receive JumpstART services. DESIGN: Retrospective cohort. METHODS: Among newly diagnosed SHC patients (23 November 2016-30 September 2018) who were matched to the NYC HIV surveillance registry to obtain HIV laboratory test results through 30 June 2019, we compared 230 JumpstART and 73 non-JumpstART patients regarding timely LTC (≤30 days), probability of VS (viral load < 200 copies/ml) by 3 months post-diagnosis, and time to and factors associated with achieving VS within the follow-up period. RESULTS: Of 303 patients, 76% (230/303) were JumpstART and the remaining were non-JumpstART patients; 36 (11%) had acute HIV infections. LTC ≤30 days was observed for 63% of JumpstART and 73% of non-JumpstART patients. By 3 months post-diagnosis, 83% of JumpstART versus 45% of non-JumpstART patients achieved VS (log-rank, P < .0001). Median times to VS among virally suppressed JumpstART and non-JumpstART patients were 31 (interquartile range [IQR]: 24-51) and 95 days (IQR: 52-153), respectively. For groups with and without timely LTC, JumpstART was associated with viral suppression within 3 months post-diagnosis, after adjusting for age and baseline viral load. CONCLUSIONS: Prompt ART initiation among SHC patients, some with acute HIV infections, resulted in markedly shortened intervals to VS. Immediate ART provision and active LTC can be key contributors to improved HIV treatment outcomes and the treatment-as-prevention paradigm, with potential for downstream, population-level benefit.

Examining the themes of STD-related Internet searches to increase specificity of disease forecasting using Internet search terms.

US surveillance of sexually transmitted diseases (STDs) is often delayed and incomplete which creates missed opportunities to identify and respond to trends in disease. Internet search engine data has the potential to be an efficient, economical and representative enhancement to the established surveillance system. Google Trends allows the download of de-identified search engine data, which has been used to demonstrate the positive and statistically significant association between STD-related search terms and STD rates. In this study, search engine user content was identified by surveying specific exposure groups of individuals (STD clinic patients and university students) aged 18-35. Participants were asked to list the terms they use to search for STD-related information. Google Correlate was used to validate search term content. On average STD clinic participant queries were longer compared to student queries. STD clinic participants were more likely to report using search terms that were related to symptomatology such as describing symptoms of STDs, while students were more likely to report searching for general information. These differences in search terms by subpopulation have implications for STD surveillance in populations at most risk for disease acquisition.

International travel patterns and travel risks for stem cell transplant recipients.

BACKGROUND: Stem cell transplantation (SCT) is being increasingly utilized for multiple medical illnesses. However, there is limited knowledge about international travel patterns and travel-related illnesses of stem cell transplant recipients (SCTRs). METHODS: An observational cross-sectional study was conducted among 979 SCTRs at Memorial Sloan Kettering Cancer Center using a previously standardized and validated questionnaire. International travel post SCT, pre-travel health advice, exposure risks, and travel-related illnesses were queried. RESULTS: A total of 516 SCTRs completed the survey (55% response rate); of these, 40% were allogeneic SCTRs. A total of 229 (44.3%) respondents reported international travel outside the United States and Canada post SCT. The international travel incidence was 32% [95% confidence interval CI 28-36] within 2 years after SCT. Using multivariable Cox regression analysis, variables significantly associated with international travel within first 2 years after SCT were history of international travel prior to SCT [hazard ratio (HR) = 5.3, 95% CI 2.3-12.0], autologous SCT (HR = 2.6, 95% CI 1.6-2.8), foreign birth (HR = 2.3, 95% CI 1.5-3.3), and high income (HR = 2.0, 95% CI 1.8-3.7). During their first trip, 64 travelers (28%) had traveled to destinations that may have required vaccination or malaria chemoprophylaxis. Only 56% reported seeking pre-travel health advice. Of those who traveled, 16 travelers (7%) became ill enough to require medical attention during their first trip after SCT. Ill travelers were more likely to have visited high-risk areas (60 vs 26%, p = 0.005), to have had a longer mean trip duration (24 vs 12 days, p = 0.0002), and to have visited friends and relatives (69 vs 21%, p < 0.0001). CONCLUSIONS: International travel was common among SCTRs within 2 years after SCT and was mainly to low-risk destinations. Although the overall incidence of travel-related illnesses was low, certain subgroups of travelers were at a significantly higher risk. Pre-travel health counseling and interventions were suboptimal.

International travel patterns and travel risks of patients diagnosed with cancer.

BACKGROUND: Immunocompromised travelers living with cancer can be at increased risk of travel-related illnesses. Their international travel patterns and associated risks remain largely unknown. METHODS: This was a retrospective cohort study of all patients diagnosed with cancer who presented for pre-travel health advice between January 1, 2003 and June 30, 2011. Demographics, travel patterns, and infectious diseases exposure risks of immunocompromised travelers were characterized and compared with those of immunocompetent travelers. Reported travel-related illnesses were assessed in both groups. RESULTS: A total of 149 travelers were included in this study. Fifty-one percent had solid tumors, 32% had hematological malignancies, and 17% underwent stem cell transplantation. Seventy travelers (47%) were immunocompromised. Immunocompromised travelers had similar demographics, trip itineraries, and infectious diseases exposure risks to hepatitis A, malaria, typhoid fever, and yellow fever as immunocompetent travelers. Most of the reported travel-related illnesses were of minor nature. CONCLUSION: Travelers with cancer who have impaired immunity had similar infectious diseases exposure risks and travel patterns as travelers whose cancer is cured or in remission. Improved understanding of travel patterns and risks of patients with cancer may assist in providing more focused pre-travel health interventions to this complex subset of travelers.