Last data update: Jun 20, 2025. (Total: 49421 publications since 2009)
Records 1-30 (of 131 Records) |
Query Trace: Delaney L[original query] |
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Mpox stigma during the 2022 outbreak among men who have sex with men in the United States
Carpino Thomas , Atkins Kaitlyn , Wiginton John Mark , Murray Sarah M , Lucas Iaah L , Delaney Kevin P , Schwartz Sheree , Sanchez Travis , Baral Stefan . Stigma and Health 2025 No Pagination Specified ![]() Mpox emerged on the global scale in 2022 and predominately affected gay, bisexual, and other men who have sex with men (GBMSM). Stigma related to mpox is a potential harm for individuals experiencing multiple levels of marginalization who may already be discriminated against in family, health care, and other social domains. To understand perceived mpox stigma among cisgender GBMSM in the United States, we conducted a study within the American Men's Internet Survey with 824 cisgender GBMSM >= 15 years from August 5 to 15, 2022. Perceived mpox stigma was most prevalent among non-Hispanic Black individuals (13.9%) compared to non-Hispanic White individuals (6.0%) and particularly among men aged 25-29 (15.1%) compared to men aged 40+ (5.6%). In adjusted logistic regression models, mpox stigma was significantly associated with knowing someone who tested for mpox (adjusted odds ratio (aOR) = 4.3 95% confidence interval, CI [2.1, 9.0]), knowing someone who was vaccinated for mpox (aOR = 2.1; 95% CI [1.2, 3.7]), or having an unexplained rash in the 3 months prior to survey completion (aOR = 3.6; 95% CI [1.9, 7.0]). These initial findings suggested people who were more connected to mpox-affected social networks and also those who had symptoms consistent with mpox were more likely to experience stigma. Taken together, these data suggest the potential harmful impact of mpox-related stigma by affecting those who would most benefit from services. Moreover, these data suggest the importance of real-time stigma measurement and mitigation for both rapidly emergent and chronic infectious diseases to improve equity, reduce fear and misinformation, and optimize the impact of public health responses. (PsycInfo Database Record (c) 2025 APA, all rights reserved) Impact Statement Stigma can have far-reaching consequences. It can exacerbate health disparities, influence social networks, and discourage individuals from seeking preventative health care, including vaccination. This study's findings highlight that, even if not widespread, stigma can concentrate in marginalized groups and drastically affect individuals' lives. By acknowledging and addressing stigma, public health agencies and providers can foster inclusivity, limit fear, promote trust in health care systems, and improve the overall health and resilience of communities. (PsycInfo Database Record (c) 2025 APA, all rights reserved) |
Use of JYNNEOS (Smallpox and Mpox Vaccine, Live, Nonreplicating) for Persons Aged ≥18 Years at Risk for Mpox During an Mpox Outbreak: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
Rao AK , Minhaj FS , Carter RJ , Duffy J , Satheshkumar PS , Delaney KP , Quilter LAS , Kachur RE , McLean C , Moulia DL , Kuhar DT , de Perio MA , Spicknall IH , Bell BP , Sánchez PJ , Hutson CL , Cohn AC . MMWR Morb Mortal Wkly Rep 2025 74 (22) 385-392 ![]() Since the worldwide eradication of smallpox in 1980, orthopoxvirus vaccines had been used nearly exclusively by persons at risk for occupational exposure to orthopoxviruses, including Monkeypox virus, the virus that causes mpox. However, during recent years, the epidemiology of mpox has been changing in countries where the animal reservoirs are believed to live and where endemic transmission has been known to occur for decades. CDC issues outbreak-specific vaccination recommendations based on the epidemiology at the time specific cases or clusters are identified; however, because of the increased risk for U.S. mpox outbreaks, the Advisory Committee on Immunization Practices (ACIP) reviewed results from a previously performed modified Grading of Recommendations Assessment, Development, and Evaluation of the 2-dose JYNNEOS (smallpox and mpox vaccine, live, nonreplicating) vaccination series and an Evidence to Recommendations (EtR) framework addressing multiple domains (e.g., benefits, harms, and target population values and preferences). Based on this assessment, ACIP recommended the use of JYNNEOS (a live, replication-deficient vaccinia virus vaccine) for persons aged ≥18 years at risk for mpox during an mpox outbreak (irrespective of clade). Because the cause of future mpox outbreaks and the populations affected by these outbreaks remain uncertain, public health authorities will continue to issue outbreak-specific vaccination guidance when outbreaks occur. A clade IIb mpox outbreak that began in 2022 continued to cause substantial morbidity and mortality >1 year later. Although CDC had issued outbreak-specific vaccination guidance, it was anticipated that the outbreak would be protracted. For this reason, ACIP reviewed a second EtR framework about outbreaks and in 2023 recommended JYNNEOS for persons aged ≥18 years at risk for acquiring mpox during the multinational clade IIb outbreak. As of 2025, cases continue to occur; however, the future need for the recommendation will be reassessed as the outbreak evolves. Mpox vaccination is not routinely recommended for health care personnel during mpox outbreaks, including during the ongoing clade IIb outbreak. |
Complete testing coverage for the early infant diagnosis algorithm and associated factors among infants exposed to HIV, Uganda, 2017-2019
Akunzirwe R , Harris JR , Kawungezi PC , Wanyana MW , Lutalo T , Namukanja PM , Delaney A , Migisha R , Nyamugisa E , Ondo D , Kasibante P , Kadobera D , Bulage L , Zalwango JF , Ario AR , Nabitaka LK . PLoS One 2025 20 (6) e0324338 ![]() BACKGROUND: Early infant diagnosis (EID) facilitates early initiation into HIV care for identified HIV-positive infants. According to the Uganda Ministry of Health, EID testing algorithm, testing for infants exposed to HIV (IEH) should occur at <6 weeks, 9 and 18 months of age, and 6 weeks after stopping breastfeeding. Uganda has faced challenges with loss to follow-up (LTFU) of IEH for EID. We assessed complete testing coverage (CTC) to the EID algorithm for IEH and associated factors. METHODS: We analyzed data from the 'Impact of the National Program for the Prevention of Vertical Transmission (PVT) of HIV in Uganda (2017-2019)' study. Mothers living with HIV whose infants tested HIV-negative at 4-12 weeks were enrolled in a prospective cohort (2017 - 2018) and followed until the IEH tested positive, died, was LTFU, or reached 18 months of age. We computed the proportion of IEH tested according to the EID algorithm among surviving infants. CTC was defined as undergoing HIV tests at three designated time points (excluding the 6 weeks after breastfeeding cessation) if HIV negative. IEH who were diagnosed with HIV but were tested at all recommended tests until that point were also considered to have CTC. We evaluated factors associated with CTC using modified Poisson regression. RESULTS: Among 1,804 IEH, 912 (51%) were male. Of the 1,804 IEH at baseline, 27 (1%) died. Among the 1,777 IEH included in the primary outcome analysis, 1,282 (72%) completed the study and 941 (53%) infants had CTC according to the EID testing algorithm including 40 (2%) who tested HIV-positive. Perceived discrimination due to HIV status [RR = 0.77, 95%CI (0.65-0.92)], having fewer pregnancies [RR = 0.97, 95%CI (0.68-0.99)], and reporting sexual violence [RR = 0.82, 95%CI (0.73-0.93)] by the mother of IEH were associated with non-CTC. CONCLUSION: About half of IEH were tested at the recommended time points. Interventions to address stigma and sexual violence for mothers may improve CTC for the EID algorithm. Investigations are needed to explore associations between sexual violence, parity, and CTC for the EID algorithm. |
Mortality rates in a cohort of infants attending immunization clinics in Uganda (2017-2019)
Sendagala S , Nakityo RB , Makumbi F , Lutalo T , Nabitaka L , Nalugoda F , Lukabwe I , Kasule J , Namara-Lugolobi E , Okwero MA , Asiimwe HT , Namukanja P , Ng'eno B , Dirlikov E , Delaney A . PLoS One 2025 20 (5) e0324122 BACKGROUND: Uganda reported a significant reduction in the mortality rate of children under 5 years of age, from 146/1,000 live births in 2000-42/1,000 live births in 2021. With the rollout of Option B+, the vertical transmission rate of HIV decreased from 13.0% (2012) to 6.0% (2019). However, its impact on the mortality rate among children is not well documented. We determined the mortality rate and associated risk factors among infants exposed and not exposed to HIV attending immunization clinics in Uganda. METHODS: We conducted an observational prospective cohort study of mother-infant pairs (MIPs) with infants exposed or unexposed to HIV. We enrolled infants aged 4-12 weeks. The inclusion criteria were biological mothers attending health facilities that provide routine immunization for children and/or postnatal care visits who were able to provide signed written informed consent; mothers or infants who were not severely ill; and those who consented to have their infants tested for HIV antibodies at baseline and follow-up visits every 3 months until the children were aged 18 months. Child-HIV infection and death were censored events. Children lost to follow-up or withdrawn from the study were censored from analyses at the last documented study visit. The outcome of interest was child mortality, and the independent variables were mother's age; infant HIV exposure status; infant sex; family socioeconomic status; marital status; education level; malaria during pregnancy; birth attendee; mother's ART initiation; mode of transport to health facilities; breastfeeding pattern; 4 or more ANC visits; and mother's baseline viral load nonsuppression and place of delivery. We used Kaplan-Meier survival curves to estimate cumulative mortality probability and the Wilcoxon log-rank test to compare differences in cumulative survival functions. We used multivariate Weibull proportional hazards and Weibull accelerated failure time (AFT) regression models with 95% confidence intervals (CIs) to identify factors associated with child death. RESULTS: Among the 16,718 MIPs identified, 11,519 (68.9%) mothers consented to study follow-up. At the 18-month follow-up, 0.7% (79/11,519) of the infants had died, 40.5% (32/79) of whom were exposed to HIV. The overall child mortality rate per 1,000 person-years was 5.0 (95% CI: 4.0--6.2) and was significantly greater among the infants exposed to HIV (14.2; 95% CI: 10.0--20.0) than among the infants not exposed to HIV (3.5; 95% CI: 2.6--4.6). In the adjusted model, the mortality risk factors were HIV exposure status (aHR5.6 95% CI: 3.5--9.4), maternal age < 25 years (aHR1.8; 95% CI: 1.1--2.9), living without a partner (aHR1.8; 95% CI: 1.1--2.9), and delivery at home (aHR2.2; 95% CI: 1.3--4.0). CONCLUSION: Single young mothers living with HIV delivering at home increased the risk of child mortality. Identifying mothers with risk factors early for support could reduce the risk of child mortality. |
Reducing HIV incidence in the southern US through routine opt-out HIV screening
Hamilton DT , Hoover KW , Delaney KP . Aids 2025 OBJECTIVES: To evaluate the potential contributions of routine opt-out testing (ROOT) in clinical settings and preexposure prophylaxis (PrEP) on achieving Ending the HIV Epidemic in the U.S. (EHE) incidence reduction goals in the South. DESIGN: Simulation Study. METHODS: An agent-based epidemic projection model simulated adherence to the CDC's ROOT guidelines. Simulations were informed by literature reviews, the National Survey of Family Growth and ARTnet. Interventions included ROOT in Community Health Center (CHC) and Emergency Departments (ED) alone and in combination. PrEP was modeled as either persistent at 2019 levels or expanding consistent with historical trends. RESULTS: ROOT in CHCs and EDs averted 13.9% (95%SI: -15.5, 42.4) of infections and increased the proportion of persons with HIV (PWH) who were aware of their status from 84.8% to 94.4% (95%SI: 92.8, 95.4). In conjunction with the ongoing expansion of PrEP the proportion diagnosed increased from 84.8% at baseline to 95.1% (95% SI: 93.9, 96.4) and 23.3% (95% SI: -7.9, 50.6) of infections were averted, reducing the annual incidence rate by 42.4% compared to the baseline scenario. CONCLUSIONS: In our analysis, ROOT coupled with the ongoing expansion of PrEP averted almost a quarter of new infections over the 8 years from 2022 to 2030. While short of the overall EHE goal of 90%, it represents substantial potential progress for a low-cost and low-barrier intervention. ROOT also provides a method for identifying PWH who are undiagnosed both in and out of priority populations, those out of care, and individuals reluctant to seek screening. |
HIV RNA testing to monitor oral PrEP use does not add clinical value: a real-world cohort study-United States, 2019-2023
Zhu W , Delaney K , Huang YA , Patel RR , Kourtis AP , Hoover KW . Clin Infect Dis 2025 BACKGROUND: The 2021 update of the CDC clinical guidelines for HIV preexposure prophylaxis (PrEP) recommended both antigen/antibody (Ag/Ab) and RNA testing at PrEP initiation and routine follow-up. We assessed real-world utilization and performance of HIV tests among oral PrEP users. METHODS: An oral PrEP user cohort was constructed using the HealthVerity database that included linked diagnoses, laboratory tests, and prescriptions from December 2018 to August 2023. Data was stratified by guideline pre- (2019-2021) and post-update (2022-2023) periods. For each period, we assessed the agreement between same-day HIV Ag/Ab and RNA results and calculated the false positive rate (FPR) and positive predictive values (PPV) of HIV Ag/Ab and RNA tests compared with adjudicated HIV status. RESULTS: The HIV RNA testing rate for follow-up increased from 16 per 100 person-years (PY) to 123 per 100 PYs after the guideline update. The positivity rate of HIV RNA tests decreased from 1.39% to 0.22%. Overall agreement between Ag/Ab and RNA results remained high. The FPRs of HIV Ag/Ab and RNA testing remained similar, but the PPV of HIV RNA testing for PrEP follow-up decreased from 100% to 67%. We estimated that 8,226 to 9,900 RNA tests would be needed for one HIV diagnosis earlier than would be detected with Ag/Ab testing alone. DISCUSSION: HIV RNA testing did not provide additional value to Ag/Ab testing during routine follow-up of oral PrEP users. Considering the cost and logistical complexity of HIV RNA testing, its use as a routine test during follow-up of oral PrEP users warrants reconsideration. |
Insta-PrEP: Improving PrEP access within a community-based LGBTQ+ testing center
McDougal SJ , Viquez L , Kwong HWH , Russell C , Murphy M , Niemann L , Violette LR , Hoover KW , Delaney KP , Tanner M , Stekler JD . AIDS 2025 39 (6) 774-776 Same-day pre-exposure prophylaxis for HIV (PrEP) is recommended to improve access to this important HIV prevention tool. A PrEP program at a community-based LGBTQ+ clinic in Seattle, Washington provided PrEP via telemedicine with a focus on converting testing-only visits to same-day 'Insta-PrEP' visits. We identified three key barriers to same-day PrEP for clients who present to clinic for testing-only visits: delays related to health insurance; longer counseling times; and disruption of clinic flow following Insta-PrEP visits. Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved. |
Real-world HIV RNA and antigen/antibody testing among people who use long-acting injectable PrEP
Zhu W , Delaney K , Huang YA , Patel RR , Kourtis AP , Hoover KW . Clin Infect Dis 2025 BACKGROUND: People who use long-acting injectable cabotegravir (CAB-LA) for preexposure prophylaxis (PrEP) can have ambiguous HIV test results if HIV is acquired during its use. The 2021 CDC PrEP guidelines recommend both HIV antigen/antibody (Ag/Ab) and RNA testing at CAB-LA initiation and follow-up. METHODS: We conducted a cohort study using the HealthVerity database to evaluate the utilization of HIV testing among people who use CAB-LA PrEP. We identified and adjudicated HIV Ag/Ab and RNA tests with a positive result, and estimated the incidence of breakthrough HIV infection or long-acting early viral inhibition (LEVI) syndrome. Testing agreement, false positive test rates, and positive predictive value were explored. RESULTS: Among 384 people who use CAB-LA PrEP with both HIV Ag/Ab and RNA testing with a median follow-up time of 4.2 months, we found one discordant pair with Ag/Ab(-) and RNA(+), and one with Ag/Ab(+) and RNA(-). Among four users with a positive Ag/Ab or RNA test, we identified one who acquired HIV before CAB-LA initiation with both Ag/Ab(+) and RNA(+), one likely false RNA(+), one likely false Ag/Ab(+), and one inconclusive Ag/Ab(+) due to insufficient follow-up. We identified no persons with confirmed breakthrough HIV infection or LEVI syndrome, or with RNA testing resulting in an earlier HIV diagnosis compared with Ag/Ab testing alone. INTERPRETATION: The frequency of breakthrough HIV infection or LEVI syndrome in this real-world cohort was low during initial three to seven months of injectable PrEP use. Ongoing assessment of the added value of HIV RNA testing for monitoring during CAB-LA PrEP use is warranted. |
Prevalence, trends, and maternal risk factors of adverse birth outcomes from a hospital-based birth defects surveillance system in Kampala, Uganda, 2015-2022
Kusolo R , Mumpe-Mwanja D , Serunjogi R , Delaney A , Namale-Matovu J , Mwambi K , Namukanja-Mayambala PM , Williams JL , Mai CT , Qi YP , Musoke P . BMC Pregnancy Childbirth 2025 25 (1) 408 BACKGROUND: Adverse birth outcomes (ABOs) cause significant infant morbidity and mortality in resource-limited settings. Many of the maternal risk factors associated with ABOs can be prevented. We present the prevalence, trends, and risk factors of selected ABOs from a hospital-based birth defects surveillance program in Kampala, Uganda. METHODS: We analyzed data for all mothers with singleton deliveries collected from four urban hospitals between 2015 and 2022. Prevalence of preterm birth [PTB], low birth weight [LBW], small for gestational age [SGA], and stillbirth [SB] and maternal HIV seroprevalence were calculated among 222,427 births. SB was defined as infant born without life ≥ 28 weeks of gestation, LBW as term live birth weighing < 2500 g and PTB as live birth born < 37 weeks of gestation. Time trends of ABOs by maternal HIV status and age were computed using quasi-Poisson regression model and presented graphically. Risk factor associations were estimated using robust Poisson models adjusting for infant sex, hospital of delivery, and birth year. RESULTS: Prevalence of PTB, LBW, SGA, and SB were 14.8%, 4.3%, 17.8%, and 3.1%, respectively. Maternal HIV seroprevalence was 7.7%. Compared to mothers aged 25-34 years, young adolescents 10-18 years was associated with PTB (adjusted risk ratio [aRR]: 1.44, 95% confidence interval (CI): 1.38-1.50); LBW (1.65,1.51-1.81); and SGA (1.18; 1.12-1.24). HIV seropositivity was associated with PTB (1.18; 1.14-1.22), LBW (1.54; 1.43-1.65), and SGA (1.28; 1.23-1.33). Compared to starting ANC in the first trimester, no antenatal care (ANC) was associated with PTB (2.44; 2.33-2.56), LBW (1.80; 1.55-2.09), SGA (1.37; 1.27-1.49), and SB (3.73; 3.32-4.15) and late attendance with LBW (1.09; 1.02-1.16), SGA (1.26; 1.22-1.30), and SB (1.09; 1.02-1.17). Our findings also indicate a rising trend in PTB among adolescent and young women aged 10-24 years, and a declining trend in LBW and SGA over time (ptrend < 0.05 for all). CONCLUSIONS: Young maternal age, maternal HIV, and late or no ANC attendance were associated with ABO. Childbearing in the ages 25-34, preventing HIV in women, and supporting early and frequent ANC attendance are important in improving birth outcomes. |
Suspected mpox symptoms and testing in men who have sex with men in the United States: Cross-sectional study
Atkins K , Carpino T , Rao A , Sanchez T , Edwards OW , Hannah M , Sullivan PS , Ogale YP , Abara WE , Delaney KP , Baral SD . JMIR Public Health Surveill 2025 11 e57399 BACKGROUND: The 2022 mpox outbreak in the United States disproportionately affected gay, bisexual, and other men who have sex with men (GBMSM). Uptake of mpox testing may be related to symptomology, sociodemographic characteristics, and behavioral characteristics. OBJECTIVE: This study aimed to describe suspected mpox symptoms and testing uptake among a sample of GBMSM recruited via the internet in the United States in August 2022. METHODS: We conducted a rapid internet-based mpox survey from August 5 to 15, 2022, among cisgender men 15 years and older who had previously participated in the 2021 American Men's Internet Survey. We estimated the prevalence of suspected mpox symptoms (fever or rash or sores with unknown cause in the last 3 mo) and uptake of mpox testing. We calculated adjusted prevalence ratios (aPRs) and 95% CIs for associations between participant characteristics and suspected mpox symptoms and summarized characteristics of GBMSM reporting mpox testing. Among symptomatic GBMSM who did not receive mpox testing, we described testing self-efficacy, barriers, and facilitators. RESULTS: Of 824 GBMSM, 126 (15.3%) reported at least 1 mpox symptom in the last 3 months; 58/126 (46%) with rash or sores, 57 (45.2%) with fever, and 11 (8.7%) with both. Increased prevalence of suspected mpox symptoms was associated with condomless anal sex (CAS; aPR 1.53, 95% CI 1.06-2.20). Mpox testing was reported by 9/824 GBMSM (1%), including 5 with symptoms. Most GBMSM reporting mpox testing were non-Hispanic White men (7/9 vs 1 Black and 1 Hispanic or Latino man), and all 9 lived in urban areas. Most reported having an sexually transmitted infections test (8/9), 2 or more partners (8/9), CAS (7/9), and group sex (6/9) in the last 3 months. Of those tested, 3 reported living with HIV and all were on treatment, whereas the remaining 6 men without HIV reported current pre-exposure prophylaxis (PrEP) use. Of symptomatic GBMSM who did not report mpox testing, 47/105 (44.8%) had low mpox testing self-efficacy. Among those with low self-efficacy, the most common barriers to testing were not knowing where to get tested (40/47, 85.1%) and difficulty getting appointments (23/47, 48.9%). Among those with high testing self-efficacy (58/105, 55.2%), the most common facilitators to testing were knowing where to test (52/58, 89.7%), convenient site hours (40/58, 69%), and low-cost testing (38/58, 65.5%). CONCLUSIONS: While all GBMSM who reported testing for mpox were linked to HIV treatment or PrEP, those with symptoms but no mpox testing reported fewer such links. This suggests targeted outreach is needed to reduce structural barriers to mpox services among GBMSM in rural areas, Black and Hispanic or Latino GBMSM, and GBMSM living with HIV. Sustaining and scaling community-tailored messaging to promote testing and vaccination represent critical interventions for mpox control among GBMSM in the United States. |
Analysis of mpox by occupation and industry in seven U.S. jurisdictions, May 2022-March 2023
Groenewold MR , de Perio MA , Moller KM , Bui D , Saadeh K , Still W , Meh I , Lavender A , Soliva S , Fields C , Hopkins B , Laramie AK , Harrington P , Stout A , Levenson C , Morris CR , Creswell PD , Segaloff HE , Somerville NJ , Dowell CH , Delaney LJ . Int J Environ Res Public Health 2025 21 (10) 1317 During responses to outbreaks, the collection and analysis of data on employed case patients' industry and occupation are necessary to better understand the relationship between work and health outcomes. The occurrence of mpox by occupation and industry has not previously been assessed in the context of the 2022 outbreak. We analyzed employment data from 2548 mpox cases reported to the U.S. Centers for Disease Control and Prevention from surveillance systems in seven U.S. jurisdictions and population-based reference data on employment patterns from the U.S. Bureau of Labor Statistics to describe the differential proportionate distribution of cases across occupation and industry groups using the proportionate morbidity ratio. In gender-specific analyses, we found that men employed in certain occupations and industries had a higher relative risk of mpox than others. While occupational transmission cannot be ruled out, it is more likely that individuals with personal and behavioral risk factors for mpox were more likely to work in these occupations and industries. This analysis provides an example of collecting and analyzing occupation and industry data in case reports to understand possible differences in risk by occupation and industry in infectious disease outbreak investigation and help inform resource allocation, messaging, and response. |
Mpox and vaccine knowledge, beliefs, and sources of trusted information among gay, bisexual, and other men who have sex with men in the U.S
Carpino TR , Atkins K , Abara W , Edwards OW , Lansky A , DiNenno E , Hannah M , Delaney KP , Murray SM , Sanchez T , Baral S . AJPM Focus 2024 3 (6) 100267 INTRODUCTION: This research aims to characterize disparities in mpox- and vaccine-related knowledge in gay, bisexual, and other men who have sex with men in the U.S. METHODS: The authors conducted a study using the American Men's Internet Survey, which includes 823 cisgender (defined as their gender identity matching their sex assigned at birth) males aged ≥15 years from August 5 to 15, 2022. The authors evaluated sociodemographic and behavioral factors associated with mpox knowledge, including race/ethnicity, region, age group, and HIV pre-exposure prophylaxis use using chi-square tests. RESULTS: The authors identified knowledge gaps, with many participants unsure about whether individuals need 2 doses of the vaccine (34.4%) and whether the vaccine confers immediate protection (27.2%). The authors observed racial and regional disparities (p<0.01), with 24.4% of non-Hispanic Black men and 18.1% of men living in the South reporting little to no mpox awareness. Among the 707 self-reported HIV-negative participants, people who used pre-exposure prophylaxis within the past year were more likely to exhibit high awareness about mpox than people who did not use pre-exposure prophylaxis. CONCLUSIONS: Findings suggest the potential to leverage existing networks (i.e., sexually transmitted infection or general health care services with pre-exposure prophylaxis use) for future targeted health service programming or education campaigns for mpox vaccination among gay, bisexual, and other men who have sex with men. |
HIV: California's 2018 criminalization reform and testing among those reporting risk behavior
Keralis JM , Bourbeau A , Delaney KP , Odunsi S , Valentine SS . J Public Health Policy 2024 HIV criminalization laws may discourage HIV testing. We tested whether California's 2018 HIV criminalization law reform increased the likelihood of past-year HIV testing compared to Nevada, which did not reform its HIV criminalization law. We fitted two difference-in-differences logistic regression models: one for all respondents reporting behaviors that increase the chances of getting or transmitting HIV, and one for male respondents reporting these behaviors. All analyses accounted for the complex survey design of BRFSS. HIV criminalization reform was significantly associated with an increased likelihood of past-year HIV testing. After reform, the predicted marginal probability of past-year HIV testing increased by six percentage points. By comparison, probabilities of a past-year HIV test decreased in Nevada. HIV criminalization law reform may increase the likelihood of getting tested by individuals who engage in behaviors that increase the chances of getting or transmitting HIV. |
Disease intervention specialist-delivered interventions and other partner services for HIV and sexually transmitted infections: A systematic review
Martin EG , Myderrizi A , Kim H , Schumacher P , Jeong S , Gift TL , Hutchinson AB , Delaney KP , Chesson HW . Am J Prev Med 2024 INTRODUCTION: Disease intervention specialists (DIS) are critical for delivering partner services programs that provide partner notification, counseling, referral, and other services for HIV, sexually transmitted infections (STIs), and other infections. This systematic review of partner services and other DIS-delivered interventions for HIV and STIs was conducted to summarize the effectiveness of these programs and identify evidence gaps. METHODS: A systematic literature review was conducted with a narrative synthesis. Articles were located using keyword searches in MEDLINE, Web of Science, CINAHL, and ProQuest through December 2022 and analyzed in 2023-2024. Included studies addressed an intervention of partner services or other DIS-delivered services for HIV or STIs; a United States setting; primary data collection; and an external comparison group or pre-post design. RESULTS: 1,915 unique records were screened for eligibility, with 30 studies included. Overall, DIS-delivered interventions improved clinical outcomes among index patients and population outcomes. Many studies focused on program process measures rather than population-level epidemiologic outcomes. All but one studies were scored as having low or medium strength of evidence. DISCUSSION: The evidence could be strengthened by establishing a streamlined set of core metrics, assessing impact using rigorous causal inference methodologies, linking program and clinical data systems, and supplementing impact evaluations with evidence on implementation strategies. |
Testing trends and co-testing patterns for HIV, hepatitis C and sexually transmitted infections (STIs) in Emergency departments
Symum H , Van Handel M , Sandul A , Hutchinson A , Tsang CA , Pearson WS , Delaney KP , Cooley LA , Gift TL , Hoover KW , Thompson WW . Preventive Med Reports 2024 44 Background: Many underserved populations use Emergency Department (EDs) as primary sources of care, representing an important opportunity to provide infectious disease testing and linkage to care. We explored national ED testing trends and co-testing patterns for HIV, hepatitis C, and sexually transmitted infections (STIs). Methods: We used 2010–2019 Healthcare Cost and Utilization Project, Nationwide Emergency Department Sample data to estimate ED visit testing rates for HIV, hepatitis C, chlamydia, gonorrhea, and syphilis infections, identified by Current Procedural Terminology codes. Trends and co-testing (visit with tests for > 1 infection) patterns were analyzed by sociodemographic, hospital, and visit characteristics. Trends were evaluated as the average annual percentage change (AAPC) using the Joinpoint Regression. Results: During 2010–2019, testing events per 1000 visits (AAPCs) increased for HIV from 1.3 to 4.2 (16.3 %), hepatitis C from 0.4 to 2.2 (25.1 %), chlamydia from 9.1 to 16.0 (6.6 %), gonorrhea from 8.4 to 15.7 (7.4 %), and syphilis from 0.7 to 2.0 (12.9 %). Rate increases varied by several characteristics across infections. The largest AAPC increases were among visits by groups with lower base rate testing in 2010, including persons aged ≥ 65 years (HIV: 36.4 %), with Medicaid (HIV: 43.8 %), in the lowest income quintile (hepatitis C: 36.9 %), living in the West (syphilis: 49.4 %) and with non-emergency diagnoses (hepatitis C: 44.1 %). Co-testing increased significantly for all infections except hepatitis C. Conclusions: HIV, hepatitis C, and STI testing increased in EDs during 2010–2019; however, co-testing patterns were inconsistent. Co-testing may improve diagnosis and linkage to care, especially in areas experiencing higher rates of infection. © 2024 |
Findings from the first year of a federally funded, direct-to-consumer HIV self-test distribution program - United States, March 2023-March 2024
Sanchez T , MacGowan RJ , Hecht J , Keralis JM , Ackah-Toffey L , Bourbeau A , Dana R , Lilo EA , Downey RS , Getachew-Smith H , Hannah M , Valencia R , Krebs E , Pingel ES , Gayden JJ , Norelli J , Mason Z , Mahn J , Cramer N , Bole R , Sullivan P , Nwaohiri AN , Stryker JE , Kourtis AP , DiNenno EA , Fanfair RN , Mermin JH , Delaney KP . MMWR Morb Mortal Wkly Rep 2024 73 (24) 558-564 In September 2022, CDC funded a nationwide program, Together TakeMeHome (TTMH), to expand distribution of HIV self-tests (HIVSTs) directly to consumers by mail through an online ordering portal. To publicize the availability of HIVSTs to priority audiences, particularly those disproportionately affected by HIV, CDC promoted this program through established partnerships and tailored resources from its Let's Stop HIV Together social marketing campaign. The online portal launched March 14, 2023, and through March 13, 2024, distributed 443,813 tests to 219,360 persons. Among 169,623 persons who answered at least one question on a postorder questionnaire, 67.9% of respondents were from priority audiences, 24.1% had never previously received testing for HIV, and 24.8% had not received testing in the past year. Among the subset of participants who initiated a follow-up survey, 88.3% used an HIVST themselves, 27.1% gave away an HIVST, 11.7% accessed additional preventive services, and 1.9% reported a new positive HIVST result. Mailed HIVST distribution can quickly reach large numbers of persons who have never received testing for HIV or have not received testing as often as is recommended. TTMH can help to achieve the goal of diagnosing HIV as early as possible and provides a path to other HIV prevention and care services. Clinicians, community organizations, and public health officials should be aware of HIVST programs, initiate discussions about HIV testing conducted outside their clinics or offices, and initiate follow-up services for persons who report a positive or negative HIVST result. |
Rapid antiretroviral therapy initiation following rollout of point-of-care early infant diagnosis testing, Uganda, 2018-2021
Migamba SM , Nyombi TN , Nsubuga EJ , Kwiringira A , Delaney A , Kabwama SN , Nakafeero M , Kwesiga B , Kadobera D , Monalisa-Mayambala P , Bulage L , Ario AR , Harris JR . AIDS Res Ther 2024 21 (1) 31 BACKGROUND: Uganda Ministry of Health (MOH) recommends a first HIV DNA-PCR test at 4-6 weeks for early infant diagnosis (EID) of HIV-exposed infants (HEI) and immediate return of results. WHO recommends initiating antiretroviral therapy (ART) ≤ 7 days from HIV diagnosis. In 2019, MOH introduced point-of-care (POC) whole-blood EID testing in 33 health facilities and scaled up to 130 facilities in 2020. We assessed results turnaround time and ART linkage pre-POC and during POC testing. METHODS: We evaluated EID register data for HEI at 10 health facilities with POC and EID testing volume of ≥ 12 infants/month from 2018 to 2021. We abstracted data for 12 months before and after POC testing rollout and compared time to sample collection, results receipt, and ART initiation between periods using medians, Wilcoxon, and log-rank tests. RESULTS: Data for 4.004 HEI were abstracted, of which 1.685 (42%) were from the pre-POC period and 2.319 (58%) were from the period during POC; 3.773 (94%) had a first EID test (pre-POC: 1.649 [44%]; during POC: 2.124 [56%]). Median age at sample collection was 44 (IQR 38-51) days pre-POC and 42 (IQR 33-50) days during POC (p < 0.001). Among 3.773 HEI tested, 3.678 (97%) had test results. HIV-positive infants' (n = 69) median age at sample collection was 94 (IQR 43-124) days pre-POC and 125 (IQR 74-206) days during POC (p = 0.04). HIV positivity rate was 1.6% (27/1.617) pre-POC and 2.0% (42/2.061) during POC (p = 0.43). For all infants, median days from sample collection to results receipt by infants' caregivers was 28 (IQR 14-52) pre-POC and 1 (IQR 0-25) during POC (p < 0.001); among HIV-positive infants, median days were 23 (IQR 7-30) pre-POC and 0 (0-3) during POC (p < 0.001). Pre-POC, 4% (1/23) HIV-positive infants started ART on the sample collection day compared to 33% (12/37) during POC (p < 0.001); ART linkage ≤ 7 days from HIV diagnosis was 74% (17/23) pre-POC and 95% (35/37) during POC (p < 0.001). CONCLUSION: POC testing improved EID results turnaround time and ART initiation for HIV-positive infants. While POC testing expansion could further improve ART linkage and loss to follow-up, there is need to explore barriers around same-day ART initiation for infants receiving POC testing. |
Modifications to sexual behaviors associated with Mpox (monkeypox) virus transmission among persons presenting for Mpox vaccination, Washington, D.C., August-October, 2022
Copen CE , Delaney KP , Agnew-Brune C , Berry I , Griffin I , Hassan R , Oakley LP , Wondmeneh S , Rhodes T , Gillani S , Lee M , Ashley P , Willut C , Mangla AT , Waltenburg MA , Jackson DA . Sex Transm Dis 2024 51 (1) 54-60 BACKGROUND: Over 30,000 mpox cases were reported during the 2022 mpox outbreak with many cases occurring among gay, bisexual and other men who have sex with men (MSM). Decreases in U.S. mpox cases were likely accelerated by a combination of vaccination and modifications to sexual behaviors associated with mpox virus transmission. We assessed reports of sexual behavior change among participants receiving mpox vaccination in Washington, DC. METHODS: During August to October 2022, 711 adults aged ≥18 years receiving mpox vaccination at two public health clinics in Washington, DC completed a self-administered questionnaire that asked whether sexual behaviors changed since learning about mpox. We calculated the frequency and percentages of participants reporting an increase, decrease, or no change in 4 of these behaviors by demographic, clinical, and behavioral characteristics with 95% confidence intervals. RESULTS: Overall, between 46% and 61% of participants reported a decrease in sexual behaviors associated with mpox virus transmission, 39% to 54% reported no change in these behaviors, and <1% reported an increase. Approximately 61% reported decreases in one-time sexual encounters (95% confidence interval [CI], 56.8%-64.7%), 54.3% reduced numbers of sex partners (95% CI, 50.4%-58.0%), 53.4% decreased sex via a dating app or sex venue (95% CI, 49.7%-58.0%), and 45.6% reported less group sex (95% CI, 40.4%-50.9%). Reported decreases in these behaviors were higher for MSM than women; in non-Hispanic Black than non-Hispanic White participants; and in participants with human immunodeficiency virus than participants without human immunodeficiency virus. CONCLUSIONS: Most participants receiving mpox vaccination reported decreasing sexual behaviors associated with mpox virus transmission, including groups disproportionately affected by the outbreak. |
Mpox knowledge, attitudes, & practices among persons presenting for JYNNEOS vaccination - District of Columbia, August-October 2022
Hassan R , Wondmeneh S , Gonzalez Jimenez N , Chapman K , Mangla A , Ashley P , Willut C , Lee M , Rhodes T , Gillani S , Copen C , Jackson DA , Waltenburg M , Delaney KP , Miles G , Agnew-Brune C , Oakley LP . Sex Transm Dis 2024 51 (1) 47-53 BACKGROUND: More than 30,000 mpox cases have been confirmed in the United States since May 2022. Mpox cases have disproportionally occurred among adult gay, bisexual, and other men who have sex with men; transgender persons; and Black and Hispanic/Latino persons. We examined knowledge, attitudes, and practices regarding mpox vaccination among adults presenting for vaccination to inform prevention efforts. METHODS: We collected mixed-methods data from a convenience sample of adults presenting for JYNNEOS vaccination at 3 DC Health mpox vaccine clinics during August-October 2022. Survey and interview topics included knowledge about mpox symptoms and vaccine protection, beliefs about vaccine access, and trusted sources of information. RESULTS: In total, 352 participants completed self-administered surveys and 62 participants completed an in-depth interview. Three main themes emerged from survey and interview data. First, most participants had a general understanding about mpox, but gaps remained in comprehensive understanding about mpox symptoms, modes of transmission, vaccine protection, personal risk, and vaccine dosing strategies. Second, participants had high trust in public health agencies. Third, participants wanted more equitable and less stigmatizing access to mpox vaccine services. CONCLUSIONS: Nonstigmatizing, inclusive, and clear communication from trusted sources, including public health agencies, is needed to address mpox knowledge gaps and increase vaccine access and uptake in affected communities. Mpox outreach efforts should continue innovative approaches, including person-level risk assessment tools, to address community needs. |
Correction: Behavior change among HIV-negative men who have sex with men not using PrEP in the United States
Goodreau SM , Barry MP , Hamilton DT , Williams AM , Wang LY , Sanchez TH , Katz DA , Delaney KP . AIDS Behav 2024 |
Modelling the impact of vaccination and sexual behaviour adaptations on mpox cases in the USA during the 2022 outbreak
Clay PA , Asher JM , Carnes N , Copen CE , Delaney KP , Payne DC , Pollock ED , Mermin J , Nakazawa Y , Still W , Mangla AT , Spicknall IH . Sex Transm Infect 2023 BACKGROUND: The 2022 mpox outbreak has infected over 30 000 people in the USA, with cases declining since mid-August. Infections were commonly associated with sexual contact between men. Interventions to mitigate the outbreak included vaccination and a reduction in sexual partnerships. Understanding the contributions of these interventions to decreasing cases can inform future public health efforts. METHODS: We fit a dynamic network transmission model to mpox cases reported by Washington DC through 10 January 2023. This model incorporated both vaccine administration data and reported reductions in sexual partner acquisition by gay, bisexual or other men who have sex with men (MSM). The model output consisted of daily cases over time with or without vaccination and/or behavioural adaptation. RESULTS: We found that initial declines in cases were likely caused by behavioural adaptations. One year into the outbreak, vaccination and behavioural adaptation together prevented an estimated 84% (IQR 67% to 91%) of cases. Vaccination alone averted 79% (IQR 64% to 88%) of cases and behavioural adaptation alone averted 25% (IQR 10% to 42%) of cases. We further found that in the absence of vaccination, behavioural adaptation would have reduced the number of cases, but would have prolonged the outbreak. CONCLUSIONS: We found that initial declines in cases were likely caused by behavioural adaptation, but vaccination averted more cases overall and was key to hastening outbreak conclusion. Overall, this indicates that outreach to encourage individuals to protect themselves from infection was vital in the early stages of the mpox outbreak, but that combination with a robust vaccination programme hastened outbreak conclusion. |
Potential contribution of PrEP uptake by adolescents 15-17 years old to achieving the "Ending the HIV Epidemic" incidence reduction goals in the US South
Hamilton DT , Wang LY , Hoover KW , Smith DK , Delaney KP , Li J , Hoyte T , Jenness SM , Goodreau SM . PLoS One 2023 18 (11) e0288588 BACKGROUND: The "Ending the HIV Epidemic" (EHE) initiative seeks to reduce new HIV infections in the U.S. by prioritizing federal resources towards highly impacted populations. Antiretroviral therapy (ART) and pre-exposure prophylaxis (PrEP) are essential for reaching EHE goals. Adolescents are often at increased risk for HIV because they may lack agency in negotiating their sexual partnerships and may not have the same access to treatment and prevention as adults. This study estimates the potential contribution of expanded PrEP coverage among adolescents ages 15-17 to achieving the EHE goals in the South. METHODS: An HIV-transmission model was built to simulate the HIV epidemic in the South. Increased ART and PrEP uptake were systematically varied with and without PrEP eligibility including individuals age<18. RESULTS: Prioritizing PrEP for adolescents had a negligible impact on incidence. At 50% uptake among eligible adolescents and 90% ART coverage, including adolescents only improved the percentage of infections averted from 80.1% to 80.3%. In 10 of 15 scenarios explored, there was no reduction in new infections when PrEP eligibility was expanded to include adolescents age<18. At 95% ART coverage at the population-level incidence among adolescents declined by over 80%, but PrEP uptake among adolescents did not contribute to additional declines in incidence among adolescents. CONCLUSIONS: Prioritizing PrEP for adolescents did not significantly contribute to reaching EHE incidence reductions goal. Focusing resources to specific adolescent populations at risk, such sexual minority males in high incidence settings, will remain an important public health goal outside the context of EHE. |
The association between safety climate and noncombat injury events among United States Air Force workers
Socias-Morales CM , Haas EJ , Gwilliam M , Yorio PL , Delaney NB , Falcon RG , Stallings HA , Burnham BR , Stuever DM , Stouder SM , Ewing GL , Collins JW , Chaumont Menendez CK . J Saf Res null [Epub ahead of print] Introduction: Work-related injuries are a common lagging safety indicator whereas safety climate assessments can help identify constructs serving as leading indicators. The National Institute for Occupational Safety and Health (NIOSH) partnered with the U.S. Department of the Air Force (DAF) Safety Center to examine the association between perceptions of safety climate survey constructs and the number of injury events within the DAF workforce. Methods: The DAF administers voluntary, anonymous, occupation-specific safety climate surveys to DAF workers using the internal Air Force Combined Mishap Reduction System (AFCMRS). Survey responses from 2014 to 2018 provided by DAF workers and injury events in maintenance, support, and operations occupations were shared with NIOSH. Exploratory Factor Analysis revealed five constructs: Leadership and Communication; Organizational Safety Priority; Error Management; Resource Adequacy; and Deployment/Official Travel Impact. Squadron-level analysis included bivariate correlations and estimated Rate Ratios (RRs). Results: 1,547 squadrons administered the survey, averaging 144 workers and 15.8 reportable injuries per squadron. Higher (more favorable) squadron-level construct scores were consistently correlated with fewer reported injuries (p < 0.001). Controlling for the number of workers, RRs revealed significant reductions in injury rates with each one-unit increase in responses: Leadership and Communication RR = 0.40 (95 %CI: 0.32-0.48); Organizational Safety Priority RR = 0.50 (95 %CI: 0.40-0.64); Error Management RR = 0.37 (95 %CI: 0.30-0.47); Deployment/Official Travel Impact RR = 0.36 (95 %CI: 0.29-0.45). Resource Adequacy revealed a non-significant lower injury rate RR = 0.87 (95 %CI: 0.73-1.04). Conclusions: This unique study quantified safety climate and the association with injuries across a multi-year period. While safety climate measurements may be limited by frequent turnover and the self-reported, voluntary, anonymous nature of AFCMRS, the strength of this study is in the census of injuries. Practical Applications: Future research should include longitudinal analyses to examine the impact on injuries when squadron leaders are provided feedback on safety climate survey results. |
Evaluating the impact of point-of-care HIV viral load assessment on linkage to care in Baltimore, MD: a randomized controlled trial
Bayan MH , Smalls T , Boudreau A , Mirza AW , Pasco C , Demko ZO , Rothman RE , Hsieh YH , Eshleman SH , Mostafa HH , Gonzalez-Jimenez N , Chavez PR , Emerson B , Delaney KP , Daugherty D , MacGowan RJ , Manabe YC , Hamill MM . BMC Infect Dis 2023 23 (1) 570 BACKGROUND: Integration of a sensitive point-of-care (POC) HIV viral load (VL) test into screening algorithms may help detect acute HIV infection earlier, identify people with HIV (PWH) who are not virally suppressed, and facilitate earlier referral to antiretroviral therapy (ART), or evaluation for pre-exposure prophylaxis (PrEP). This report describes a randomized clinical trial sponsored by the Centers for Disease Control and Prevention (CDC): "Ending the HIV Epidemic Through Point-of-Care Technologies" (EHPOC). The study's primary aim is to evaluate the use of a POC HIV VL test as part of a testing approach and assess the impact on time to linkage to ART or PrEP. The study will recruit people in Baltimore, Maryland, including patients attending a hospital emergency department, patients attending an infectious disease clinic, and people recruited via community outreach. The secondary aim is to evaluate the performance characteristics of two rapid HIV antibody tests approved by the United States Food and Drug Administration (FDA). METHODS: The study will recruit people 18 years or older who have risk factors for HIV acquisition and are not on PrEP, or PWH who are not taking ART. Participants will be randomly assigned to either the control arm or the intervention arm. Participants randomized to the control arm will only receive the standard-of-care (SOC) HIV screening tests. Intervention arm participants will receive a POC HIV VL test in addition to the SOC HIV diagnostic screening tests. Follow up will consist of an interim phone survey conducted at week-4 and an in-person week-12 visit. Demographic and behavioral information, and oral fluid and blood specimens will be collected at enrollment and at week-12. Survey data will be captured in a Research Electronic Data Capture (REDCap) database. Participants in both arms will be referred for either ART or PrEP based on their HIV test results. DISCUSSION: The EHPOC trial will explore a novel HIV diagnostic technology that can be performed at the POC and provide viral assessment. The study may help inform HIV testing algorithms and contribute to the evidence to support same day ART and PrEP recommendations. TRIAL REGISTRATION: NIH ClinicalTrials.gov NCT04793750. Date: 11 March 2021. |
Performance of Repeat BinaxNOW SARS-CoV-2 Antigen Testing in a Community Setting, Wisconsin, November-December 2020 (preprint)
Shah MM , Salvatore PP , Ford L , Kamitani E , Whaley MJ , Mitchell K , Currie DW , Morgan CN , Segaloff HE , Lecher S , Somers T , Van Dyke ME , Bigouette JP , Delaney A , DaSilva J , O'Hegarty M , Boyle-Estheimer L , Abdirizak F , Karpathy SE , Meece J , Ivanic L , Goffard K , Gieryn D , Sterkel A , Bateman A , Kahrs J , Langolf K , Zochert T , Knight NW , Hsu CH , Kirking HL , Tate JE . medRxiv 2021 2021.04.05.21254834 Repeating the BinaxNOW antigen test for SARS-CoV-2 by two groups of readers within 30 minutes resulted in high concordance (98.9%) in 2,110 encounters. BinaxNOW test sensitivity was 77.2% (258/334) compared to real-time reverse transcription-polymerase chain reaction. Repeating antigen testing on the same day did not significantly improve test sensitivity while specificity remained high.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was funded by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesData will be made available upon reasonable request. |
Quantitative Comparison of SARS-CoV-2 Nucleic Acid Amplification Test and Antigen Testing Algorithms: A Decision Analysis Simulation Model (preprint)
Salvatore PP , Shah MM , Ford L , Delaney A , Hsu CH , Tate JE , Kirking HL . medRxiv 2021 2021.03.15.21253608 Background Antigen tests for SARS-CoV-2 offer advantages over nucleic acid amplification tests (NAATs, such as RT-PCR), including lower cost and rapid return of results, but show reduced sensitivity. Public health organizations continue to recommend different strategies for utilizing NAATs and antigen tests in various settings. There has not yet been a quantitative comparison of the expected performance of these strategies.Methods We utilized a decision analysis approach to simulate the expected outcomes of six algorithms for implementing NAAT and antigen testing, analogous to testing strategies recommended by public health organizations. Each algorithm was simulated 50,000 times for four SARS-CoV-2 infection prevalence levels ranging from 5% to 20% in a population of 100000 persons seeking testing. Primary outcomes were number of missed cases, number of false-positive diagnoses, and total test volumes. Outcome medians and 95% uncertainty ranges (URs) were reported.Results Algorithms that use NAATs to confirm all negative antigen results minimized missed cases but required high NAAT capacity: 92,200 (95% UR: 91,200-93,200) tests (in addition to 100,000 antigen tests) at 10% prevalence. Substituting repeat antigen testing in lieu of NAAT confirmation of all initial negative antigen tests resulted in 2,280 missed cases (95% UR: 1,507-3,067) at 10% prevalence. Selective use of NAATs to confirm antigen results when discordant with symptom status (e.g., symptomatic persons with negative antigen results) resulted in the most efficient use of NAATs, with 25 NAATs (95% UR: 13-57) needed to detect one additional case at 10% prevalence compared to exclusive use of antigen tests.Conclusions No single SARS-CoV-2 testing algorithm is likely to be optimal across settings with different levels of prevalence and for all programmatic priorities; each presents a trade-off between prioritized outcomes and resource constraints. This analysis provides a framework for selecting setting-specific strategies to achieve acceptable balances and trade-offs between programmatic priorities and constraints.Disclaimer The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. Centers for Disease Control and Prevention.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was funded by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesCode for the algorithm simulations can be found on the CDC Epidemic Prediction Initiative GitHub site (https://github.com/cdcepi). |
Characteristics of children and antigen test performance at a SARS-CoV-2 community testing site (preprint)
Ford L , Whaley MJ , Shah MM , Salvatore PP , Segaloff HE , Delaney A , Currie DW , Boyle-Estheimer L , O'Hegarty M , Morgan CN , Meece J , Ivacic L , Thornburg NJ , Tamin A , Harcourt JL , Folster JM , Medrzycki M , Jain S , Wong P , Goffard K , Gieryn D , Kahrs J , Langolf K , Zochert T , Tate JE , Hsu CH , Kirking HL . medRxiv 2021 2021.07.06.21259792 Background Performance characteristics of SARS-CoV-2 antigen tests among children are limited despite the need for point-of-care testing in school and childcare settings. We describe children seeking SARS-CoV-2 testing at a community site and compare antigen test performance to real-time reverse transcription-polymerase chain reaction (RT-PCR) and viral culture.Methods Two anterior nasal specimens were self-collected for BinaxNOW antigen and RT-PCR testing, along with demographics, symptoms, and exposure information from individuals ≥5 years at a community testing site. Viral culture was attempted on residual antigen or RT-PCR positive specimens. Demographic and clinical characteristics, and the performance of SARS-CoV-2 antigen tests, were compared among children (<18 years) and adults.Results About one in ten included specimens were from children (225/2110); 16.4% (37/225) were RT-PCR positive. Cycle threshold values were similar among RT-PCR positive specimens from children and adults (22.5 vs 21.3, p=0.46) and among specimens from symptomatic and asymptomatic children (22.5 vs 23.2, p=0.39). Sensitivity of antigen test compared to RT-PCR was 73.0% (27/37) among specimens from children and 80.8% (240/297) among specimens from adults; among specimens from children, specificity was 100% (188/188), positive and negative predictive value were 100% (27/27) and 94.9% (188/198) respectively. Virus was isolated from 51.4% (19/37) of RT-PCR positive pediatric specimens; all 19 had positive antigen test results.Conclusions With lower sensitivity relative to RT-PCR, antigen tests may not diagnose all positive COVID-19 cases; however, antigen testing identified children with live SARS-CoV-2 virus.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:This activity was reviewed by CDC and was conducted consistent with applicable federal law and CDC policy. See e.g., 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesThe datasets generated during and analyzed during the current study are available from the corresponding author on reasonable request. |
Modeling an Integrated HIV Prevention and Care Continuum to Achieve the Ending the HIV Epidemic Goals (preprint)
Jenness SM , Johnson JA , Hoover KW , Smith DK , Delaney KP . medRxiv 2020 2020.03.02.20030254 Objective We sought to evaluate which combinations of HIV prevention and care activities would have the greatest impact towards reaching the US Ending the HIV Epidemic (EHE) plan goals of reducing HIV incidence at least 75% by 2025 and 90% by 2030.Design A stochastic HIV transmission model for men who have sex with men (MSM), calibrated to local surveillance estimates in the Atlanta area, a focal EHE target jurisdiction.Methods Model scenarios varied HIV screening rates relative to current levels, under different assumptions of how HIV-negative MSM would be linked to PrEP initiation, and also considered improvements to HIV care linkage and retention for those screening positive.Results A 10-fold relative increase in HIV screening rates (to approximately biannual screening for black and Hispanic MSM and quarterly for white MSM) would lead to 43% of infections averted if integrated with PrEP initiation. Improvements to HIV care retention would avert 41% of infections if retention rates were improved 10-fold. If both screening and retention were jointly improved 10-fold, up to 74% of cumulative infections would be averted. Under this scenario, it would take 4 years to meet the 75% EHE goal and 12 years to meet the 90% goal for MSM in Atlanta.Conclusions Interventions to improve HIV screening linked with PrEP for those screening negative, and HIV care retention would have a substantial impact on HIV prevention. However, additional interventions may be necessary to reach the EHE goal of a 90% reduction in incidence for Atlanta MSM by 2030.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis work was supported by Centers for Disease Control and Prevention cooperative agreement number U38 PS004646 and National Institutes of Health grants R21 MH112449 and R01 AI138783.Author DeclarationsAll relevant ethical guidelines have been followed; any necessary IRB and/or ethics committee approvals have been obtained and details of the IRB/oversight body are included in the manuscript.YesAll necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesModel data and analysis scripts are available on our Github repository linked below. https://github.com/EpiModel/CombPrev |
Evaluation of the Abbott ARCHITECT HIV Ag/Ab Combo Assay for Determining Recent HIV-1 Infection (preprint)
Curtis KA , Rudolph DL , Pan Y , Delaney K , Anastos K , DeHovitz J , Kassaye SG , Hanson CV , French AL , Golub E , Adimora AA , Ofotokun I , Bolivar H , Kempf MC , Peters PJ , Switzer WM . bioRxiv 2020 2020.11.09.374017 Background Given the challenges and costs associated with implementing HIV-1 incidence assay testing, there is great interest in evaluating the use of commercial HIV diagnostic tests for determining recent HIV infection. A diagnostic test with the capability of providing reliable data for the determination of recent HIV infection without substantial modifications to the test protocol would have a significant impact on HIV surveillance. The Abbott ARCHITECT HIV Ag/Ab Combo Assay is an antigen/antibody immunoassay, which meets the criteria as the first screening test in the recommended HIV laboratory diagnostic algorithm for the United States.Methods In this study, we evaluated the performance characteristics of the ARCHITECT HIV Ag/Ab Combo signal-to-cutoff ratio (S/Co) for determining recent infection, including estimation of the mean duration of recent infection (MDRI) and false recent rate (FRR), and selection of recency cutoffs.Results The MDRI estimates for the S/Co recency cutoff of 400 is within the 4 to 12 months range recommended for HIV incidence assays, and the FRR rate for this cutoff was 1.5%. Additionally, ARCHITECT Combo S/Co values were compared relative to diagnostic test results from two prior prospective HIV-1 diagnostic studies in order to validate the use of the S/Co for both diagnostic and recency determination.Conclusion Dual-use of the ARCHITECT Combo assay data for diagnostic and incidence purposes would reduce the need for separate HIV incidence testing and allow for monitoring of recent infection for incidence estimation and other public health applications. |
From people to Panthera: Natural SARS-CoV-2 infection in tigers and lions at the Bronx Zoo (preprint)
McAloose D , Laverack M , Wang L , Killian ML , Caserta LC , Yuan F , Mitchell PK , Queen K , Mauldin MR , Cronk BD , Bartlett SL , Sykes JM , Zec S , Stokol T , Ingerman K , Delaney MA , Fredrickson R , Ivančić M , Jenkins-Moore M , Mozingo K , Franzen K , Bergeson NH , Goodman L , Wang H , Fang Y , Olmstead C , McCann C , Thomas P , Goodrich E , Elvinger F , Smith DC , Tong S , Slavinski S , Calle PP , Terio K , Torchetti MK , Diel DG . bioRxiv 2020 2020.07.22.213959 We describe the first cases of natural SARS-CoV-2 infection detected in animals in the United States. In March 2020, four tigers and three lions at the Bronx Zoo developed mild respiratory signs. SARS-CoV-2 RNA was detected by rRT-PCR in respiratory secretions and/or feces from all seven affected animals; viral RNA and/or antibodies were detected in their keepers. SARS-CoV-2 was isolated from respiratory secretions or feces from three affected animals; in situ hybridization co-localized viral RNA with cellular damage. Whole genome sequence and haplotype network analyses showed tigers and lions were infected with two different SARS-CoV-2 strains, suggesting independent viral introductions. The source of SARS-CoV-2 infection in the lions is unknown. Epidemiological data and genetic similarities between keeper and tiger viruses indicate human to animal transmission.Competing Interest StatementThe authors have declared no competing interest. |
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