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Article ; Online: The augmented synthetic control method in public health and biomedical research.

Krajewski, Taylor / Hudgens, Michael

2024 Volume 33, Issue 3, Page(s) 376–391

Abstract: Estimating treatment (or policy or intervention) effects on a single individual or unit has become increasingly important in health and biomedical sciences. One method to estimate these effects is the synthetic control method, which constructs a ... ...

Abstract	Estimating treatment (or policy or intervention) effects on a single individual or unit has become increasingly important in health and biomedical sciences. One method to estimate these effects is the synthetic control method, which constructs a synthetic control, a weighted average of control units that best matches the treated unit's pre-treatment outcomes and other relevant covariates. The intervention's impact is then estimated by comparing the post-intervention outcomes of the treated unit and its synthetic control, which serves as a proxy for the counterfactual outcome had the treated unit not experienced the intervention. The augmented synthetic control method, a recent adaptation of the synthetic control method, relaxes some of the synthetic control method's assumptions for broader applicability. While synthetic controls have been used in a variety of fields, their use in public health and biomedical research is more recent, and newer methods such as the augmented synthetic control method are underutilized. This paper briefly describes the synthetic control method and its application, explains the augmented synthetic control method and its differences from the synthetic control method, and estimates the effects of an antimalarial initiative in Mozambique using both the synthetic control method and the augmented synthetic control method to highlight the advantages of using the augmented synthetic control method to analyze the impact of interventions implemented in a single region.
MeSH term(s)	Public Health ; Research Design ; Biomedical Research ; Mozambique
Language	English
Publishing date	2024-02-06
Publishing country	England
Document type	Journal Article
ZDB-ID	1136948-6
ISSN	1477-0334 ; 0962-2802
ISSN (online)	1477-0334
ISSN	0962-2802
DOI	10.1177/09622802231224638
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Article ; Online: Documenting Competing Needs to Well-Being Among Those on Community Supervision in the South.

LeMasters, Katherine / Krajewski, Taylor / Dong, Kimberly / Brinkley-Rubinstein, Lauren

Journal of correctional health care : the official journal of the National Commission on Correctional Health Care

2023 Volume 30, Issue 1, Page(s) 14–21

Abstract: Although the harms of incarceration on health are well known, little is known about individuals' competing priorities to maintaining their health while on probation and parole after release from incarceration. We explored individuals' competing needs on ... ...

Abstract	Although the harms of incarceration on health are well known, little is known about individuals' competing priorities to maintaining their health while on probation and parole after release from incarceration. We explored individuals' competing needs on probation and parole (lack of health insurance/access, hazardous alcohol use, substance use, food insecurity, un/underemployment, housing insecurity, lack of social support, length of recent incarceration, prohibitive monthly fees, criminal legal discrimination) to achieving well-being. We explored overlap between competing needs and overall well-being. This descriptive, cross-sectional analysis assesses the relationship between competing needs and current well-being of participants in The Southern Pre-Exposure Prophylaxis Study. Of 364 enrolled participants, 48% were thriving. The most common competing need was substance use (73%). Of the 10 competing needs, participants experienced a median 4 (interquartile range [IQR] 3-6). Those considered to be thriving experienced a median 4 (IQR 3-5) competing needs while those not thriving experienced a median 5 (IQR 4-6;
MeSH term(s)	Humans ; Cross-Sectional Studies ; Criminals ; Substance-Related Disorders/epidemiology ; Employment
Language	English
Publishing date	2023-12-27
Publishing country	United States
Document type	Journal Article
ZDB-ID	2233559-6
ISSN	1940-5200 ; 1078-3458
ISSN (online)	1940-5200
ISSN	1078-3458
DOI	10.1089/jchc.23.04.0027
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Article ; Online: Context specific HIV risk: evidence from screening into the southern pre-exposure prophylaxis study (SPECS).

LeMasters, Katherine / Krajewski, Taylor / Nowotny, Kathryn / Oser, Carrie / Mollan, Katie / Brinkley-Rubinstein, Lauren

AIDS care

2022 Volume 35, Issue 4, Page(s) 474–479

Abstract: While Pre-exposure prophylaxis (PrEP) is efficacious in preventing HIV, little is known about PrEP use among those on community supervision. The Southern Pre-Exposure Prophylaxis Study (SPECS) investigates barriers and facilitators for PrEP initiation ... ...

Abstract	While Pre-exposure prophylaxis (PrEP) is efficacious in preventing HIV, little is known about PrEP use among those on community supervision. The Southern Pre-Exposure Prophylaxis Study (SPECS) investigates barriers and facilitators for PrEP initiation and use among adults on community supervision (e.g., probation, parole). Challenges to PrEP use in this setting are abundant. SPECS uses a mixed-methods sequential design, including a multi-site, prospective cohort study in three southern states - North Carolina, Florida, and Kentucky. This analysis describes individual demographic, criminal legal, and HIV risk factor characteristics, by site and enrollment status. Pooled association analyses accounted for site via stratified statistical tests. Between June 2019-March 2020, SPECS screened 702 individuals and enrolled 276 participants (39%). Of those who were eligible, 98% agreed to enroll. Age, gender, and sexual orientation varied by enrollment and by site, while race/ethnicity varied by site but not enrollment status. Criminal legal histories varied by enrollment and HIV risk factors varied by site. SPECS provides a granular and detailed assessment of HIV risk in three diverse southern settings. It highlights how the level and type of HIV risk varies by location and by nature of criminal legal involvement and calls for the need for context-specific interventions for HIV prevention.
MeSH term(s)	Adult ; Humans ; Male ; Female ; HIV Infections/prevention & control ; HIV Infections/drug therapy ; Pre-Exposure Prophylaxis/methods ; Prospective Studies ; Sexual Behavior ; Anti-HIV Agents/therapeutic use
Chemical Substances	Anti-HIV Agents
Language	English
Publishing date	2022-04-04
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	1012651-x
ISSN	1360-0451 ; 0954-0121
ISSN (online)	1360-0451
ISSN	0954-0121
DOI	10.1080/09540121.2022.2059054
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Article: Collateral consequences of COVID-19 for people on probation and parole.

LeMasters, Katherine / Benson, Angela / Corsi, Christopher / Krajewski, Taylor / Seide, Kapriskie / Brinkley-Rubinstein, Lauren / Nowotny, Kathryn

Health & justice

2023 Volume 11, Issue 1, Page(s) 18

Abstract: Background: While the severe detrimental impact of COVID-19 on incarcerated people is well known, little is known about the experience of COVID-19 on those on community supervision. Our objective was to better understand the experience of the COVID-19 ... ...

Abstract	Background: While the severe detrimental impact of COVID-19 on incarcerated people is well known, little is known about the experience of COVID-19 on those on community supervision. Our objective was to better understand the experience of the COVID-19 pandemic and its collateral consequences for those on community supervision (e.g., probation, parole). Beginning in December 2020, we conducted 185 phone surveys about COVID-19 with participants in The Southern Pre-Exposure Prophylaxis (PrEP) Study across its three sites - Florida, Kentucky, and North Carolina. We conducted rapid assessment interviews with both closed- and open-ended questions. We calculated descriptive statistics for close-ended questions and conducted a content analysis for open-ended questions. Results: The COVID-19 pandemic affected those on community supervision through their experiences in the community and while incarcerated with over one-quarter of participants being reincarcerated during this time. In addition to many (128/185) experiencing COVID-19 symptoms, about half (85/185) of participants reported a diagnosis in their network with 16 of those participants losing loved ones to the pandemic. Participants experienced disruptions to their social network, healthcare, and livelihoods. Though many maintained their support systems, others felt isolated and depressed. Experiences during COVID-19 exacerbated difficulties already faced by those with criminal involvement. Conclusions: The public health community must recognize those experiencing probation and parole, not only those housed in carceral facilities, as disproportionately impacted by the COVID-19 pandemic. We must tailor programs and services to meet their needs.
Language	English
Publishing date	2023-03-30
Publishing country	England
Document type	Journal Article
ZDB-ID	2740401-8
ISSN	2194-7899
ISSN	2194-7899
DOI	10.1186/s40352-023-00221-0
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Article: Aided recall of

Vereen, Rhyan N / Krajewski, Taylor J / Wu, Euphy Y / Zhang, Jonathan H / Sanzo, Nora / Noar, Seth M

Preventive medicine reports

2022 Volume 28, Page(s) 101864

Abstract: E-cigarette use among youth remains a significant public health concern. In 2018, ...

Abstract	E-cigarette use among youth remains a significant public health concern. In 2018,
Language	English
Publishing date	2022-06-17
Publishing country	United States
Document type	Journal Article
ZDB-ID	2785569-7
ISSN	2211-3355
ISSN	2211-3355
DOI	10.1016/j.pmedr.2022.101864
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Article ; Online: Retention strategies among those on community supervision in the South: Lessons learned during the COVID-19 pandemic.

Uhrig Castonguay, Breana J / LeMasters, Katherine / Corsi, Chris / Batty, Evan J / Krajewski, Taylor J / Travis, Madelene / Waleed, Craig / Oser, Carrie B / Nowotny, Kathryn M / Brinkley-Rubinstein, Lauren

PloS one

2023 Volume 18, Issue 4, Page(s) e0283621

Abstract: Objectives: Cohort studies must implement effective retention strategies to produce internally valid and generalizable results. Ensuring all study participants are retained, particularly those involved in the criminal legal system, ensures study ... ...

Abstract	Objectives: Cohort studies must implement effective retention strategies to produce internally valid and generalizable results. Ensuring all study participants are retained, particularly those involved in the criminal legal system, ensures study findings and future interventions will be relevant to this group, who are often lost to follow-up: critical to achieving health equity. Our objective was to characterize retention strategies and describe overall retention among an 18-month longitudinal cohort study of persons on community supervision prior to and during the COVID-19 pandemic. Methods: We implemented various retention strategy best-practices (e.g., multiple forms of locator information, training study staff on rapport building, study-branded items). During the COVID-19 pandemic, we developed and describe new retention strategies. We calculated overall retention and analyzed differences between those retained and lost to follow-up by demographic characteristics. Results: Prior to the start of the COVID-19 pandemic, 227 participants enrolled across three sites (N = 46 North Carolina; N = 99 Kentucky; N = 82 Florida). Of these, 180 completed the final 18-month visit, 15 were lost to follow-up, and 32 were ineligible. This resulted in an overall retention of 92.3% (180/195). While most participant characteristics did not differ by retention status, a greater proportion of those experiencing unstable housing were lost to follow-up. Conclusion: Our findings highlight that when retention strategies are flexible, particularly during a pandemic, high retention is still achievable. In addition to retention best-practices (e.g., frequent requests for updated locator information) we suggest other studies consider retention strategies beyond the study participant (e.g., paying participant contacts) and incentivize on-time study visit completion (e.g., providing a bonus when completed the study visit on time).
MeSH term(s)	Humans ; COVID-19 ; Longitudinal Studies ; Pandemics ; Cohort Studies ; Patient Selection
Language	English
Publishing date	2023-04-05
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0283621
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Article ; Online: Infectious Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Virus in Symptomatic Coronavirus Disease 2019 (COVID-19) Outpatients: Host, Disease, and Viral Correlates.

Mollan, Katie R / Eron, Joseph J / Krajewski, Taylor J / Painter, Wendy / Duke, Elizabeth R / Morse, Caryn G / Goecker, Erin A / Premkumar, Lakshmanane / Wolfe, Cameron R / Szewczyk, Laura J / Alabanza, Paul L / Loftis, Amy James / Degli-Angeli, Emily J / Brown, Ariane J / Dragavon, Joan A / Won, John J / Keys, Jessica / Hudgens, Michael G / Fang, Lei /

Wohl, David A / Cohen, Myron S / Baric, Ralph S / Coombs, Robert W / Sheahan, Timothy P / Fischer, William A

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2022 Volume 75, Issue 1, Page(s) e1028–e1036

Abstract: Background: Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectious virus isolation in outpatients with coronavirus disease 2019 (COVID-19) has been associated with viral RNA levels and symptom duration, little is known about ... ...

Abstract	Background: Although severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infectious virus isolation in outpatients with coronavirus disease 2019 (COVID-19) has been associated with viral RNA levels and symptom duration, little is known about the host, disease, and viral determinants of infectious virus detection. Methods: COVID-19 adult outpatients were enrolled within 7 days of symptom onset. Clinical symptoms were recorded via patient diary. Nasopharyngeal swabs were collected to quantitate SARS-CoV-2 RNA by reverse transcriptase polymerase chain reaction and for infectious virus isolation in Vero E6-cells. SARS-CoV-2 antibodies were measured in serum using a validated ELISA assay. Results: Among 204 participants with mild-to-moderate symptomatic COVID-19, the median nasopharyngeal viral RNA was 6.5 (interquartile range [IQR] 4.7-7.6 log10 copies/mL), and 26% had detectable SARS-CoV-2 antibodies (immunoglobulin (Ig)A, IgM, IgG, and/or total Ig) at baseline. Infectious virus was recovered in 7% of participants with SARS-CoV-2 antibodies compared to 58% of participants without antibodies (prevalence ratio [PR] = 0.12, 95% confidence interval [CI]: .04, .36; P = .00016). Infectious virus isolation was also associated with higher levels of viral RNA (mean RNA difference +2.6 log10, 95% CI: 2.2, 3.0; P < .0001) and fewer days since symptom onset (PR = 0.79, 95% CI: .71, .88 per day; P < .0001). Conclusions: The presence of SARS-CoV-2 antibodies is strongly associated with clearance of infectious virus. Seropositivity and viral RNA levels are likely more reliable markers of infectious virus clearance than subjective measure of COVID-19 symptom duration. Virus-targeted treatment and prevention strategies should be administered as early as possible and ideally before seroconversion. Clinical trials registration: NCT04405570.
MeSH term(s)	Adult ; Antibodies, Viral ; COVID-19 ; COVID-19 Testing ; Communicable Diseases ; Humans ; Immunoglobulin A ; Outpatients ; RNA, Viral ; SARS-CoV-2
Chemical Substances	Antibodies, Viral ; Immunoglobulin A ; RNA, Viral
Language	English
Publishing date	2022-01-10
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciab968
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Article ; Online: The Antiviral Mechanism of Action of Molnupiravir in Humans with COVID-19

Sheahan, Timothy P / Stevens, Laura J / Narowski, Tara M / Krajewski, Taylor J / Lee, Chanhwa / Mollan, Katie R / Gribble, Jennifer / Moreria, Fernando R / Castillo, Izabella N / Cuadra, Edwing / Alabanza, Paul / James Loftis, Amy / Coombs, Robert W / Goecker, Erin A / Greninger, Alexander L / Chappell, James D / Brown, Ariane J / Won, John / Lipansky, Felicia /

Holman, Wayne / Szewczyk, Laura J / Baric, Ralph S / Painter, Wendy P / Eron, Joseph J / Premkumar, Lakshmanane / Denison, Mark R / Fischer, William A

medRxiv

Abstract: Meaningful metrics of antiviral activity are essential for determining the efficacy of therapeutics in human clinical trials. Molnupiravir (MOV) is a broadly acting antiviral nucleoside analog prodrug that acts as a competitive alternative substrate for ... ...

Abstract	Meaningful metrics of antiviral activity are essential for determining the efficacy of therapeutics in human clinical trials. Molnupiravir (MOV) is a broadly acting antiviral nucleoside analog prodrug that acts as a competitive alternative substrate for the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp). We developed an assay, Culture-PCR, to better understand the impact of MOV therapy on infectious SARS-CoV-2. Culture-PCR revealed MOV eliminated infectious virus within 48 hours in the nasopharyngeal compartment, the upper airway location with the greatest levels of infectious virus. MOV therapy was associated with increases in mutations across the viral genome but select regions were completely unaffected, thus identifying regions where mutation likely abrogates infectivity. MOV therapy did not alter the magnitude or neutralization capacity of the humoral immune response, a documented correlate of protection. Thus, we provide holistic insights into the function of MOV in adults with COVID-19.
Keywords	covid19
Language	English
Publishing date	2023-11-27
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2023.11.21.23298766
Database	COVID19

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Article: Infectious SARS-CoV-2 Virus in Symptomatic COVID-19 Outpatients: Host, Disease, and Viral Correlates.

Wohl, David A / Cohen, Myron S / Baric, Ralph S / Coombs, Robert W / Sheahan, Timothy P / Fischer, William A

medRxiv : the preprint server for health sciences

2021

Abstract: Background: While SARS-CoV-2 infectious virus isolation in outpatients with COVID-19 has been associated with viral RNA levels and symptom duration, little is known about the host, disease and viral determinants of infectious virus detection.: Methods! ...

Abstract	Background: While SARS-CoV-2 infectious virus isolation in outpatients with COVID-19 has been associated with viral RNA levels and symptom duration, little is known about the host, disease and viral determinants of infectious virus detection. Methods: COVID-19 adult outpatients were enrolled within 7 days of symptom onset. Clinical symptoms were recorded via patient diary. Nasopharyngeal swabs were collected to quantitate SARS-CoV-2 RNA by reverse transcriptase polymerase chain reaction and for infectious virus isolation in Vero E6-cells. SARS-CoV-2 antibodies were measured in serum using a validated ELISA assay. Results: Among 204 participants with mild-to-moderate symptomatic COVID19, the median nasopharyngeal viral RNA was 6.5 (IQR 4.7-7.6 log Conclusions: The presence of SARS-CoV-2 antibodies is strongly associated with clearance of infectious virus isolation. Seropositivity and viral RNA levels are likely more reliable markers of infectious virus clearance than subjective measure of COVID-19 symptom duration. Virus-targeted treatment and prevention strategies should be administered as early as possible and ideally before seroconversion. Clinicaltrialsgov identifier: NCT04405570.
Language	English
Publishing date	2021-06-25
Publishing country	United States
Document type	Preprint
DOI	10.1101/2021.05.28.21258011
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Article ; Online: SARS-CoV-2 infectious virus, viral RNA in nasopharyngeal swabs, and serostatus of symptomatic COVID-19 outpatients in the United States

Mollan, Katie R. / Eron, Joseph J. / Krajewski, Taylor J. / Painter, Wendy / Duke, Elizabeth R. / Morse, Caryn G. / Goecker, Erin A. / Premkumar, Lakshmanane / Wolfe, Cameron R. / Szewczyk, Laura J. / Alabanza, Paul L. / James Loftis, Amy / Degli-Angeli, Emily J. / Brown, Ariane J. / Dragavon, Joan A. / Won, John J. / Keys, Jessica / Hudgens, Michael G. / Wohl, David A. /

Cohen, Myron S. / Baric, Ralph S. / Coombs, Robert W. / Sheahan, Timothy P. / Fischer, William A.

medRxiv

Abstract: Background: SARS-CoV-2 infectious virus isolation in the upper airway of COVID-19 patients is associated with higher levels of viral RNA. However, comprehensive evaluation of the relationships between host and disease factors and infectious, replication ... ...

Abstract	Background: SARS-CoV-2 infectious virus isolation in the upper airway of COVID-19 patients is associated with higher levels of viral RNA. However, comprehensive evaluation of the relationships between host and disease factors and infectious, replication competent virus is needed. Methods: Symptomatic COVID-19 outpatients were enrolled from the United States. Clinical symptoms were recorded via patient diary. Nasopharyngeal swabs were collected to quantitate SARS-CoV-2 RNA by reverse transcriptase polymerase chain reaction and for infectious virus isolation in Vero E6-cells. SARS-CoV-2 antibodies were measured in serum using a validated ELISA assay. Findings: Among 204 participants within one week of reported symptom onset (median=5, IQR 4-5 days), median age was 40 (min-max: 18-82 years), median nasopharyngeal viral RNA was 6.5 (IQR 4.7-7.6 log10 copies/mL), and 26% had detectable SARS-CoV-2 antibodies at baseline. Infectious virus was recovered in 7% of participants with antibodies compared to 58% of participants without antibodies (probability ratio (PR)=0.12, 95% CI: 0.04, 0.36; p=0.00016). Infectious virus isolation was also associated with higher levels of viral RNA (mean RNA difference +2.6 log10, 95% CI: 2.2, 3.0; p<0.0001) and fewer days since symptom onset (PR=0.79, 95% CI: 0.71, 0.88 per day; p<0.0001). Interpretation: The presence of SARS-CoV-2 antibodies is strongly associated with clearance of infectious virus isolation. Seropositivity and viral RNA are likely more reliable markers of infectious virus suppression than subjective measure of COVID-19 symptoms. Virus-targeted treatment and prevention strategies should be administered as early as possible and ideally before seroconversion. Funding: Ridgeback Biotherapeutics, LP and NIH ClinicalTrials.gov Identifier: NCT04405570
Keywords	covid19
Language	English
Publishing date	2021-06-01
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.05.28.21258011
Database	COVID19

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