92 results on '"Kissinger PJ"'
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2. Trichomonas vaginalisvirus: a review of the literature
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Graves, KJ, primary, Ghosh, AP, additional, Kissinger, PJ, additional, and Muzny, CA, additional
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- 2019
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3. Trichomonas vaginalis virus: a review of the literature.
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Graves, KJ, Ghosh, AP, Kissinger, PJ, and Muzny, CA
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- 2019
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4. Frequent douching and clinical outcomes among HIV-infected women.
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Clark RA, Theall KP, Amedee AM, and Kissinger PJ
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- 2007
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5. Partner notification for HIV and syphilis: effects on sexual behaviors and relationship stability.
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Kissinger PJ, Niccolai LM, Magnus M, Farley TA, Maher JE, Richardson-Alston G, Dorst D, Myers L, Peterman TA, Kissinger, Patricia J, Niccolai, Linda M, Magnus, Manya, Farley, Thomas A, Maher, Julie E, Richardson-Alston, Gwangi, Dorst, Dennis, Myers, Leann, and Peterman, Thomas A
- Abstract
Background: Partner notification (PN), originally designed for syphilis control, has been used to control the spread of HIV since 1985. Because HIV infection is noncurable, the benefit of contact tracing and treatment demonstrated for the control of syphilis may not apply to HIV. For HIV, PN must facilitate behavior change that will reduce the spread of the infection. One concern is that HIV PN can promote the breakup of old partnerships and increase the acquisition of new partners, thereby spreading HIV infections.Goal: The purpose of this study was to determine the effect of partner notification (PN) on sexual behavior and relationship stability among HIV partnerships, with use of syphilis partnerships for comparison.Study Design: Partnerships were eligible if the index case was interviewed by a disease intervention specialist (DIS) for PN and named at least one sex partner. Partnership information was reported by index cases interviewed at baseline and 3 and 6 months post-PN. Trends in partnership dissolution and acquisition, sexual abstinence, condom use, emotional abuse, and physical violence reported by HIV infection and syphilis index cases were compared.Results: A total of 157 index cases (76 HIV infection and 81 syphilis) reported 220 partnerships (94 HIV and 126 syphilis). The PN process was completed for 32.7% of partnerships and it was completed more often for partnerships that were classified as main and cohabiting. After PN, 46.8% of partnerships dissolved, 15.9% of cases acquired a new partner, and emotional abuse and physical violence decreased significantly. HIV index cases were somewhat more likely to report using condoms at last sex act and less likely to acquire a new sex partner after PN compared to syphilis index cases. There was no difference post-PN between HIV infection and syphilis partnerships for partnership dissolution, physical violence, emotional abuse and abstention from sex.Conclusion: HIV PN did not appear to cause greater partnership dissolution, new partner acquisition, or violence compared with syphilis PN. [ABSTRACT FROM AUTHOR]- Published
- 2003
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6. Association between ancillary services and clinical and behavioral outcomes among HIV-infected women.
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Magnus M, Schmidt N, Kirkhart K, Schieffelin C, Fuchs N, Brown B, and Kissinger PJ
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- 2001
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7. Early repeat Chlamydia trachomatis and Neisseria gonorrhoeae infections among heterosexual men.
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Kissinger PJ, Reilly K, Taylor SN, Leichliter JS, Rosenthal S, Martin DH, Kissinger, Patricia J, Reilly, Kathleen, Taylor, Stephanie N, Leichliter, Jami S, Rosenthal, Susan, and Martin, David H
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- 2009
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8. Lack of association between genital tract HIV-1 RNA shedding and hormonal contraceptive use in a cohort of Louisiana women.
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Clark RA, Theall KP, Amedee AM, Dumestre J, Wenthold L, and Kissinger PJ
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- 2007
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9. Research and professional briefs. Ethnic differences in body image attitudes and perceptions among women infected with human immunodeficiency virus.
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Clark RA, Niccolai L, Kissinger PJ, Peterson Y, and Bouvier V
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- 1999
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10. Predictors of Adherence to a COVID-19 Serial Testing Program Among University Affiliates in the Deep South.
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Ratnayake A, Hassig S, He H, Lederer A, and Kissinger PJ
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Objective: Serial testing programs were used at many US universities during the earlier stages of the COVID-19 pandemic to minimize the risk of SARS-CoV-2 transmission among affiliates, though the effectiveness of such programs was contingent on adherence. In this study, researchers sought to determine factors associated with testing adherence., Design: Cross-sectional analyses were done in Spring and Fall of 2021., Setting: This study took place at a medium size, private university in the Deep South., Participants: Participants included university affiliates, including faculty/staff and students., Main Outcome Measures: Adherence to a mandated but unenforced serial testing program was assessed. All variables were ascertained through university records. Logistic regression models were used to determine factors associated with testing during both semesters., Results: In the Spring 2021 semester, staff and faculty had 23% greater odds of being tested compared to students. Paradoxically, the odds of adherence to testing decreased by 4% per year of age. In the Fall 2021 semester, the odds of being tested was 82% greater for staff and faculty compared to students and 27% higher for those who had a previous positive test compared to those who did not. Men had a 13% lower odds of testing than women. In both semesters, those who were unvaccinated had a significantly lower odds of testing compared to those who were vaccinated (86% and 92%, respectively), P < .001., Conclusions: Testing adherence was associated with vaccination status, suggesting that offering serial testing for those who are not vaccinated may not be an effective strategy in mitigating infection, in the absence of any enforcement. Additional factors such as age, sex, and affiliation status and testing adherence changed over the course of the pandemic suggesting the complexity of testing behaviors., Competing Interests: The authors declare no conflicts of interest., (Copyright © 2025 Wolters Kluwer Health, Inc. All rights reserved.)
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- 2025
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11. Hepatitis C Care in the Greater New Orleans Area: Patient Perspectives on the Barriers and Facilitators to Care.
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Lane BL, Seal DW, Robertson DJ, Kendall C, Hall CDX, Mgbere O, and Kissinger PJ
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- Humans, Female, Male, Middle Aged, New Orleans, Adult, Interviews as Topic, Patient Acceptance of Health Care psychology, Qualitative Research, Aged, Health Services Accessibility, Hepatitis C, Chronic therapy, Hepatitis C, Chronic psychology
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Increasing engagement in hepatitis C virus (HCV) care and treatment will help mitigate HCV incidence, morbidity, and mortality in the United States. This study aimed to understand the multilevel factors affecting engagement in HCV care after implementation of a subscription-based payment model for HCV treatment. Semi-structured interviews were conducted with patients with chronic HCV from a federally qualified health center in New Orleans, Louisiana. We used a convenience sampling method to recruit patients for the study. The interviews conducted between May 2020 and February 2021 explored factors influencing linkage to and retention in HCV care, using the socio-ecological model as the guiding framework. An analysis of the interviews with 39 patients revealed multilevel barriers to care, including instability, provider attitudes, prior care experiences, and the corrections system. Facilitators identified included personal health journey, network HCV experiences, and HCV awareness. A multilevel approach to facilitate engagement in HCV care is imperative.
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- 2025
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12. Spontaneous resolution of Trichomonas vaginalis infection in men.
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Van Gerwen OT, Aaron KJ, Schroeder J, Kissinger PJ, and Muzny CA
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- Humans, Male, Adult, Trichomonas Infections drug therapy, Trichomonas Infections epidemiology, Young Adult, Trichomonas Vaginitis drug therapy, Trichomonas Vaginitis diagnosis, Trichomonas Vaginitis epidemiology, Middle Aged, Antiprotozoal Agents therapeutic use, Nucleic Acid Amplification Techniques, Trichomonas vaginalis isolation & purification, Trichomonas vaginalis genetics, Metronidazole therapeutic use, Remission, Spontaneous
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Objectives: We aimed to investigate the early natural history of Trichomonas vaginalis in men recently testing positive for this infection by a nucleic acid amplification test (NAAT). We hypothesised that 50% of men would spontaneously resolve their infection (in the absence of treatment) on repeat T. vaginalis NAAT., Methods: Men ages ≥18 years at the Jefferson County Health Department Sexual Health Clinic testing positive for T. vaginalis by NAAT during standard-of-care (SOC) within the past 30 days and presenting to the clinic for treatment were approached. At enrolment, participants completed a questionnaire, provided urine for repeat T. vaginalis NAAT, and were treated with 2 g oral metronidazole. Those with a repeat positive enrolment NAAT were seen for a 4-week test-of-cure (TOC) visit. At TOC, men provided urine for repeat NAAT. We determined the proportion of men with spontaneous resolution of T. vaginalis and evaluated predictors of spontaneous resolution. In those with a repeat positive enrolment T. vaginalis NAAT, we evaluated the proportion with persistent infection at TOC as a secondary outcome., Results: Between October 2021 and January 2023, 53 men with a recent positive SOC T. vaginalis NAAT were approached; 37 (69.8%) participated. The mean participant age was 32.9 years (SD 9.9); all identified as Black. The majority (97.3%) reported sex with women only; 35.1% reported sex with >1 partner in the last month. At enrolment, 26/37 (70.3%) had a repeat positive T. vaginalis NAAT in the absence of treatment after an average of 8.4 days (SD 5.9). Sexual partner gender, number of recent sexual partners, genital symptoms, unprotected sex with any partner and recent antibiotic use were not associated with spontaneous resolution. Of the 26 men attending a TOC visit, 17 (65.4%) returned and all except one (94.1%) were cured., Conclusion: Most men do not spontaneously clear T. vaginalis infection during early repeat testing., Competing Interests: Competing interests: OVG has received research grant support from NIH, Abbott Molecular, Gilead Sciences, Visby and Moderna, served on a scientific advisory board for Scynexis, and done consulting for El Sevier, GSK, Abbott Molecular and Thermo Fisher for which she received honoraria. CAM has received research grant support to her institution from NIH/NIAID, Lupin Pharmaceuticals, Gilead Sciences, Visby Medical and Abbott Molecular. She also reports honorarium and/or consulting fees from Scynexis, Cepheid, BioNTech, BioMed Diagnostics, Visby Medical, Elsevier, UpToDate, Abbott Molecular and Roche. All other authors have no relevant interests to disclose., (© Author(s) (or their employer(s)) 2024. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2024
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13. Ability to Recontact Sex Partners and Partner Treatment Success Among Young Heterosexual Black Men With Chlamydia.
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Taylor C, Ratnayake A, Lederer A, Gomes G, He H, and Kissinger PJ
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- Adolescent, Adult, Female, Humans, Male, Young Adult, Black or African American, Chlamydia trachomatis, Heterosexuality, Chlamydia Infections prevention & control, Contact Tracing methods, Sexual Partners
- Abstract
Purpose: Patient-delivered partner therapy (PDPT) allows index patients who test positive for Chlamydia trachomatis (Ct) to provide treatment to partners directly. PDPT is contingent upon an index being able to contact their partner. The aims of this study were to assess factors related to being able to contact a partner and being able to successfully deliver their treatment., Methods: Participants were Black men who have sex with women aged 15-26 enrolled in a community Ct screening/treatment program in New Orleans, LA who tested positive for Ct and completed a computer-assisted survey. Factors associated with the index's ability to contact their recent sex partner(s) and to successfully deliver PDPT to his partner(s) were compared by characteristics of the relationship., Results: Of 104 young men who tested positive for Ct, the median age was 20.3 years and information was reported on 184 female partners, of whom 143 (77.7%) were deemed contactable by the index. Only the index wanting to have sex with the partner again was significantly associated with their ability to contact the partner (odds ratio [OR] 5.38, 95% confidence interval [CI] 2.18, 13.23). Only 72/184 (39.1%) partners received PDPT. The index being interested in sex with partner again (OR 2.54, 95% CI 1.23-5.27) was associated with greater odds of successful PDPT delivery whereas if index believed their partner had other partners, successful PDPT was less likely (OR 0.51, 95% CI 0.26-0.99). There was low agreement between an index's ability to contact their partner and the delivery of PDPT (kappa = 0.04 [-0.062, 0.143)., Discussion: Asking patients if they can recontact prior sexual parters may be insufficient to ensure that their partners receive PDPT., (Copyright © 2024 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2024
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14. Vaccine Hesitancy at Nine Community Sites Across the United States, Early in COVID-19 Vaccine Rollout.
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Ratnayake A, Hernandez JH, Justman J, Farley JE, Hirsch-Moverman Y, Ho K, Mayer S, Oluyomi A, Sobieszczyk ME, Swaminathan S, Skalland T, Tapsoba JD, and Kissinger PJ
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Background: Vaccine hesitancy has been a significant concern throughout the COVID-19 pandemic. Vaccine hesitancy can be attributed to lack of confidence in vaccines, complacency about the health threat, or lack of convenience of vaccination. To date, few studies have used methods designed to include populations underrepresented in research when identifying factors associated with vaccine hesitancy., Methods: Between January and July 2021, potential participants were recruited from community venues selected through time-location sampling in 15 defined communities in the United States. Study staff administered a questionnaire on demographics, COVID-19 behaviors and attitudes, and vaccination status or intention to consenting individuals. Vaccine hesitancy was analyzed among those age 18 years and older from nine of the 15 sites and was defined as self-reported neutral, unlikely, or very unlikely vaccine intention. Logistic regression modeling, adjusted for site, identified factors associated with vaccine hesitancy., Results: Among 11,559 individuals, vaccine hesitancy by site ranged from 8.7 to 31.1%. Vaccine hesitancy was associated with being Black compared to White, being White compared to Asian, younger age, unstable housing, being unemployed, lower income, having a disability, providing care in home, not reporting inability to visit sick or elderly relatives during the pandemic, not reporting increased anxiety during the pandemic, and not spending more time with loved ones during the pandemic., Conclusions: In these selected US communities, early in vaccine rollout, there were significant racial disparities in vaccine hesitancy. Additionally, individuals who were more marginalized due to their socioeconomic status were more likely to report vaccine hesitancy. Vaccine campaigns should make efforts to remove barriers to vaccination, by improving convenience., (© 2024. The Author(s).)
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- 2024
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15. Assessment of sociodemographic factors associated with time to self-reported COVID-19 infection among a large multi-center prospective cohort population in the southeastern United States.
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Beron AJ, Yukich JO, Berry AA, Correa A, Keating J, Bott M, Wierzba TF, Weintraub WS, Friedman-Klabanoff DJ, Mongraw-Chaffin M, Gibbs MA, Taylor YJ, Kissinger PJ, Hayes DV, Schieffelin JS, Burke BK, and Oberhelman RA
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- Humans, Female, Male, Adult, Southeastern United States epidemiology, Prospective Studies, Middle Aged, Adolescent, Young Adult, SARS-CoV-2 isolation & purification, Sociodemographic Factors, Aged, Risk Factors, COVID-19 epidemiology, Self Report
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Objective: We aimed to investigate sociodemographic factors associated with self-reported COVID-19 infection., Methods: The study population was a prospective multicenter cohort of adult volunteers recruited from healthcare systems located in the mid-Atlantic and southern United States. Between April 2020 and October 2021, participants completed daily online questionnaires about symptoms, exposures, and risk behaviors related to COVID-19, including self-reports of positive SARS CoV-2 detection tests and COVID-19 vaccination. Analysis of time from study enrollment to self-reported COVID-19 infection used a time-varying mixed effects Cox-proportional hazards framework., Results: Overall, 1,603 of 27,214 study participants (5.9%) reported a positive COVID-19 test during the study period. The adjusted hazard ratio demonstrated lower risk for women, those with a graduate level degree, and smokers. A higher risk was observed for healthcare workers, those aged 18-34, those in rural areas, those from households where a member attends school or interacts with the public, and those who visited a health provider in the last year., Conclusions: We identified subgroups within healthcare network populations defined by age, occupational exposure, and rural location reporting higher than average rates of COVID-19 infection for our surveillance population. These subgroups should be monitored closely in future epidemics of respiratory viral diseases., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Beron et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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- 2024
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16. The Rise and Fall of Expedited Partner Treatment.
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Kissinger PJ and Fortenberry JD
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- Humans, Female, Male, Sexually Transmitted Diseases drug therapy, Sexually Transmitted Diseases prevention & control, Gonorrhea drug therapy, Sexual Partners, Contact Tracing
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Competing Interests: Conflict of Interest and Sources of Funding: None declared.
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- 2024
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17. HIV Screening Among Young Black Men Who Have Sex with Women in New Orleans, LA.
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Ratnayake A, Gomes G, and Kissinger PJ
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- Adolescent, Adult, Female, Humans, Male, Young Adult, New Orleans epidemiology, Sexual Behavior, Black or African American psychology, HIV Infections diagnosis, HIV Infections prevention & control, HIV Infections epidemiology, HIV Infections ethnology, HIV Testing statistics & numerical data, Mass Screening statistics & numerical data, Sexual Partners
- Abstract
There are significant disparities in HIV acquisition, with Black individuals facing disproportionately more new diagnoses. Per Centers for Disease Control and Prevention (CDC), all people aged 13-64 should be tested at least once in their lifetime, and men at increased risk (e.g., those who have male sexual contact, multiple partners, have partners with multiple partners, or share drug injection equipment) should be tested annually. The study included young Black men who have sex with women (MSW), aged 15-26, and who live in New Orleans, LA. Survey data was used to elicit the frequency and factors associated with three self-reported outcomes: (1) history of ever HIV testing, (2) HIV screening in the last year among those who were recommended per CDC, and (3) HIV positivity. Of the 1321 men included, 694/1321 men (52.5%) reported ever having been HIV tested. There were 708/1321 (54.2%) men who met the recommendation for annual screening and 321/708 (45.3%) of these eligible men reported being tested in the previous year. Of those ever tested, 44/694 (6.3%) self-reported testing positive. In logistic regression analysis, older age (OR: 1.27, p < 0.001), prior STI testing (OR: 6.45, p < 0.001), and prior incarceration (OR:1.70, p = 0.006) were positively associated with having ever received an HIV test, and ever having a male partner (OR: 3.63, p = 0.014) was associated with HIV positivity. Initiatives to improve HIV testing rates among young Black men who have sex with women are needed to reduce the burden of HIV and help the End the Epidemic initiative., (© 2024. The Author(s).)
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- 2024
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18. Effectiveness of Incentivized Peer Referral to Increase Enrollment in a Community-Based Chlamydia Screening and Treatment Study Among Young Black Men.
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Campbell MB, Ratnayake A, Gomes G, Stoecker C, and Kissinger PJ
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- Adolescent, Adult, Humans, Male, Young Adult, Community Health Services, COVID-19 ethnology, Motivation, New Orleans epidemiology, Black or African American statistics & numerical data, Chlamydia Infections ethnology, Chlamydia Infections diagnosis, Chlamydia Infections prevention & control, Mass Screening statistics & numerical data, Peer Group, Referral and Consultation statistics & numerical data
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Objectives: Young Black men are under-represented in sexual health services and research, a condition likely magnified during COVID-19 shutdowns due to disruption of STI screening and treatment services. We examined the effect of incentivized peer referral (IPR) increasing peer referral among young Black men in a community-based chlamydia screening program., Methods: Young Black men in New Orleans, LA, age 15-26 years enrolled in a chlamydia screening program between 3/2018 and 5/2021 were included. Enrollees were provided with recruitment materials to distribute to peers. Starting July 28, 2020, enrollees were also offered a $5 incentive for each peer enrolled. Enrollment was compared before and after the incentivize peer referral program (IPR) was implemented using multiple time series analysis (MTSA)., Results: The percentage of men referred by a peer was higher during IPR compared to pre-IPR (45.7% vs. 19.7%, p < 0.001). After the COVID-19 shutdown was lifted, there were 2.007 more recruitments per week (p = 0.044, 95% CI (0.0515, 3.964)) for IPR, compared to pre-IPR. Overall, there was a trending increase in recruitments in the IPR era relative to the pre-IPR era (0.0174 recruitments/week, p = 0.285, 95% CI (- 0.0146, 0.0493)) with less recruitment decay during IPR compared to pre-IPR., Conclusions: IPR may be an effective means of engaging young Black men in community-based STI research and prevention programs, particularly when clinic access is limited., Clinical Trials Registry Site and Number: Clinicaltrials.gov identifier NCT03098329., (© 2023. W. Montague Cobb-NMA Health Institute.)
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- 2024
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19. Challenges in Male Partner Referral Among Trichomonas vaginalis -Infected Women.
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Pearlman RL, Van Gerwen OT, Aaron KJ, Kissinger PJ, and Muzny CA
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- Humans, Male, Female, Sexual Partners, Referral and Consultation, Public Health, Prevalence, Trichomonas vaginalis, Trichomonas Vaginitis
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Abstract: This study assessed feasibility of male partner referral by Trichomonas vaginalis -infected women. Of 93 women approached, only 20 enrolled. Only 1 male partner contacted the study but was unable to be reached for scheduling. Other public health interventions are necessary to engaged T. vaginalis -infected women and their male partners in care., (Copyright © 2024 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2024
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20. Prevalence of SARS-CoV-2 Infection among Children and Adults in 15 US Communities, 2021
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Justman J, Skalland T, Moore A, Amos CI, Marzinke MA, Zangeneh SZ, Kelley CF, Singer R, Mayer S, Hirsch-Moverman Y, Doblecki-Lewis S, Metzger D, Barranco E, Ho K, Marques ETA, Powers-Fletcher M, Kissinger PJ, Farley JE, Knowlton C, Sobieszczyk ME, Swaminathan S, Reed D, Tapsoba JD, Emel L, Bell I, Yuhas K, Schrumpf L, Mkumba L, Davis J, Lucas J, Piwowar-Manning E, and Ahmed S
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- Adult, Child, Humans, SARS-CoV-2, Cross-Sectional Studies, Prevalence, Seroepidemiologic Studies, COVID-19 epidemiology, Vaccines
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During January-August 2021, the Community Prevalence of SARS-CoV-2 Study used time/location sampling to recruit a cross-sectional, population-based cohort to estimate SARS-CoV-2 seroprevalence and nasal swab sample PCR positivity across 15 US communities. Survey-weighted estimates of SARS-CoV-2 infection and vaccine willingness among participants at each site were compared within demographic groups by using linear regression models with inverse variance weighting. Among 22,284 persons >2 months of age and older, median prevalence of infection (prior, active, or both) was 12.9% across sites and similar across age groups. Within each site, average prevalence of infection was 3 percentage points higher for Black than White persons and average vaccine willingness was 10 percentage points lower for Black than White persons and 7 percentage points lower for Black persons than for persons in other racial groups. The higher prevalence of SARS-CoV-2 infection among groups with lower vaccine willingness highlights the disparate effect of COVID-19 and its complications.
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- 2024
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21. Syphilis Screening Among Young Black Men Who Have Sex With Women in New Orleans, LA.
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Ratnayake A, Gomes G, and Kissinger PJ
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- Male, Female, Humans, Homosexuality, Male, New Orleans, Neisseria gonorrhoeae, Chlamydia trachomatis, Prevalence, Syphilis diagnosis, Syphilis epidemiology, HIV Infections, Gonorrhea diagnosis, Sexual and Gender Minorities, Chlamydia Infections diagnosis, Chlamydia Infections epidemiology
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Background: Current US syphilis screening focuses on men who have sex with men (MSM), because of the increased risk of infection in their sexual networks, and on pregnant people, because of complications associated with congenital syphilis. However, screening for men who have sex with women (MSW) who are at increased risk of syphilis is also recommended. Factors associated with syphilis testing and positivity were assessed among young, Black MSW., Methods: Data from the Check It study-a seek, test, and treat study for chlamydia in New Orleans, LA, among Black MSW aged 15 to 26 years-were used. Survey data were used to elicit self-reported syphilis testing, self-reported testing results, and sociodemographic and behavioral factors associated with these 2 outcomes., Results: Per the Centers for Disease Control and Prevention, all men in the study were recommended for syphilis screening because of their age, race, and geographic location. Of the 1458 men included, 272 (18.7%) reported ever having been syphilis tested, 267 men reported their results, and 23 (8.6%) reported testing positive. In logistic regression, older age (odds ratio [OR], 1.21 per year older; P < 0.001), prior Chlamydia trachomatis , Neisseria gonorrhoeae , and/or HIV testing (OR, 50.32; P < 0.001), and younger age at sexual debut (0.90 per year older, P = 0.005) were significantly associated with prior syphilis testing. In addition, testing positive for C. trachomatis and/or N. gonorrhoeae during the study was significantly associated with a history of syphilis positivity (OR, 3.08; P = 0.031)., Conclusions: Although syphilis testing was associated with factors that might increase the risk of acquisition, only 19% of individuals meeting Centers for Disease Control and Prevention testing recommendations had ever been screened., Competing Interests: Conflict of Interest and Sources of Funding: The authors have no conflicts of interest to declare., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2024
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22. The Association Between Human Immunodeficiency Virus and Bacterial Vaginosis and Metronidazole Treatment Failure for Trichomonas vaginalis.
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Frechtling D, Chopra S, Ratnayake A, and Kissinger PJ
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- Female, Humans, Metronidazole therapeutic use, HIV, Treatment Failure, Trichomonas vaginalis, Vaginosis, Bacterial complications, Vaginosis, Bacterial drug therapy, Trichomonas Vaginitis complications, Trichomonas Vaginitis drug therapy, HIV Infections
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Background: Trichomonas vaginalis (TV) is a common sexually transmitted infection. High rates of repeated infections have been observed, particularly among women living with human immunodeficiency virus (HIV). Trichomonas vaginalis frequently cooccurs with bacterial vaginosis (BV). The purpose of this study was to determine if coinfections with TV, BV, and HIV could lead to differential treatment failure outcomes., Methods: Data were pooled from 2 prior randomized control trials comparing 2 g oral single-dose versus 500-mg twice daily oral 7-day dose metronidazole for the treatment of TV in HIV infected and HIV uninfected women. Trichomonas vaginalis rates 1-month postcompletion of treatment were compared by arm, HIV and BV status after removing those who had sexual reexposure, and/or did not complete their treatment., Results: Data for 795 subjects were included in the study, of which 76 (9.6%) experienced treatment failure. In the final multivariable model, which included treatment dose, HIV status, and BV status, odds of treatment failure infection in the 7-day dose group were lower than the odds in the single dose group (odds ratio, 040; 95% confidence interval, 0.23-0.68). Treatment failure was lower in the multidose arm compared with single dose for both HIV-infected (4.0% vs 10.3%; P = 0.0568) and HIV-uninfected (7.3% vs 15.4%; P = 0.0037). Neither HIV nor BV was associated with higher treatment failure., Conclusions: Human immunodeficiency virus infection and BV status did not significantly alter the rate of repeat infection for either single dose or 7-day dose metronidazole. Among all women, 7-day metronidazole lowered the odds of treatment failure., Competing Interests: Conflict of Interest: None declared., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2024
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23. Where Do Tinidazole and Secnidazole Fit in With the Treatment of Trichomoniasis?
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Muzny CA and Kissinger PJ
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- Humans, Female, Tinidazole therapeutic use, Metronidazole therapeutic use, Trichomonas Infections drug therapy, Nitroimidazoles, Trichomonas Vaginitis drug therapy
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Competing Interests: Conflict of Interest and Sources of Funding: C.A.M. has received research grant support from Lupin Pharmaceuticals, Gilead Sciences, Inc, and Abbott Molecular; is a consultant for Lupin Pharmaceuticals, BioNTech, and BioFire Diagnostics; and has received honoraria from Elsevier, Abbott Molecular, Cepheid, Becton Dickinson, Roche Diagnostics, and Lupin Pharmaceuticals. P.J.K. does not have any conflicts to declare. C.A.M. and P.J.K. did not receive funding to develop this article.
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- 2023
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24. Are Prior Sexual Risk Behaviors Associated With Adherence to COVID-19 Preventative Behaviors Among Young Black Men?
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Ratnayake A, Campbell MB, Gomes G, and Kissinger PJ
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- Male, Humans, Female, Sexual Behavior, Sexual Partners, Risk-Taking, COVID-19 epidemiology, COVID-19 prevention & control, Sexually Transmitted Diseases prevention & control, Substance-Related Disorders, HIV Infections epidemiology, HIV Infections prevention & control
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Background: Behavioral clustering is a phenomenon in which several risk or protective behaviors co-occur in an individual. We sought to determine if prior sexual risk behaviors among young Black men who have sex with women could predict subsequent nonadherence to COVID-19 prevention behaviors., Methods: Young Black men who have sex with women aged 15 to 24 years previously enrolled in a community-based Chlamydia trachomatis (Ct) screening program were enrolled in a substudy between May and June 2020 and asked about adherence to 4 COVID-19 recommended nonpharmaceutical prevention behaviors (handwashing, mask wearing, social distancing, and following stay at home orders). Data from the original study were used to elicit the follow prepandemic behaviors including having multiple sex partners, inconsistent condom use, prior sexually transmitted infection testing behaviors, and substance use. Wilcoxon rank sum tests were used to assess the association between historic risk behaviors and COVID-19 behavior score., Results: There were 109 men included in the analysis, with a mean (SD) age of 20.5 (2.0) years. Inconsistent condom use, multiple sex partners, and prior HIV/sexually transmitted infection testing status were not associated with fewer COVID-19 preventive behaviors, but men who used any nonprescription drugs ( P = 0.001) or marijuana only ( P = 0.028) had a lower median COVID-19 preventative score compared with those who did not engage in those activities., Conclusions: Although none of the sexual risk behavior variables were associated, self-reported nonprescription drug and marijuana use were both significant predictors of lower adherence to COVID-19 preventative behaviors among young Black men. Young men who use drugs may need additional support to promote COVID-19 preventative behavior uptake., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2023
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25. Internet-Delivered Sexually Transmitted Infection and Teen Pregnancy Prevention Program: A Randomized Trial.
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Kissinger PJ, Green J, Latimer J, Schmidt N, Ratnayake A, Madkour AS, Clum G, Wingood GM, DiClemente RJ, and Johnson C
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- Adolescent, Pregnancy, Female, Humans, Uridine Triphosphate, Contraception, Condoms, Internet, Pregnancy in Adolescence prevention & control, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases prevention & control
- Abstract
Background: Black older-teenaged women have disproportionately high rates of sexually transmitted infections (STI) and unintended pregnancy (UTP). Internet-based interventions can be delivered to large groups of people in a relatively inexpensive manner. In this randomized trial, we examine the efficacy of an evidence-based STI/UTP prevention intervention adapted for older teens and for Internet delivery., Methods: Black women aged 18-19 years who were not pregnant/seeking to become pregnant were enrolled (n = 637) and randomized to an 8-session intervention or attention control and were followed up at 6/12 months postintervention. The primary outcome was defined as uptake of reliable contraceptives. Other secondary outcomes were examined, including intention to use condoms, intention to use reliable contraception, and STI or pregnancy rates., Results: Overall, at baseline, reliable contraception was 54.8% and dual protection was 29.4%, and the prevalence of STI was 11.1%. Participants were similar by arm for most factors considered. Participation and follow-up rates were excellent (60.9% and 80.3%). There was no statistically significant difference in uptake of reliable contraception for intervention versus controls at 6 months (1.45 [0.99-2.12]) or 12 months (1.33 [0.92-1.91]). At 6 months, several secondary outcomes were improved/trended toward improvement in intervention compared with control, but this effect waned by 12 months, except for intention to use condoms which remained improved., Conclusion and Relevance: The intervention was efficacious for increasing some self-reported UTP and STI prevention behaviors, which waned over time, and the intervention had minimal impact on STI or pregnancy rates suggesting that this type of online intervention may need additional components., Competing Interests: Conflict of Interest: None declared., (Copyright © 2023 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2023
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26. Delays in fibrosis staging reduce the likelihood of achieving hepatitis C treatment and cure.
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Jones AT, Moreno-Walton L, Sossamon SD, Tahmeena F, Tran T, Briones C, Stevens R, Isaacson K, He H, Rhodes S, Percak J, and Kissinger PJ
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- Humans, Antiviral Agents therapeutic use, Retrospective Studies, Hepacivirus, Liver Cirrhosis complications, Sustained Virologic Response, Hepatitis C diagnosis, Hepatitis C drug therapy, Hepatitis C complications, Hepatitis C, Chronic diagnosis, Hepatitis C, Chronic drug therapy, Hepatitis C, Chronic complications
- Abstract
Background: Updated 2021 hepatitis C virus (HCV) treatment guidelines no longer recommend fibrosis staging for treatment-naïve patients without cirrhosis; however, numerous US state Medicaid plans continue to restrict initiation of HCV therapy by fibrosis stage. The study objective was to determine whether delays from HCV diagnosis to fibrosis staging impact the likelihood of initiating/completing HCV treatment and achieving sustained virologic response (SVR)., Methods: A retrospective cohort study was performed among patients diagnosed with chronic HCV by an urban US emergency department who subsequently underwent fibrosis staging. Time elapsed from HCV diagnosis to hepatic fibrosis staging was evaluated on the likelihood of treatment initiation, treatment completion and SVR., Results: Among fibrosis staging modalities, hepatic ultrasounds occurred more quickly following HCV diagnosis (3.5 months, IQR = 12.4 months), compared to FibroSure (8.5 months, IQR = 20.4 months) and FibroScan (9.9 months, IQR = 18.0 months) ( p <.001). Each six-month delay in fibrosis staging decreased the likelihood of initiating treatment by 5% (adjusted relative risk (aRR)=0.95; 95% confidence interval (CI)=0.91-0.998; p =.04) and the likelihood of SVR by 7% (aRR = 0.93; 95% CI = 0.87-0.995; p =.04) after adjusting for insurance, race/ethnicity and history of HIV testing., Conclusions: Delays in hepatitis fibrosis staging were significantly associated with decreased likelihood of HCV treatment initiation and SVR.
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- 2023
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27. Sexual Networks and STI Infection Among Young Black Men Who Have Sex With Women in a Southern U.S. City.
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Sauter SR, Ratnayake A, Campbell MB, and Kissinger PJ
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- Adolescent, Female, Humans, Male, Sexual Partners, New Orleans epidemiology, Young Adult, Adult, Health Risk Behaviors, Heterosexuality statistics & numerical data, Gonorrhea epidemiology, Gonorrhea ethnology, Chlamydia Infections epidemiology, Chlamydia Infections ethnology, Sexual Behavior ethnology, Sexual Behavior statistics & numerical data, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases ethnology, Black or African American statistics & numerical data
- Abstract
Purpose: The configuration of one's sexual network has been shown to influence sexually transmitted infection (STI) acquisition in some populations. Young Black men who have sex with women (MSW) have high rates of STIs, yet little is known about their sexual networks. The purpose of this study is to describe the characteristics of sexual networks and their association with selected STI infections among young Black MSW., Methods: Black MSW aged 15-26 years who were enrolled in the New Orleans community-based screening program named Check It from March 2018 to March 2020 were tested for C. trachomatis and N. gonorrhoeae infection and asked about the nature of their sexual partnerships. Sexual partnerships with women were defined as dyadic, somewhat dense (either themselves or their partner had multiple partners), and dense (both they and their partner(s) had multiple partners)., Results: Men (n = 1,350) reported 2,291 sex partners. The percentage of men who reported their networks were dyadic, somewhat dense, and dense was 48.7%, 27.7%, and 23.3%, respectively; 11.2% were STI-positive and 39.2% thought their partner(s) had other partners. Compared to men in dyadic relationships, those in somewhat dense network did not have increased risk of STI infection, but those in dense networks were more likely to have an STI (adjusted odds ratio = 2.06, 95% confidence interval [1.35-3.13])., Discussion: Young Black MSW, who had multiple partners and who thought their partner(s) had other sex partners were at highest risk for STIs. Providers should probe not only about the youth's personal risk but should probe about perceived sexual partners' risk for more targeted counseling/STI testing., (Copyright © 2022 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.)
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- 2023
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28. A framework for using real-time evaluative interview feedback for health promotion program and evaluation improvement: The Check It case study.
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Lederer AM, Foster AM, Schmidt N, Gomes GR, Scott G Jr, Watson S, and Kissinger PJ
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- Male, Humans, Program Evaluation methods, Feedback, Program Development methods, Health Promotion
- Abstract
Formative evaluation is a crucial strategy for health promotion program improvement. Early and ongoing formative evaluation can make a major impact on program outcomes; however, there are few frameworks that provide actual guidance on how programmatic or research teams can systematically perform this kind of important work. In this article we describe the use of an iterative real-time interview feedback framework we developed for Check It, a community-wide chlamydia screening and treatment program for young African American men in New Orleans, Louisiana. The framework considers the diverse and needed perspectives of multiple stakeholders, including participants, interviewers, transcribers, program staff, and lead researchers and/or administrators. Interviews were conducted with N = 15 Check It participants utilizing this approach. Employing the framework led to critical insights that resulted in several vital programmatic and evaluation improvements. Lessons learned, including strengths and challenges of utilizing the framework, are also shared so that this model can be replicated or adapted by program planning and evaluation professionals for other kinds of programs., Competing Interests: Conflict of interest statement The authors have no conflicts of interest to disclose., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
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- 2023
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29. Past incarceration and chlamydia infection among young Black men in New Orleans.
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Stapleton JL, Ratnayake A, Gomes G, He H, and Kissinger PJ
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- Male, Adolescent, Humans, Female, New Orleans, Sexual Behavior, Chlamydia trachomatis, Correctional Facilities, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases prevention & control, Chlamydia Infections epidemiology, Chlamydia Infections diagnosis
- Abstract
Background: Young Black men are disproportionately and adversely affected by incarceration and sexually transmitted infections (STIs), both of which share common social and structural determinants. It is well documented that incarcerated individuals, including youth, are more likely to acquire STIs in the carceral setting compared to the general population. However, the effects of imprisonment on sexual health outcomes after imprisonment are not well-understood. The relationship between incarceration history (having ever spent time in a correctional institution such as prison, jail, or juvenile detention) and chlamydia positivity was examined in this study., Methods: A secondary analysis of the Check it Program, a Chlamydia trachomatis (Ct) community-based seek, test, and treat screening program for Black men aged 15-24 who have sex with women in New Orleans was conducted. Participants completed a computer-assisted self-administered questionnaire on relevant sexual and social histories and provided a urine specimen for a Ct urine nucleic acid amplification test. Bivariate and multivariable regressions were used to estimate the association between incarceration history and chlamydia positivity., Results: Participants ( N = 1,907) were enrolled from May 2017 to March 2020. Of those, 351/1,816 (19.3%) reported past incarceration and 203/1,888 (10.8%) tested positive for Ct. When adjusted for age, insurance status, and condom use, having a history of incarceration was positively associated with a positive Ct test (adjusted odds ratio (95% confidence interval):1.61 (1.12, 2.31), p = 0.0095)., Conclusions: Interacting with the carceral system is associated with a positive Ct test post-incarceration. Incarceration may be an important marker for Ct acquisition in young Black men who have sex with women and those with a history of incarceration should be prioritized for Ct screening after release., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Stapleton, Ratnayake, Gomes, He and Kissinger.)
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- 2023
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30. Using time-weighted average change from baseline of SARS-CoV-2 viral load to assess impact of hydroxychloroquine as postexposure prophylaxis and early treatment for COVID-19.
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Kumbhakar R, Neradilek M, Barnabas RV, Stewart J, Stankiewicz Karita HC, Landovitz RJ, Kissinger PJ, Jerome KR, Paasche-Orlow MK, Bershteyn A, Chu HY, Neuzil KM, Greninger AL, Luk A, Wald A, Brown ER, and Johnston C
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- Humans, Hydroxychloroquine therapeutic use, Viral Load, COVID-19 prevention & control, SARS-CoV-2, COVID-19 Drug Treatment
- Abstract
Two randomized controlled trials demonstrated no clinical benefit of hydroxychloroquine (HCQ) for either postexposure prophylaxis or early treatment of SARS-CoV-2 infection. Using data from these studies, we calculated the time-weighted average change from baseline SARS-CoV-2 viral load and demonstrated that HCQ did not affect viral clearance., (© 2022 Wiley Periodicals LLC.)
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- 2022
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31. Anal and Oral Sex Behaviors Among Young Black Men Who Have Vaginal Sex: Evidence of the Need for Extragenital Testing for Chlamydia and Gonorrhea.
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Ratnayake A, Campbell MB, Jones A, Gomes G, Martin DH, and Kissinger PJ
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- Adolescent, Male, Female, Humans, Sexual Behavior, Condoms, Sexual Partners, Gonorrhea epidemiology, Sexually Transmitted Diseases epidemiology, Chlamydia, Chlamydia Infections diagnosis, Chlamydia Infections epidemiology
- Abstract
Background: Unprotected oral and anal sex may result in extragenital sexually transmitted infections. The purposes of this study were to describe sexual behaviors, barrier use, and chlamydia/gonorrhea (Ct/GC) positivity among young Black men who have sex with women, and to examine the potential influence of extragenital infections on genital infections., Methods: Young Black men who had vaginal sex were screened for Ct/GC in New Orleans, LA, from August 14, 2019, to February 29, 2020. Audio/computer-assisted self-interviews were used to collect data on demographics and sexual behaviors. χ2 /Fisher exact or t test/Wilcoxon rank tests were used to assess differences in behaviors by Ct/GC positivity., Results: Among 373 men studied, 619 female partnerships were reported in the past 2 months. Vaginal sex was reported in all partnerships per study protocol, receiving fellatio in 42.7%, performing cunnilingus in 35.7%, and penile-anal sex in 5.9%. Although 31.4% of the men consistently used condoms for vaginal sex with all partners, consistent barrier use was low during cunnilingus (0.5%) and fellatio (5.1%). Urethral infection rates among all men in the sample were 12.6% for Ct and 1.6% for GC. There was no significant difference in Ct/GC rates between those using and not using condoms consistently during vaginal sex ( P = 0.38)., Conclusions: Unprotected oral sex with female partners was common. The high rate of genital infection among men who used condoms consistently for vaginal sex suggests that oral infections could be serving as a reservoir of genital infection. Testing at all sites of exposure for youth who engage in heterosexual sex is merited., Competing Interests: Conflict of Interest and Sources of Funding: None reported., (Copyright © 2022 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2022
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32. Self-Assessed Severity as a Determinant of Coronavirus Disease 2019 Symptom Specificity: A Longitudinal Cohort Study.
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Bershteyn A, Dahl AM, Dong TQ, Deming ME, Celum CL, Chu HY, Kottkamp AC, Greninger AL, Hoffman RM, Jerome KR, Johnston CM, Kissinger PJ, Landovitz RJ, Laufer MK, Luk A, Neuzil KM, Paasche-Orlow MK, Pitts RA, Schwartz MD, Stankiewicz Karita HC, Thorpe LE, Wald A, Zheng CY, Wener MH, Barnabas RV, and Brown ER
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- COVID-19 Testing, Humans, Longitudinal Studies, SARS-CoV-2, COVID-19 diagnosis
- Abstract
Coronavirus disease 2019 symptom definitions rarely include symptom severity. We collected daily nasal swab samples and symptom diaries from contacts of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) case patients. Requiring ≥1 moderate or severe symptom reduced sensitivity to predict SARS-CoV-2 shedding from 60.0% (95% confidence interval [CI], 52.9%-66.7%) to 31.5% (95% CI, 25.7%- 38.0%) but increased specificity from 77.5% (95% CI, 75.3%-79.5%) to 93.8% (95% CI, 92.7%-94.8%)., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America.)
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- 2022
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33. Closing the hepatitis C treatment gap: United States strategies to improve retention in care.
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Jones AT, Briones C, Tran T, Moreno-Walton L, and Kissinger PJ
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- Antiviral Agents therapeutic use, Hepacivirus, Humans, United States, Hepatitis C drug therapy, Hepatitis C epidemiology, Hepatitis C, Chronic drug therapy, Retention in Care
- Abstract
The hepatitis C virus (HCV) treatment landscape is shifting given the advent of direct-acting antivirals and a global call to action by the World Health Organization. Eliminating HCV is now an issue of healthcare delivery. Treatment is limited by the complexity of the HCV care continuum, expensive therapy and competing health burdens experienced by an underserved HCV population. The objective of this literature review was to assess strategies to improve retention in HCV care, with particular focus on those implemented in the United States. We identified barriers in HCV care retention and propose solutions to increase HCV treatment delivery. The following recommendations are herein described: improving the cohesion of health services through localized care and integrated case management, expanding the supply of non-specialist HCV treatment providers, leveraging patient navigators and care coordinators, improving adherence through directly observed therapy and reducing cost barriers through value-based payment and pharmaceutical subscription models., (© 2022 John Wiley & Sons Ltd.)
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- 2022
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34. Cost-effectiveness of Check It: A Novel Community-Based Chlamydia Screening and Expedited Treatment Program for Young Black Men.
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Stoecker C, Monnette A, Qu Z, Schmidt N, Craig-Kuhn MC, and Kissinger PJ
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- Adolescent, Adult, Chlamydia trachomatis, Cost-Benefit Analysis, Female, Humans, Male, Mass Screening, Quality-Adjusted Life Years, Young Adult, Chlamydia Infections diagnosis, Chlamydia Infections drug therapy, Chlamydia Infections epidemiology
- Abstract
Background: We assessed the cost-effectiveness of the Check It program, a novel community-based chlamydia screening and expedited partner treatment program for young Black men conducted in New Orleans since 2017., Methods: We implemented a probabilistic cost-effectiveness model using a synthetic cohort of 16 181 men and 13 419 women intended to simulate the size of the Black, sexually active population in New Orleans ages 15-24 years., Results: The Check It program cost $196 838 (95% confidence interval [CI]: $117 320-$287 555) to implement, saved 10.2 quality-adjusted life-years (QALYs; 95% CI: 7.7-12.7 QALYs), and saved $140 950 (95% CI: -$197 018 to -$105 620) in medical costs per year. The program cost $5468 (95% CI: cost saving, $16 717) per QALY gained. All iterations of the probabilistic model returned cost-effectiveness ratios less than $50 000 per QALY gained., Conclusions: The Check It program (a bundled seek, test, and treat chlamydia prevention program for young Black men) is cost-effective under base case assumptions. Communities where Chlamydia trachomatis rates have not declined could consider implementing a similar program., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2022
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35. Burden of trichomoniasis among older adults in the United States: a systematic review.
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Lindrose AR, Htet KZ, O'Connell S, Marsh J, and Kissinger PJ
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- Aged, Humans, Incidence, Mass Screening, Prevalence, United States epidemiology, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases prevention & control, Trichomonas Infections epidemiology
- Abstract
Despite being one of the most common sexually transmitted infections (STIs) in the United States, the epidemiology of trichomoniasis remains understudied. One population that has been historically overlooked regarding STIs is that of older adults, despite many individuals remaining sexually active well into their older years. We investigated the reported prevalence and incidence of trichomoniasis in adults aged ≥45years in the United States using a systematic literature review. Twelve articles were included in the review, all assessing prevalence of trichomoniasis in this age group. Notably, no included articles assessed trichomoniasis incidence. Data collected encompassed several decades, from 1993 to 2016. Estimates of infection prevalence varied widely and ranged from 0.2% to 21.4% in included populations, with the highest prevalence typically seen among individuals seeking diagnostic testing for STIs. Several studies found increased risk for trichomoniasis in older patients compared to younger age groups. This is the first review to examine the risk of trichomoniasis in older adults, and the surprisingly high prevalence suggests that older adults may merit increased screening for trichomoniasis and sexual health education.
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- 2022
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36. Emergency department versus community screening on hepatitis C follow-up care.
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Jones AT, Moreno-Walton L, Tran T, Briones C, Okeke-Eweni K, Stevens R, Isaacson K, He H, and Kissinger PJ
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- Aftercare, Emergency Service, Hospital, Fibrosis, Humans, Mass Screening, RNA, Retrospective Studies, Hepacivirus, Hepatitis C diagnosis, Hepatitis C drug therapy, Hepatitis C epidemiology
- Abstract
Objectives: Emergency department (ED) hepatitis C virus (HCV) screening programs are proliferating, and it is unknown whether EDs are more effective than traditional community screening at promoting HCV follow-up care. The objective of this study was to investigate whether patients screened HCV seropositive (HCV+) in the ED are linked to care and retained in treatment more successfully than patients screened HCV+ in the community., Methods: A retrospective cohort study was performed including patients screened HCV+ at twelve screening facilities in New Orleans, LA from March 1, 2015 to July 31, 2017. Treatment outcomes, including retention and time to follow-up care, were assessed using the HCV continuum of care model., Results: ED patients (n = 3008) were significantly more likely to achieve RNA confirmation (aRR = 1.91, 95% CI = 1.54-2.37), initiate HCV therapy (aRR = 2.23 [1.76-2.83]), complete HCV therapy (aRR = 1.77 [1.40-2.24]), and achieve HCV functional cure (aRR = 2.80 [1.09-7.23]) compared to community-screened patients (n = 322). ED screening was associated with decreased likelihood of fibrosis staging (aRR = 0.65 [0.51-0.82]) and no difference in linkage to specialty care (aRR = 1.03 [0.69-1.53]). In time to follow up, RNA confirmation occurred at faster rates in the ED (aHR = 2.26 [1.86-2.72]), although these patients completed fibrosis staging at slower rates (aHR = 0.49 [0.38-0.63]) than community patients., Conclusions: Compared to community screening, HCV screening in the ED was associated with higher rates of disease confirmation, treatment initiation/completion, and cure. Our findings provide new evidence that EDs may be the most effective setting to screen patients for HCV to promote follow-up care., Competing Interests: Declaration of Competing Interest None., (Copyright © 2022 Elsevier Inc. All rights reserved.)
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- 2022
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37. Diagnosis and Management of Trichomonas vaginalis: Summary of Evidence Reviewed for the 2021 Centers for Disease Control and Prevention Sexually Transmitted Infections Treatment Guidelines.
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Kissinger PJ, Gaydos CA, Seña AC, Scott McClelland R, Soper D, Secor WE, Legendre D, Workowski KA, and Muzny CA
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- Centers for Disease Control and Prevention, U.S., Female, Humans, Infant, Newborn, Male, Metronidazole therapeutic use, Pregnancy, United States epidemiology, HIV Infections diagnosis, HIV Infections drug therapy, HIV Infections epidemiology, Premature Birth, Sexually Transmitted Diseases diagnosis, Sexually Transmitted Diseases drug therapy, Sexually Transmitted Diseases epidemiology, Trichomonas Infections diagnosis, Trichomonas Infections drug therapy, Trichomonas Infections epidemiology, Trichomonas Vaginitis diagnosis, Trichomonas Vaginitis drug therapy, Trichomonas Vaginitis epidemiology, Trichomonas vaginalis
- Abstract
Trichomonas vaginalis is likely the most prevalent nonviral sexually transmitted infection, affecting an estimated 3.7 million women and men in the United States. Health disparities are prominent in the epidemiology of trichomoniasis, as African Americans are >4 times more likely to be infected than persons of other races. Since publication of the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines, additional data have bolstered the importance of T. vaginalis infection sequelae in women, including increased risk of human immunodeficiency virus (HIV) acquisition, cervical cancer, preterm birth, and other adverse pregnancy outcomes. Less is known about the clinical significance of infection in men. Newly available diagnostic methods, including point-of-care assays and multiple nucleic acid amplification tests, can be performed on a variety of genital specimens in women and men, including urine, allowing more accurate and convenient testing and screening of those at risk for infection. Repeat and persistent infections are common in women; thus, rescreening at 3 months after treatment is recommended. In vitro antibiotic resistance to 5-nitroimidazole in T. vaginalis remains low (4.3%) but should be monitored. High rates of T. vaginalis among sexual partners of infected persons suggest a role for expedited partner treatment. A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the proportion of women with Trichomonas infection at 1 month test of cure compared with women receiving single-dose therapy (2 g). The 2-g single-dose oral metronidazole regimen remains the preferred treatment in men., (© The Author(s) 2022. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2022
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38. Report From the National Academies of Sciences, Engineering and Medicine-STI: Adopting a Sexual Health Paradigm-A Synopsis for Sexually Transmitted Infection Practitioners, Clinicians, and Researchers.
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Rietmeijer CA, Kissinger PJ, Guilamo-Ramos V, Gaydos CA, Hook EW 3rd, Mead A, Yang S, Geller A, and Vermund SH
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- Adolescent, Adult, Humans, Public Health, Sexual Behavior, HIV Infections prevention & control, Sexual Health education, Sexually Transmitted Diseases diagnosis, Sexually Transmitted Diseases epidemiology, Sexually Transmitted Diseases prevention & control
- Abstract
Abstract: Despite decades of medical, diagnostic, and public health advances related to diagnosis and management of sexually transmitted infections (STIs), rates of reportable STIs continue to grow. A 2021 National Academies of Sciences, Engineering, and Medicine report on the current state of STI management and prevention in the United States, entitled Sexually Transmitted Infections: Adopting a Sexual Health Paradigm, offers recommendations on future public health programs, policy, and research. This new report builds upon the 1997 Institute of Medicine report, The Hidden Epidemic: Confronting Sexually Transmitted Diseases, and provides 11 recommendations organized under 4 action areas: (1) adopt a sexual health paradigm, (2) broaden ownership and accountability for responding to STIs, (3) bolster existing systems and programs for responding to STIs, and (4) embrace innovation and policy change to improve sexual health. We present our interpretive synopsis of this report, highlighting elements of particular interest to STI and sexual health practitioners, including clinicians, researchers, disease intervention specialists, community outreach workers, and public health staff. The report asserts that it is possible to create a healthier and more equitable future where fewer adolescents and adults are infected, fewer babies are born with STIs, and people entering their sexual debut and continuing throughout the life span are taught the language and skills to conceptualize and enact their own vision for what it means to be sexually healthy., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2022
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39. Trajectory of Viral RNA Load Among Persons With Incident SARS-CoV-2 G614 Infection (Wuhan Strain) in Association With COVID-19 Symptom Onset and Severity.
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Stankiewicz Karita HC, Dong TQ, Johnston C, Neuzil KM, Paasche-Orlow MK, Kissinger PJ, Bershteyn A, Thorpe LE, Deming M, Kottkamp A, Laufer M, Landovitz RJ, Luk A, Hoffman R, Roychoudhury P, Magaret CA, Greninger AL, Huang ML, Jerome KR, Wener M, Celum C, Chu HY, Baeten JM, Wald A, Barnabas RV, and Brown ER
- Subjects
- Adult, COVID-19 complications, Female, Humans, Incidence, Longitudinal Studies, Male, Middle Aged, Molecular Diagnostic Techniques methods, Polymerase Chain Reaction methods, Prospective Studies, Serologic Tests, COVID-19 virology, RNA, Viral, SARS-CoV-2, Severity of Illness Index, Viral Load, Virus Shedding
- Abstract
Importance: The SARS-CoV-2 viral trajectory has not been well characterized in incident infections. These data are needed to inform natural history, prevention practices, and therapeutic development., Objective: To characterize early SARS-CoV-2 viral RNA load (hereafter referred to as viral load) in individuals with incident infections in association with COVID-19 symptom onset and severity., Design, Setting, and Participants: This prospective cohort study was a secondary data analysis of a remotely conducted study that enrolled 829 asymptomatic community-based participants recently exposed (<96 hours) to persons with SARS-CoV-2 from 41 US states from March 31 to August 21, 2020. Two cohorts were studied: (1) participants who were SARS-CoV-2 negative at baseline and tested positive during study follow-up, and (2) participants who had 2 or more positive swabs during follow-up, regardless of the initial (baseline) swab result. Participants collected daily midturbinate swab samples for SARS-CoV-2 RNA detection and maintained symptom diaries for 14 days., Exposure: Laboratory-confirmed SARS-CoV-2 infection., Main Outcomes and Measures: The observed SARS-CoV-2 viral load among incident infections was summarized, and piecewise linear mixed-effects models were used to estimate the characteristics of viral trajectories in association with COVID-19 symptom onset and severity., Results: A total of 97 participants (55 women [57%]; median age, 37 years [IQR, 27-52 years]) developed incident infections during follow-up. Forty-two participants (43%) had viral shedding for 1 day (median peak viral load cycle threshold [Ct] value, 38.5 [95% CI, 38.3-39.0]), 18 (19%) for 2 to 6 days (median Ct value, 36.7 [95% CI, 30.2-38.1]), and 31 (32%) for 7 days or more (median Ct value, 18.3 [95% CI, 17.4-22.0]). The cycle threshold value has an inverse association with viral load. Six participants (6%) had 1 to 6 days of viral shedding with censored duration. The peak mean (SD) viral load was observed on day 3 of shedding (Ct value, 33.8 [95% CI, 31.9-35.6]). Based on the statistical models fitted to 129 participants (60 men [47%]; median age, 38 years [IQR, 25-54 years]) with 2 or more SARS-CoV-2-positive swab samples, persons reporting moderate or severe symptoms tended to have a higher peak mean viral load than those who were asymptomatic (Ct value, 23.3 [95% CI, 22.6-24.0] vs 30.7 [95% CI, 29.8-31.4]). Mild symptoms generally started within 1 day of peak viral load, and moderate or severe symptoms 2 days after peak viral load. All 535 sequenced samples detected the G614 variant (Wuhan strain)., Conclusions and Relevance: This cohort study suggests that having incident SARS-CoV-2 G614 infection was associated with a rapid viral load peak followed by slower decay. COVID-19 symptom onset generally coincided with peak viral load, which correlated positively with symptom severity. This longitudinal evaluation of the SARS-CoV-2 G614 with frequent molecular testing serves as a reference for comparing emergent viral lineages to inform clinical trial designs and public health strategies to contain the spread of the virus.
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- 2022
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40. Impact of Check It: A Novel Community-Based Chlamydia Screening and Expedited Treatment Program for Young Black Men.
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Stoecker C, Shao Y, Schmidt N, Martin DH, and Kissinger PJ
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- Black People, Female, Humans, Louisiana epidemiology, Male, Mass Screening methods, Black or African American, Chlamydia, Chlamydia Infections diagnosis, Chlamydia Infections epidemiology, Chlamydia Infections prevention & control
- Abstract
Objectives: This study aimed to estimate the impact of the Check It program, a novel community-based chlamydia seek, test, and treat program for young Black men who have sex with women, on test positivity rates for chlamydia in young Black women., Methods: We used a synthetic control model to compare chlamydia test positivity rates in Orleans Parish (intervention site) with other similar parishes (control sites) in Louisiana. We estimated a model that used all other parishes as potential contributors to a synthetic control for Louisiana as well as a sample limited to the 40 parishes in Louisiana with the largest Black populations., Results: The Check It program was associated with a 1.69-percentage-point decline in chlamydia positivity in the first full year of operation and a 2.44-percentage-point decline in chlamydia positivity in the second full year of operation compared with control sites with the largest Black populations (P = 0.05). Results were similar when the treatment site was compared with all other sites in Louisiana., Conclusions: The Check It program was associated with a significant decline in chlamydia testing positivity rates among women in Orleans Parish compared with control sites. Screening of young Black men who have sex with women can decrease rates in women living in the same community. Future recommendations for chlamydia screening of young men should be considered., Competing Interests: Conflict of Interest and Sources of Funding: This study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Allergy and Infectious Diseases (grant no. R01-HD086794). The authors have no conflicts to declare., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2022
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41. Check It: A Community-Based Chlamydia Seek, Test, and Treat Program for Young Black Men Who Have Sex With Women in New Orleans, Louisiana.
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Schmidt N, Gomes G, Scott G Jr, Wise B, Craig-Kuhn MC, Lederer AM, Martin DH, and Kissinger PJ
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- Adolescent, Adult, Chlamydia trachomatis, Female, Humans, Louisiana, Male, New Orleans epidemiology, Young Adult, Chlamydia Infections diagnosis, Chlamydia Infections drug therapy, Chlamydia Infections epidemiology, Sexual Partners
- Abstract
Background: Check It is a novel, bundled, community-based seek, test, and treat Chlamydia trachomatis (Ct) screening program for 15- to 24-year-old Black men in New Orleans who have sex with women. The program design addressed barriers and facilitators to Ct screening/treatment by enlisting trusted community partners, incorporating participant input, providing free index/partner expedited treatment, developing relatable marketing materials and an educational Web site, encouraging peer referral, and providing a modest monetary incentive., Methods: Areas of high poverty were identified using census data; ethnographic/key informant interviews identified sites in those areas where the target population congregated. Black youth informed Web site design and social marketing. Content was inspirational/educational/amusing and endorsed recruitment and brand awareness. A community advisory board, participant interviews, community partner feedback, and recruitment staff involvement in the process evaluation helped refine the program in an ongoing manner., Results: During formative stages, 41 key informant/community advisory board members informed program refinement. Community partners provided venue locations (n = 65) and participant referrals. Between May 22, 2017, and February 28, 2020, 1890 men were enrolled (acceptance rate, 96.0%) with Ct infection rate of 10.2%. Overall study treatment was provided to 86.1% (71.4%-90.9%) of participants who tested positive and 28.5% (14.5%-41.5%) of their partners. Findings from in-depth interviews with participants (n = 43) led to increased treatment uptake., Conclusions: C. trachomatis community screening of young Black men was successful through collaboration with trusted community partners, by tailoring implements/marketing with participant input, reducing barriers to treatment, and providing modest monetary incentives. The Check It program can serve as a roadmap for reducing health disparities in this population., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2022
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42. Implementation of a fully remote randomized clinical trial with cardiac monitoring.
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Mayfield JJ, Chatterjee NA, Noseworthy PA, Poole JE, Ackerman MJ, Stewart J, Kissinger PJ, Dwyer J, Hosek S, Oyedele T, Paasche-Orlow MK, Paolino K, Friedman PA, Waters C, Moreno J, Leingang H, Heller KB, Morrison SA, Krows ML, Barnabas RV, Baeten J, Johnston C, and Sridhar AR
- Abstract
Background: The coronavirus disease 2019 (COVID-19) pandemic has challenged researchers performing clinical trials to develop innovative approaches to mitigate infectious risk while maintaining rigorous safety monitoring., Methods: In this report we describe the implementation of a novel exclusively remote randomized clinical trial (ClinicalTrials.gov NCT04354428) of hydroxychloroquine and azithromycin for the treatment of the SARS-CoV-2-mediated COVID-19 disease which included cardiovascular safety monitoring. All study activities were conducted remotely. Self-collected vital signs (temperature, respiratory rate, heart rate, and oxygen saturation) and electrocardiographic (ECG) measurements were transmitted digitally to investigators while mid-nasal swabs for SARS-CoV-2 testing were shipped. ECG collection relied on a consumer device (KardiaMobile 6L, AliveCor Inc.) that recorded and transmitted six-lead ECGs via participants' internet-enabled devices to a central core laboratory, which measured and reported QTc intervals that were then used to monitor safety., Results: Two hundred and thirty-one participants uploaded 3245 ECGs. Mean daily adherence to the ECG protocol was 85.2% and was similar to the survey and mid-nasal swab elements of the study. Adherence rates did not differ by age or sex assigned at birth and were high across all reported race and ethnicities. QTc prolongation meeting criteria for an adverse event occurred in 28 (12.1%) participants, with 2 occurring in the placebo group, 19 in the hydroxychloroquine group, and 7 in the hydroxychloroquine + azithromycin group., Conclusions: Our report demonstrates that digital health technologies can be leveraged to conduct rigorous, safe, and entirely remote clinical trials., Competing Interests: Competing interestsThe Mayo Clinic and P.A.N., M.J.A., and P.A.F. have a potential equity/royalty relationship with AliveCor® regarding its QTc solution, which was developed in partnership between the Mayo Clinic and AliveCor®. The rest of the authors declare no competing interests., (© The Author(s) 2021.)
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- 2021
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43. Facilitators and Barriers to Patient-Delivered Partner Therapy Acceptance for Chlamydia trachomatis Among Young African American Men Who Have Sex With Women in a Southern Urban Epicenter.
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Lederer AM, Hindmarch G, Schmidt N, Gomes GR, Scott G Jr, Watson S, and Kissinger PJ
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- Adolescent, Black or African American, Contact Tracing, Female, Humans, Male, Sexual Partners, Chlamydia Infections drug therapy, Chlamydia Infections epidemiology, Chlamydia trachomatis
- Abstract
Background: Chlamydia trachomatis (Ct) disproportionately affects African American young people living in the Southern United States and can have negative consequences if left untreated. Patient-delivered partner therapy (PDPT) is an evidence-based practice in which individuals diagnosed with Ct can provide treatment directly to their sex partners. However, PDPT acceptance rates need improvement. Although reasons for PDPT acceptance have been explored previously, the facilitators and barriers to expedited partner therapy acceptance among young southern African American men who have sex with women have not yet been examined., Methods: Twenty semistructured interviews were conducted as part of a community-based Ct screening and treatment intervention among African American men aged 15 to 25 years who had female sex partners. Participants were asked about why they did or did not accept PDPT for their sex partners. Data were transcribed and analyzed in NVivo qualitative software using an inductive thematic approach., Results: Participants' decision making was multifaceted. Facilitators for PDPT acceptance included being able to cure their partner, convenient access to treatment, believing it was the right thing to do, having a close relationship with a partner, concern for the partner's well-being, and the perceived severity of Ct. Barriers to PDPT acceptance were the belief that a partner did not need treatment, not having a close relationship with the partner, being unable to contact the partner, and fear of conflict., Conclusions: Findings had similarities to other studies, indicating some universal messaging may be warranted alongside culturally tailored interventions for specific patient populations to increase PDPT acceptance. Implications for patient-provider communication are provided., Competing Interests: Conflict of Interest and Sources of Funding: The authors report no conflicts of interest. Check It is funded by the National Institutes of Health (NIH 5R01HD086794-02). This research was also supported by the Donna and Richard Esteves Fund at the Newcomb Institute of Tulane University., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2021
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44. Epidemiology, Natural History, Diagnosis, and Treatment of Trichomonas vaginalis in Men.
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Van Gerwen OT, Camino AF, Sharma J, Kissinger PJ, and Muzny CA
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- Humans, Male, Prevalence, Sexual Partners, Sexually Transmitted Diseases diagnosis, Sexually Transmitted Diseases drug therapy, Sexually Transmitted Diseases epidemiology, Trichomonas Infections diagnosis, Trichomonas Infections drug therapy, Trichomonas Infections epidemiology, Trichomonas vaginalis, Urethritis
- Abstract
Trichomonas vaginalis infections in men are traditionally considered to be benign and consequently have been overlooked. However, men with this common sexually transmitted infection can experience urethritis, prostatitis, reduced fertility, and amplified human immunodeficiency virus risk. In addition, men are often asymptomatic and can unknowingly spread the infection to their female sexual partners. With advances in T. vaginalis diagnostics, more men are being diagnosed, yet the optimal method of treatment in men remains unknown. The purpose of this review is to discuss the epidemiology, natural history, diagnosis, and treatment of T. vaginalis among men., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)
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- 2021
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45. Human Immunodeficiency Virus and Hepatitis C Linkage-to-Care Initiative for New Orleans Residents Experiencing Homelessness During the COVID-19 Pandemic.
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Cironi KA, Jones AT, Hauser EM, Olsen JW, and Kissinger PJ
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- Cohort Studies, HIV, Hepacivirus, Humans, New Orleans, Pandemics, SARS-CoV-2, COVID-19, HIV Infections drug therapy, HIV Infections epidemiology, Hepatitis C drug therapy, Hepatitis C epidemiology, Ill-Housed Persons
- Abstract
Background: People experiencing homelessness are disproportionately infected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV). In response to COVID-19, cities nationwide temporarily housed people experiencing homelessness in unused hotels. One such initiative in New Orleans also enacted a screening, counseling, and linkage-to-care model for HIV and HCV treatment for this temporarily housed population between May and July 2020., Methods: A nonconcurrent cohort study was performed assessing follow up in the treatment of HIV and HCV for this population. Outcome data were collected on seropositive patients' electronic medical record to assess patient progression through the treatment cascade., Results: Of 102 unhoused residents, 25 (24.5%) tested HCV seropositive. Of the HCV positive 21/25 (84%) were connected to the associated clinic for follow up care and 10 (40%) obtained HCV treatment medication. Furthermore, all 3 patients who tested seropositive for HIV either started or re-initiated antiviral treatment. The greatest barrier to providing medication for the HCV seropositive patients, once care was initiated, was loss-to-follow-up., Conclusions: Targeting homeless persons living in temporary residences for HCV and HIV screening can be effective at promoting access to care for those infected due to this population's high HCV seropositivity especially significant if the patient has a history of intravenous drug use or is older than 40 years. However, continued outreach strategies are needed to assist patients in retention of care., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2021
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46. Changes in Sexual Behavior Related to the COVID-19 Stay-at-Home Orders Among Young Black Men Who Have Sex With Women in New Orleans, LA.
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Craig-Kuhn MC, Schmidt N, Scott G Jr, Gomes G, TatahMentan M, Enaholo O, Guzman S, Tannis A, Hall J, Triggs DR, and Kissinger PJ
- Subjects
- Black or African American, Condoms, Female, Humans, Male, New Orleans, SARS-CoV-2, Sexual Behavior, Sexual Partners, COVID-19, HIV Infections
- Abstract
Background: COVID-19 stay-at-home orders enacted in New Orleans, LA on March 16, 2020, may have caused changes in the way young men interacted with sex partners., Methods: An online substudy was conducted (May 21, 2020 to June 9, 2020) among Black men who have sex with women, 18 years and older, and who had previously enrolled in the parent study Check It (May 17, 2017 to March 6, 2020) to assess changes in sexual behavior during the stay-at-home orders., Results: Among 111 participants, from enrollment in Check It to during stay-at-home orders, recent vaginal sex declined from 96.4% to 47.8% (P < 0.0001), reports of multiple female sex partners declined from 45.0% to 14.4% (P < 0.0001), and sexual abstinence increased from 3.6% to 38.7% (P < 0.0001). Among those who did have vaginal sex, condomless sex rates did not change between enrollment in Check It and the substudy (64.5% vs 67.9%, P = 0.68). During stay-at-home orders oral sex, virtual sex, and pornography viewing were 40.5%, 42.3%, and 76.6%, respectively. Some (17.1%) acquired a new sex partner during stay-at-home orders, and 44.1% left their home to meet a partner for sex. Only 27.9% had seen information about safe sex during the pandemic. Income was diminished for 62.2% and 23.4% moved away from New Orleans when stay-at-home orders were enacted., Conclusions: Although there was an overall reduction in physical sex, half of participants reported physical sex, with many leaving their home to have sex during stay-at-home orders and many not using condoms. Others adopted sexual abstinence, increased virtual sex, and/or pornography viewing, which may have protected them from both sexually transmitted infections and COVID-19., Competing Interests: Conflict of Interest: None declared., (Copyright © 2021 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2021
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47. Adapting Index/Partner Services for the Treatment of Chlamydia Among Young African American Men in a Community Screening Program.
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Jones AT, Craig-Kuhn MC, Schmidt N, Gomes G, Scott G Jr, Watson S, Hines P, Davis J, Lederer AM, Martin DH, and Kissinger PJ
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- Chlamydia trachomatis, Contact Tracing, Female, Humans, Male, Sexual Partners, Black or African American, Chlamydia Infections diagnosis, Chlamydia Infections drug therapy, Chlamydia Infections epidemiology
- Abstract
Background: Screening for asymptomatic Chlamydia trachomatis (Ct) among men has not been recommended because feasibility and efficacy are unknown. Check It is a seek-test-treat community-based Ct screening program for African American men who have sex with women and who are 15 to 24 years of age. This is an evaluation of adaptations made to the program aimed at improving index/partner notification and treatment rates., Methods: The original Check It intervention included free testing and treatment, contact tracing performed by a third party, expedited index therapy, and expedited partner therapy via pharmacy pickup. The intervention was adapted after a series of in-depth interviews eliciting information to refine the program. Changes included continuity of testing, notification, and treatment by the same staff; expanded hours; and patient-delivered partner therapy with a medication mail-delivery option. Rates of index male and partner treatment were compared using log-binomial models and generalized estimating equations., Results: Men in the adapted intervention (n = 85) were more likely than men in the original intervention (n = 99) to be contacted (relative risk [RR], 1.14; 95% confidence interval [CI], 1.02-1.27), make a treatment plan (RR, 1.14; 95% CI, 1.01-1.27), and complete treatment (RR, 1.45; 95% CI, 1.20-1.75). Female sexual partners were significantly more likely to complete treatment in postadaptation (n = 153) compared with preadaptation (n = 161; RR, 3.02; 95% CI, 1.81-5.05)., Conclusions: Compared with third-party notification and expedited index therapy/expedited partner therapy available by pharmacy pickup only, patient-delivered partner therapy with mail-delivery option, staff available at nontraditional hours, and staff continuity across testing, notification, and treatment significantly improved index and partner treatment completion., Competing Interests: Conflict of Interest and Sources of Funding: None declared., (Copyright © 2020 American Sexually Transmitted Diseases Association. All rights reserved.)
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- 2021
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48. Hydroxychloroquine as Postexposure Prophylaxis to Prevent Severe Acute Respiratory Syndrome Coronavirus 2 Infection : A Randomized Trial.
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Barnabas RV, Brown ER, Bershteyn A, Stankiewicz Karita HC, Johnston C, Thorpe LE, Kottkamp A, Neuzil KM, Laufer MK, Deming M, Paasche-Orlow MK, Kissinger PJ, Luk A, Paolino K, Landovitz RJ, Hoffman R, Schaafsma TT, Krows ML, Thomas KK, Morrison S, Haugen HS, Kidoguchi L, Wener M, Greninger AL, Huang ML, Jerome KR, Wald A, Celum C, Chu HY, and Baeten JM
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Antiviral Agents adverse effects, COVID-19 diagnosis, COVID-19 Nucleic Acid Testing, Double-Blind Method, Female, Humans, Hydroxychloroquine adverse effects, Male, Middle Aged, SARS-CoV-2, Time Factors, Treatment Outcome, United States, Young Adult, Antiviral Agents therapeutic use, COVID-19 prevention & control, Hydroxychloroquine therapeutic use, Post-Exposure Prophylaxis, COVID-19 Drug Treatment
- Abstract
Background: Effective prevention against coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is currently limited to nonpharmaceutical strategies. Laboratory and observational data suggested that hydroxychloroquine had biological activity against SARS-CoV-2, potentially permitting its use for prevention., Objective: To test hydroxychloroquine as postexposure prophylaxis for SARS-CoV-2 infection., Design: Household-randomized, double-blind, controlled trial of hydroxychloroquine postexposure prophylaxis. (ClinicalTrials.gov: NCT04328961)., Setting: National U.S. multicenter study., Participants: Close contacts recently exposed (<96 hours) to persons with diagnosed SARS-CoV-2 infection., Intervention: Hydroxychloroquine (400 mg/d for 3 days followed by 200 mg/d for 11 days) or ascorbic acid (500 mg/d followed by 250 mg/d) as a placebo-equivalent control., Measurements: Participants self-collected mid-turbinate swabs daily (days 1 to 14) for SARS-CoV-2 polymerase chain reaction (PCR) testing. The primary outcome was PCR-confirmed incident SARS-CoV-2 infection among persons who were SARS-CoV-2 negative at enrollment., Results: Between March and August 2020, 671 households were randomly assigned: 337 (407 participants) to the hydroxychloroquine group and 334 (422 participants) to the control group. Retention at day 14 was 91%, and 10 724 of 11 606 (92%) expected swabs were tested. Among the 689 (89%) participants who were SARS-CoV-2 negative at baseline, there was no difference between the hydroxychloroquine and control groups in SARS-CoV-2 acquisition by day 14 (53 versus 45 events; adjusted hazard ratio, 1.10 [95% CI, 0.73 to 1.66]; P > 0.20). The frequency of participants experiencing adverse events was higher in the hydroxychloroquine group than the control group (66 [16.2%] versus 46 [10.9%], respectively; P = 0.026)., Limitation: The delay between exposure, and then baseline testing and the first dose of hydroxychloroquine or ascorbic acid, was a median of 2 days., Conclusion: This rigorous randomized controlled trial among persons with recent exposure excluded a clinically meaningful effect of hydroxychloroquine as postexposure prophylaxis to prevent SARS-CoV-2 infection., Primary Funding Source: Bill & Melinda Gates Foundation.
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- 2021
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49. Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.
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Johnston C, Brown ER, Stewart J, Karita HCS, Kissinger PJ, Dwyer J, Hosek S, Oyedele T, Paasche-Orlow MK, Paolino K, Heller KB, Leingang H, Haugen HS, Dong TQ, Bershteyn A, Sridhar AR, Poole J, Noseworthy PA, Ackerman MJ, Morrison S, Greninger AL, Huang ML, Jerome KR, Wener MH, Wald A, Schiffer JT, Celum C, Chu HY, Barnabas RV, and Baeten JM
- Abstract
Background: Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission., Methods: In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility., Findings: Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60, p = 0.047) but not HCQ/AZ (HR=1.25, p = 0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group (HCQ: HR=1.02, 95% CI-0.63-1.64, p = 0.95, HCQ/AZ: HR=0.91, 95% CI=0.57-1.45, p = 0.70)., Interpretation: Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection., Funding: The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program. Trial registration ClinicalTrials.gov number NCT04354428., (© 2021 The Author(s).)
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- 2021
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50. Dysregulation of IL-17/IL-22 Effector Functions in Blood and Gut Mucosal Gamma Delta T Cells Correlates With Increase in Circulating Leaky Gut and Inflammatory Markers During cART-Treated Chronic SIV Infection in Macaques.
- Author
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Walker EM, Slisarenko N, Gerrets GL, Grasperge BF, Mattison JA, Kissinger PJ, Welsh DA, Veazey RS, Jazwinski SM, and Rout N
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- Animals, Biomarkers blood, Chronic Disease drug therapy, Drug Therapy, Combination methods, Female, Inflammation blood, Inflammation immunology, Macaca mulatta, Monkey Diseases virology, Signal Transduction immunology, Simian Acquired Immunodeficiency Syndrome blood, Simian Acquired Immunodeficiency Syndrome virology, Interleukin-22, Anti-Retroviral Agents therapeutic use, Interleukin-17 blood, Interleukins blood, Intestinal Mucosa immunology, Intraepithelial Lymphocytes immunology, Monkey Diseases drug therapy, Monkey Diseases immunology, Simian Acquired Immunodeficiency Syndrome drug therapy, Simian Acquired Immunodeficiency Syndrome immunology, Simian Immunodeficiency Virus
- Abstract
HIV-associated inflammation has been implicated in the premature aging and increased risk of age-associated comorbidities in cART-treated individuals. However, the immune mechanisms underlying the chronic inflammatory state of cART-suppressed HIV infection remain unclear. Here, we investigated the role of γδT cells, a group of innate IL-17 producing T lymphocytes, in the development of systemic inflammation and leaky gut phenotype during cART-suppressed SIV infection of macaques. Plasma levels of inflammatory mediators, intestinal epithelial barrier disruption (IEBD) and microbial translocation (MT) biomarkers, and Th1/Th17-type cytokine functions were longitudinally assessed in blood and gut mucosa of SIV-infected, cART-suppressed macaques. Among the various gut mucosal IL-17/IL-22-producing T lymphocyte subsets including Th17, γδT, CD161
+ CD8+ T, and MAIT cells, a specific decline in the Vδ2 subset of γδT cells and impaired IL-17/IL-22 production in γδT cells significantly correlated with the subsequent increase in plasma IEBD/MT markers (IFABP, LPS-binding protein, and sCD14) and pro-inflammatory cytokines (IL-6, IL-1β, IP10, etc.) despite continued viral suppression during long-term cART. Further, the plasma inflammatory cytokine signature during long-term cART was distinct from acute SIV infection and resembled the inflammatory cytokine profile of uninfected aging (inflammaging) macaques. Overall, our data suggest that during cART-suppressed chronic SIV infection, dysregulation of IL-17/IL-22 cytokine effector functions and decline of Vδ2 γδT cell subsets may contribute to gut epithelial barrier disruption and development of a distinct plasma inflammatory signature characteristic of inflammaging. Our results advance the current understanding of the impact of chronic HIV/SIV infection on γδT cell functions and demonstrate that in the setting of long-term cART, the loss of epithelial barrier-protective functions of Vδ2 T cells and ensuing IEBD/MT occurs before the hallmark expansion of Vδ1 subsets and skewed Vδ2/Vδ1 ratio. Thus, our work suggests that novel therapeutic approaches toward restoring IL-17/IL-22 cytokine functions of intestinal Vδ2 T cells may be beneficial in preserving gut epithelial barrier function and reducing chronic inflammation in HIV-infected individuals., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2021 Walker, Slisarenko, Gerrets, Grasperge, Mattison, Kissinger, Welsh, Veazey, Jazwinski and Rout.)- Published
- 2021
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