Browsing by Author "Mayer, Kenneth H."

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    2889. One vs Three Weekly Doses of Benzathine Penicillin G for Treatment of Early Syphilis in Persons with and without HIV: A Multicenter Randomized Controlled Trial (RCT)
    (Oxford University Press, 2023-11-27) Hook, Edward W.; Workowski, Kimberly; Dionne, Jodie A.; McNeil, Candice J.; Taylor, Stephanie N.; Batteiger, Teresa; Dombrowski, Julia C.; Mayer, Kenneth H.; Seña, Arlene C.; Wiesenfeld, Harold C.; Perlowski, Charlotte; Newman, Lori; Zhu, Chunming; Mejia-Galvis, Jorge E.; Medicine, School of Medicine
    Background: Syphilis rates in the United Stated (U.S.) have increased steadily for over a decade. Despite over 75 years as the drug of choice for syphilis treatment, controversy persists on optimal duration of therapy with benzathine penicillin G (BPG) for persons with early(primary, secondary, and early latent) syphilis, particularly for persons co-infected with HIV. Given the ongoing national shortages of BPG, optimizing duration of therapy is an urgent concern. Methods: We conducted a multicenter RCT comparing a single intramuscular (IM) injection of BPG, 2.4 million units to BPG administered for three successive weeks for treatment of early syphilis in persons with and without HIV. The primary outcome of the study was a > 4-fold decline in RPR titer measured at 6 months. Intention to treat (ITT) and per protocol analyses were performed and were similar. ITT analyses are presented here. Results: A total of 249 persons with early syphilis were enrolled at 10 participating sites. Most (97%) participants were were categorized as male sex, black race (62%), and 153 (64%) were living with HIV. The syphilis stage distribution was 19% primary, 47% secondary, and 33% early latent and did not differ significantly by HIV status. Serologic response (> 4-fold decline in RPR titer) at 6 months was 76% (95% Confidence Interval (CI) 0.68-0.82) in the single dose group and did not differ significantly from the three-dose group (70%, 95% CI 0.61-0.77). There were no treatment failures (> 4-fold increase in RPR titer). Among persons with and without HIV there was no significant difference in RPR response at 6 months: 76% in the single-dose group vs. 71% in the 3-dose group (95% CI 0.05-0.17). Most participants experienced mild to moderate local injection site pain and tenderness. Conclusion: Treatment of persons with early syphilis with more than a single dose of 2.4 million units of BPG offers no therapeutic benefit irrespective of HIV infection status and was associated with increased rates of injection site discomfort.
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    Coinfection with Chlamydial and Gonorrheal Infection among US Adults with Early Syphilis
    (Wolters Kluwer, 2022) Dionne-Odom, Jodie; Workowski, Kimberly; Perlowski, Charlotte; Taylor, Stephanie N.; Mayer, Kenneth H.; McNeil, Candice J.; Hamill, Matthew M.; Dombrowski, Julia C.; Batteiger, Teresa A.; Sena, Arlene C.; Wiesenfeld, Harold C.; Newman, Lori; Hook, Edward W., III; Medicine, School of Medicine
    Among 865 adults with early syphilis considered for a multicenter treatment trial, 234 (27%) were excluded before enrollment because of bacterial sexually transmitted infection coinfection. Coinfection with Neisseria gonorrhoeae (29%), Chlamydia trachomatis (22%), or both (23%) was common. Study findings highlight the need for comprehensive bacterial sexually transmitted infection screening in patients with syphilis.
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    The Impact of Advertisement Messaging on Enrollment of Young Men Who Have Sex With Men for Web-Based Research: Observational Study
    (2020) Fontenot, Holly B.; Abuelezam, Nadia N.; Rosenberger, Joshua G.; Novak, David; Mayer, Kenneth H.; Zimet, Gregory; Pediatrics, School of Medicine
    Background: Recruiting young men who have sex with men (YMSM) in community settings is difficult. The use of Web-based social networks and dating apps for recruitment can be successful approaches, although little work has been done on the impact of study advertisement content on recruitment. Objective: The aim of this study was to evaluate the effects of advertisement message content on the recruitment of YMSM (aged 18-26 years) for a Web-based focus group study, examining perspectives and preferences for a mobile app that was designed to support sexual health among YMSM. Methods: Between March and April 2017, a recruitment campaign to promote human papillomavirus vaccination was launched on a popular social networking and dating app for YMSM, with 3 different text-based advertisement themes (technology, cancer prevention, and sexual innuendo). The campaign recruited YMSM across 3 states (Massachusetts, New York, and Pennsylvania). We examined the click-through rates, conversion rates, and enrollment rates of each of the advertisements and examined differences in views and clicks by age, state, and time of day. Results: The sexual innuendo advertisement had the highest click rates when compared with both the technology (click rate ratio [CRR] 2.06, 95% CI 1.74-2.45) and cancer prevention (CRR 1.62, 95% CI 1.38-1.90) advertisements. The sexual innuendo advertisement also had higher study enrollment rates compared with the technology (CRR 1.90, 95% CI 1.23-2.83) and cancer prevention (CRR 2.06, 95% CI 1.37-3.13) advertisements. No differences were observed in clicks or enrollment by age, state, or time of day. Conclusions: Our marketing campaign, targeting YMSM, was effective in recruiting participants for a qualitative study, using Web-based focus groups. The sexual innuendo advertisement was the most effective and cost-efficient advertisement of the 3 approaches trialed. Different populations need different targeted strategies for study recruitment. Researchers should work with key representatives to develop and test culturally relevant messaging and approaches that utilize current and popular technologies.
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    Jarisch-Herxheimer Reaction After Benzathine Penicillin G Treatment in Adults With Early Syphilis: Secondary Analysis of a Randomized Clinical Trial
    (American Medical Association, 2025-02-03) Dionne, Jodie A.; Zhu, Chunming; Mejia-Galvis, Jorge; Workowski, Kimberly; Batteiger, Teresa A.; Dombrowski, Julia C.; Mayer, Kenneth H.; McNeil, Candice J.; Seña, Arlene C.; Taylor, Stephanie; Wiesenfeld, Harold C.; Hamill, Matthew M.; Perlowski, Charlotte; Hook, Edward W., III; Medicine, School of Medicine
    Importance: Syphilis rates have been increasing in the US for the past decade. The incidence of the Jarisch-Herxheimer reaction (JHR) after penicillin treatment for early syphilis is reported to range from 8% to 56%. Objectives: To prospectively assess the incidence of JHR signs and symptoms among adults with early syphilis treated with benzathine penicillin G and to document factors associated with JHR and benzathine penicillin G treatment response outcomes. Design, setting, and participants: The main study was designed as a phase 4 randomized clinical trial to compare the treatment efficacy of 1 vs 3 doses of benzathine penicillin G in adults with early syphilis, measured as serologic response at 6 months. A total of 249 adults with or without HIV were screened and enrolled between October 31, 2018, and March 3, 2020. Participants were screened and enrolled at 10 US study sites in the Sexually Transmitted Infections Clinical Trials Group. Statistical analysis for this secondary analysis took place between March 2023 and August 2024. Intervention: Participants received a first dose of benzathine penicillin G, 2.4 million units intramuscularly, at the enrollment visit. The JHR assessment window was day 1 to day 7 after the first dose of benzathine penicillin G. Main outcomes and measures: Primary outcomes in this study were the incidence of symptoms consistent with JHR within 7 days after benzathine penicillin G treatment. Unelicited and elicited symptoms were assessed by participant self-report using a standardized checklist during contact made by a study clinician. Factors associated with JHR were collected at baseline, and serologic treatment response was assessed at 6 months. Posttreatment incident JHR symptoms were captured as safety outcomes for this trial. Analysis was performed on an intention-to-treat basis. Results: Of 249 participants, the median age was 32 years (IQR, 27-41 years), 242 (97.2%) were men, and 153 (61.4%) were living with HIV. One or more JHR symptoms occurred in 59 participants (23.7%) treated for early syphilis, with a median symptom onset at 4.9 hours (IQR, 3.0-9.2 hours) and a median duration of 12.8 hours (IQR, 5.0-24.0 hours). Symptom onset was within 12 hours of treatment for 49 of 57 participants (86.0%). Among 59 symptomatic participants, myalgias (30 [50.8%]), chills (27 [45.8%]), weakness (23 [39.0%]), and feverishness (21 [35.6%]) were most common. In adjusted models, JHR was associated with secondary syphilis (adjusted odds ratio [AOR], 2.91 [95% CI, 1.51-5.61]) and the absence of HIV (AOR for living with HIV, 0.49 [95% CI, 0.26-0.94]). The proportion of participants with a serologic treatment response to benzathine penicillin G at 6 months was higher among participants with JHR (84.7% [50 of 59] vs 68.9% [131 of 190] without JHR). Conclusions and relevance: In this prespecified secondary analysis of a randomized clinical trial of early syphilis treatment wtih benzathine penicillin G in adults, approximately 1 in 4 participants experienced short-lived JHR symptoms, which were associated with secondary syphilis stage, lack of HIV, and successful treatment outcomes at 6 months. These messages could be used in patient counseling.
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    Mobile App Strategy to Facilitate Human Papillomavirus Vaccination Among Young Men Who Have Sex With Men: Pilot Intervention Study
    (2020) Fontenot, Holly B.; White, Bradley Patrick; Rosenberger, Joshua G.; Lacasse, Hailee; Rutirasiri, Chokdee; Mayer, Kenneth H.; Zimet, Gregory; Pediatrics, School of Medicine
    Background: Mobile app-based interventions have been identified as potential facilitators for vaccination among young men who have sex with men (MSM). Objective: This pilot study aimed to test the feasibility of a theoretically informed mobile health (mHealth) tool designed to reduce health disparities and facilitate human papillomavirus (HPV) vaccination among a sample of young MSM. Methods: The development of the mHealth tool was guided by previous research, implementation intention theory, and design thinking. We recruited MSM aged 18-26 years through a popular online dating app and linked participants to our mHealth tool, which provided HPV vaccine information and fostered access to care. Results: A total of 42 young MSM participated in this pilot study in Boston, Massachusetts. Participants reported variable HPV knowledge (ie, high knowledge of HPV risk factors and low knowledge of HPV-related cancer risks for men) and positive vaccine beliefs and attitudes. Of those who were either unvaccinated, not up to date, or did not report vaccine status, 23% (8/35) utilized the mHealth tool to obtain HPV vaccination. Participants primarily utilized the tool’s (1) educational components and (2) capabilities facilitating concrete vaccine action plans. Conclusions: We recruited an underserved at-risk population of youth via an online dating app for our mHealth intervention that resulted in in-person health care delivery. This study was limited by enrollment challenges, including low willingness to download the mHealth tool to mobile devices.
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    Perspectives and preferences for a mobile health tool designed to facilitate HPV vaccination among young men who have sex with men
    (Taylor & Francis: STM, Behavioural Science and Public Health Titles, 2019-01-30) Fontenot, Holly B.; Rosenberger, Joshua G.; McNair, Katelyn T.; Mayer, Kenneth H.; Zimet, Gregory; Pediatrics, School of Medicine
    We sought to understand young men who have sex with men (YMSM) perspectives and preferred features for a mobile health (mHealth) tool designed to facilitate human papillomavirus (HPV) vaccination. YMSM were recruited on a popular social/sexual networking app to participate in online focus groups. Discussions were designed to elicit what the men would want in a mHealth tool specific for sexual health and HPV. Demographic data were analyzed using descriptive statistics and focus group data were analyzed using conventional content analysis. Forty-eight YMSM participated. Mean age was 23.4 years, and 70.0% reported their race as Black. Qualitative themes included general HPV knowledge and awareness, current patterns in technology use, desired app qualities, and desired app content. Youth described varying levels of HPV knowledge, utilized apps to engage socially, and for travel, banking, gaming, news and entertainment, and few used apps to facilitate personal health or engage with healthcare systems. Participants desired credible, relatable, secure, and easy to use interfaces that provided sexual health and HPV information in a positive context. They described ways to creatively engage and directly connect youth to health providers. We identified a culturally relevant youth driven approach to facilitate HPV vaccination and sexual health among YMSM.