CDC Clinical Guidelines on the Use of Doxycycline Postexposure Prophylaxis for Bacterial Sexually Transmitted Infection Prevention, United States, 2024.

No vaccines and few chemoprophylaxis options exist for the prevention of bacterial sexually transmitted infections (STIs) (specifically syphilis, chlamydia, and gonorrhea). These infections have increased in the United States and disproportionately affect gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW). In three large randomized controlled trials, 200 mg of doxycycline taken within 72 hours after sex has been shown to reduce syphilis and chlamydia infections by >70% and gonococcal infections by approximately 50%. This report outlines CDC's recommendation for the use of doxycycline postexposure prophylaxis (doxy PEP), a novel, ongoing, patient-managed biomedical STI prevention strategy for a selected population. CDC recommends that MSM and TGW who have had a bacterial STI (specifically syphilis, chlamydia, or gonorrhea) diagnosed in the past 12 months should receive counseling that doxy PEP can be used as postexposure prophylaxis to prevent these infections. Following shared decision-making with their provider, CDC recommends that providers offer persons in this group a prescription for doxy PEP to be self-administered within 72 hours after having oral, vaginal, or anal sex. The recommended dose of doxy PEP is 200 mg and should not exceed a maximum dose of 200 mg every 24 hours.Doxy PEP, when offered, should be implemented in the context of a comprehensive sexual health approach, including risk reduction counseling, STI screening and treatment, recommended vaccination and linkage to HIV PrEP, HIV care, or other services as appropriate. Persons who are prescribed doxy PEP should undergo bacterial STI testing at anatomic sites of exposure at baseline and every 3-6 months thereafter. Ongoing need for doxy PEP should be assessed every 3-6 months as well. HIV screening should be performed for HIV-negative MSM and TGW according to current recommendations.

Bay-Substitution of Perylene Bisimides with Bidentate Nucleophiles: The Case of Aryloxide Anions.

In this study, we delve into the regioselectivity of nucleophilic reactions involving brominated perylene bisimides (PBIs) and various bidentate aryloxide anions, previously associated with an SRN1 mechanism. We present herein a new perspective, suggesting that a single-electron-transfer aromatic nucleophilic substitution (SeT-SNAr) mechanism is a more plausible scenario. Our study reveals the favorable impact of photostimulation on reaction yields, making our method a convenient approach for accessing O-arylated PBIs.

"Make it more than a pill, make it an experience of health:" results from an open pilot intervention to retain young African American men who have sex with men in PrEP care.

Uptake and retention in clinical care for pre-exposure prophylaxis (PrEP) is suboptimal, particularly among young African American men who have sex with men (MSM) in the Deep South. We conducted a two-phase study to develop and implement an intervention to increase PrEP persistence. In Phase I, we conducted focus groups with 27 young African American MSM taking PrEP at a community health center in Jackson, Mississippi to elicit recommendations for the PrEP persistence intervention. We developed an intervention based on recommendations in Phase I, and in Phase II, ten participants were enrolled in an open pilot. Eight participants completed Phase II study activities, including a single intervention session, phone call check-ins, and four assessments (Months 0, 1, 3, and 6). Exit interviews demonstrated a high level of acceptability and satisfaction with the intervention. These formative data demonstrate the initial promise of a novel intervention to improve PrEP persistence among young African American MSM.

Perspectives on a peer-driven intervention to promote pre-exposure prophylaxis (PrEP) uptake among men who have sex with men in southern New England: a qualitative study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) is a highly effective pharmaceutical intervention that prevents HIV infection, but PrEP uptake across the US has been slow among men who have sex with men (MSM), especially among Black/African American (B/AA) and Hispanic /Latino (H/L) MSM. This study investigates the acceptability and essential components of a peer-driven intervention (PDI) for promoting PrEP uptake among MSM, with a specific focus on B/AA and H/L communities. METHODS: We conducted 28 semi-structured, qualitative interviews with MSM in southern New England to explore the components of a PDI, including attitudes, content, and effective communication methods. A purposive sampling strategy was used to recruit diverse participants who reflect the communities with the highest burden of HIV infection. RESULTS: Of 28 study participants, the median age was 28 years (interquartile range [IQR]: 25, 35). The sample comprised B/AA (39%, n = 11) and H/L (50%, n = 14) individuals. Notably, nearly half of the participants (46%) were current PrEP users. We found that many participants were in favor of using a PDI approach for promoting PrEP. Additionally, several participants showed interest in becoming peer educators themselves. They emphasized the need for strong communication skills to effectively teach others about PrEP. Moreover, participants noted that peer education should cover key topics like how PrEP works, how effective it is, and any possible side effects. CONCLUSIONS: Our study shows that effective PDIs, facilitated by well-trained peers knowledgeable about PrEP, could enhance PrEP uptake among MSM, addressing health disparities and potentially reducing HIV transmission in B/AA and H/L communities.

Vital Signs: Missed Opportunities for Preventing Congenital Syphilis - United States, 2022.

Introduction: Congenital syphilis cases in the United States increased 755% during 2012-2021. Syphilis during pregnancy can lead to stillbirth, miscarriage, infant death, and maternal and infant morbidity; these outcomes can be prevented through appropriate screening and treatment. Methods: A cascading framework was used to identify and classify missed opportunities to prevent congenital syphilis among cases reported to CDC in 2022 through the National Notifiable Diseases Surveillance System. Data on testing and treatment during pregnancy and clinical manifestations present in the newborn were used to identify missed opportunities to prevent congenital syphilis. Results: In 2022, a total of 3,761 cases of congenital syphilis in the United States were reported to CDC, including 231 (6%) stillbirths and 51 (1%) infant deaths. Lack of timely testing and adequate treatment during pregnancy contributed to 88% of cases of congenital syphilis. Testing and treatment gaps were present in the majority of cases across all races, ethnicities, and U.S. Census Bureau regions. Conclusions and implications for public health practice: Addressing missed opportunities for prevention, primarily timely testing and appropriate treatment of syphilis during pregnancy, is important for reversing congenital syphilis trends in the United States. Implementing tailored strategies addressing missed opportunities at the local and national levels could substantially reduce congenital syphilis.

Patterns of Pre-exposure Prophylaxis (PrEP) Use in a Population Accessing PrEP in Jackson, Mississippi.

Pre-exposure prophylaxis (PrEP) persistence is suboptimal in the United States. In the Deep South, a region with high rates of new HIV diagnosis, patterns of PrEP discontinuation remain unexplored. We evaluated data from a clinic-based PrEP program in Jackson, Mississippi and included patients initiating PrEP between August 2018 and April 2021. We considered patients to have a gap in PrEP coverage if they had at least 30 days without an active PrEP prescription; those who restarted PrEP after 30 days were classified as 'stopped and restarted' and those who never obtained a new PrEP prescription were classified as 'stopped and did not restart'. Patients without a gap in coverage were considered 'continuously on PrEP'. We estimated median time to first PrEP discontinuation and examined factors associated with time to first PrEP discontinuation. Of 171 patients who received an initial 90-day PrEP prescription; 75% were assigned male at birth and 74% identified as Black. The median time to first discontinuation was 90 days (95% CI 90-114). Twenty-two percent were continuously on PrEP, 28% stopped and restarted (median time off PrEP = 102 days), and 50% stopped and did not restart. Associations with early PrEP stoppage were notable for patients assigned sex female vs male (adjusted hazard ratio [aHR] = 1.6, 95% CI 1.0-2.5) and those living over 25 miles from clinic vs. 0-10 miles (aHR 1.89, 95% CI 1.2-3.0). Most patients never refilled an initial PrEP prescription though many patients re-started PrEP. Interventions to improve persistence and facilitate re-starts are needed.

Family-Related Factors and HIV-Related Outcomes Among Black Young Men Who Have Sex with Men in Mississippi.

Given their disproportionate HIV incidence, there is a critical need to identify factors related to HIV risk among Black young men who have sex with men (YMSM) in the southeastern United States. This study investigated the association of family factors and HIV-related outcomes among Black YMSM in Mississippi ages 14-20 (n = 72). Multivariable regression models evaluated associations of family factors and outcomes. Greater parent/child communication about sex was associated with fewer lifetime male sex partners and lower odds of lifetime anal sex. Greater parental monitoring was associated with greater likelihood of future condom use. Sexual orientation disclosure was associated with more lifetime male sex partners. Parental monitoring and parent/child communication about sex were protective, suggesting that family-based interventions are promising for HIV prevention among Black YMSM in Mississippi. Results also indicated that YMSM who are "out" to family are important to reach, and families could be useful in encouraging healthy behaviors.

Factors associated with suboptimal retention in HIV pre-exposure prophylaxis care among men who have sex with men.

Despite the efficacy of HIV pre-exposure prophylaxis (PrEP), retention in care in the United States remains suboptimal. The goal of this study was to explore factors that lead to suboptimal retention in PrEP care for men who have sex with men (MSM) in real-world clinical settings in the United States. Trained interviewers conducted semi-structured interviews with MSM (N = 49) from three clinics who had been engaged in PrEP care in the Midwest (n = 15), South (n = 15), and Northeast (n = 19) geographic regions and had experienced a lapse in PrEP use. Factors that emerged as related to suboptimal retention in PrEP care included structural factors such as transportation and out-of-pocket costs; social factors such as misinformation on media and in personal networks; clinical factors such as frequency and timing of appointments; and behavioral factors such as changes in sexual behavior and low perceived risk for HIV. Participants suggested reducing the out-of-pocket costs of medications and lab visits, having flexible appointment times, culturally responsive services, and comprehensive patient navigation to help retention in care. These findings leveraged real-world experiences and opinions of patients to inform gaps in current services and how to make changes to optimize PrEP care.

Persistence in a pharmacist-led, same-day PrEP program in Mississippi: a mixed-methods study.

INTRODUCTION: Mississippi has one of the highest rates of HIV in the United States but low PrEP uptake. Understanding patterns of PrEP use can improve PrEP initiation and persistence. METHODS: This is a mixed-method evaluation of a PrEP program in Jackson, Mississippi. Between November 2018-December 2019, clients at high risk for HIV attending a non-clinical testing site were referred to a pharmacist for same-day PrEP initiation. The pharmacist provided a 90-day PrEP prescription and scheduled a follow-up clinical appointment within three months. We linked client records from this visit to electronic health records from the two largest PrEP clinics in Jackson to determine linkage into ongoing clinical care. We identified four distinct PrEP use patterns, which we used for qualitative interview sampling: 1) filled a prescription and linked into care within three months; 2) filled a prescription and linked into care after three months; 3) filled a prescription and never linked into care; and 4) never filled a prescription. In 2021, we purposively sampled patients in these four groups for individual interviews to ascertain barriers and facilitators to PrEP initiation and persistence, using guides informed by the Theory of Planned Behavior. RESULTS: There were 121 clients evaluated for PrEP; all were given a prescription. One-third were less than 25 years old, 77% were Black, and 59% were cisgender men who have sex with men. One-quarter (26%) never filled their PrEP prescription, 44% picked up the prescription but never linked into clinical care, 12% linked into care at some point after three months (resulting in a gap in PrEP coverage), and 18% linked into care within 3 months. We interviewed 26 of 121 clients. Qualitative data revealed that cost, stigmas related to sexuality and HIV, misinformation about PrEP, and perceived side effects were barriers to uptake and persistence. Individuals' desire to stay healthy and the support of PrEP clinic staff were facilitators. CONCLUSIONS: The majority of individuals given a same-day PrEP prescription either never started PrEP or stopped PrEP within the first three months. Addressing noted barriers of stigma and misinformation and reducing structural barriers may increase PrEP initiation and persistence.

Exploring Parents' Intentions to Monitor and Mediate Adolescent Social Media Use and Implications for School Nurses.

Social media may promote health and social connectedness, but its misuse and frequency of use may pose risks. Social media use during adolescence requires parental monitoring and mediation to mitigate potentially harmful effects such as depression, anxiety, and risk-taking behaviors. While parents and health care professionals convey concern surrounding exposure to inappropriate content, prolonged screen time, and cyberbullying, appropriate social media monitoring remains challenging. The purpose of this study was to explore parental monitoring and mediation of social media use in adolescents. Online recruitment yielded a nationwide sample (n = 836) of parents of adolescents. The results of the online survey indicated that parents are concerned about adolescent social media use and endorse positive attitudes toward monitoring. Yet parents perceived little control over monitoring. Findings from this study support the school nurse in promoting healthy social media use, media literacy among parents and adolescents, and the use of screening tools.

Chalcogen Atoms as Electron Donors in Proton-Coupled Electron Transfer Reactions.

Proton-coupled electron transfer (PCET) reactions are crucial for the optimal functioning of a broad scope of chemical and biological processes. In this report, we present an unprecedented type of concerted PCET (cPCET), in which a chalcogen atom acts as the electron donor. The nature of this mechanism is key for understanding the reactivity of different radical-trapping antioxidants having heavy chalcogens (S, Se, or Te) in their structures. Moreover, this chalcogen-assisted cPCET is likely to be occurring in multiple systems of biological interest.

The persistent and evolving HIV epidemic in American men who have sex with men.

Men who have sex with men (MSM) in the USA were the first population to be identified with AIDS and continue to be at very high risk of HIV acquisition. We did a systematic literature search to identify the factors that explain the reasons for the ongoing epidemic in this population, using a social-ecological perspective. Common features of the HIV epidemic in American MSM include role versatility and biological, individual, and social and structural factors. The high-prevalence networks of some racial and ethnic minority men are further concentrated because of assortative mixing, adverse life experiences (including high rates of incarceration), and avoidant behaviour because of negative interactions with the health-care system. Young MSM have additional risks for HIV because their impulse control is less developed and they are less familiar with serostatus and other risk mitigation discussions. They might benefit from prevention efforts that use digital technologies, which they often use to meet partners and obtain health-related information. Older MSM remain at risk of HIV and are the largest population of US residents with chronic HIV, requiring culturally responsive programmes that address longer-term comorbidities. Transgender MSM are an understudied population, but emerging data suggest that some are at great risk of HIV and require specifically tailored information on HIV prevention. In the current era of pre-exposure prophylaxis and the undetectable equals untransmittable campaign, training of health-care providers to create culturally competent programmes for all MSM is crucial, since the use of antiretrovirals is foundational to optimising HIV care and prevention. Effective control of the HIV epidemic among all American MSM will require scaling up programmes that address their common vulnerabilities, but are sufficiently nuanced to address the specific sociocultural, structural, and behavioural issues of diverse subgroups.

Telehealth Services: Implications for Enhancing Sexually Transmitted Infection Prevention.

ABSTRACT: In the United States, sexually transmitted infections (STIs) are among the most persistent threats to health equity. Increasing access to STI prevention and control services through the provision of Remote Health and Telehealth can improve sexual health outcomes. Telehealth has been shown to increase access to care and even improve health outcomes. The increased flexibility offered by Telehealth services accommodates both patient and provider. Although both Telehealth and Remote Health strategies are important for STI prevention, share common attributes, and, in some circumstances, overlap, this article will focus more specifically on considerations for Telehealth and how it can contribute to increasing health equity by offering an important complement to and, in some cases, substitute for in-person STI services for some populations. Telehealth assists a variety of different populations, including those experiencing STI disparities; however, although the Internet offers a promising resource for many American households and increasing percentages of Americans are using its many resources, not all persons have equal access to the Internet. In addition to tailoring STI programs to accommodate unique patient populations, these programs will likely be faced with adapting services to fit reimbursement and licensing regulations.

A Comparison of Single-Dose Versus Multidose Metronidazole by Select Clinical Factors for the Treatment of Trichomonas vaginalis in Women.

BACKGROUND: In a randomized controlled trial of 2 g (single-dose) metronidazole (MTZ) versus 500 mg twice daily for 7 days (multidose) for Trichomonas vaginalis treatment, multidose was superior. We examined if the effect was similar by select clinical factors to determine if treatment recommendations could be targeted. METHODS: The primary outcome was T. vaginalis repeat infection at test-of-cure (TOC) 4 weeks after completion of therapy. Analyses were stratified by T. vaginalis history, baseline genital symptoms, and concurrent diagnosis of bacterial vaginosis (BV) per Nugent score at baseline. RESULTS: Women who returned for TOC (n = 540) were included. At baseline, 52.9% had a self-reported history of T. vaginalis; 79.3%, genital symptoms; 5.8%, a gonorrhea diagnosis; and 47.5%, BV. During follow-up, 97.4% took all MTZ as instructed and 34.5% had interval condomless sex with a baseline partner. At TOC, 14.8% tested positive for T. vaginalis. In stratified analysis, women randomized to single-dose MTZ had a higher rate of TOC T. vaginalis positivity than those randomized to multidose if they were symptomatic at baseline (21.4% vs. 10.8%, P = 0.003) or had a reported history of T. vaginalis (24.1% vs. 12.6%, P = 0.01). Test-of-cure T. vaginalis positivity was higher for women receiving a single dose (18.9%) versus multidose (10.8%), irrespective of baseline BV status (P > 0.06). In multivariable analysis, only a history of T. vaginalis and single-dose MTZ were independently associated with a positive TOC for T. vaginalis. CONCLUSIONS: Although multidose MTZ is recommended for all women with T. vaginalis, it is especially important for women with a T. vaginalis history and, given high posttreatment infection rates, a TOC should be performed.

Human Immunodeficiency Virus/Sexually Transmitted Infection Testing Preferences for Young Black Men Who Have Sex With Men in the Southeastern United States: Implications for a Post-COVID-19 Era.

BACKGROUND: Little is known regarding human immunodeficiency virus (HIV)/sexually transmitted infection (STI) testing preferences for location, staffing, and hours of operation among Young Black men who have sex with men (YBMSM) in the Southeastern United States, a population at high risk for HIV/STIs. We used a discrete choice experiment to explore these preferences. METHODS: Young Black men who have sex with men ages 16 to 35 years in Birmingham, AL and Jackson, MS completed online surveys evaluating their preferences (best/worst) for HIV/STI testing locations, staffing, hours, method of results notification, and cost. They also selected preferred combinations of these variables through choice tasks. Results were analyzed using joint best/worst and discrete choice experiment models. RESULTS: Between June 2018 and December 2019, participants in Alabama (n = 54) and Mississippi (n = 159) completed online surveys. Both groups preferred stationary testing locations over mobile testing vans, with the most significant difference favoring STI testing-only clinics in Mississippi and local health departments in Alabama (P < 0.001). Technician-performed tests or self-testing were significantly less preferred compared with clinician-performed testing for both groups (P < 0.0001 and P < 0.0001, respectively). Free testing and phone results notification (versus text) were preferred by both groups. The most desirable combination among all participants was weekday clinician-performed testing at the health department for $5. CONCLUSIONS: Young Black men who have sex with men in the Southeastern United States prefer traditional testing locations staffed by experienced personnel. Combination choices are influenced by services that are low or no cost. More research is needed to inform the best way(s) to provide affordable, high-quality HIV/STI testing services for YBMSM, particularly in the post-COVID-19 era when sexual health care delivery models are evolving toward home-based and remote health-focused strategies.

HIV and Sexually Transmitted Infections Among Persons with Monkeypox - Eight U.S. Jurisdictions, May 17-July 22, 2022.

High prevalences of HIV and other sexually transmitted infections (STIs) have been reported in the current global monkeypox outbreak, which has affected primarily gay, bisexual, and other men who have sex with men (MSM) (1-5). In previous monkeypox outbreaks in Nigeria, concurrent HIV infection was associated with poor monkeypox clinical outcomes (6,7). Monkeypox, HIV, and STI surveillance data from eight U.S. jurisdictions* were matched and analyzed to examine HIV and STI diagnoses among persons with monkeypox and assess differences in monkeypox clinical features according to HIV infection status. Among 1,969 persons with monkeypox during May 17-July 22, 2022, HIV prevalence was 38%, and 41% had received a diagnosis of one or more other reportable STIs in the preceding year. Among persons with monkeypox and diagnosed HIV infection, 94% had received HIV care in the preceding year, and 82% had an HIV viral load of <200 copies/mL, indicating HIV viral suppression. Compared with persons without HIV infection, a higher proportion of persons with HIV infection were hospitalized (8% versus 3%). Persons with HIV infection or STIs are disproportionately represented among persons with monkeypox. It is important that public health officials leverage systems for delivering HIV and STI care and prevention to reduce monkeypox incidence in this population. Consideration should be given to prioritizing persons with HIV infection and STIs for vaccination against monkeypox. HIV and STI screening and other recommended preventive care should be routinely offered to persons evaluated for monkeypox, with linkage to HIV care or HIV preexposure prophylaxis (PrEP) as appropriate.

African American Clergy Recommendations to Enhance the Federal Plan to End the HIV Epidemic: A Qualitative Study.

African Americans in the southern United States continue to be disproportionately affected by HIV. Although faith-based organizations (FBOs) play important roles in the social fabric of African American communities, few HIV screening, care, and PrEP promotion efforts harness the power of FBOs. We conducted 11 focus groups among 57 prominent African American clergy from Arkansas, Mississippi, and Alabama. We explored clergy knowledge about the Ending the HIV Epidemic: A Plan for America (EHE); normative recommendations for how clergy can contribute to EHE; and how clergy can enhance the HIV care continua and PrEP. We explored how clergy have responded to the COVID-19 crisis, and lessons learned from pandemic experiences that are relevant for HIV programs. Clergy reported a moral obligation to participate in the response to the HIV epidemic and were willing to support efforts to expand HIV screening, treatment, PrEP and HIV care. Few clergy were familiar with EHE, U = U and TasP. Many suggested developing culturally tailored messages and were willing to lend their voices to social marketing efforts to destigmatize HIV and promote uptake of biomedical interventions. Nearly all clergy believed technical assistance with biomedical HIV prevention and care interventions would enhance their ability to create partnerships with local community health centers. Partnering with FBOs presents important and unique opportunities to reduce HIV disparities. Clergy want to participate in the EHE movement and need federal resources and technical assistance to support their efforts to bridge community activities with biomedical prevention and care programs related to HIV. The COVID-19 pandemic presents opportunities to build important infrastructure related to these goals.

Where's the "Everyday Black Woman"? An intersectional qualitative analysis of Black Women's decision-making regarding HIV pre-exposure prophylaxis (PrEP) in Mississippi.

BACKGROUND: Black cisgender women in the U.S. South bear a disproportionate burden of HIV compared to cisgender women in other racial and ethnic groups and in any other part of the US. Critical to decreasing new HIV infections is the improved delivery of pre-exposure prophylaxis (PrEP) for Black cisgender women as it remains underutilized in 2021. Informed by intersectionality, the study sought to characterize the sociostructural influences on Black cisgender women's deliberations about PrEP within the context of interlocking systems of oppression including racism, sexism, and classism. METHODS: Six focus groups were conducted with 37 Black women residing in Jackson, Mississippi. This sample was purposively recruited to include Black cisgender women who were eligible for PrEP but had never received a PrEP prescription. RESULTS: Six themes were identified as concerns during PrEP deliberation among Black women: 1) limited PrEP awareness, 2) low perceived HIV risk, 3) concerns about side effects, 4) concerns about costs, 5) limited marketing, and 6) distrust in the healthcare system. Three themes were identified as facilitators during PrEP deliberations: 1) women's empowerment and advocacy, 2) need for increased PrEP-specific education, and 3) the positive influence of PrEP-engaged women's testimonials. Black women shared a limited awareness of PrEP exacerbated by the lack of Black women-specific marketing. Opportunities to support Black women-specific social marketing could increase awareness and knowledge regarding PrEP's benefits and costs. Black women also shared their concerns about discrimination in healthcare and distrust, but they felt that these barriers may be addressed by patient testimonials from PrEP-engaged Black women, empowerment strategies, and directly addressing provider biases. CONCLUSIONS: An effective response to PrEP implementation among Black women in the South requires developing programs to center the needs of Black women and carry out active strategies that prioritize peer advocacy while reinforcing positive and mitigating negative influences from broader social and historical contexts.

Efficacy and Safety of Single Oral Dosing of Secnidazole for Trichomoniasis in Women: Results of a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Delayed-Treatment Study.

BACKGROUND: Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection. We evaluated the efficacy and safety of secnidazole vs placebo in women with trichomoniasis. METHODS: Women with trichomoniasis, confirmed by a positive T. vaginalis culture, were randomized to single-dose oral secnidazole 2 g or placebo. The primary endpoint was microbiological test of cure (TOC) by culture 6-12 days after dosing. At the TOC visit, participants were given the opposite treatment. They were followed for resolution of infection afterward and offered treatment at subsequent visits, if needed. Fifty patients per group (N = 100) provided approximately 95% power to detect a statistically significant difference between treatment groups. RESULTS: Between April 2019 and March 2020, 147 women enrolled at 10 sites in the United States. The modified intention-to-treat (mITT) population included 131 randomized patients (secnidazole, n = 64; placebo, n = 67). Cure rates were significantly higher in the secnidazole vs placebo group for the mITT population (92.2% [95% confidence interval {CI}: 82.7%-97.4%] vs 1.5% [95% CI: .0%-8.0%]) and for the per-protocol population (94.9% [95% CI: 85.9%-98.9%] vs 1.7% [95% CI: .0%-8.9%]). Cure rates were 100% (4/4) in women with human immunodeficiency virus (HIV) and 95.2% (20/21) in women with bacterial vaginosis (BV). Secnidazole was generally well tolerated. The most frequently reported treatment-emergent adverse events (TEAEs) were vulvovaginal candidiasis and nausea (each 2.7%). No serious TEAEs were observed. CONCLUSIONS: A single oral 2 g dose of secnidazole was associated with significantly higher microbiological cure rates vs placebo, supporting a role for secnidazole in treating women with trichomoniasis, including those with HIV and/or BV. CLINICAL TRIALS REGISTRATION: NCT03935217.

Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.

BACKGROUND: Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections. METHODS: Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment. RESULTS: Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%). CONCLUSIONS: Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible. CLINICAL TRIALS REGISTRATION: NCT02961751.