Spontaneous resolution of Trichomonas vaginalis infection in men.

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.

A Case of Varicella Zoster and Mpox Coinfection in a Patient Living With HIV.

ABSTRACT: We present a case of recurrent, cutaneous mpox with coinfection of disseminated varicella zoster in an immunocompromised patient with poorly controlled HIV. This case demonstrates the importance of maintaining a high index of suspicion for mpox despite prior infection and vaccination, as suboptimal immune response is possible in immunocompromised patients, and also noting the potential for coinfection necessitating timely diagnosis and appropriate testing.

Challenges in Male Partner Referral Among Trichomonas vaginalis -Infected Women.

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.

The Relationship Between HIV Pre-exposure Prophylaxis Stigma and Treatment Adherence Among Current HIV Pre-exposure Prophylaxis Users in the Southeastern U.S.

Despite efficacy in HIV prevention, Pre-exposure Prophylaxis (PrEP) is underutilized in the US, especially among populations at highest risk. PrEP-related stigma may play a role. We developed measures of PrEP-related stigma dimensions and PrEP adherence. We administered them to current PrEP users. We hypothesized that PrEP-related stigma would negatively impact PrEP adherence. Questionnaire measures were developed using data from previous qualitative work and existing validated HIV-related stigma measures. The resultant survey was administered to current PrEP users from two Birmingham, Alabama PrEP clinics. Plasma tenofovir disoproxil fumarate levels were collected to measure PrEP adherence. Exploratory factor analyses were performed to determine the factor structure of each PrEP-related stigma dimension (internalized, perceived, experienced, anticipated, disclosure concerns). Separate binary logistic (or linear) regressions were performed to assess associations between PrEP-related stigma dimensions and adherence (treatment adherence self-efficacy, self-reported adherence, and plasma tenofovir levels), adjusting for education, race, and time on PrEP. In 2018, 100 participants completed the survey, with 91 identifying as male and 66 as white. Only internalized stigma was associated with lower self-reported PrEP adherence. Exploratory mediation analyses suggested that the association between all stigma dimensions and self-reported PrEP adherence is mediated by PrEP adherence self-efficacy. No associations were found between any PrEP-related stigma measures and plasma tenofovir levels. Internalized PrEP stigma may reduce PrEP adherence, possibly by reducing PrEP adherence self-efficacy among experienced PrEP users. Further investigation of how stigma dimensions affect PrEP adherence in populations at risk for HIV may shed light on drivers of PrEP underutilization.

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.

Epidemiology, Natural History, Diagnosis, and Treatment of Trichomonas vaginalis in Men.

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.

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.

Management of Trichomoniasis in the Setting of 5-Nitroimidazole Hypersensitivity.

ABSTRACT: Metronidazole and other 5-nitroimidazoles are the mainstay of Trichomonas vaginalis treatment, with few efficacious and safe treatment options available outside of this class. Patients with trichomoniasis and a history of a clinically confirmed hypersensitivity reaction to 5-nitroimidazoles present a management challenge for clinicians. The first step in managing such patients is metronidazole desensitization. In situations where this cannot be performed or tolerated, treatment with alternative regimens outside of the 5-nitroimidazole class, such as intravaginal boric acid or paromomycin, may be possible.

Prevalence of and Factors Associated With Genital and Extragenital Chlamydia and Gonorrhea Among Transgender Women in HIV Care in the United States, 2005 to 2016.

BACKGROUND: Data on testing rates and prevalence of and factors associated with genital and extragenital chlamydia and gonorrhea among transgender women with HIV in the United States are limited. METHODS: This retrospective cohort analysis included transgender women living with HIV enrolled in the US Centers for AIDS Research Network of Integrated Clinical Systems cohort between January 2005 and December 2016 with chlamydia or gonorrhea testing performed in HIV clinic. The primary outcome was a positive test result for chlamydia or gonorrhea at urogenital or extragenital (rectal/pharyngeal) sites. Factors associated with infection were examined using logistic regression and generalized estimating equations to account for multiple tests per woman. RESULTS: Among 312 transgender women in HIV care, 252 (81%) were tested for chlamydia or gonorrhea at least once. Annual testing rates were low: 23% to 53% at genital sites and 24% to 47% at extragenital sites. A total of 88 infections were detected, and 22% of women (55/252) had at least one positive test result. Most infections occurred at extragenital sites (80% of chlamydia and 82% of gonorrhea positive test results). Factors associated with infection in an adjusted model were as follows: age 18 to 29 years compared with ≥50 years (adjusted odds ratio [aOR], 7.6; 95% confidence interval [CI], 1.8-31.2), CD4 count >350 compared with CD4 <200 (aOR, 5.5; 95% CI, 1.2-25.1), and higher engagement in HIV care (aOR, 2.2; 95% CI, 1.0-4.5). CONCLUSIONS: Among transgender women living with HIV, testing rates for chlamydia and gonorrhea are inadequate, particularly at extragenital sites where most infections occur.

Updates in trichomonas treatment including persistent infection and 5-nitroimidazole hypersensitivity.

PURPOSE OF REVIEW: The purpose of this review is to update information on treatment of Trichomonas vaginalis. T. vaginalis is estimated to be the most common treatable sexually transmitted infection. In the world and is associated with poor birth outcomes, cervical cancer, sperm motility and morphology issues, and HIV acquisition and transmission. RECENT FINDINGS: The efficacy of the recommended 2-g oral single-dose metronidazole (MTZ) for the treatment of T. vaginalis in women has recently been challenged. Two recent multicentered randomized trials and a meta-analysis have demonstrated that the 7-day dose of MTZ 500 mg twice daily was nearly two times more efficacious at clearing infection compared with the 2-g dose. Partner treatment is also essential, since up to 70% of male sexual partners can be infected and rescreening of treated women at 3 months is also recommended given the high repeat infection rates. Future studies should examine the importance of treating asymptomatic T. vaginalis, best treatment for men, the influence of the microbiome on treatment efficacy and different formulations of intravaginal treatments for hypersensitivity. SUMMARY: 7-day 500 mg twice daily MTZ should be used as the first line treatment for T. vaginalis-infected women.

The Role of Prevotella Species in Female Genital Tract Infections.

Female genital tract infections (FGTIs) include vaginal infections (e.g., bacterial vaginosis [BV]), endometritis, pelvic inflammatory disease [PID], and chorioamnionitis [amniotic fluid infection]. They commonly occur in women of reproductive age and are strongly associated with multiple adverse health outcomes including increased risk of HIV/sexually transmitted infection acquisition and transmission, infertility, and adverse birth outcomes such as preterm birth. These FGTIs are characterized by a disruption of the cervicovaginal microbiota which largely affects host immunity through the loss of protective, lactic acid-producing Lactobacillus spp. and the overgrowth of facultative and strict anaerobic bacteria. Prevotella species (spp.), anaerobic Gram-negative rods, are implicated in the pathogenesis of multiple bacterial FGTIs. Specifically, P. bivia, P. amnii, and P. timonensis have unique virulence factors in this setting, including resistance to antibiotics commonly used in treatment. Additionally, evidence suggests that the presence of Prevotella spp. in untreated BV cases can lead to infections of the upper female genital tract by ascension into the uterus. This narrative review aims to explore the most common Prevotella spp. in FGTIs, highlight their important role in the pathogenesis of FGTIs, and propose future research in this area.

Microbial interactions among Gardnerella, Prevotella and Fannyhessea prior to incident bacterial vaginosis: protocol for a prospective, observational study.

INTRODUCTION: The aetiology of bacterial vaginosis (BV), a biofilm-associated vaginal infection, remains unknown. Epidemiologic data suggest that it is sexually transmitted. BV is characterised by loss of lactic acid-producing lactobacilli and an increase in facultative and strict anaerobic bacteria. Gardnerella spp are present in 95%-100% of cases; Gardnerella vaginalis has been found to be more virulent than other BV-associated bacteria (BVAB) in vitro. However, G. vaginalis is found in women with normal vaginal microbiota and colonisation is not sufficient for BV development. We hypothesise that Gardnerella spp initiate BV biofilm formation, but incident BV (iBV) requires incorporation of other key BVAB (ie, Prevotella bivia, Fannyhessea vaginae) into the biofilm that alter the transcriptome of the polymicrobial consortium. This study will investigate the sequence of microbiologic events preceding iBV. METHODS AND ANALYSIS: This study will enrol 150 women aged 18-45 years with normal vaginal microbiota and no sexually transmitted infections at a sexual health research clinic in Birmingham, Alabama. Women will self-collect twice daily vaginal specimens up to 60 days. A combination of 16S rRNA gene sequencing, qPCR for Gardnerella spp, P. bivia and F. vaginae, and broad range 16S rRNA gene qPCR will be performed on twice daily vaginal specimens from women with iBV (Nugent score 7-10 on at least 2 consecutive days) and controls (with comparable age, race, contraceptive method and menstrual cycle days) maintaining normal vaginal microbiota to investigate changes in the vaginal microbiota over time for women with iBV. Participants will complete daily diaries on multiple factors including sexual activity. ETHICS AND DISSEMINATION: This protocol is approved by the University of Alabama at Birmingham Institutional Review Board (IRB-300004547) and written informed consent will be obtained from all participants. Findings will be presented at scientific conferences and published in peer-reviewed journals as well as disseminated to providers and patients in communities of interest.

Providing gender-affirming care to transgender and gender-diverse individuals with and at risk for HIV.

Transgender and gender-diverse populations have unique medical and psychosocial needs. It is important that clinicians address these needs with a gender-affirming approach in all aspects of health care for these populations. Given the significant burden of HIV experienced by transgender people, such approaches in providing HIV care and prevention are essential both to engage this population in care and to work toward ending the HIV epidemic. This review presents a framework for practitioners caring for transgender and gender-diverse individuals to deliver affirming, respectful health care in HIV treatment and prevention settings.

Bacterial Vaginosis in Postmenopausal Women.

Purpose of Review: Bacterial vaginosis (BV) is the most common vaginal infection worldwide, but most research has been conducted in premenopausal women. After menopause, endogenous estrogen production decreases, often leading to the genitourinary syndrome of menopause (GSM), characterized by vulvovaginal dryness and irritation. The estrogen-deficient postmenopausal state results in an elevated vaginal pH and depletion of vaginal lactobacilli. Use of traditional BV diagnostics (Amsel criteria, Nugent score) is difficult in post-menopausal women, especially those not on estrogen replacement therapy, as these methods were originally developed in premenopausal women. In this review, we discuss recent clinical data on BV in postmenopausal women, difficulties in diagnosis using traditional methods, the role of BV molecular diagnostics, and our current expert opinion for managing BV in this population. Recent Findings: BV prevalence has been found to range between 2%-57% among postmenopausal women per Amsel and Nugent criteria. This is likely an over-estimate of the true prevalence due to limitations in these criteria which were only validated in pre-menopausal women. Despite increasing diagnostic options for BV in recent years, including highly sensitive and specific BV nucleic acid amplification tests (NAATs), the physiologic changes of menopause and limited inclusion of postmenopausal women in clinical studies, diagnosis is difficult in this population. Recent studies utilizing 16s rRNA gene sequencing suggest that the vaginal microbiota of premenopausal and postmenopausal women is quite different, even if BV is not present. Data also suggest that obese postmenopausal women have significantly lower rates of BV compared to non-obese postmenopausal women, although further research is needed in this area. Multiple treatment options exist for vaginal atrophy and BV in this population. Summary: Data are limited regarding optimal diagnostic approaches for BV in postmenopausal women; BV NAATs and 16s rRNA gene sequencing may have a role for diagnosing BV in symptomatic women although further studies are needed. Menopausal women with characteristic vaginal symptoms and an elevated vaginal pH should be initially treated for estrogen deficiency prior to considering a diagnosis of BV; subsequent treatment for BV should be driven by symptoms.

Efficacy of single-dose oral secnidazole for the treatment of trichomoniasis in women co-infected with trichomoniasis and bacterial vaginosis: a post hoc subgroup analysis of phase 3 clinical trial data.

OBJECTIVES: Bacterial vaginosis (BV) and trichomoniasis are the most common causes of vaginitis. Both infections are associated with increased risk of acquisition and transmission of HIV and other sexually transmitted infections as well as adverse reproductive health outcomes. Co-infection is common, with rates ranging from 60% to 80%. We evaluated the efficacy of single-dose oral secnidazole 2 g for the treatment of trichomoniasis in a subgroup of women co-infected with BV and trichomoniasis. DESIGN: Post hoc analysis of data from a phase 3 randomised, double-blind, placebo-controlled, delayed-treatment study. SETTING: 10 centres in the USA. PARTICIPANTS: Subgroup of women (aged ≥12 years) with a confirmed diagnosis of Trichomonas vaginalis and co-infection with BV clinically diagnosed using Amsel's criteria. INTERVENTION: Single dose of secnidazole 2 g or placebo. OUTCOME MEASURES: The primary efficacy outcome was the microbiological cure (negative culture for T. vaginalis) at the test of cure (TOC) visit 6-12 days after dosing in the modified intent-to-treat population (mITT). At TOC, participants received the opposite treatment. RESULTS: Of the 131 T. vaginalis-infected participants in the mITT, 79 (60.3%) met ≥3 Amsel's criteria for BV at enrolment. Microbiological cure rates for trichomoniasis at TOC among this subgroup of women were 97.7% (42/43) for secnidazole and 0% (0/36) for placebo. CONCLUSION: Single-dose oral secnidazole 2 g was highly efficacious in curing trichomoniasis in women co-infected with BV. Appropriate and effective treatment options for co-infection are essential for reducing transmission and reinfection. Secnidazole is the only single-dose medication approved by the Food and Drug Administration for the treatment of BV in women and trichomoniasis in women and men. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT03935217; post-results.

Sexual healthcare and at-home STI test collection: attitudes and preferences of transgender women in the Southeastern United States.

Background: HIV and sexually transmitted infections (STIs) disproportionally affect transgender women in the United States, particularly in the Southeast where rates of HIV and bacterial STIs are especially high. Despite the high HIV/STI burden among transgender women, their engagement in sexual healthcare services, including HIV/STI testing, is low. Understanding reasons for this disconnect is essential in developing HIV/STI prevention efforts for this population, especially in the Southeastern US, where access to affirming sexual healthcare providers and resources is limited. We aimed to perform an exploratory qualitative study to describe the attitudes and preferences of transgender women living in Alabama with regards to sexual healthcare and at-home STI test collection. Methods: Transgender women ≥18 years old residing in Alabama were invited to participate in virtual individual in-depth interviews via Zoom. The interview guide explored participant experiences engaging with sexual healthcare services as well as preferences related to extragenital (i.e., rectal, pharyngeal) and at-home STI testing for gonorrhea and chlamydia. A trained qualitative researcher coded transcripts after each interview and iteratively amended the interview guide as themes emerged. Data were coded and thematically analyzed using NVivo qualitative software. Results: Between June 2021-April 2022, 22 transgender women were screened and 14 eligible women enrolled. Eight participants were white (57%), and six were black (43%). Five participants (36%) were living with HIV and engaged with HIV care services. Interview themes included preference for sexual healthcare environments specializing in LGBTQ+ care, enthusiasm toward at-home STI testing, an emphasis on affirming patient-provider interactions in sexual healthcare settings, a preference for sexual healthcare providers involved in STI testing who were not cisgender men, and gender dysphoria around sexual health discussions and testing. Conclusion: Transgender women in the Southeastern US prioritize affirming provider-patient interactions, however resources in the region are limited. Participants were enthusiastic about at-home STI testing options, which have the potential to mitigate gender dysphoria. Further investigation into development of remote sexual healthcare services for transgender women should be performed.

Trichomoniasis.

Trichomoniasis is the most common nonviral sexually transmitted infection worldwide. It has been associated with a variety of adverse sexual and reproductive health outcomes for both men and women. In this review, the authors discuss updates in its epidemiology, pathophysiology, clinical significance, diagnosis, and treatment.

Why Wait? The Ethics of Disclosing HIV Screening Results.

Counseling patients on their HIV test results is an important part of undergraduate and graduate medical education. However, many trainees and physicians feel ill prepared to counsel patients on potentially distressing results. We present a case involving early disclosure of a false-positive HIV screening test result to a patient and the downstream effects of this premature disclosure. This case highlights the importance of understanding the various HIV testing options available and the importance of education on effectively counseling patients on screening versus confirmatory HIV test results.

Impact of testosterone use on the vaginal microbiota of transgender men, including susceptibility to bacterial vaginosis: study protocol for a prospective, observational study.

INTRODUCTION: The effect of testosterone (T) therapy on the vaginal microbiota of transgender men (TGM) is not well characterised, although one cross-sectional study comparing the vaginal microbiota of cisgender women to TGM on T≥1 year found that, in 71% of the TGM, the vaginal microbiota was less likely to be Lactobacillus-dominated and more likely to be enriched with >30 other bacterial species, many associated with bacterial vaginosis (BV). This prospective study aims to investigate changes in the composition of the vaginal microbiota over time in TGM who retain their natal genitalia (ie, vagina) and initiate T. In addition, we will identify changes in the vaginal microbiota preceding incident BV (iBV) in this cohort while investigating behavioural factors, along with hormonal shifts, which may be associated with iBV. METHODS AND ANALYSIS: T-naïve TGM who have not undergone gender-affirming genital surgery with normal baseline vaginal microbiota (ie, no Amsel criteria, normal Nugent Score with no Gardnerella vaginalis morphotypes) will self-collect daily vaginal specimens for 7 days prior to initiating T and for 90 days thereafter. These specimens will be used for vaginal Gram stain, 16S rRNA gene sequencing and shotgun metagenomic sequencing to characterise shifts in the vaginal microbiota over time, including development of iBV. Participants will complete daily diaries on douching, menses and behavioural factors including sexual activity during the study. ETHICS AND DISSEMINATION: This protocol is approved through the single Institutional Review Board mechanism by the University of Alabama at Birmingham. External relying sites are the Louisiana State University Health Sciences Center, New Orleans Human Research Protection Program and the Indiana University Human Research Protection Program. Study findings will be presented at scientific conferences and peer-reviewed journals as well as shared with community advisory boards at participating gender health clinics and community-based organisations servicing transgender people. REGISTRATION DETAILS: Protocol # IRB-300008073.