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1.
Sex Transm Dis ; 49(12): 826-830, 2022 12 01.
Article in English | MEDLINE | ID: mdl-36150068

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.


Subject(s)
Chlamydia Infections , Chlamydia , Gonorrhea , Sexually Transmitted Diseases , Adolescent , Male , Female , Humans , Gonorrhea/epidemiology , Sexual Behavior , Condoms , Sexually Transmitted Diseases/epidemiology , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Sexual Partners
2.
Biology (Basel) ; 11(9)2022 Sep 17.
Article in English | MEDLINE | ID: mdl-36138842

ABSTRACT

Prospective cohort studies of sexually transmitted infections (STIs) are logistically impractical owing to time and expenses. In schools, students are readily available for school-related follow-ups and monitoring. Capitalizing on the logistics that society already commits to ensure regular attendance of adolescents in school, a school-based STI screening in New Orleans made it possible to naturally observe the occurrence of chlamydia and to determine its incidence among 14-19-year-old adolescents. Among participants screened repeatedly, we calculated incidence rates, cumulative incidence, and incidence times. Male (n = 3820) and female (n = 3501) students were observed for 6251 and 5143 person-years, respectively, during which 415 boys and 610 girls acquired chlamydia. Incidence rates per 100 person-years were 6.6 cases for boys and 11.9 cases for girls. In multivariable analysis, the adjusted hazard ratio was 5.34 for boys and 3.68 for girls if the student tested positive for gonorrhea during follow-up, and 2.76 for boys and 1.59 for girls if at first participation the student tested positive for chlamydia, and it increased with age among boys but not among girls. In joinpoint trend analysis, the annual percentage change in the incidence rate was 6.6% for boys (95% CI: -1.2%, 15.1%) and 0.1% for girls (95% CI: -5.3%, 5.7%). Annual cumulative incidence was 5.5% among boys and 8.6% among girls. Median incidence time was 9.7 months for boys and 6.9 months for girls. Our findings can be used to refine assumptions in mathematical modeling and in cost analysis studies of C. trachomatis infection, and provide strong evidence in support of annual chlamydia screening for adolescent boys.

4.
Sex Transm Dis ; 49(1): 1-4, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34407010

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.


Subject(s)
Chlamydia Infections , Chlamydia , Black People , Chlamydia Infections/diagnosis , Chlamydia Infections/epidemiology , Chlamydia Infections/prevention & control , Female , Humans , Louisiana/epidemiology , Male , Mass Screening/methods
5.
Sex Transm Dis ; 49(1): 5-11, 2022 01 01.
Article in English | MEDLINE | ID: mdl-34310525

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.


Subject(s)
Chlamydia Infections , Sexual Partners , Adolescent , Adult , Chlamydia Infections/diagnosis , Chlamydia Infections/drug therapy , Chlamydia Infections/epidemiology , Chlamydia trachomatis , Female , Humans , Louisiana , Male , New Orleans/epidemiology , Young Adult
6.
Sex Transm Dis ; 49(3): 231-236, 2022 03 01.
Article in English | MEDLINE | ID: mdl-34694277

ABSTRACT

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.


Subject(s)
Trichomonas Vaginitis , Trichomonas vaginalis , Vaginosis, Bacterial , Female , Humans , Metronidazole , Trichomonas Vaginitis/complications , Trichomonas Vaginitis/diagnosis , Trichomonas Vaginitis/drug therapy , Vaginosis, Bacterial/complications , Vaginosis, Bacterial/diagnosis , Vaginosis, Bacterial/drug therapy
7.
Sex Educ ; 21(4): 404-416, 2021.
Article in English | MEDLINE | ID: mdl-34483728

ABSTRACT

The purpose of this study was to examine the association between institution-delivered sex education given under real-world conditions and sexually transmitted infection (STI) rates, STI fatalism, and prior STI testing among African American men aged 15-24 who have sex with women. Participants were tested at community venues for Chlamydia and gonorrhoea and undertook a survey to elicit history of sex education and sexual health information. Among 1196 participants, 73.0% reported having received institution-delivered sex education topics including STI information (90.5%), condoms (89.2%), pregnancy/birth (72.1%) and birth control (67.1%). Among a subset of participants asked about the quality of sex education, 85.7% reported it was 'very good' or 'OK'. Prevalence rate for Chlamydia and/or gonorrhoea was 10.5%. Those who received sex education were more likely to have lower STI fatalism (51.0% vs. 42.4%, p=0.01) and more likely to report previous Chlamydia screening (44.1% vs. 31.6%, p<0.01), but did not have a significantly lower rate of Chlamydia and/or gonorrhoea (9.9% vs. 12.4%, p=0.20) compared to those who did not receive sex education. These findings suggest that institution-delivered sex education given under real-world conditions has beneficial effects on STI risk factors among young African American men.

8.
Front Cell Infect Microbiol ; 11: 615770, 2021.
Article in English | MEDLINE | ID: mdl-33912473

ABSTRACT

In vitro studies indicate IFNγ is central to Chlamydia trachomatis (Ct) eradication, but its function may be compromised by anaerobes typically associated with bacterial vaginosis (BV), a frequent co-morbidity in women with Ct. Here we investigated the associations between natural clearance of cervical Ct infection, the vaginal microbiome, and the requirements for IFNγ by evaluating the vaginal microbial and cytokine composition of Ct treatment visit samples from women who cleared Ct infection in the interim between their Ct screening and Ct treatment visit. The pilot cohort was young, predominantly African American, and characterized by a high rate of BV that was treated with metronidazole at the Ct screening visit. The rate of natural Ct clearance was 23.6% by the Ct treatment visit (median 9 days). 16S rRNA gene sequencing revealed that metronidazole-treated women who had a Lactobacillus spp.-dominant vaginal microbiota (CST 2 or 3) at the Ct treatment visit, were more prevalent in the Ct clearing population than the non-clearing population (86% v. 50%). L. iners (CST2) was the major Lactobacillus spp. present in Ct clearers, and 33% still remained anaerobe-dominant (CST1). Vaginal IFNγ levels were not significantly different in Ct clearers and non-clearers and were several logs lower than that required for killing Ct in vitro. An expanded panel of IFNγ-induced and proinflammatory cytokines and chemokines also did not reveal differences between Ct clearers and non-clearers, but, rather, suggested signatures better associated with specific CSTs. Taken together, these findings suggest that BV-associated bacteria may impede Ct clearance, but a Lactobacillus spp.-dominant microbiome is not an absolute requirement to clear. Further, IFNγ may be required at lower concentrations than in vitro modeling indicates, suggesting it may act together with other factors in vivo. Data also revealed that the vaginal bacteria-driven inflammation add complexity to the genital cytokine milieu, but changes in this microbiota may contribute to, or provide cytokine biomarkers, for a shift to Ct clearance.


Subject(s)
Chlamydia trachomatis , Microbiota , Chlamydia trachomatis/genetics , Female , Humans , Pilot Projects , RNA, Ribosomal, 16S/genetics , Vagina
9.
Sex Transm Dis ; 48(5): 323-328, 2021 05 01.
Article in English | MEDLINE | ID: mdl-33137012

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.


Subject(s)
Black or African American , Chlamydia Infections , Chlamydia Infections/diagnosis , Chlamydia Infections/drug therapy , Chlamydia Infections/epidemiology , Chlamydia trachomatis , Contact Tracing , Female , Humans , Male , Sexual Partners
11.
Clin Infect Dis ; 69(12): 2170-2176, 2019 11 27.
Article in English | MEDLINE | ID: mdl-30768180

ABSTRACT

BACKGROUND: Trichomonas vaginalis virus (TVV) is a non-segmented, 4.5-5.5 kilo-base pair (kbp), double-stranded RNA virus infecting T. vaginalis. The objectives of this study were to examine the TVV prevalence in US Trichomonas vaginalis isolates and TVV's associations with patient demographics, clinical outcomes, and metronidazole resistance. METHODS: Archived T. vaginalis isolates from the enrollment visits of 355 women participating in a T. vaginalis treatment trial in Birmingham, Alabama, were thawed and grown in culture. Their total RNA was extracted using a Trizol reagent. Contaminating, single-stranded RNA was precipitated using 4.0 M Lithium Chloride and centrifugation. The samples were analyzed by gel electrophoresis to visualize a 4.5 kbp band representative of TVV. In vitro testing for metronidazole resistance was also performed on 25/47 isolates obtained from the women's test of cure visits. RESULTS: TVV was detected in 142/355 (40%) isolates at the enrollment visit. Women with TVV-positive (TVV+) isolates were significantly older (P = .01), more likely to smoke (P = .04), and less likely to report a history of gonorrhea (P = .04). There was no association between the presence of clinical symptoms or repeat T. vaginalis infections with TVV+ isolates (P = .14 and P = .44, respectively). Of 25 test of cure isolates tested for metronidazole resistance, 0/10 TVV+ isolates demonstrated resistance, while 2/15 TVV-negative isolates demonstrated mild to moderate resistance (P = .23). CONCLUSIONS: Of 355 T. vaginalis isolates tested for TVV, T. vaginalis isolates tested for TVV, the prevalence was 40%. However, there was no association of TVV+ isolates with clinical symptoms, repeat infections, or metronidazole resistance. These results suggest that TVV may be commensal to T. vaginalis.


Subject(s)
Coinfection , RNA Virus Infections/epidemiology , RNA Virus Infections/virology , RNA Viruses , Trichomonas Vaginitis/epidemiology , Trichomonas Vaginitis/microbiology , Trichomonas vaginalis/virology , Adult , Drug Resistance , Female , Humans , Metronidazole/pharmacology , Metronidazole/therapeutic use , Middle Aged , Parasitic Sensitivity Tests , Patient Outcome Assessment , Public Health Surveillance , RNA Virus Infections/diagnosis , RNA Viruses/genetics , Randomized Controlled Trials as Topic , Risk Factors , Trichomonas Vaginitis/diagnosis , Trichomonas Vaginitis/drug therapy , Young Adult
12.
Sex Transm Dis ; 46(5): 312-316, 2019 05.
Article in English | MEDLINE | ID: mdl-30601374

ABSTRACT

BACKGROUND: The optimal timing for nucleic acid amplification testing (NAAT) posttreatment for Trichomonas vaginalis has not been fully established. Testing too soon posttreatment may detect remnant nucleic acid that is not from viable organisms, falsely misclassifying person as infected. The purpose of this study was to examine how long T. vaginalis nucleic acid is detectable postmetronidazole (MTZ) treatment. METHODS: Women diagnosed with T. vaginalis treated with MTZ (2 g single-dose or 500 mg twice daily for 7 days multidose) self-collected a vaginal swab for NAAT at baseline and each week postcompletion of treatment through test of cure (TOC) at week 4, when a culture was also performed. Women who reported interim sexual exposure or who were culture positive at 4 weeks were excluded. Time to first negative NAAT was examined using Kaplan Meier analysis. RESULTS: All women receiving multidose metronidazole were NAAT-negative by 21 days and those receiving single dose by 28 days postcompletion of treatment. Though over half (60.7%) of the cohort reinitiated sex during follow-up¸ all reported using condoms during sex or that they and their partner were treated before sex. Six (6.7%) of 89 had a positive NAAT following their first negative NAAT. CONCLUSIONS: The optimal timing for T. vaginalis retesting after completion of treatment is 3 weeks for those receiving multidose MTZ and 4 weeks for those receiving single-dose, though sexual reexposure and false negatives should be considered.


Subject(s)
Metronidazole/therapeutic use , Trichomonas Infections/diagnosis , Trichomonas vaginalis/isolation & purification , Adult , Aged , DNA, Protozoan/genetics , Female , Humans , Middle Aged , Nucleic Acid Amplification Techniques , Sexual Partners , Time Factors , Trichomonas Infections/parasitology , Trichomonas vaginalis/genetics , Young Adult
13.
Clin Infect Dis ; 69(3): 459-465, 2019 07 18.
Article in English | MEDLINE | ID: mdl-30351348

ABSTRACT

BACKGROUND: Mycoplasma genitalium has been significantly and nonsignificantly associated with cervicitis, urethritis, or vaginal discharge. This study examined the associations of M. genitalium with selected sexually transmitted infections (STIs) and demographic, behavioral, and clinical factors among women attending a sexually transmitted disease (STD) clinic in New Orleans. METHODS: Women aged ≥18 years who presented to the New Orleans STD clinic provided sociodemographic data and sexual behavior; STI, obstetric, and gynecologic history; and urine, vaginal, endocervical, and rectal specimens. Specimens were tested for M. genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma hominis, Ureaplasma species, and yeast. Bacterial vaginosis (BV) was diagnosed by Nugent score, and cervicitis was defined as ≥30 polymorphonuclear leukocytes per high-power microscopic field on a cervical Gram stain or yellow mucopus on an endocervical swab. RESULTS: Among 400 women studied, M. genitalium was independently significantly associated with age <25 years (P < .03) and with ≥2 sexual partners in the last 12 months (P < .003). Neisseria gonorrhoeae (adjusted odds ratio [AOR], 1.75; P = .103), C. trachomatis (AOR, 1.43; P = .247), and T. vaginalis (AOR, 1.60; P = .120) independently increased the odds of infection with M. genitalium. Controlling for other STIs and BV, there was a positive trend for M. genitalium to predict cervicitis (AOR, 3.18 [95% confidence interval, .99-10.2]; P = .05). CONCLUSIONS: Mycoplasma genitalium in our study displayed the clinical features of C. trachomatis and N. gonorrhoeae, the 2 organisms that drive research agendas in diagnosis, treatment, and prevention of bacterial STIs.


Subject(s)
Mycoplasma Infections/epidemiology , Mycoplasma Infections/microbiology , Sexually Transmitted Diseases, Bacterial/microbiology , Adolescent , Adult , Age Factors , Cervix Uteri/microbiology , Cross-Sectional Studies , Female , Humans , Middle Aged , Mycoplasma genitalium , New Orleans/epidemiology , Prevalence , Prospective Studies , Sexual Partners , Sexually Transmitted Diseases, Bacterial/epidemiology , Vagina/microbiology , Vaginosis, Bacterial/epidemiology , Young Adult
14.
J Infect Dis ; 219(2): 305-314, 2019 01 07.
Article in English | MEDLINE | ID: mdl-30535155

ABSTRACT

Background: Identification of bacteria in human vaginal specimens is commonly performed using 16S ribosomal RNA (rRNA) gene sequences. However, studies utilize different 16S primer sets, sequence databases, and parameters for sample and database clustering. Our goal was to assess the ability of these methods to detect common species of vaginal bacteria. Methods: We performed an in silico analysis of 16S rRNA gene primer sets, targeting different hypervariable regions. Using vaginal samples from women with bacterial vaginosis, we sequenced 16S genes using the V1-V3, V3-V4, and V4 primer sets. For analysis, we used an extended Greengenes database including 16S gene sequences from vaginal bacteria not already present. We compared results with those obtained using the SILVA 16S database. Using multiple database and sample clustering parameters, each primer set's ability to detect common vaginal bacteria at the species level was determined. We also compared these methods to the use of DADA2 for denoising and clustering of sequence reads. Results: V4 sequence reads clustered at 99% identity and using the 99% clustered, extended Greengenes database provided optimal species-level identification of vaginal bacteria. Conclusions: This study is a first step toward standardizing methods for 16S rRNA gene sequencing and bioinformatics analysis of vaginal microbiome data.


Subject(s)
Bacteria/classification , Microbiota , Vagina/microbiology , Vaginosis, Bacterial/microbiology , Amidohydrolases , Bacteria/genetics , Bacteria/isolation & purification , Computational Biology/methods , Computer Simulation , DNA, Bacterial , Databases, Genetic , Female , Genes, Bacterial , High-Throughput Nucleotide Sequencing/methods , Humans , Intercellular Signaling Peptides and Proteins/genetics , Microbiota/genetics , Phylogeny , RNA, Ribosomal, 16S/genetics , Sequence Analysis, DNA
15.
Lancet Infect Dis ; 18(11): 1251-1259, 2018 11.
Article in English | MEDLINE | ID: mdl-30297322

ABSTRACT

BACKGROUND: Among women, trichomoniasis is the most common non-viral sexually transmitted infection worldwide, and is associated with serious reproductive morbidity, poor birth outcomes, and amplified HIV transmission. Single-dose metronidazole is the first-line treatment for trichomoniasis. However, bacterial vaginosis can alter treatment efficacy in HIV-infected women, and single-dose metronidazole treatment might not always clear infection. We compared single-dose metronidazole with a 7-day dose for the treatment of trichomoniasis among HIV-uninfected, non-pregnant women and tested whether efficacy was modified by bacterial vaginosis. METHODS: In this multicentre, open-label, randomised controlled trial, participants were recruited at three sexual health clinics in the USA. We included women positive for Trichomonas vaginalis infection according to clinical screening. Participants were randomly assigned (1:1) to receive either a single dose of 2 g of metronidazole (single-dose group) or 500 mg of metronidazole twice daily for 7 days (7-day-dose group). The randomisation was done by blocks of four or six for each site. Patients and investigators were aware of treatment assignment. The primary outcome was T vaginalis infection by intention to treat, at test-of-cure 4 weeks after completion of treatment. The analysis of the primary outcome per nucleic acid amplification test or culture was also stratified by bacterial vaginosis status. This trial is registered with ClinicalTrials.gov, number NCT01018095, and with the US Food and Drug Administration, number IND118276, and is closed to accrual. FINDINGS: Participants were recruited from Oct 6, 2014, to April 26, 2017. Of the 1028 patients assessed for eligibility, 623 women were randomly assigned to treatment groups (311 women in the single-dose group and 312 women in the 7-day-dose group; intention-to-treat population). Although planned enrolment had been 1664 women, the study was stopped early because of funding limitations. Patients in the 7-day-dose group were less likely to be T vaginalis positive at test-of-cure than those in the single-dose group (34 [11%] of 312 vs 58 [19%] of 311, relative risk 0·55, 95% CI 0·34-0·70; p<0·0001). Bacterial vaginosis status had no significant effect on relative risk (p=0·17). Self-reported adherence was 96% in the 7-day-dose group and 99% in the single-dose group. Side-effects were similar by group; the most common side-effect was nausea (124 [23%]), followed by headache (38 [7%]) and vomiting (19 [4%]). INTERPRETATION: The 7-day-dose metronidazole should be the preferred treatment for trichomoniasis among women. FUNDING: National Institutes of Health.


Subject(s)
Antiprotozoal Agents/administration & dosage , Metronidazole/administration & dosage , Trichomonas Vaginitis/drug therapy , Trichomonas vaginalis/isolation & purification , Adolescent , Adult , Female , Humans , Middle Aged , Time Factors , Treatment Outcome , United States , Vaginosis, Bacterial/complications , Young Adult
16.
J Infect Dis ; 218(6): 966-978, 2018 08 14.
Article in English | MEDLINE | ID: mdl-29718358

ABSTRACT

Background: The sequence of events preceding incident bacterial vaginosis (iBV) is unclear. Methods: African American women who have sex with women, who had no Amsel criteria and Nugent scores of 0-3, were followed for 90 days to detect iBV (defined as a Nugent score of 7-10 on at least 2-3 consecutive days), using self-collected vaginal swab specimens. For women with iBV (cases) and women maintaining normal vaginal flora (healthy women), 16S ribosomal RNA gene sequencing targeting V4 was performed. Longitudinal vaginal microbiome data were analyzed. Results: Of 204 women screened, 42 enrolled; of these, 45% developed iBV. Sequencing was performed on 448 specimens from 14 cases and 8 healthy women. Among healthy women, Lactobacillus crispatus dominated the vaginal microbiota in 75%. In contrast, prior to iBV, the vaginal microbiota in 79% of cases was dominated by Lactobacillus iners and/or Lactobacillus jensenii/Lactobacillus gasseri. The mean relative abundance of Prevotella bivia, Gardnerella vaginalis, Atopobium vaginae, and Megasphaera type I became significantly higher in cases 4 days before (P. bivia), 3 days before (G. vaginalis), and on the day of (A. vaginae and Megasphaera type I) iBV onset. The mean relative abundance of Sneathia sanguinegens, Finegoldia magna, BV-associated bacteria 1-3, and L. iners was not significantly different between groups before onset of iBV. Conclusion: G. vaginalis, P. bivia, A. vaginae, and Megasphaera type I may play significant roles in iBV.


Subject(s)
Gardnerella vaginalis/isolation & purification , Megasphaera/isolation & purification , Prevotella/isolation & purification , Sequence Analysis, DNA/methods , Vagina/microbiology , Vaginosis, Bacterial/microbiology , Adult , Black or African American , DNA, Bacterial/genetics , DNA, Ribosomal/genetics , Female , Humans , Longitudinal Studies , Microbiota , Prospective Studies , RNA, Ribosomal, 16S/genetics , Vaginosis, Bacterial/ethnology , Young Adult
17.
Am J Reprod Immunol ; 79(2)2018 02.
Article in English | MEDLINE | ID: mdl-29286178

ABSTRACT

PROBLEM: Toll-like (TLR) receptor genetic variants have been implicated in bacterial vaginosis (BV). We determined whether TLR variants are associated with fastidious BV-associated microbes that are linked with infertility following pelvic inflammatory disease (PID). METHOD OF STUDY: Sneathia spp., Atopobium vaginae, BVAB1, and Ureaplasma urealyticum were measured in 250 women from the PID Evaluation and Clinical Health (PEACH) study. Relative risk (RR) and 95% confidence intervals (CI) were calculated adjusting for chlamydia and gonorrhea. Principal component analysis was used to adjust for population stratification. A false discovery rate q-value of 0.05 was significant. RESULTS: TLR2-1733C>A (P = .003) and TLR2-616A>G (P = .004) were associated with cervical A. vaginae. TLR2-1733C>A and TLR6-438C>T were associated with A. vaginae detection in the endometrium, but this was not significant after adjustment for multiple comparisons (FDR q-value = 0.06). CONCLUSION: Host gene variants in TLR2 signaling pathways were modestly associated with cervical A. vaginae in women with clinical PID.


Subject(s)
Corynebacterium Infections/genetics , Corynebacterium/physiology , Endometrium/immunology , Toll-Like Receptor 2/genetics , Vaginosis, Bacterial/genetics , Adolescent , Adult , Corynebacterium Infections/immunology , Cross-Sectional Studies , Endometrium/microbiology , Female , Genetic Predisposition to Disease , Genotype , Humans , Polymorphism, Single Nucleotide , Principal Component Analysis , Risk , Signal Transduction , Toll-Like Receptors/genetics , Vaginosis, Bacterial/immunology , Young Adult
18.
J Infect Dis ; 216(suppl_2): S396-S405, 2017 07 15.
Article in English | MEDLINE | ID: mdl-28838074

ABSTRACT

Mycoplasmagenitalium is one of the major causes of nongonococcal urethritis (NGU) worldwide but an uncommon sexually transmitted infection (STI) in the general population. The risk of sexual transmission is probably lower than for Chlamydia trachomatis. Infection in men is usually asymptomatic and it is likely that most men resolve infection without developing disease. The incubation period for NGU caused by Mycoplasma genitalium is probably longer than for NGU caused by C. trachomatis. The clinical characteristics of symptomatic NGU have not been shown to identify the pathogen specific etiology. Effective treatment of men and their sexual partner(s) is complicated as macrolide antimicrobial resistance is now common in many countries, conceivably due to the widespread use of azithromycin 1 g to treat STIs and the limited availability of diagnostic tests for M. genitalium. Improved outcomes in men with NGU and better antimicrobial stewardship are likely to arise from the introduction of diagnostic M. genitalium nucleic acid amplification testing including antimicrobial resistance testing in men with symptoms of NGU as well as in their current sexual partner(s). The cost effectiveness of these approaches needs further evaluation. The evidence that M. genitalium causes epididymo-orchitis, proctitis, and reactive arthritis and facilitates human immunodeficiency virus transmission in men is weak, although biologically plausible. In the absence of randomized controlled trials demonstrating cost effectiveness, screening of asymptomatic men cannot be recommended.


Subject(s)
Male Urogenital Diseases/microbiology , Mycoplasma Infections/drug therapy , Mycoplasma genitalium/isolation & purification , Urethritis/microbiology , Anti-Bacterial Agents/therapeutic use , Azithromycin/therapeutic use , Drug Resistance, Bacterial , Female , Humans , Macrolides/therapeutic use , Male , Male Urogenital Diseases/drug therapy , Nucleic Acid Amplification Techniques , Sexual Partners , Urethritis/drug therapy
19.
J Infect Dis ; 216(suppl_2): S427-S430, 2017 07 15.
Article in English | MEDLINE | ID: mdl-28838075

ABSTRACT

This article lays out the research priorities for Mycoplasma genitalium research agreed upon by the participants in a 2016 National Institutes of Allergy and Infectious Diseases-funded Technical Consultation focused on this organism. The state of current knowledge concerning the microbiology, epidemiology, clinical manifestations of infection, treatment, and public health significance of M. genitalium reviewed at the meeting is described in detail in the individual articles included in this supplemental edition of the Journal of Infectious Diseases. Here we summarize the points made in these articles most relevant to the formulation of the research priorities listed in this article. The most important recommendation resulting from this Technical Consultation is the initiation of clinical trials designed to determine definitively whether screening for and treatment of M. genitalium infections in women and their sexual partners improve reproductive health in women and/or prevent human immunodeficiency virus transmission.


Subject(s)
Mycoplasma Infections/diagnosis , Mycoplasma Infections/epidemiology , Mycoplasma genitalium , Public Health/trends , Research/trends , Adult , Anti-Bacterial Agents/therapeutic use , Clinical Trials as Topic , Consensus , Drug Resistance, Microbial , Female , HIV Infections/prevention & control , HIV Infections/transmission , Humans , Mycoplasma Infections/drug therapy , National Institutes of Health (U.S.) , Practice Guidelines as Topic , United States
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