Trichomoniasis

This study is a multicenter, randomized, double-blind, active-controlled, dose-ranging clinical trial designed to evaluate the efficacy and safety of the investigational drug compared to the active comparator in the treatment of vulvovaginal candidiasis. The trial consists of three phases: screening/enrollment (D-3 to D-1), treatment period (D1 to D3), and follow-up period (D4, D11±2, D25±3). Eligible subjects in this study will be randomized in a 1:1:1:1 ratio to three investigational drug arms with different dosing regimens and one active control arm. Specifically, Group A will receive WXSH0102 tablets with 1400 mg on the first day followed by a maintenance dose of 700 mg for two consecutive days, Group B will receive WXSH0102 tablets with 1000 mg on the first day followed by a maintenance dose of 500 mg for two consecutive days, Group C will receive WXSH0102 tablets with 600 mg on the first day followed by a maintenance dose of 300 mg for two consecutive days, and Group D (active control group) will receive fluconazole capsules for only one day on D1. All medications will be administered orally.

This CBPR study will advance prevention science and practice through testing an innovative intervention to promote and support the use of needed HIV, STI, and HCV prevention and care services among GBMSM and transgender women; and developing priorities and recommendations to improve their health that will be disseminated to inform public health practice, research, and policy. By integrating peer navigation and mHealth strategies, the proposed study provides a unique opportunity to improve health among vulnerable, hidden, and neglected populations living in rural Appalachia. Findings from this research may inform strategies and approaches to address other health disparities in other rural populations.

In Kenya, HIV incidence among adolescent girls and young women (AGYW) ages 15-24 years is 1-2 per 100 person-years and approximately 30% of AGYW have had at least one sexually transmitted infection (STI). Kisumu and Migori counties in Western Kenya have some of the highest HIV/STI incidence in the country. Food insecurity (FI) and poverty are also highly prevalent in Western Kenya. FI and poverty are important drivers of vulnerability to HIV and STIs among AGYW. Poverty alleviation interventions have the potential to reduce STIs and HIV risk among AGYW but, to date, these interventions have reported mixed findings on HIV/STI outcomes, have been primarily targeted at the individual level, and none have focused on agriculture or FI. Therefore, there remains a critical need to develop sustainable, multi-level, economic and FI interventions that improve AGYW STI/HIV prevention outcomes. Our team has successfully developed a household-level agricultural intervention in Western Kenya called Shamba Maisha ("farm life" in Kiswahili; SM) to reduce household FI. In our prior pilot study with AGYW, the investigators found that SM was feasible, acceptable, and associated with less FI and improved mental health. In this proposal, the investigators will build upon our promising SM work by examining the effectiveness and implementation of our SM intervention, including provision of a water pump and agricultural implements for use at home, training in agriculture delivered at school-based demonstration farms, and adolescent-caregiver relationship strengthening training. The investigators plan to conduct this school- and home-based cluster randomized trial with 800 AGYW and their primary caregivers recruited from schools in Kisumu and Migori counties. The investigators will randomize 20 schools in Kisumu and Migori in a 1:1 ratio to intervention or control conditions and follow AGYW-caregiver dyads for 18 months with surveys and STI/pregnancy testing to assess intervention impacts. The study has the following aims: Aim 1. Determine the impact of SM on adolescent HIV prevention and sexual and reproductive health outcomes (primary outcome is gonorrhea and/or chlamydia incidence). Aim 2. Assess the effect of SM on intermediate outcomes theorized from our published conceptual framework to be on the causal pathway, including household food security and wealth, and adolescent and caregiver factors including mental health and aspects of the caregiver-AGYW relationship dyad (e.g., communication). Aim 3. Identify critical implementation facilitators and barriers influencing SM effectiveness and delivery and conduct a programmatic cost assessment. The investigators will also evaluate the extent to which SM can have "spillover" nutritional benefits for a larger population of adolescents who had access to demonstration farms at intervention schools but did not receive other aspects of the intervention. The ultimate goal is to provide an innovative household-level intervention to halt the cycle of FI, and poor HIV-related outcomes among vulnerable populations including AGYW, consistent with the "Ending the HIV Epidemic".

The high prevalence of the Genitourinary Syndrome of the Menopause (GSM) previously known as vulvovaginal atrophy, atrophic vaginitis or urogenital atrophy, does not correlate with the fact that up until today GSM is still hugely underreported, underdiscussed, underdiagnosed as well as undertreated. Postmenopausal women suffering from symptoms of GSM will be recruited after a routine visit at a Women's Unit at a General Hospital. The participants will self-assess their symptoms with the use of the Day-to-Day impact of Vaginal Aging (DIVA) questionnaire at baseline and after 8 weeks of use of the tested product. Self-assessment with PROMs will allow to obtain a greater knowledge of the physical and emotional state of patients as well as to deliver valuable information to women. Criteria for a successful outcome will be if the use of the hormone-free agent is well accepted and if symptoms and quality of life improve after 8 weeks of intervention. Daily dosage of XCMIM20m ((2-(trimethylazaniumyl) acetate; (2R,3R,4S)-pentane-1,2,3,4,5-pentol; Hexadecanoic acid; (9Z, 12Z)-octadeca-9,12-dienoic acid; octadecanoic acid; (Z)-hexadec-9-enoic acid; (Z)-octadec-9-enoic acid)) will be 2 ml of total product, divided in two applications of 1 ml every 12 hours, preferably morning and bedtime. To be spread topically onto the vulvar area, including the vaginal introitus. The gel will be further applied before sexual intercourse. No intravaginal applicator will be used as the agent will be manually applied directly onto the vulvar area from a 50 ml airless pump dispenser. Four pump applications from the pump dispenser are equivalent to 1ml of tested gel. Adverse effects, such as allergic reaction, skin irritation, itching, discomfort, yeast infection, or any other, will be collected and if so, a detailed description and follow-up of the problem will be noted.

This CHOICES-TEEN intervention study will use a Phase II Behavioral Treatment Trial to employ a single blind randomized design with an attention control (AC) group to assess the efficacy of the CHOICES-TEEN intervention. Young women, 14-19 years of age, entering the Harris County Juvenile Probation (HCJP) system's probation and field diversion and community probation program will be eligible for screening into the study. The investigators anticipate recruiting N=435 with 92% retention based on prior experience, yielding a total sample size of N=400, stratified by program, with 200 randomized to the CHOICES-TEEN intervention (plus Standard Care; CT) or the Attention only group (AC) using urn randomization. Both groups will be assessed at 3-, 6- and 9-month follow up. Eligibility will be determined based on the following inclusion/exclusion information. This efficacy trial will: (1) Test the efficacy of CHOICES-TEEN (CT) compared with attentional control (AC) on reducing the risk of substance-exposed pregnancy (SEP) and HIV/STI among high-risk female youth involved with the juvenile justice system by reducing alcohol use, increasing marijuana cessation, reducing pregnancy risk, and increasing condom use; (2) Test the efficacy of CT, compared to an attentional control condition, in increasing cognitive self-regulation abilities; (3) Test proposed intervention mediators/mechanisms of action for CT overall and by race/ethnicity; and (4) Test the moderating effect of initial readiness to change on risk of SEP and risk of HIV/STI. Female adolescents between the ages of 14-19 will be recruited for eligibility screening from the aforementioned community probation program. Voluntarily referred youth will be screened for eligibility in the study after obtaining parental permission and youth assent. All youth enrolled in the study must be identified as being at risk for substance-exposed pregnancy and HIV/STI. Eligible youth who provide written informed consent (and parents who provide written permission) will then be randomized to the CHOICES-TEEN intervention or the Attentional Control Condition. The investigators anticipate recruiting N=435 with 92% retention based on prior experience with similar studies, yielding a final sample size for analyses of N=400. Randomization, stratified by program, will result in n=200 participants per condition with participants clustered within k=4 forensic programs. Investigators assume a conservative ICC =0.20 due to clustering. Absolute risk reductions in risk of SEP range from 14.8% to 25.1% based on Project CHOICES, Project CHOICES Plus and our pilot CHOICES-TEEN. For the purposes of sample size justification, investigators will assume N=435 randomized in 1:1 fashion (minimum 400 completers), stratified by program, and ICC = 0.20 and a conservative estimate of an ARR=15% for reduced risk of SEP and HIV/STI. Finally, investigators stipulate that if the posterior probability that there is an effect of treatment (Odd Ratio\>1.0) is greater than 0.75 and that the median treatment effect estimate exceeds an Odds Ratio=1.5, this constitutes sufficient evidence to warrant subsequent investigation. M=1000 Monte Carlo simulations, using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 81.9% of the time. Data analyses. The data analytic strategy will use generalized linear mixed and structural equation modeling (SAS 9.4, R v. 3.4, Stan,v. 2.17 and MPlus v. 8.3) for both continuous and discrete outcomes. All analyses will be conducted on an intention-to-treat basis. To address missingness, Bayesian approaches will implement joint modeling of observed outcomes and the missing data which is robust to ignorable missingness (i.e., MCAR and MAR). Sensitivity analyses will evaluate robustness of analytic conclusions to missing data. Non-ignorable missing data patterns (i.e., MNAR) will be addressed through pattern-mixture modeling methods.Specification of diffuse, neutral priors will reflect the initial uncertainty regarding effect sizes. For all generalized linear mixed models, priors for regression coefficients will be specified as \~Normal (µ=0, σ2=1 x 106) (for non-normal outcomes this refers to the prior for the coefficient within the link function), level one error variances will be specified as \~Inverse Gamma (shape=0.001, scale=0.001). Choice of prior distribution for level two variances will follow Gelman's recommendations. Bayesian Structural Equation Modeling (BSEM) prior specification will adapt recommendations from Muthén and Asparouhov 230. Priors for the comparison of proportions will be specified as \~Beta (α=0.5, β=0.5). Similar procedures will be used in secondary analyses to investigate subgroups of youth using specific substances (i.e. alcohol and marijuana), as well as intervention effects as a function of baseline readiness to change as a potential moderator. Mediational modeling will examine the degree to which putative mechanisms of behavioral change transmit the effects of the intervention on the specified outcomes. BSEM will investigate mediation of treatment effects due to CT on SEP and HIV/STI risk at 9 months by hypothesized mechanisms (processes of change, cognitive self-regulation, and confidence and temptation) measured at 3 months utilizing MPlus v. 8.3. Examination of the posterior distribution of the indirect effects will evaluate the probability that mediational effects exist. Specific Data Analyses - Hypothesis 1: CT, compared to Attentional Control (AC) AC will be associated with reduced risk of SEP and HIV/STI at 9-months post intake. The primary outcome is reduced risk of SEP and HIV/STI at 9 months, however at each time point (3-, 6-, and 9-month) multilevel logistic models will evaluate the risk of SEP and HIV/STI as a function of treatment condition while addressing clustering due to forensic program assignment. At each time point generalized linear multilevel models will evaluate the presence/absence of risk drinking, presence/absence of marijuana use, presence/absence of vaginal intercourse without effective contraception, and presence/absence of vaginal or anal intercourse without condom use as a function of treatment condition while addressing clustering due to forensic program assignment. Hypothesis 2: Compared to AC, CT will improve cognitive self-regulation abilities at 3-, 6-, and 9-month post intake as measured by self-report self-regulation measures. At each time point (3- and 9-month) generalized multilevel linear models will evaluate self-regulation as a function of treatment condition while addressing clustering due to forensic program assignment. Hypothesis 3: The processes of change, confidence and temptation, and cognitive self- regulation, for each risk behavior at 3-months will mediate the effect of treatment on SEP risk and HIV/STI risk at 9-months post intake for CT. Multilevel Bayesian structural equation modeling (M-BSEM) will evaluate the degree to which processes of change, cognitive self-regulation, confidence and temptation measured at 3 months follow-up mediate the effect of treatment on SEP and HIV/STI risk at 9 month follow-up. Multilevel elements will address clustering as a function of forensic program assignment. Multigroup analyses testing the mediation models will find invariance between Non-Hispanic Black, Hispanic, and Non-Hispanic White. Hypothesis 4: Female youth with low baseline readiness to change risk behavior will have less risk of SEP and HIV/STI at 3-, 6- and 9-months post intake in the CT intervention condition, designed to increase motivation and goal striving, than female youth with low baseline readiness to change risk behavior in the AC condition. At each time point (3-, 6-, and 9-month) multilevel logistic models will evaluate the risk of SEP and HIV/STI as a function of treatment condition, baseline readiness and the interaction of treatment and baseline readiness. These models will use the approach advocated by Simon and Dixon. Sample Size. The investigators anticipate recruiting N=435 with 92% retention based on our experience with Project CHOICES, CHOICES Plus, and CP-T yielding a final sample size for analyses of N=400. Randomization, stratified by program, will result in n=200 participants per condition with participants clustered within k=4 forensic program assignments. Investigators assume a conservative ICC = 0.20 due to clustering. Absolute risk reductions in risk of SEP range from 14.8% to 25.1% based on Project CHOICES, Project CHOICES Plus and our pilot CHOICES-TEEN. For the purposes of sample size justification, investigators will assume N=435 randomized in 1:1 fashion (minimum 400 completers), stratified by program, and ICC = 0.20 and a conservative estimate of an ARR=15% for reduced risk of SEP and HIV/STI. Finally, investigators stipulate that if the posterior probability that there is an effect of treatment (Odd Ratio\>1.0) is greater than 0.75 and that the median treatment effect estimate exceeds an Odds Ratio=1.5, this constitutes sufficient evidence to warrant subsequent investigation. M=1000 Monte Carlo simulations, using a normal approximation to the posterior indicates that under the preceding assumptions the proposed design will identify an effect of treatment 81.9% of the time.

Cross-sectional study: A total of 920 men who have sex with men aged 18 or above and normally living in Hong Kong would be recruited. Eligible participants would be asked to complete a self-administered online survey, submit self-collected urine specimen and rectal swabs for Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium testing in the laboratory, and submit HIV self-test results. Mathematical modelling study: A compartmental model would be constructed to simulate the transmission dynamics of MG infection and resistant MG infection, and analyse the impact of different test-and-treat strategies.

This is a clinic-based, multi-site, randomized, two-arm study to compare the effectiveness of two mobile technologies designed to support PrEP adherence and continuation in cisgender and transgender men who have sex with men (MSM) and transgender women (TGW). All study participants will receive PrEP per standard of care at each of the study sites. Participants randomized to PrEPmate will receive an interactive bidirectional text-messaging intervention that supports PrEP use through personalized communication between patients and providers. Key components include (1) weekly short message service (SMS) check-ins and a bidirectional SMS messaging platform; (2) customized daily SMS pill-taking reminders; (3) link to online PrEP Basics and videos and testimonials. Participants randomized to Dot Diary will receive a mobile app that promotes self-management of PrEP use and sexual health. Key components include (1) a digital pill-taking and sexual diary, with pill-taking reminders; (2) sex-positive badges earned via app use; and (3) real-time feedback on protection levels afforded by PrEP. Each participant will be followed for approximately 12 months. Staff at the participating clinics will also participate in in-depth interviews to give feedback on implementation challenges and experiences in the clinic-setting, and experience working with patients using the mobile technologies.

Using the intervention functions of Behavior Change Wheel (BCW) and BCTs, we constructed an intervention program for college students' risky sexual behaviors by combining literature analysis, qualitative research, Delphi's expert correspondence, and pre-experiment (20 students in the test group and 20 students in the control group). Before the intervention (T0) and at the end of the intervention (12 weeks, T1), we measured students' psychosexual health, social support, and sexual self-efficacy using relevant scales to ensure the effectiveness of the intervention. By clarifying the influencing factors of college students' risky sexual behaviors, the proposed intervention program for college students' risky sexual behaviors can effectively reduce the incidence of college students' risky sexual behaviors, improve the level of college students' psychosexual health, increase the level of social support, improve the sense of sexual self-efficacy, improve the level of risk perception, enhance the ability of risky decision-making, reduce the risky behaviors, and reduce the occurrence of adverse outcomes, thus providing a reference and reference for the prevention and control of college students' risky sexual behaviors. This will provide reference for the prevention and control of risky sexual behaviors among college students.

Objective: To develop and validate a predictive model for acquiring sexually transmitted infections (STIs) in individuals using HIV pre-exposure prophylaxis (PrEP) within the national program providing this strategy. Methods: Ambispective cohort study, multicentric (23 Spanish hospitals). All PrEP users, with follow-up within the program, will be included. Entry into the program will be considered as the baseline visit. From there, patients are followed quarterly, following the national protocols for monitoring PrEP users in Spain. At each visit, diagnosis of different STIs (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. Primary outcome variable: development of an STI (Yes/No). The following STIs will be considered: syphilis, Neisseria gonorrhoeae (NG) infection, Chlamydia trachomatis (CT) infection, lymphogranuloma venereum (LGV), Mycoplasma genitalium (MG) infection, genital herpes, hepatitis A, hepatitis B, hepatitis C, HIV infection, and MPOX. Secondary outcome variable: number of diagnosed STIs. In order to determine factors associated with acquiring an STI, multivariate analyses will be conducted using logistic regression. The best models will be analyzed in the validation population. To compare the models, we will follow the Bayesian approach suggested by Benavoli et al.

The goal of this clinical trial is to learn if doxycycline post-exposure prophylaxis (doxy-PEP) can help prevent bacterial sexually transmitted infections (STIs) among sexual and gender minorities in Rio de Janeiro, Brazil, including men who have sex with men, transgender women, and travestis who are living with HIV or using HIV pre-exposure prophylaxis (PrEP). Bacterial STIs such as syphilis, gonorrhea, and chlamydia remain common in these populations, even with existing prevention strategies. This study aims to answer the following questions: whether doxy-PEP can reduce the number of new STIs, whether it is safe and well tolerated, whether participants use it as recommended, and whether its use may contribute to antibiotic resistance or changes in the body's natural bacteria. Doxy-PEP involves taking a dose of doxycycline, an antibiotic, shortly after sexual activity to reduce the risk of acquiring STIs. Participants will first receive information and counseling about doxy-PEP, including its possible benefits and risks, and will then choose whether or not to use this prevention strategy. Those who choose to use doxy-PEP will take doxycycline after sex as instructed and will be followed for up to 48 weeks, with clinic visits approximately every three months. During these visits, participants will be tested for STIs, monitored for side effects, and asked about medication use, sexual health, and overall well-being. Researchers will collect information on new STI diagnoses, safety, and how consistently participants use doxy-PEP. The study will also explore participants' experiences and perceptions of this strategy. The results of this study will help determine whether doxy-PEP is a practical and acceptable approach for STI prevention in Brazil and may inform future public health strategies.