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Sexually Transmitted Diseases clinical trials

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NCT ID: NCT06463431 Not yet recruiting - Clinical trials for Stress Disorders, Post-Traumatic

Cognitive Processing Therapy to Treat PTSD and Sexually Transmitted Infections Among Men Who Have Sex With Men

CPT-T
Start date: August 27, 2024
Phase: N/A
Study type: Interventional

Gay, bisexual, queer, and other men who have sex with men (GBM) continue to bear a disproportionate burden of the sexually transmitted and blood-borne infections (STBBI), largely attributable to efficient transmission during condomless anal sex (CAS). In 2020, GBM accounted for 46.6% of new HIV diagnoses in Canada. Incidence of syphilis, chlamydia and gonorrhea have risen among men who have sex with men (MSM), especially among HIV+ GBM living in Canadian urban centres, including Toronto. Post-traumatic stress disorder prevalence is also higher among GBM than among heterosexual men. Post-traumatic stress disorder (PTSD) is a risk factor for CAS and related STBBI among GBM. Despite the strong association between PTSD and STBBI risk among GBM, no studies have examined the efficacy of PTSD treatment on STBBI risk among GBM. PTSD is highly treatable via cognitive-behavioural therapies, including by Cognitive Processing Therapy. The present study will provide preliminary feasibility and acceptability data for a novel and innovative STI/HIV prevention intervention for GBQM. This intervention builds upon empirically supported treatments for PTSD, including PTSD-related substance use, by adding risk reduction counselling to reduce sexually transmitted infections (STI) and HIV sexual risk behaviour. The present study will provide trial data for a novel and innovative STBBI prevention psychotherapy for GBM that could be administered by mental health providers across Canada. The intervention will consist of 15 1-hour sessions of an integrated cognitive-behavioural approach using Cognitive Processing Therapy (CPT) to treat PTSD and to reduce STBBI risks among GBQM. The primary outcome will be condomless anal sex with casual partners. The secondary outcomes will be PTSD prevalence, trauma symptoms, problematic substance use, and PTSD-related avoidance of negative thoughts and feelings. This psychotherapy intervention will build upon empirically supported interventions to reduce HIV risk

NCT ID: NCT06414408 Not yet recruiting - Clinical trials for Sexually Transmitted Diseases, Bacterial

Randomized Directly Observed Therapy Study to Interpret Clinical Trials of Doxy-PEP

DOT-Doxy-PEP
Start date: September 1, 2024
Phase: Early Phase 1
Study type: Interventional

Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis

NCT ID: NCT06369220 Not yet recruiting - Clinical trials for Chlamydia Trachomatis Infection

A Study of the Cobas® Liat CT/NG/MG Test Versus Current Standard Practice for Managing Participants at Increased Risk of Sexually Transmitted Infections

Start date: June 15, 2024
Phase: N/A
Study type: Interventional

This study is designed to assess the comparative clinical utility of the point of care cobas® liat CT/NG/MG to current standard practices in the diagnosis and treatment of urogenital infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG).

NCT ID: NCT06266416 Not yet recruiting - HIV Infections Clinical Trials

IMARA for Black Male Caregivers and Girls Empowerment (IMAGE)

IMAGE
Start date: April 25, 2024
Phase: N/A
Study type: Interventional

The scientific premise of this research is that individual, interpersonal, and structural factors impact Black girls' sexual reproductive health outcomes (sexually transmitted infection (STI) and Human Immunodeficiency Virus (HIV)) and experience of sexual violence. This study expands STI/HIV prevention programs to include Black male caregivers, a potentially valuable yet underutilized resource to protect Black girls and reduce their exposure to STI/HIV and sexual violence.

NCT ID: NCT06203951 Not yet recruiting - Hiv Clinical Trials

Improving Perinatal Outcomes Among Kenyan Pregnant Women With an Integrated STI Testing Model

ANC-STI
Start date: June 1, 2024
Phase: N/A
Study type: Interventional

The investigators will conduct a 3-arm individual-level RCT in Kisumu and Siaya, Kenya to compare perinatal outcomes associated with 3 models of STI testing and management in antenatal care. The investigators will enroll 3132 pregnant women and randomize 1:1:1 to receive standard-of-care (syndromic management only without CT, NG, or TV testing) vs. CT, NG, and TV testing using Xpert® assays universally vs. only among women without STI symptoms. All women with STIs detected and/or symptoms per Ministry of Health algorithms will receive immediate treatment, EPT per national guidelines, and tests of cure. All participants will be enrolled during routine antenatal care and followed through 9-months postpartum. The investigators will quantify and compare a composite outcome of pregnancy loss/stillbirth, PTB, LBW, SGA, and neonatal death, between randomization arms, in addition to several secondary and exploratory outcomes.

NCT ID: NCT06188442 Not yet recruiting - Gonorrhea Clinical Trials

Superiority of On-demand PrEP Versus PEP on Using Doxycycline for Preventing STI in MSM

Start date: April 2024
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare the effectiveness of doxycycline taken for on-demand pre-exposure prophylaxis (DoxyODPrEP) and its post-exposure use (DoxyPEP) in preventing bacterial sexually transmitted infections (STI), including chlamydia, gonorrhoea, and syphilis among men who have sex with men (MSM). The main questions it aims to answer are: 1. Is DoxyODPrEP superior to DoxyPEP? 2. Are both regimens safe? 3. Does the MSM community accept the use of doxycycline to prevent bacterial STI? Participants will be asked to take doxycycline according to the study arm they are randomly assigned to, and attend regular clinical follow-ups during the 2-year observation period. Researchers will compare the bacterial STI incidences between the two groups to see if DoxyODPrEP is superior to DoxyPEP.

NCT ID: NCT06183502 Not yet recruiting - Clinical trials for Sexually Transmitted Infections

HIV/STD Risk and PrEP Implementation Messaging Among Gay, Bisexual, and Other Men Who Have Sex With Men

MIC-DROP
Start date: August 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about awareness around PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors in men having sex with men. The main objective is to study a prospective cohort of MSM in Atlanta, Chicago, and San Diego to understand men's strategies to prevent HIV/Sexually Transmissible Infections (STIs), including PrEP use and adherence, condom use, sexual risk-taking behavior, and substance-using behaviors Participants will complete: - Quantitative surveys quarterly - HIV/ STI testing every 6 months - Qualitative assessments: focus group discussions and in-depth interviews

NCT ID: NCT05983679 Not yet recruiting - HIV Infections Clinical Trials

Prevalence of Sexually Transmitted Infections (STIs) and Coinfections in the General Population

PREMINF
Start date: December 4, 2024
Phase:
Study type: Observational [Patient Registry]

Prevalence of Sexually Transmitted Infections (STIs) and co-infections in the general population

NCT ID: NCT05981807 Not yet recruiting - Clinical trials for Sexually Transmitted Diseases

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

PrevHPV-TG
Start date: October 2023
Phase:
Study type: Observational

The goal of this observational study is to estimate the prevalence of HPV infections anal and ENT level and according to HIV status in transgender (TG) population. The main question it aims to answer is: - What is the prevalence of HPV lesions in transgender population (TG); - What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital, anal and ENT level

NCT ID: NCT05910580 Not yet recruiting - Pregnancy Clinical Trials

Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the effectiveness of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) among adult patients who screen positive to one or more risky alcohol or substance use behaviors while seeking care at a sexual and reproductive health (SRH) clinic. The main questions it aims to answer are: - Does SBIRT impact patients' alcohol and substance use, SRH, mental health, physical health, quality of life, and wellbeing? - Does SBIRT effectiveness differ by ethnicity, socioeconomic status, age, gender, and urbanicity? - Does SBIRT effectiveness differ by delivery mode (in-person vs. telemedicine)? Participants will receive in-person SBIRT, telemedicine SBIRT, or usual care. Participants will complete surveys at interviews at baseline, 30 days, and 3 months. Researchers will compare patients who received SBIRT to patients who receive usual care to see if patients who receive the SBIRT intervention have a greater reduction in negative outcomes as compared to those who receive usual care. In this setting, usual care consists of basic quantity and frequency questions asked inconsistently as part of the admission process and varying by provider, with no standardized approach to screening, treatment, follow-up, or referral.