Syphilis

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) to understand how different PET/CT scans can predict outcomes during radioligand therapy with 177Lu-PSMA-617. This is an exploratory, prospective study conducted at a single center, focusing on imaging tumor heterogeneity to help assess therapy effects and patient response. The study is designed specifically for Veterans undergoing this treatment. Participants will receive several types of PET/CT scans at different times: before starting LuPSMA radioligand therapy (RLT), and then after the 2nd, 4th, and 6th treatment cycles. These scans include 18F-Fluciclovine PET/CT (Axumin), 18F-DCFPyL PET/CT, and 18F-FDG PET/CT. The 18F-Fluciclovine scans will be performed within seven days of the PSMA PET scans to compare imaging results at each time point. During the study, detailed imaging measures such as lesion uptake and tumor volume will be collected and analyzed over time. Patients will be followed at the institution to correlate these imaging results with clinical outcomes. The main outcome measured is the impact of 18F-Fluciclovine PET/CT on predicting outcomes of the 177Lu-PSMA-617 therapy from enrollment through 34 weeks of treatment.

Researchers are evaluating the accuracy and reliability of the MedMira Inc. Multiplo4 Complete Syphilis (TP/nTP) Antibody Test (a point-of-care test or POCT) to diagnose infectious syphilis. This study responds to a rise in infectious syphilis cases in Canada, especially among heterosexuals and females of childbearing age, which has led to increased congenital syphilis and stillbirths. The goal is to compare this rapid test's performance to the standard syphilis serology testing used in clinical settings. Participants attending a sexual health clinic in Ottawa for routine syphilis testing will undergo testing with both the investigational Multiplo Complete Syphilis Antibody Test and conventional syphilis serology tests. The study involves a single visit lasting approximately 30 minutes during which both tests will be conducted in parallel to evaluate the new device's sensitivity and specificity. During the visit, participants will provide informed consent and be tested using both methods. Researchers will measure the accuracy of the investigational test compared to the gold standard. The study is designed to include individuals 16 years and older attending the clinic for syphilis testing, including follow-up visits. The study does not involve masking or randomization and aims to complete data collection by July 2026.

Researchers are evaluating a community-based screening intervention aimed at reducing disparities in chlamydia infections among Black youth aged 15 to 26 years living in the Deep South. The study focuses on testing for four sexually transmitted infections (STIs): chlamydia, gonorrhea, syphilis, and HIV, with a special emphasis on measuring the impact on chlamydia rates in women. Participants will be tested for chlamydia, gonorrhea, syphilis, and HIV at community venues at no cost. Those who test positive for chlamydia or gonorrhea, along with their sexual partners, will be offered expedited treatment options, also at no cost, through participating pharmacies. Additionally, individuals who test positive are encouraged to be rescreened three months after treatment to monitor infection status. During the study, which can last up to 60 months, participants will undergo STI testing and counseling. Researchers will track infection rates for chlamydia and gonorrhea in women over time. The study includes offering counseling and treatment options for positive cases, and participants may be rescreened after treatment. The aim is to assess whether this approach reduces chlamydia rates in the target community while providing ongoing support and monitoring throughout the study period.

Researchers are evaluating the clinical performance and usability of the TruPlex HIV/HepB/Syphilis Rapid Test in point-of-care settings. The study aims to assess the test's accuracy using various blood samples collected by trained operators, including capillary blood, EDTA whole blood, EDTA plasma, and SST serum. The study also evaluates how well trained healthcare professionals can interpret contrived test results and monitors the test system's reliability, including rates of invalid results. Trained healthcare professionals will collect non-invasive samples such as fingerstick capillary blood and venous blood to process into plasma and serum for testing on the TruPlex device. At least two lots of the TruPlex test will be used. Participants will complete usability questionnaires to assess their experience and success in understanding the test labels. They will also interpret a set of predefined contrived test results representing strong and weak positives, negatives, and invalid results to evaluate interpretation accuracy. Participants will provide fingerstick and venous blood samples and complete the study's testing on the allocated day. Blood samples will also be sent to a central laboratory for confirmatory testing of HIV, Syphilis, and Hepatitis B using approved assays. Remaining samples may be stored for further testing or future research. The study will measure the clinical performance of the TruPlex test over six months, along with usability and interpretation evaluations. Participants will be monitored throughout the study duration, which includes a six-month evaluation period.

This research aims to improve the use of HIV, STI, and HCV prevention and care services among racially and ethnically diverse gay, bisexual, and other men who have sex with men (GBMSM) and transgender women living in rural Appalachia. By combining peer navigation with mobile health (mHealth) strategies, the study seeks to reduce health disparities in these vulnerable populations and inform public health practices and policies. Participants will be assigned to one of two groups: an intervention group receiving a culturally compatible, bilingual approach that includes peer navigation and mHealth communication, or a delayed-intervention group. Community health leaders will raise awareness, support service access, and conduct in-person group sessions over 12 months. They will also use social media and apps to communicate and support participants throughout the intervention. During the study, researchers will track HIV, STI, and HCV testing rates at baseline, immediately after the 12-month intervention, and again 12 months later. They will also monitor the use of prevention methods like PrEP, syringe services, and gender-affirming care. Participants will be involved in group activities, receive ongoing support via mHealth platforms, and have their service use regularly assessed to measure the intervention's impact through 24 months from baseline.

Researchers are evaluating a multisectoral agricultural intervention called Shamba Maisha aimed at improving reproductive and sexual health among adolescent girls and young women (AGYW) aged 15-19 in Kisumu and Migori counties of Western Kenya. This region has high rates of HIV and sexually transmitted infections (STIs), along with widespread food insecurity and poverty, which contribute to vulnerability to these infections. The study focuses on reducing the incidence of gonorrhea and chlamydia and improving related health outcomes by addressing household food security and adolescent-caregiver relationships. The Shamba Maisha intervention includes providing families with water pumps, seeds, and farming tools, along with training on agricultural techniques delivered at both home and school demonstration farms. Girls will engage in practical farming activities at school, which also benefits the wider school community. Additionally, families participate in sessions to strengthen communication and reduce stress between caregivers and adolescents, including discussions on sexual health. Control group participants will have the chance to receive the full intervention after the study concludes. Participants will be followed for 18 months, with data collected through surveys and testing for STIs and pregnancy at four time points: baseline, 6, 12, and 18 months. Researchers will measure outcomes such as STI incidence, household food insecurity, adolescent and caregiver mental health, body mass index, condom use, intimate partner violence, empowerment, and educational attainment. The study will also assess factors affecting implementation and costs, aiming to inform sustainable strategies to reduce food insecurity and improve HIV prevention among vulnerable youth.

Researchers are evaluating the effectiveness of cefixime compared to benzathine penicillin G in treating early syphilis, including patients with and without HIV infection. This Phase 3, randomized, open-label trial aims to find an alternative treatment option to penicillin, especially useful for those with penicillin allergies or where penicillin shortages exist. The study involves 400 participants recruited from multiple sites in the U.S. and Peru. Participants will be assigned to one of two treatment groups: one receiving oral cefixime 400 mg twice daily for 10 days, and the other receiving a single intramuscular injection of 2.4 million units of benzathine penicillin G. The study is designed to compare these treatments over time to assess their effectiveness in managing syphilis. Throughout the study, participants will have follow-up visits every 3 months for 9 months to monitor their clinical progress and serological response through RPR titer measurements. The primary outcome measure is the response to treatment evaluated at 6 months. The study includes ongoing assessments to ensure participant safety and adherence to treatment protocols.

Researchers are conducting a nationwide observational study in Denmark to track and understand infections of the central nervous system (CNS) among adults aged 18 years and older. This study systematically registers clinical characteristics and outcomes of all community-acquired CNS infections diagnosed or treated at infectious disease departments across the country since January 1, 2015. The aim is to monitor trends in infections such as bacterial meningitis, viral meningitis, encephalitis, brain abscess, neuroborreliosis, and neurosyphilis, among others. The study involves collecting detailed information on diagnosis at admission, symptoms, timing and type of diagnostic tests like lumbar puncture and cranial imaging, and treatments given. These treatments and diagnostic procedures are determined by local physicians and are not standardized across sites. The study ensures data quality through regular case reviews and annual checks of hospital records using specific diagnosis codes to identify CNS infection cases. Participants are monitored for outcomes using the Glasgow Outcome Scale at various time points depending on the infection type, such as 2 weeks for neurosyphilis and 8 weeks for brain abscess. Data on timing of hospital admission, diagnostic procedures, and antibiotic treatment are collected from hospital records. The study's main measure is the yearly incidence of CNS infections, capturing clinical course and patient outcomes to improve understanding of these serious infections over time.

Researchers are evaluating the CHOICES-TEEN (CT) intervention compared with an Attentional Control (AC) condition to reduce risks of substance-exposed pregnancy (SEP) and HIV/STI among high-risk female youth aged 14 to 19 involved with the juvenile justice system. This trial also investigates how CT may improve cognitive self-regulation and explores factors that influence the intervention's effects based on race/ethnicity and readiness to change behavior. Participants are randomly assigned to either the CHOICES-TEEN intervention or the attentional control group. The CT intervention includes four sessions using Motivational Interviewing and cognitive-behavioral methods delivered by trained counselors, with one session in person and three via Telehealth. The control group attends four sessions focused on life skills education covering topics like time management, sleep, nutrition, exercise, and financial management, similarly delivered both in person and by Telehealth. Throughout the study, participants complete assessments at 3, 6, and 9 months to measure changes in risks related to alcohol- and marijuana-exposed pregnancy, HIV, and STIs. Data collection includes self-reports of substance use, sexual activity, and contraception use. Researchers also evaluate cognitive self-regulation abilities and intervention mechanisms. The study lasts at least 9 months with follow-up assessments to monitor participant progress and safety.

Researchers are evaluating the clinical performance of the MagIA H3S, an In-Vitro Diagnostics Medical Device designed to detect multiple infections including HIV, Hepatitis B, Hepatitis C, and Syphilis. This observational study focuses on samples collected both prospectively and retrospectively from individuals in Ivory Coast and Kenya. The aim is to assess how well this multiplex point-of-care test identifies these infections in various populations. The study uses serum or plasma samples from different groups, including those with positive results for HIV-1, HIV-2, HCV, Hepatitis B surface antigen, or syphilis antibodies, as well as negative samples from blood donors, hospitalized patients, and vulnerable populations like drug users and prisoners. Additionally, negative samples containing potential interfering substances, such as samples from pregnant women or individuals with other infections or high levels of certain blood components, are also included to evaluate the test's accuracy in complex cases. Participants provide informed consent, and their samples undergo testing to measure the device's ability to detect antibodies or antigens related to these infections. The main outcomes include evaluating the performance of MagIA H3S in detecting HIV, Hepatitis B and C, and syphilis antibodies, as well as assessing cross-reactivity with other substances or co-infections. The study will monitor these outcomes at baseline using the collected serum or plasma samples, with no direct intervention or treatment involved.