Genital Herpes

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 studying a new treatment approach for patients with surgically removable head and neck squamous cell carcinoma (HNSCC), a common and serious type of cancer in the head and neck region. The study evaluates the safety and tolerability of combining immune-targeted therapy with a lysogenic herpes simplex virus (HSV) as a neoadjuvant treatment to reduce tumor size before surgery. This innovative combination aims to improve surgery outcomes and lower the chances of cancer returning or spreading. Participants receive a combination of treatments including Tislelizumab given on days 1 and 22, and continuous daily Afatinib from days 1 to 42. They also receive injections of the lysogenic HSV virus directly into lymph nodes, with dosing based on lymph node size, given twice two weeks apart. After these treatments, patients undergo standard surgical removal of the tumor. The HSV virus injection includes an initial dose-escalation phase followed by a dose-expansion phase to find the most effective dose. During the study, patients are closely monitored for side effects and treatment tolerance, including checking for dose-limiting toxicities during surgery. Researchers will assess how well the tumor responds to treatment by examining major and complete pathological responses and overall tumor shrinkage up to eight weeks after treatment. They will also monitor adverse events for up to 12 weeks and follow disease-free survival for one year. The study duration and procedures are planned to provide detailed information on the safety and effects of this combined therapy.

Researchers are evaluating a combination of immune-targeted therapy and lysogenic herpes simplex virus (HSV) virotherapy as a neoadjuvant treatment for patients with surgically resectable head and neck squamous cell carcinoma (HNSCC). This study aims to improve surgical success and reduce the risk of recurrence and metastasis by using these therapies before surgery. The trial is a prospective, single-arm study focused on the safety and tolerability of this innovative approach for patients with locally advanced HNSCC without distant metastasis. Participants will receive tislelizumab on days 1 and 22, afatinib daily from days 1 to 42, and injections of lysogenic HSV virus into lymph nodes in two doses spaced two weeks apart. The virus dose will be adjusted based on lymph node size, with a dose-escalation phase followed by a dose-expansion phase using the most effective dose. After these treatments, patients will undergo standard surgery to remove the tumor. During the study, researchers will monitor participants for dose-limiting toxicities during surgery and evaluate responses such as major pathologic response and complete pathologic response. Additional assessments include adverse events up to 12 weeks, objective response rate up to 8 weeks, and one-year disease-free survival. Participants will attend scheduled visits for treatment administration, surgery, and follow-up to assess safety and treatment effects throughout the trial period.

Herpes simplex viruses (HSV) are very common, affecting nearly 90% of people, and stay in the body for life in a dormant state. When the immune system is weakened, HSV can reactivate and cause infections like cold sores or more serious conditions such as meningitis. In intensive care patients on mechanical ventilation with pneumonia, HSV is often detected in the respiratory tract. This research aims to determine whether treating HSV with acyclovir improves survival in these critically ill patients. The study randomly assigns 616 ventilated ICU patients with pneumonia and HSV detected in their lung fluid to receive either acyclovir treatment or no antiviral therapy. Acyclovir is given intravenously at a dose of 10 mg per kg of body weight every 8 hours for up to 10 days or until ICU discharge if earlier. The trial compares survival rates after 30 days between the two groups and also looks at ventilation-free days, vasopressor-free days, and safety outcomes. Participants will be closely monitored during the study with regular assessments including organ function scores, kidney function tests, microbiological cure, length of ICU and hospital stay, and quality of life measures up to 180 days. Safety will be tracked by recording serious adverse events. This comprehensive evaluation will help clarify whether antiviral therapy benefits ventilated patients with pneumonia and HSV in their lungs.

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 studying the management of Genitourinary Syndrome of Menopause (GSM), a condition causing symptoms like vaginal atrophy that affects quality of life in postmenopausal women. This trial aims to assess the safety and effects of a new hormone-free gel called XCMIM20m applied topically to the vulvovaginal area. The study uses a patient-reported outcome measure called the Day-to-Day Impact of Vaginal Aging (DIVA) questionnaire to compare symptoms before and after treatment. Participants will apply 2 ml of the XCMIM20m gel daily, divided into two 1 ml doses taken about 12 hours apart, preferably morning and bedtime, for 8 weeks. The gel is manually applied to the vulvar area, including the vaginal opening, without an intravaginal applicator. Adverse effects like irritation or infections will be monitored and recorded throughout the study. Women will self-assess their symptoms using the DIVA questionnaire at the start and end of the 8-week treatment to evaluate changes in GSM symptoms and quality of life. Researchers will track any side effects and collect detailed information if any occur. The primary measurement is the change in symptom impact on quality of life after 8 weeks of using the gel, with additional focus on the most affected quality of life areas.

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.

This research aims to understand the burden and transmission patterns of Mycoplasma genitalium (MG) infection among men who have sex with men living in Hong Kong. The study includes a cross-sectional component and a mathematical modeling component to analyze the spread and resistance of MG infections. It seeks to inform test-and-treat strategies for this sexually transmitted infection. Participants who are men aged 18 or older, living in Hong Kong, will complete an online survey and collect their own urine and rectal swab samples for laboratory testing of MG, Chlamydia trachomatis, and Neisseria gonorrhoeae. They will also provide results of an HIV self-test. The modeling study will use these data to simulate transmission dynamics and evaluate different testing and treatment approaches. During the study, participants will undergo laboratory testing for infections and complete questionnaires about their sexual health and testing history. Researchers will measure the prevalence of MG and resistance mutations, as well as other sexually transmitted infections, over one year. The study involves self-sampling and self-reporting, with the total participation period lasting about one year to assess ongoing infection rates and co-infections.

Researchers are studying whether two doses of the 9-valent HPV vaccine given to women aged 27 to 45 produce a similar immune response compared to the standard three-dose series. The vaccine is already approved for this age group with a three-dose schedule, but younger individuals typically receive two doses. This trial aims to see if two doses can provide an immune response that is not inferior to three doses in this adult female population. Participants will be randomly assigned to one of two groups: one group will receive two doses of the vaccine at 0 and 6 months, while the other group will receive three doses at 0, 2, and 6 months. After 12 months, women who received two doses will be offered a third dose. Blood samples will be collected four times over the course of 12 months to measure immune response. During the study, women will provide blood samples at the start, 1 month, 7 months, and 12 months after the first vaccine dose. They will also be monitored for antibody responses to multiple HPV types. Participants will receive compensation after each blood draw, and reliable telephone access is required for communication throughout the study. The total participation period lasts about 13 months, including the optional third dose offered at the end for the two-dose group.