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NCT07407569
The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion. The primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time. Candidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers: * The University Hospital of Antwerp (UZA). * The University Hospital of Leuven (UZ Leuven). * Ghent University Hospital (UZ Gent). Women are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints. The following laboratory procedures will be applied to reach study objectives * Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples. * Assessment of HPV infectivity: Detection of HPV16 E1\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples. * Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.
NCT07471113
The goal of this study is to learn about the impact of a mobile application-supported education program on women's HPV literacy and their beliefs regarding breast cancer screening. The main questions it aims to answer are: * Does a mobile application-supported program increase HPV literacy levels among women? * Does this intervention strengthen women's positive beliefs and attitudes toward breast cancer screening? Researchers will examine how this holistic, health-based intervention changes participants' awareness and screening perspectives. Participants will: * Use a mobile application designed to provide education on HPV and breast cancer * Complete surveys regarding their HPV knowledge and breast cancer screening beliefs before and after the program * Engage with health-related content through the mobile platform for the duration of the study.
NCT07214584
The goal of this study is to test two commercially available technologies for their ability to detect treatment response in patients with cervical cancer following surgery, radiation, and chemotherapy: one based on polymerase chain reaction (PCR; NavDx) and the other on branched DNA (Quantivirus HPV \[DNA\]). A 9-month feasibility study will be performed to examine the side-by-side utility of both NavDx and Quantivirus HPV DNA assays in predicting cervical cancer treatment response. These tests could prove to be highly sensitive methods for evaluating minimal residual disease and for quantitation of response to surgery, radiation, and chemotherapy in patients with cervical cancer. Primary Goal: Feasibility for NavDx HPV DNA assay (Naveris, Inc) to be used for personalized prediction of tumor response before and after treatment. Secondary Goals: 1. Comparability of the Quantivirus HPV DNA/mRNA assay (DiaCarta, Inc) with the NavDx HPV DNA assay and, 2. Feasibility of the Quantivirus technology for measuring treatment response within the first day to 2 weeks of radiation, surgery, or a new chemotherapy.
NCT05495906
There are very little data on human papillomavirus (HPV) vaccination among the 18 million women living with HIV (WLWH) globally, who constitute a population most vulnerable to HPV and the resultant cervical cancer. Particularly, there are no data to date on reduced-dose schedules of nonavalent HPV (9vHPV) vaccination in WLWH and there are very little data on the 9vHPV vaccine in this population overall. It is critical to examine the 9vHPV vaccine in WLWH now because the quadrivalent HPV (4vHPV) vaccine has been discontinued. Additionally, in order to reach the World Health Organization's global goal of cervical cancer elimination, we must determine the role of various HPV prevention strategies in this important population including reduced vaccine dosing which can drastically increase the feasibility of HPV vaccination programs globally. This randomized clinical trial will enrol WLWH aged 18-45 from across Canada who have not previously received an HPV vaccine. Participants will be randomized 1:1 to receive 3 doses of 9vHPV vaccine at the routine vaccine schedule of 0/2/6 months or 2 doses at an expanded schedule of 0/6 months with a third dose at month 12 to adhere to current recommendations for WLWH. We will compare the immune response generated to two versus three doses of 9vHPV vaccine and will follow participants for 2 years to examine the immune response over time. This study, which builds upon our team's prior work on HPV vaccination in WLWH, will determine whether two doses of 9vHPV vaccine can be used in WLWH instead of three, and will examine additional aspects of HPV vaccination in WLWH including the immune response to three doses, vaccine safety and efficacy, and attitudes towards self-collected HPV samples in this population. These data will inform global public health policy and programming and will inform the global strategy for cervical cancer elimination.
NCT06436274
The Efficacy of Human Papillomavirus (HPV) Vaccination to Prevent Infection Among Women Living with HIV: A Prospective, Individual, Double-Blind, Randomized Controlled Study is evaluating immediate or delayed single-dose nonavalent HPV vaccination among women living with HIV who received prior HPV vaccination.
NCT05744960
This trial will look at the impact of clinic-level financial incentives to improve provider communication and increase HPV vaccine uptake. Some clinics will receive communication training. Other clinics will receive the same training and a clinic-level financial incentive program with a monthly data feedback report to increase HPV vaccine uptake.
NCT07060261
This prospective research study aims to see if pre-operative MRI can predict the margin status after transoral robotic surgery (TORS) for human papillomavirus positive (HPV+) tonsillar squamous cell carcinoma (SCC). The pre-operative MRI will have a standard MR neck without and with contrast, with added axial T2 weighted sequence and T2 SPACE sequence through the tonsils. Three neuroradiologists will grade the thickness of the pharyngeal constrictor muscle (the muscle that surrounds the tonsils) on a five-point scale. The study will determine if the pre-operative MRI grading will correlate with positive, insecure (\<1mm), or secure (\>1mm) margin during TORS surgery for your HPV+ tonsillar SCC.
NCT07207655
Health education is one approach to influencing individuals, groups, or communities to achieve better health. The literature indicates that increasing awareness of HPV, along with participation in early screening and vaccination programs, can positively influence attitudes and behaviors. Therefore, this research will be conducted to determine the effect of education using the card game method on the knowledge and health beliefs of hearing-impaired individuals regarding Human Papilloma Virus (HPV).
NCT07110909
This randomized controlled study is being conducted between January and April 2025 at a Family Health Center in the Black Sea Region with 103 women (intervention group: 50, control group: 53) selected via randomizer.org. Participants complete pre-tests, receive HPV and cervical cancer prevention education, and take post-tests to evaluate the impact of the intervention. Keywords: HPV, education, knowledge, awareness, midwife.
NCT07036211
The goal of the Transmission of Oncogenic HPV Infection Among Families (TREVINO) study is to improve understanding of how high-risk human papillomavirus (HPV) infections are transmitted within families. The research focuses on transmission between sexual partners and between parents and children. It also examines how the various microbes may influence the persistence of HPV infections and the development of HPV-related cancers. The study will include up to 300 couples recruited from gynecology and ear, nose, and throat (ENT) clinics in Finland, as well as their children. Participants include individuals with persistent HPV infection, cervical precancer or cancer, or HPV-related head and neck cancer, along with their partners and potentially their offspring. Participants will provide self-collected samples from the oral and genital areas at multiple time points over up to five years. Questionnaires addressing medical, behavioural, and environmental factors will be completed. The study is conducted at Tampere University Hospital and Kuopio University Hospital in Finland. Results will inform HPV screening and prevention programs, improve understanding of family-level transmission, and identify potential microbial and genetic markers linked to cancer risk.
NCT04178174
This is a randomized clinical trial comparing the outcomes of short-course chemoradiation consisting in stereotactic boost to the gross tumor and de-esclalated chemoradiation to the elective neck in human papilloma associated oropharynx cancer vs. the current standard 7-week course chemoradiation.
NCT06624839
This is a phase 2, open-label study to assess the immunogenicity of the 9-valent human papillomavirus (HPV) recombinant vaccine (Gardasil9) in people born male with current or past exposure to androgen blockers or estrogen (BM-EABE). Investigators will enroll BM-EABE with HIV and HIV negative controls (BM-EABE or men who have sex with a person with a penis (MSPP)) and administer Gardasil9 at timepoints Day 0, Month 2, and Month 6. The immune response to the vaccine will be analyzed at Month 7 (1 month following the final vaccine dose).
NCT05065840
People living with HIV (PLWH) are 28 times more likely to be diagnosed with Human Papillomavirus (HPV) - associated anal cancer than the general population. The HPV vaccine is an effective and safe approach to prevent and reduce the risk of HPV-related disease among PLWH. HPV vaccine programs tailored and implemented in the HIV population are lagging for this high-risk group. The CDC's 4 Pillars Transformation Program is a multi-level, evidence-based intervention that has been successfully used to increase HPV vaccination in the general population and is ready to be tested in the high-risk HIV population, particularly PLWH in the rural South. This program offers providers and clinic staff evidence-based strategies to increase HPV vaccination uptake via training and educational resources. This study proposes to tailor and refine the 4 Pillars Program and conduct this project in three HIV clinics in Georgia.
NCT06909370
According to the World Health Organization (WHO), 400 million treatable sexually transmitted diseases (STDs) such as syphilis, chlamydia and human papillomavirus (HPV) occur each year in people aged 15-49, mostly in developing countries. As HPV is a sexually transmitted virus, it has been shown to be the most important aetiological factor in cervical cancer in women (99.7%). Vaccination and education of young people about sexuality and STDs are very important in the prevention of HPV. In this respect, the aim of this study was to find out the level of knowledge, concern and awareness of HPV infection among university students and to increase their awareness by informing them about the subject through their peers. The study was conducted as a pre-test and post-test one-group study. The sample of the study consisted of all final year students of Physiotherapy and Rehabilitation (85 students), Nutrition and Dietetics (60 students), Audiology (35 students), Child Development (80 students), Health Management (44 students) and Social Work (45 students) studying in the spring semester of the 2023-2024 academic year. The students were trained by the Gynaecology Nursing Intern student group (9 students) of the Department of Nursing. Data were collected using the Sociodemographic Characteristics Form, the HPV Knowledge Scale and the Human Papilloma Virus Awareness and Concern Level Scale (HPV-FAS). The relevant forms and the consent form were completed by the students before, after and one month after the training.
NCT05229679
The aim of the trial is to determine whether organized screening with primary HPV analysis provide higher cancer protection in the age group 23-29 years compared to primary cytology.
NCT06743880
* Cervical cancer is caused by persistent infection with certain strains of the human papillomavirus (HPV), which is a very common virus transmitted through sexual activity. * HPV infections can lead to the development of precancerous lesions on the cervix, which if left untreated, can progress to invasive cervical cancer over time. * Cervical cancer is the second most common cancer among women in Egypt, after breast cancer. * According to the latest available data, the age-standardized incidence rate of cervical cancer in Egypt is approximately 6.3 per 100,000 women. * However, the actual burden of cervical cancer in Egypt is likely underestimated, as many cases may go undetected or unreported, especially in rural and underserved areas. The main objectives of this KAP study are: 1. To assess the level of knowledge about HPV and HPV vaccination among the target population. 2. To investigate the attitudes and perceptions towards HPV vaccination. 3. To identify the current practices and uptake of HPV vaccination. 4. To explore the factors influencing the knowledge, attitudes, and practices related to HPV vaccination.
NCT06598176
The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.
NCT03638427
The purpose of this study is to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood in a smart menstrual pad. In other words, can the investigators detect the high risk strains of the human papilloma virus (HPV) that are associated with cervical cancer in self-collected menstrual blood, as an alternative to collecting vaginal swabs.
NCT02072148
In general, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients. Patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. There are exploratory biomarkers of risk of recurrence that will be collected and studied. There are currently few trials examining the role of de-escalation using surgery alone in intermediate and early T-stage HPV related disease. New surgical techniques have broadened the range of patients capable of achieving a complete resection and the functional outcomes in such patients are outstanding. Furthermore, the sensitivity of HPVOPC to chemotherapy and radiotherapy raise the possibility that delayed or salvage treatment in early stage patients would be highly effective, would result in similar survival outcomes and radiotherapy could be applied to a much smaller population then current standards call for. Looked at from a different perspective, the need for post-operative radiotherapy in this younger, HPV+ and more functional population has not been validated in clinical trials to date.
NCT03418480
HARE-40 is a phase I/II vaccine dose escalation study with two different arms: Arm 1A will perform intrapatient dose escalation in patients with previously treated HPV16+ Head \& Neck Cancer using two dose cohorts to establish a safe, tolerable and recommended dose of HPV vaccine. Arm 1B will perform intrapatient dose escalation in patients with advanced HPV16+ cancer (head and neck, anogenital, penile, cervical and other) using a single cohort to establish a safe, tolerable and recommended dose of HPV vaccine.