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NCT ID: NCT06380114 Not yet recruiting - Hpv Clinical Trials

Stand Up 2 HPV: Standing Orders to Improve HPV Vaccination

Start date: July 2024
Phase: N/A
Study type: Interventional

Each year in the U.S., ≥20,000 women and 14,000 men are affected by HPV-related cancers, including cervical and oropharyngeal cancer. However, in 2020, only 59% of U.S. adolescents aged 13-17 were up-to-date for HPV vaccination, and rates for 11-12 year olds, the primary target age group for HPV vaccination (when the immune reaction is better and before exposure to HPV infection), are even lower. Standing orders (written protocols that authorize designated members of the healthcare team to vaccinate without first obtaining a patient-specific physician order) have been shown to work in inpatient settings and for adults, but have not been evaluated for HPV vaccine, which some parents consider controversial. Also, the ways in which organizational readiness for change (resources, motivation, staff attributes, leadership support and culture) moderate the effect of standing orders has not been studied. A physician's recommendation is correlated with HPV vaccine acceptance, and the investigators have developed a successful online, interactive, communication education program that will be adapted to train nurses and staff in addition to physicians. The investigators propose testing standing orders for HPV vaccine in an Accountable Care Organization (ACO) in Western New York, and assessing which provider and practice factors moderate the effect of standing orders. Advantages of this setting include a diverse group of rural, urban and suburban practices, and the ACO provides data infrastructure and analytics that allow practices to evaluate vaccination rates in real time. Using a 2-arm cluster randomized trial (n=40 practices), the investigators will assess the effectiveness of standing orders (SO) + HPV communication education (intervention arm) relative to HPV communication education alone (control arm) on HPV vaccination for 11-17 year-olds.

NCT ID: NCT06252012 Not yet recruiting - Nurse's Role Clinical Trials

The Effect of Cervical Cancer Awareness Education Based on Mobile Application

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

Cervical cancer is one of the most common cancer types affecting women in our country and in the world and causing morbidity. However, the availability of a vaccine for cervical cancer, preventable risk factors and early diagnosis tests offer a unique opportunity to reduce the rate of cervical cancer. In this context, there are studies showing that the practices developed by policies differ and that the classical health approach is insufficient. The effectiveness of the trainings given may vary according to time, place, trainer and personal characteristics of the individual. At the same time, in order to improve the attitudes and behaviours of individuals in terms of prevention and early diagnosis of cervical cancer, awareness of individuals about cervical cancer should be increased. In this way, women will have a say about their own health and their conscious participation in health care services will be realised. Therefore, the aim of this project is to apply cervical cancer awareness training to women and to examine its effect on women's cervical cancer prevention and early diagnosis behaviours. Original value; The fact that there is no mobile application developed for cervical cancer in Turkey reveals the national value of the research. In addition, the mobile application has international unique value as it is the first mobile application structured to provide awareness on cervical cancer prevention and early diagnosis behaviours. The project method was planned for the development and implementation of the mobile application programme. The research design will be a randomised controlled study. The 120 women who meet the inclusion criteria and who apply to more than one family health centre will be randomly assigned to the intervention and control groups. The effect of the mobile application programme on women's attitudes and behaviours towards cervical cancer prevention and early diagnosis will be evaluated at the 6th and 12th weeks. In the evaluation of the data, t-test for independent groups, anova and chi-square tests will be used to measure the effect of the intervention. Widespread effect; In this way, it is planned to reduce the time spent by professionals for care-related activities, to strengthen time management, to provide advantages and improvements in the performance of nurses in patient care management by using technological resources in the health care provided.

NCT ID: NCT06220747 Not yet recruiting - Hpv Clinical Trials

Effectiveness of HPV Vaccine Among Adolescents and Reproductive Women

Start date: March 2024
Phase:
Study type: Observational

To assess the effectiveness of HPV vaccine 2 doses or less to prevent HPV high risk infection among adolescents and adults. We conduct the test-negative control study including 12-45 women who interest to do a check-up pap smear. Cases were women who met the inclusion criteria and tested positive for HPV DNA, and controls were defined as women who met inclusion criteria but tested negative. For the proposed HPV VE study, we will enroll nine controls for each enrolled case. The participants will be interviewed about their demographics and vaccine histories. Potential confounders data will be collected by interview or self- report questionnaire. HPV DNA test will be done by urine or self-cervical sampling (optional). In case the participant has previous HPV test result within 1 year, the result will be recorded and analysed without repeating the test.

NCT ID: NCT06144229 Not yet recruiting - Hiv Clinical Trials

Real-world Effectiveness of HPV Vaccine in Women Living With HIV and Its Impact on Cervical Cancer Screening Accuracies

LiVes-LLC
Start date: April 2024
Phase:
Study type: Observational

This study will examine both Human papillomavirus (HPV) vaccine effectiveness and Primary high-risk HPV PHS screening triage strategies in women living with HIV (WLHIV) by partnering with the Pediatric HIV/AIDs Cohort Study (PHACS) led, in part, by our investigative team. Among WWH, the study will examine the effectiveness of the HPV vaccine The study will screen approximately 810 WWH using a self-sampling kit and those who are PHS[+] will attend a clinical visit to have colposcopy/biopsy and 4 triage tests. WWH with <CIN 2+ are asked to return annually for colposcopy and HPV genotyping for up to 3 yrs. WWH PHS[-] will be asked to return in Year 2 for rescreening. Those PHS[+] will be followed as above and PHS[-] will be asked to obtain self-collected vaginal samples for HPV genotyping annually for 3 years.

NCT ID: NCT06052696 Not yet recruiting - HPV Clinical Trials

Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL

VulVaccin
Start date: December 1, 2023
Phase: Phase 4
Study type: Interventional

Problem description: Yearly, approximately 45000 women develop vulvar cancer worldwide. It is estimated that about 30% of all vulvar carcinomas are HPV related. As with other HPV related (pre)malignancies, the incidence has been rising over the past 20 years. The peak incidence of premalignant lesions of the vulva, also called Vulvar High Grade Squamous Intraepithelial Lesion (vHSIL), lies between 35 and 40 years of age. Multiple treatments are available, including surgery, laser vaporization, and topical imiquimod, with comparable success rate. Despite treatment, at least 30% of women will develop a recurrence within 2 years, with a much higher lifetime risk of recurrence. This results in multiple treatments with sometimes disfiguring effects and associated negative psychosocial and psychosexual impact. Woman with vulvar HSIL have a lifelong increased risk of vulvar cancer, and approximately 10% of women with (treated) vulvar HSIL will develop vulvar cancer within 10 years of first diagnosis. The risk of malignancy is significantly higher in women with recurrent disease, compared to women without recurrence. Solution / research direction, To date, a successful strategy for reduction of recurrences of HSIL has not been established. The available positive evidence on the use of concurrent HPV vaccination in the treatment of vulvar HSIL is rising, yet insufficient to guide clinical practice. There is limited data that prophylactic HPV vaccination after treatment of vulvar HSIL reduces the chance of recurrence, therefore leading to a reduction in repeated (surgical) interventions. There are no randomised controlled studies supporting this data. Aim The aim of current project is to determine the effectiveness of nonavalent HPV vaccination versus placebo in preventing recurrence in women treated for vulvar HSIL. Plan of investigation This is a randomised, double blinded, placebo controlled trial in women treated for vulvar HSIL. Adult female patients, diagnosed with vulvar HSIL planned for treatment and no prior HPV vaccination will be included. Randomisation will be in a 1:1 ratio to additional nonavalent HPV vaccination versus additional placebo vaccination. Expected outcome. Based on previous non-randomised studies, a significant reduction in recurrences, improvement of quality of life and a reduction of economic burden of the disease is expected.

NCT ID: NCT05938192 Not yet recruiting - Cervical Cancer Clinical Trials

Treatments of HPV-related Lesions

Start date: July 2023
Phase:
Study type: Observational

In the recent years, the widespread adoption of primary and secondary preventions has dramatically reduced the incidence of cervical cancer in developed countries. However, cervical cancer still represents a major health concern, being the third most common malignancy among women aged <39 years, and the second most common cause of death for cancer among females between 20 and 39 years in the United States. Cervical cancer is one of the most preventable types of cancer, since it develops over a long time and the causative agent has been recognized. Persistent infection from human papillomavirus (HPV) is the main factor causing cervical cancer. Generally, persistent HPV infection causes cervical dysplasia (also known as cervical intraepithelial neoplasia), which potentially evolves in cancer. Although the majority of women with HPV infection will never develop lesions, a relatively high number of women is at risk of developing cervical dysplasia. Women with cervical dysplasia who have appropriate follow-up and treatments are at low risk of developing cervical cancer. However, recurrent cervical dysplasia is a well-known risk factor for cervical cancer. Additionally, recurrent cervical dysplasia might be cause of morbidity since adjunctive surgical treatments are associated with fertility and obstetrical issues in women who wish to preserve their childbearing potential. With this background, identifying the best treatment modality for patients with cervical dysplasia is of paramount importance. However, the management of residual/recurrent dysplasia after primary treatment is often challenging. Moreover, it is important to classify patients based on their risk of having persistent/recurrent dysplasia after primary treatment. Assessing these classes of risks is useful in tailoring appropriate surveillance and determining the need for adjunctive treatments. Our study group estimated the risk of developing persistent/recurrent dysplasia in several investigations, observing that positive surgical margins, surgical techniques, high-risk HPV infection at the time of diagnosis, and HPV persistence are the main prognostic factors. Our data corroborated a considerable body of literature investigating this issue. However, it is difficult to estimate the risk of developing persistent/recurrent dysplasia for each patient. Similarly, few investigations evaluated outcomes of patientsaffected by vaginal intraepithelial neoplasia with discor-dant results. In fact, there is no consensus on the optimaltreatment modality for those patients. Treatments in-cluded: topical application of imiquimod or 5-fluorouracil(5-FU), as well as ablative and excisional proceduresexecuted via conventional surgery, electrosurgery andcarbon dioxide LASER. The risk of developinginvasive vaginal cancer in those patients remains unclear,ranging between 2% and 12% in different series.Recently, a multi-institutional Italian study reports thatmore than 10% of women initially diagnosed with high-grade vaginal intraepithelial neoplasia are detected withoccult invasive vaginal cancer at the time of excisionalprocedure, thus suggesting the need to achieve a histologi-cal diagnosis before proceeding to ablative or medicaltreatments Here, we aim to evaluate the importance of various prognostic factors in influencing the risk of persistent/recurrent lesions of the uterine cervix and the vagina

NCT ID: NCT05919901 Not yet recruiting - HPV Clinical Trials

Multi-level School-based Intervention to Improve HPV Vaccine Uptake and Completion in South Africa

Start date: January 1, 2025
Phase: Phase 2
Study type: Interventional

Human Papillomavirus (HPV) is the most common sexually transmitted infection globally, and is causally linked to cervical, anogenital, and oropharyngeal cancers. HPV-associated cancers have a disproportionate impact in low-resource settings and nowhere is this evident than in South Africa, which has a uniquely vulnerable population due to the convergence of the largest HIV epidemic globally, with HPV rates of up to 85% in young women under the age of 25. For the clinical trial phase of this study, we intend to evaluate preliminary effects of a communications strategy and key criteria to advance to a full scale hybrid type 2 trial. Our systems-focused approach leverages established partnerships with area schools serving diverse populations who are not always effectively served by traditional healthcare channels.

NCT ID: NCT05236855 Not yet recruiting - Cervical Cancer Clinical Trials

Spectroscopy and Artificial Intelligence to Disrupt the Status Quo in Cervical Cancer Screening

Start date: March 1, 2022
Phase:
Study type: Observational

Cervical cancer kills one woman every two minutes, 90% of these women are from low- and middle-income countries. Newly developed testing using biofluids has proven successful in identifying disease markers in, for example, brain cancers and endometrial cancers. Early studies have revealed that this technology is also showing potential for gynaecological cancers using validated human papillomavirus (HPV) test specimens. Urine samples, more easily collected, may make screening more accessible and acceptable to women. Spectroscopy is a portable and relatively simple technology; results are instant, reproducible and reliable. Once we confirm that spectroscopy has the ability to identify potential CIN 2+ by detecting HPV in urine, the test can be miniaturized and adapted to a point of care test. This will be more economical and logistically simpler than what is currently available; no consumables and pre-processing of samples are required. Women with abnormal cervical screening and women with normal screening as controls will be recruited, cervical and urine samples will be obtained. These will be tested for HPV DNA using standard methods and also by spectroscopy for HPV. These spectroscopy signals will be analyzed using artificial intelligence. The results will be compared to tissue samples obtained at colposcopy. This will allow evaluation of the new spectroscopy test. This preliminary study aims to prove the concept the spectroscopy as a simple, affordable screen can be used to radically change cervical cancer screening. Enabling a test that has point of care capabilities has huge implications for women in developed and more significantly in low-and middle-income countries, where cervical cytology and HPV testing have significant logistical problems. A non-invasive test will be preferred by many women. We believe spectroscopy will disrupt the status quo of 'no screening' in the low and middle income countries (LMICs), accelerate elimination of cervical cancer, and thus avert 15 million deaths in next 50 years.

NCT ID: NCT03745846 Not yet recruiting - Clinical trials for Cervical Intraepithelial Neoplasia

A Efficacy and Safety Study of Composite Gel Containing Black Raspberry Extract in Removing HPV From Patients With Cervical Intraepithelial Neoplasia(CIN) After Cervical Conization

Start date: December 2018
Phase: Phase 2
Study type: Interventional

To evaluate the efficacy and safety of composite gel containing black raspberry extract in removing HPV From patients With cervical intraepithelial neoplasia(CIN) after cervical conization