Active clinical trials for "Papilloma"

The overall purpose of the project is to evaluate an algorithm for an HPV self-sampling based cervical cancer screening algorithm in a mid-size town in Ethiopia that could be applicable for nationwide implementation in low and middle-income countries (LMIC). Specific aims are the following: To evaluate the algorithm using Visual Inspection with Acetic acid (VIA) and VIA together with Lugol's Iodine (VILI) as triage and to use HPV self-sample to follow up those treated and those with persisting HPV. To evaluate the prevalence of Chlamydia trachomatis and Neisseria gonorrhoeae and their effect on the quality of VIA. To determine immune response profiles in high-risk HPV-positive women who cleared, persisted, or developed Cervical Intraepithelial Neoplasia 2/3 (CIN). To assess how specific cervicovaginal microbiota compositions are associated with HPV infection, cervical dysplasia, and cancer

This intervention study will use parent-, provider-, and health center-level strategies to promote HPV vaccination among 11-17 year olds receiving care in 8 community health centers in Florida, will explore factors related to the intervention effect, and will explore implementation outcomes of the intervention.

This study will look at whether monitoring HPV ctDNA levels is an effective way to detect cancer relapse risk in people with HPV-OPC. All participants will have recently had surgery to treat their disease, or they will be scheduled to have this surgery. In Arm A the researchers will see whether monitoring participants' HPV ctDNA levels can safely identify patients who do not need radiation therapy (RT) after surgery and whose RT can be delayed until their HPV ctDNA levels become detectable. In Arm B, the researchers will see whether patients who usually need 6-6.5 weeks of CRT can be selected by HPV ctDNA to receive 3 weeks of CRT.

This study is an open-label nonrandomized exploratory proof of concept and descriptive 4-year immunogenicity study to assess immunogenicity after administration of a 2-dose regimen of 9-valent human papillomavirus vaccine (9vHPV) vaccine separated by 12 months (months 0, 12).

Cervical cancer is the most common cause of cancer and a leading cause of death among HIV-infected women living in resource-limited settings. Although screening for premalignant lesions is an effective way of reducing cervical cancer incidence, its uptake in low-resource settings to date is low. The use of HPV testing for primary screening is currently recommended by many guidelines - including the WHO guidelines for cervical cancer screening in resource-limited settings - because of its greater sensitivity and ease of use compared to other options. However, these WHO guidelines have both highlighted the need to conduct more research on appropriate HPV-based algorithms among HIV-infected women, as immunodeficiency may affect the screening performance. Indeed, HPV infections in HIV-infected women are very common, so there is a need for additional triage to identify women most at risk and there remains considerable uncertainty on the optimal option for such triage. Most of the evidence available comes from HIV-negative populations living in high-resource settings and is not necessarily relevant for low-resource contexts where the epidemiological background is different, women access late to screening and may not have follow up visits, where financial constraints are important and health service resources limited. Hence, the proposed project aims to provide evidence on the effectiveness and feasibility of HPV-based screening algorithms among HIV-infected women in low-resource settings. This multicenter cross-sectional study will include 3,000 HIV-infected women (30-49 years old) receiving HAART and followed in Abidjan (Ivory Coast), Bobo-Dioulasso (Burkina Faso) and Phnom Penh (Cambodia). After self-collection of cervico-vaginal samples, each participant will have an HPV test with partial genotyping primary using the Xpert HPV assay, a real-time PCR assay that provides the possibility of identifying 14 HR-HPV types within one hour. The Xpert HPV test has been chosen because of the wide availability of the Genexpert platform in HIV care centers from resource-limited settings. Furthermore, it can specifically detect HPV-16, 18 and 45, the most carcinogenic HPV types in both HIV-negative and HIV-positive women, separately from other high-risk HPV types. VIA will be another triage option either alone or combined to HPV DNA genotyping. In addition, participants treated for cervical lesion will be followed over 12 months to assess the risk of post-treatment lesions (CIN2+/HSIL) and to identify associated risk-factors.

The human papillomavirus (HPV) causes 90% of cervical cancers and is implicated in multiple other cancers. The HPV vaccine can prevent the vast majority of these cancers, but it is underused in adolescents, especially among those within vaccine hesitant (VH) parents. The proposed research is to develop and pilot test a tailored, health communication intervention aimed to increase HPV vaccination among VH parents. The proposed research is innovative because no evidence-based health communication interventions target HPV VH parents, and we will use stakeholder engagement throughout this study. The research will add knowledge on how tailored education provided before a doctor's visit can play a role in improving HPV vaccination rates among underserved, VH parents.

In France, cervical cancer screening is based on a cervical smear for women aged 25 to 30 years and on High Risk- HPV (HR-HPV) testing for women aged 30 to 65 years. One of the main concerns in France is poor attendance to this screening program, up to 40% of women, which led French Health Authorities to implement population-based organized cervical cancer screening (DO CCU), based on remind letters, starting in 2019. Our project is a complementary strategy to DO CCU based on direct proposal of a vaginal self-sample device for HR-HPV testing to non-attendee women while attending health care centers. Our hypothesis is that contacting under-screened women directly and proposing them a self-sample device to be used at home will increase their participation to cervical cancer screening. This project will be held in the Departments of Hérault and Aude, which are among those in the region of Occitanie (south of France) with the lowest participation to cervical cancer screening. Women aged 50 to 65 years with no cervical smear and/or gynecological examination for more than three years, will be recruited in two sites: in a mobile unit for breast cancer screening implemented in the whole Department of Hérault and in a Medical and Social Care located in a particularly deprived area of Aude (Limoux-Quillan). In each site, non attendee-women will be proposed by a trained mid-wife, a vaginal self-sample device to perform at home and send back by mail to the laboratory of the Hospital of Montpellier, which will perform HR-HPV testing. Women with positive HR-HPV DNA test will be asked to perfom a cervical smear and completion of follow-up will be monitored. The primary objective of this study will be to evaluate attendance of under-screened women to vaginal self-sampling for cervical cancer screening, i.e. the number of women who accepted a self-sample device among women to whom it has been proposed. A second objective will be to analyse psycho-social factors associated with cervical cancer screening in this population of non-attendee women, i.e. their socio-economic environment and the way women perceive and are implicated in cervical cancer screening. This secondary objective will be based on a specific questionnaire at recruitment and on semi-directive phone interviews in a sub-group of women. The efficacy of this screening strategy (number of women who performed vaginal self sample and sent it to the laboratory, and number of women who completed follow-up in case of a positive HR-HPV test) will also be monitored. The number of women to be recruited is 300 for each site. The total estimated duration of the project is 48 months, including 24 months for women's recruitment. Expected results from this project are: An increase in participation to cervical cancer screening of non-attendee women aged 50 to 65 years in the Departments of Hérault and Aude. Women's education about cervical cancer screening through discussion with the midwife during recruitment and information tools developed for the project Information of local health staff and community-based associations about cervical cancer screening and the place of HR-HPV testing. Identification of psycho-social factors and potential barriers to compliance to cervical cancer screening. Identification of organizational and practical difficulties that must be overcome to improve preventive actions towards deprived populations.

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.

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 do this project in three HIV clinics in Georgia (AID Atlanta, AID Newnan, and Albany Model Rural HIV Clinic) and enroll n=365 PLWH who are age 18-45 years from those clinics.

The educational intervention to be delivered by the CHE(Community Health Educator) consists of "toolkit education materials" developed by the National Cancer Institute (NCI) and a small media intervention (i.e., video) that our research team has developed. The NCI-produced toolkit education materials consist of Power Point presentations, flyers, and posters that contain information about HPV(Human Papilloma Virus), HPV-related cancers, and the importance of the HPV vaccine series for adolescents (9-17 years old) and young adults (18-26 year old) who are eligible for the vaccine.