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NCT07574190
The overarching goal of this study is to increase cervical cancer (CC) screening rates among Indigenous women in the U.S. Specifically, the study aims to develop and evaluate a culturally tailored, multilevel, multimedia mobile web app intervention (wPap) for women of the Yankton Sioux Tribe (YST) living on the YST Reservation in South Dakota. The wPap intervention will be tested in a randomized clinical trial (RCT) involving 120 YST women aged 25-65. Participants will be randomly assigned to either: (a) the wPap intervention group (n = 60), receiving personalized, culturally tailored multilevel multimedia messages through a mobile web app along with health navigator support, or (b) a waitlist control group (n = 60), receiving printed educational materials on cervical cancer and screening guidelines along with health navigator support. The intervention will last seven days, with assessments conducted at baseline, one week post-intervention, and six months post-intervention via surveys and telephone follow-up. The study tests the following hypotheses: (H1) women in the wPap intervention group will achieve higher CC screening rates than the waitlist control group; (H2) the wPap group will demonstrate greater improvements in knowledge, attitudes/beliefs, self-efficacy, and intention to undergo CC screening; and (H3) the wPap group will report higher satisfaction and acceptance of the intervention compared with the waitlist control group. Findings will inform the feasibility, acceptability, and efficacy of mobile web app interventions tailored to Indigenous communities to improve CC screening.
NCT01287871
This study aims to 1) implement a culturally and contextually rooted innovative multifoci, social marketing intervention involving societal focused media campaign elements to break down the barriers and facilitate timely and appropriate screening practices for cervical cancer; 2) measure cervical cancer stigma from a culturally relevant theoretical and conceptual framework; and 3) assess the influence of stigma on hindering seeking the PAP test. Further, this is an international study that will bring together a multi-disciplinary investigatory team, community advocates and State health agencies to deliver a social marketing intervention in Southern California (the Inland Empire region specifically) and Trinidad and Tobago.
NCT07468578
Aims: The project aims to explore the acceptability and feasibility of a self-sampling, urine-based HPV test (INDICAID HPV Urine Test) in a community setting, and the effectiveness of DNA methylation test for triaging high-risk HPV (HR-HPV) positive women to colposcopy examination compared to the current standard triage methods of cytology and HPV16/18 genotyping. There are two main hypotheses: 1. Urine self-sampling for HPV testing is an acceptable cervical screening option for women in the community. 2. Combining urine HPV testing with DNA methylation will increase the detection rate of high-grade lesions without increasing the colposcopy referral rate. Target participants: Women between the ages of 26-65 and have a history of sexual activity, not have a history of total hysterectomy or cervical cancer, not currently pregnant, not currently under treatment of cervical dysplasia or cervical cancer. This is a prospective study and women who are willing to undergo urine self-sampling for HPV test will be recruited from various communities, such as Specialist out-patient clinics of Queen Mary Hospital (Hong Kong), public areas in Queen Mary Hospital (such as lobby of out-patient clinics and corridors), District Health Centres, the Family Planning Association (FPA) clinics, Anticancer Society, Christian Action, Non Government Organizations (NGO), private organizations, and online. A total of 8,620 women are needed to be recruited to the study: approximately 4,700 onsite and 4,000 online. Study procedures: Self-collected urine samples from study subjects recruited in various communities will be examined using the INDICAID HPV Urine Test. Women with positive urine HPV results will undergo further testing, including urine DNA methylation and co-testing (cytology and HPV genotyping). They will be triaged to colposcopy when test results show clinical indications. The acceptability and feasibility of the urine test will be assessed by calculating the self-sample uptake rate and analyzing participant-reported questionnaires. The detection rate of high-grade lesions and the colposcopy referral rate will be compared between DNA methylation testing and the current standard methods.
NCT07462039
This randomized controlled pretest-posttest experimental study aims to evaluate the effect of virtual reality (VR) on pain and anxiety levels experienced during Pap smear sampling. Although cervical cancer is largely preventable through regular screening, many women avoid Pap smear testing due to anxiety, fear of pain, and discomfort during gynecological examinations. Innovative, non-invasive interventions are needed to improve women's screening experiences and participation rates. The study will be conducted in a gynecology outpatient clinic with 60 women aged 18-65 years who meet the inclusion criteria and provide informed consent. Participants will be randomly assigned to either the intervention group (VR headset during the procedure) or the control group (standard care). Women in the intervention group will watch a 360° relaxing nature video during the Pap smear procedure. Data will be collected using a Personal Information Form, the State Anxiety Inventory, and the Visual Analog Scale (VAS). The findings may support integrating VR into clinical practice to enhance patient comfort during screening procedures.
NCT07451340
Cervical cancer remains an important public health issue affecting women's health. Cervical cancer screening plays a key role in reducing morbidity and mortality through early detection. Women's decisions to participate in screening are influenced not only by knowledge, but also by psychosocial factors such as social norms, perceived threat, perceived benefits and barriers, and self-efficacy. The Cervical Cancer Screening Uptake Questionnaire (CCSTQ) is a multidimensional instrument designed to assess psychological and social determinants that may influence women's participation in cervical cancer screening. The aim of this study is to translate and culturally adapt the CCSTQ into Turkish and to evaluate its psychometric properties among Turkish women.
NCT07376031
Thermal ablation of women ≥40 years of age with persistent Human papillomavirus (HPV) infection. A pilot and intervention study. Cervical heat treatment is a relatively new form of treatment19 where a smaller, defined area of the cervix is destroyed by insertion of a heated probe. Cervical heat treatment is already used in specialist medical practice for patients with erythroplakia, contact bleeding, chronic cervicitis and discharged. In a collaboration between Region Zealand and the Capital Region of Denmark, 120 women are randomized to receive thermal ablation for HPV infections without severe disease with a matched control group of 120 women who do not receive ablation. All women are monitored through repeated cervical cytology re-tests at defined follow-up (FU) times. The study cohort consist of 1) sample on enrollment date, 2) 3 months FU sample, 3) 6 months FU sample, 4) 12 months FU sample. All samples are collected in SurePath liquid-based cytology medium and HPV tested using the BD Onclarity HPV test (BD Integrated Diagnostic systems, Sparks, MD)20-22 supplemented by a full genotyping analysis (Seegene, Seoul, Korea)21,23. Methylation status is examined using the QiaSure FAM19A4/miRNA 122-4 methylation test (Qiagen, Hilden, Germany). This project element aims to determine whether thermal ablation impact viral clearance compared to the control group, and whether DNA methylation status is significant amongst women who are persistently HPV positive before and after thermal ablation.
NCT07181278
Context. Cervical cancer (CC) is a leading cause of death among women living with HIV (WLHIV) in resource-limited settings. Yet, effective methods for screening and preventing CC are available. The recommanded approach for CC screening is based on multiple steps, including initial test to detect human papillomavirus (HPV) infection, visual inspection to identify women with HPV at risk for precancerous lesion and treatment when required. Dropout may occur at these different steps, compromising the success of the CC elimination strategy. Performing all the screening and treatment sequences in a single visit has been recommanded based on the results of a large South African trial. Yet, in many contexts, including those with limited resources, the screening and treatment activities are performed in multiple visites for logistical reasons, resulting in many dropouts. Different strategies for delivering screening with HPV testing for WLHIV are possible. A first approach ("centralized approach") consists of having well equipped reference centres with experienced health workers and referring women to these centers. An alternative consists of having a mobile unit who can bring equipment and health workers and perform the CC screening in the usual places of patient care ("decentralised" or mobile team approach). Each of these two approaches has advantages and limitations in terms of coverage, completeness, cost and quality of screening. It is necessary to evaluate them in real life to inform national decision-makers on the best strategy to use in their countries. The OptiTri-MU study aims to evaluate and compare the effectiveness of these two strategies for delivering CC screening ("centralized" screening versus "decentralized" screening). It will also assess the implementation of each strategy and include three sub-studies designed to evaluate : * the performance of urinary HPV testing. * the performance of different methods to identify women requiring a treatment. * the risk of post-treatment cervical disease. Design This is a trial in which the intervention (mobile team) will be implemented gradually. All sites starts with the centralized screening strategy. At each period, a new site is ransomly selected and start the the decentralized screening strategy. There will be 6 periods of 10 weeks. The effectiveness of the intervention will be assessed by comparing the outcomes at each site before and after implementation and by comparing the sites with each other. The primary outcome for effectiveness is the screening completeness 120 days after enrollment. The study will also assess the implementation of each screening strategy in terms of : * Success through the measure of fidelity, reach and completeness * Identification of adaptation, barriers and facilitating/leverage factors * Perception, feasibility and acceptability of the screening strategies (by patients and health care workers) Other study objectives include : * To assess the performance of different methods to identify women requiring a treatment * To assess the performance of HPV testing on a urine sample compared with vaginal self-collected or cervical (clinician-collected) samples * To assess the efficacy of treatment in terms of post-treatment cervical lesions Study population. Participants will be WLHIV aged 25 to 49 and eligible for CC screening. Health care workers will also be invited to participate to the implementation research. The data collected will be quantitative and qualitative.
NCT05390567
Project CONTINUITY (Connecting You to Care in the Community) was developed to increase adherence to cervical cancer screening regimens from initial screening to needed follow-up care by (1) providing personalized approaches to improve adherence through the combined use of patient choice for the initial screening method (Pap/HPV co-testing vs. HPV self-test collection), community clinical navigators and community health workers (CHWs), customized messages and support for patient portal access for test results and (2) implementing strategies to address social determinants of health (SDoH) that may influence an individual's ability to adhere to the screening regimen, with an initial focus on removing transportation barriers through the use of a mobile outreach clinics (MOC).
NCT06995157
Cervical cancer (CC), primarily caused by persistent infection with high-risk human papillomavirus (HPV) types, remains a significant public health issue. Despite the availability of prophylactic HPV vaccines and improved screening methods, vaccination coverage and uptake remain suboptimal in many countries, including Slovenia. In 2020, the WHO launched a global strategy to eliminate CC, emphasizing 90% HPV vaccination coverage among girls, 70% screening of women at key ages, and 90% treatment of identified cases by 2030. The EVEN FASTER concept proposes that targeting a specific age group of women-those bridging unvaccinated and vaccinated cohorts-with simultaneous HPV screening and vaccination may significantly reduce HPV transmission. Swedish data support this, showing a 62-64% reduction in high-risk HPV infections following combined interventions in women aged 23-30. In Slovenia, HPV vaccination has been available since 2006 for girls, and since 2021 for boys, with average uptake around 50%. However, no comparable model has been implemented or studied locally. This proposed clinical study will assess HPV vaccine acceptability among women in Slovenia, identify barriers to uptake, define an optimal target age group for intervention, and evaluate the effectiveness of offering concurrent screening and vaccination to accelerate CC prevention in this region. Women will be invited to participate during their preventive gynecological examination within Slovenia's national cervical cancer screening program (ZORA). Inclusion criteria include regular cervical smears (CS) every 3 years following a previously normal result, first or second CS after entering the ZORA program, follow-up CS after abnormal cytology, non-neoplastic findings, or cervical procedures, and CS due to clinical indications. Exclusion criteria include pregnancy, menstruation, cervical or vaginal inflammation, other medical conditions preventing CS collection, prior hysterectomy, prior CS taken for this study, or known hypersensitivity to HPV vaccine components. Eligible women will be invited by the attending gynecologist and nurse. After the exam, participants will complete an anonymous questionnaire covering demographics, screening history, vaccination status, and vaccine attitudes. Assistance will be provided if needed. Women aged ≤35 who are unvaccinated will receive counseling on HPV vaccination, including benefits and risks. Those consenting will receive free vaccination with the nonavalent Gardasil®9 vaccine, following a three-dose schedule (0, 1-2, 6 months). Around 500 women aged ≤35 are expected in this sub-group, with fewer than half anticipated to accept vaccination. Data will be anonymized and analyzed using SPSS (p \< 0.05).
NCT06915610
Cervical cancer screening (CCS) is important to prevent and control cervical cancer (CC). In Portugal, CCS starts with the assessment of the presence of Human Papillomavirus (HPV) in cervical-vaginal samples, collected by a health professional. However, self-sampling (self-collection of vaginal samples by the participants in CCS), is being considered in several settings, aiming to improve participation in CCS, while also exploring its potential to reduce costs. The goal of this study is to learn how self-sampling could be introduced in the CCS program in Portugal, by testing different strategies to combine the self-collection of samples with the collection of samples by a health professional, which is currently the standard of care. Researchers will conduct a study comparing the following ways of conducting CCS: * Sample collection by health professionals - SOC; * Self-sampling - SS; * Asking the participants if they prefer to collect their own samples, or to have the samples collected by a health professional, and then proceed as they prefer - CHOICE. After assessing the adherence to CCS in each of the groups define above, the participants will be given the possibility to participate through a method different from the initially proposed or chosen, as follows: * SOC will be complemented with invitation for SS; * SS will be complemented with invitation for the SOC; * CHOICE participants will be invited again to CHOICE, being given a new opportunity to choose how they prefer to be screened. This study design allows for comparisons between these groups, to understand how using these strategies alone and complementarily works, and also for comparisons within each group, to understand how one strategy being used on the top of the previous may contribute to increase adherence to screening. The researchers will additionally collect information of the adherence to CCS in the year before the study is conducted, to be used as an additional benchmark. For a better understanding on the potential barriers and facilitators to incorporating self-sampling in the CCS program, this study will also comprise interviews with the health professionals involved in the study, as well as with females eligible for screening who had been invited to participate. Depending on the results of HPV testing and complementary cytological evaluations, participants may be referred for further assessment, according to the standard of care in the Portuguese National Health Service. This study will address the possibility of improving the yielding of the referral for further assessment, by testing, in parallel to the current standard of care, a method that is expected to contribute to reducing the number of referrals of false-positives. Therefore, this study is expected to provide evidence based on different methods of assessment, showing the extent to which SS may contribute to improve adherence do CCS, and testing new methods that may reduce the referral of false-positives for further assessment.
NCT06931184
SELF-SAMPLING IN CERVICAL CANCER ROUTINE SCREENING (FALCON) -Study implements a self-sampling option for the non-attendees of the national cervical cancer screening program in the Wellbeing Services County of Pirkanmaa. HPV primary testing is currently preferred method for cervical cancer screening. The HPV-DNA self-sampling has been shown to have screening performance equal to that of provider-obtained samples. In 2024, those turning 30, 35, 40, 45, 50, 55, 60, or 65 had the opportunity to participate in the FALCON study if they do not respond to the first invitation to cervical cancer screening. From March 2025 also women living in Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia can take part to the study. The main objective of the FALCON study is to increase the current coverage of the cervical cancer screening program in the Pirkanmaa, Kanta-Häme, Central Finland, Päijät-Häme, and Ostrobothnia region and assess how acceptable self-sampling is for women.
NCT05256862
This study is to analyse the effect of a bundle of measures on the proportion of females being screened for cervical cancer in the Kilombero and Ulanga Antiretroviral Cohort (KIULARCO), comparing the time period before implementation (01/2017-01/2020) and after implementation (02/2020-06/2022). It is to assess the performance of two novel diagnostic tests (QuantiGene-molecular profiling histology (QG-MPH) and PT Monitor® immunoassay) and established tests (Seegene Anyplex™ II 28 HPV Test and Prevo-check®) as potential triage tests for the development of future clinical decision algorithms for CC screening.
NCT06844097
The team aims to test the effectiveness of an intervention to increase gender-affirming cervical cancer prevention behaviors targeted at medical students studying in Puerto Rico and Florida. The team expects that after exposure to the intervention, relative to the control group, participants in the experimental condition will manifest more favorable changes in knowledge, attitudes, and behaviors of adequate care towards Latinx transmasculine and non-binary people.
NCT06800664
The investigators propose to develop and/or adapt implementation strategies and a structured implementation plan to translate the HOPE intervention into existing healthcare practice in Ghana. These "implementation support strategies (ISS)" are implementation strategies relevant to implementation support, which is concerned with moving (implementation) research into (implementation) practice. The ultimate goal is to facilitate health system adoption and sustainment.
NCT05286749
The primary purpose of this study is to determine whether educational workshops paired with self-collected high-risk human papillomaviruses (hrHPV) screening will increase participation in cervical cancer screening among Southeast Asian Immigrant and Refugee populations in Wisconsin compared with offering clinician collected screening (total sample size: 250 participants). The investigators hypothesize that participation in cervical cancer screening will be higher among women in the intervention group as compared to the control group.
NCT04965857
Quality assurance of the laboratory examinations. Prospective non-interventional study with ThinPrep slides collected during the German Co-Screening Program and routinely sent to the lab to prospectively evaluate the clinical performance of the Hologic Genius Digital Cytology (DC) system vs. the liquid-based cytology (LBC) manual microscopic approach
NCT05426642
The aim of this quasi-experimental study is to evaluate the women's motivation related to cervical cancer screening. The experiment group will receive the e-health video KaSEH and brochure as the intervention. Where as, the control group will receive brochure as the intervention. There is three phase of evaluation which are pre-intervention, intra-intervention and post-intervention. The evaluation will be assess using the self-administered questionnaire based on Protection Motivation Theory. The estimated duration of this quasi-experiment is six month.
NCT03808064
This study aims to evaluate the effect of a Female Community Health Volunteer (FCHV) led community-based educational intervention through home visits increasing cervical cancer screening uptake.
NCT04650711
Cyclin kinase inhibitor P16INK4A has overexpression in cervical cancer, and hence becoming an alternative method for cervical cancer screening. This study is to investigate the clinical value of P16INK4A and high-risk human papillomavirus (hrHPV) detection of cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). All eligible participants accept P16INK4A testing, with cytology and/or hrHPV assay. P16INK4A immunohistochemical staining is performed on the retained specimens of cytology. The primary endpoint is the diagnostic accuracy of P16INK4A compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.
NCT03750214
This is a multi-center, prospective, non-randomized, confirmatory study to evaluate the safety and performance of the Biop Digital Colposcope and the accuracy of the image registration procedure between the Biop Digital Colposcope unit and the Biop Micro Colposcope probe unit.