Clinical Research Directory

Implementation of Evidence-Based Strategy (PC TEACH) for the Optimization of HPV Vaccination in Rural Primary Care

This study evaluates the implementation of evidence based strategies to optimize HPV vaccination in rural primary care settings. Some of the largest disparities in human papillomavirus vaccination (HPVV) rates exist in rural communities, which represent missed opportunities for cancer prevention. Primary care provider visits in these communities serve as a crucial opportunity to communicate the importance of timely vaccination that is essential to effective cancer prevention. This study implements and tests a practice-level intervention (PC TEACH) using practice facilitation of evidence-based strategies to expand reach to rural community-based primary care settings to optimize delivery and increase HPVV rates. PC TEACH program may help rural communities overcome access and awareness factors that keep them from receiving HPVV.

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S03)

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S02)

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine

Human papilloma virus (HPV) is the most common viral infection of the reproductive system and is spread through contact with infected genital skin, mucous membranes, or bodily fluids. This study will assess an experimental vaccine called 10 valent Human Papillomavirus Virus (10vHPV) for the safety, reactivity, and immune response, in healthy adults, compared to Gardasil 9. There are two phases in this study - Phase 1 will include up to 36 healthy adults aged 18-25 years, Phase 2 will include 36 healthy adults aged 26-45 years. Participants will be randomised in a 2-to-1 ratio to receive either 10vHPV or Gardasil 9. 10vHPV or Gardasil 9 will be administered as a 0.5 mL single dose via intramuscular injection in the deltoid muscle of the upper arm. In Phase 1, participants will receive a single dose on Day 1, and in Phase 2, participants will receive a single dose on Day 1, 2 months, and 6 months.

Epidemiology of Anal Human Papillomavirus Carriage in Female Solid Organ Transplant Recipients With More Than 10 Years of Immunosuppression

Anal canal cancer is primarily associated with persistent infection by high-risk human papillomavirus (HR-HPV), particularly HPV-16. Women who have undergone solid organ transplantation are at increased risk of anal cancer because of the chronic immunosuppression required to maintain graft function. However, epidemiological data regarding the prevalence of anal HPV-16 and other HR-HPV types in this population remain limited and sometimes conflicting. EPAHTOS is a single-center, cross-sectional, observational study (French Category 2 Interventional Research Involving Human Participants \[RIPH 2\]) conducted at Montpellier University Hospital. The study aims to evaluate the prevalence of anal HPV-16 carriage among women aged 18 to 75 years who underwent kidney, liver, and/or heart transplantation more than 10 years previously, or who have received cumulative immunosuppressive therapy for more than 10 years. A total of 190 participants will be enrolled. At the inclusion visit, participants will receive information about the study, provide written informed consent, complete a self-administered questionnaire including questions on HPV infection risk factors, and perform a self-collected anal sample for the detection of high-risk HPV by polymerase chain reaction (PCR). This test allows identification of HPV-16 as well as other HR-HPV genotypes. The primary objective is to estimate the prevalence of anal HPV-16 carriage. Secondary objectives include assessing the distribution of other anal HR-HPV genotypes, describing cytological abnormalities associated with HR-HPV infections, estimating the prevalence of anal histological lesions detected by high-resolution anoscopy among eligible participants, identifying factors associated with HR-HPV carriage, evaluating the feasibility of anal self-sampling, and describing the distribution of cervical HR-HPV infections. In accordance with French recommendations, participants testing positive for HPV-16 will receive standard clinical management including reflex anal cytology and, in the event of a cytological abnormality, referral for proctology consultation with high-resolution anoscopy. Within the framework of the study, participants carrying an HR-HPV genotype other than HPV-16 and presenting abnormal cytology will also be offered standard proctological evaluation to ensure that clinically significant anal lesions are not overlooked. The results of this study will provide updated information on the epidemiology of HPV infections among female solid organ transplant recipients and may contribute to the development of future anal cancer screening strategies in this high-risk population.

Papilozumib Vaginal Gel for Exocervical Mucosal Restoration in Women With Human Papillomavirus (HPV)

This randomized, open-label, multicenter clinical study is designed to evaluate Papilozumib® vaginal gel in women aged 30 to 50 years who test positive for human papillomavirus (HPV) and present with either normal cervical cytology or cytological findings of atypical squamous cells of undetermined significance (ASC-US), low-grade squamous intraepithelial lesion (LSIL), or atypical glandular cells (AGC), accompanied by corresponding colposcopic findings. Eighty-one participants will be randomly assigned in equal groups to receive either Papilozumib® vaginal gel, Papilozumib® vaginal gel plus an oral supplement, or standard clinical care without study treatment. All participants will be followed for six months. The primary objective is to assess exocervical mucosa restoration 30 days after treatment initiation using a 5-point colposcopic scale. Additional assessments include cervical cytology, HPV clearance, vaginal health, treatment adherence, satisfaction, tolerability, safety, and exploratory analyses of the vaginal and intestinal microbiota.

Intralesional Acyclovir Versus Intralesional Zinc Sulphate in the Treatment of Plantar Warts

This clinical trial aims to compare the efficacy and safety of intralesional acyclovir versus intralesional zinc sulphate in the treatment of plantar warts.

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S01)

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. It is known to cause a variety of cancers including cancer of the cervix. Even though there are ways to detect cervical cancer early, many individuals do not undergo screening that involves pelvic exams. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. Without appropriate screening and care, preventable pre-cancers may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own vaginal sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. This study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Extended Follow-up of Women Who Received One, Two, and Three Doses of the HPV Vaccine in the Costa Rica Vaccine Trial (CVT), ESCUDDO-CVT Study

This study is extending follow up of women who participated in the Costa Rica Vaccine Trial (CVT) and received one dose or two doses of the human papillomavirus (HPV) vaccine, along with a group of women who received three doses. It also studies the stability of HPV defenses in these groups of women for up to 20 years after initial vaccination. Studying samples of blood in the laboratory may provide information on how long one, two, and three doses of the vaccine provide protection against HPV. The results of this study may also help researchers learn whether one dose of HPV vaccine is enough to protect against HPV.

Long-Term Immune Persistence After Bivalent HPV Vaccination in Females From Study 311-HPV-1005

This is a single-center, open-label, prospective observational extension of Study 311-HPV-1005 (NCT04965350). The study follows females who received at least one dose of a bivalent human papillomavirus vaccine containing HPV-16 and HPV-18 L1 virus-like particles in the base study. No vaccine is administered in this extension. Participants in the immunogenicity persistence subset provide blood samples at Months 42 and 66 after the first dose in the base study for measurement of HPV-16 and HPV-18 neutralizing antibodies. Participants eligible for the breakthrough-case cohort are followed for HPV-related cervical disease, including HPV-16- or HPV-18-related cervical intraepithelial neoplasia grade 2 or worse.

ESCUDDO Long Term Follow Up

This phase IV trial evaluates the long term protection provided by either one or two doses of the 9v human papillomavirus (HPV) vaccine for participants who were part of the ESCUDDO study.

Comparison of Self-collection Using Dry Compared to Wet Swabs for HPV Detection

This study will compare the performance of self-collected vaginal swabs, transported without liquid media (dry swabs) and self-collected vaginal swabs, transported in liquid media (wet swabs) for detection of hrHPV DNA LBC as the reference standard.

Long-term Immune Persistence of a Bivalent HPV Vaccine in Females From Study 311-HPV-1004

This long-term extension study evaluates the persistence of neutralizing antibody responses to a bivalent human papillomavirus vaccine in females who previously participated in study 311-HPV-1004 (NCT02740777). Participants belonged to one of three vaccination cohorts in the base study: adolescents who received two doses at Months 0 and 6, adolescents who received three doses at Months 0, 2, and 6, and adults who received three doses at Months 0, 2, and 6. No vaccine is administered in the extension study. Blood samples are collected at Months 84, 108, and 132 after the first dose in the base study and tested for HPV-16 and HPV-18 neutralizing antibodies using a high-throughput pseudovirus-based neutralization assay.

Preventive Human Papillomavirus (HPV) Vaccine Trial in Kidney Transplant Recipients

This phase II trial studies whether the nonavalent human papillomavirus vaccine given to adults prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

HPV Infection, Sexually Transmitted Infections and Anal Dysplasia in the Transgender Population

The goal of this observational study is to estimate the prevalence of HPV infections anal and ENT level and according to HIV status in transgender (TG) population. The main question it aims to answer is: * What is the prevalence of HPV lesions in transgender population (TG); * What kind of high risk HPV (hrHPV) and low risk HPV (lrHPV) are detected at the genital, anal and ENT level

Point of Care - Triage and Treatment for Cervical Pre-cancer

This study evaluates a modified two-probe thermal ablation protocol using the IRIS™ device and retrospectively assesses an AI-based Automated Visual Evaluation (AVE) triage algorithm among HPV-positive women in El Salvador. The primary objective is to estimate 1-year cure rates of CIN2+ following treatment. A secondary objective is to evaluate the diagnostic performance of AVE compared with histopathology.

Extended Follow Up of Young Women in Costa Rica Who Received Vaccine for Human Papillomavirus Types 16 and 18 and Unvaccinated Controls

This research trial studies extended follow up of young women in Costa Rica who received vaccine for human papillomavirus types 16 and 18 and unvaccinated controls. Collecting information from young women in Costa Rica who have received vaccine for human papillomavirus types 16 and 18 and a new group of unvaccinated controls enrolled for the follow-up period, may help doctors learn more about the risks and benefits of prophylactic human papillomavirus vaccine.

Evaluating Clearance of High-Risk HPV and Safety After Administration of ABI-2280 Vaginal Inserts

This is a blinded study to assess safety, tolerability, and efficacy of ABI-2280 vaginal inserts in participants diagnosed with persistent cervical hrHPV infection. This study will have up to 11 cohorts with various dose strengths and regimens. Each cohort will start with a sentinel cohort of 8 participants. Sentinel cohorts may be expanded to include an additional up to 32 participants to provide additional proof of concept data to further understanding of benefit/risk of a given dose/dose regimen.

Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial (LMI-001-A-S04)

This clinical trial evaluates the use of self-collected vaginal samples for human papillomavirus (HPV) testing in patients referred for a colposcopy and/or cervical excisional procedures to improve cervical cancer prevention. HPV is a common virus which usually causes infections that last only a few months, but sometimes can last longer. HPV is known to cause a variety of cancers including cervical cancer. Even though there are ways to detect cervical cancer, many individuals are not diagnosed. Over half of all new cervical cancer cases are among those who have either never been screened or who are not screened enough. The low screening numbers show more testing needs to be done. Without appropriate screening and care, preventable precancer may turn into cancer. A new way to detect cervical cancer is to have individuals collect their own sample for HPV testing to know their risk for cervical cancer. This may give individuals more flexibility and comfort having the ability to collect samples themselves, compared to a doctor performing a speculum examination and collecting the samples in a clinic. Information gathered from this study compares clinical accuracy of HPV testing on self-collected vaginal samples versus cervical samples collected by clinician. The Self-collection for HPV Testing to Improve Cervical Cancer Prevention (SHIP) Trial is part of the National Cancer Institute (NCI)'s Cervical Cancer 'Last Mile' Initiative, a public private partnership that seeks to increase access to cervical cancer screening. The SHIP Trial focuses on developing clinical evidence to inform the US Food and Drug Administration (FDA)'s regulatory reviews of self-collection approaches as alternative sample collection approaches for cervical cancer screening. Several industry partner-specific self-collection device and assay combinations will be non-competitively and independently evaluated with a similar study design framework to inform pre-approval and/or post-approval regulatory requirements.

Dual-Modality Immunotherapy for HPV Clearance (DUAL-HPV)

Persistent high-risk human papillomavirus infection is an important precursor of cervical cancer and related cervical lesions. This single-center, randomized, assessor-blinded, parallel-group controlled trial evaluates whether dual-modality immunotherapy consisting of an oral immunomodulator plus a vaginal ovule improves HPV clearance compared with standard supportive care. A total of 76 participants will be randomized in a 1:1 ratio. The primary outcome is HPV clearance confirmed by repeat HPV testing and cervical cytology after the 3-month treatment period. Treatment adherence and adverse events will also be monitored.

Promoting HPV Vaccination Among Young Adults in Texas

This clinical trial studies how to improve the human papillomavirus (HPV) vaccination rate in young adults in Texas. This trial aims to learn more about how researchers and health care providers can increase HPV vaccination among college students.

Effect of Health Belief Model-Based Education on Cervical Cancer Knowledge and HPV Vaccine Attitudes in Women

This study evaluated the effect of a Health Belief Model-based educational intervention on women's knowledge of cervical cancer and their attitudes and beliefs toward HPV vaccination. The study was conducted among women aged 18-49 years attending a primary health care center in Van, Türkiye. Participants were assigned to intervention and control groups. The intervention group received a structured, face-to-face educational program, while the control group received routine care. Data were collected using validated questionnaires before and after the intervention. The findings contributed to a better understanding of strategies to improve preventive health behaviors and increase HPV vaccination awareness among women.

Anal Cytology Collection Procedures in Predicting High-Grade Anal Dysplasia in Men Who Have Sex With Men

This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.

Clinical Study to Evaluate SIIPL qHPV Vaccine (CERVAVAC®) in Women Living With HIV Aged 15-25 Years

Human papillomavirus (HPV) infection is the most common viral infection of the reproductive tract. Up to 80%of the sexually active females and men will be infected with HPV at some point in their lives and some may be repeatedly infected. The main burden of HPV-related disease is due to cervical cancer. Since cervical screening only detects precancerous and cancerous changes after they have occurred, HPV vaccination is primary prevention. People with HIV infection, even when effectively treated with antiretroviral therapy (ARV),are at higher risk of acquiring infection with multiple HPV types and are also known to be predisposed to a higher risk of HPV infection and subsequent CIN lesions. Vaccination of this high-risk group with HPV vaccine is highly beneficial. SIIPL's qHPV vaccine CERVAVAC®, India's first indigenous qHPV vaccine has received marketing authorization in India. The current study is a Phase 3b study to evaluate the immunogenicity and safety of two- and three-dose schedules of SIIPL qHPV vaccine in women living with HIV (WLWH) aged 15-25years.