Clinical Research Directory

Single-Dose HPV Vaccination for the Prevention of Cervical Cancer in Young Adult Women in Costa Rica, The PRISMA ESCUDDO Trial

This phase IV trial tests whether a single dose of the human papillomavirus (HPV) vaccine works in preventing cervical cancer in young women in Costa Rica. Human papilloma viruses, called HPV, are a group of viruses that very frequently cause infection in both men and women, mainly in the genital organs. There are many types of HPV, and some can cause cancer. The World Health Organization recommends a two-dose schedule for adolescents 9-14 and three doses for individuals 15 years old or older. This study examines whether a single dose of HPV vaccine can reduce the frequency with which women between ages 18-30 become infected with HPV.

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.

Self-Collection for Cervical Cancer Screening and HPV Vaccination for Cancer Prevention Among Women in Emergency Care in Northeast Florida

Human Papilloma Virus (HPV) is a cause of cervical cancer in women. This study is being done to identify sites for cervical cancer screening and education regarding HPV vaccination outside of the traditional settings of primary care and gynecologic clinics. Identifying non-traditional cancer screening settings may increase cancer screening completion and HPV vaccination among women with limited health care knowledge and access who are vulnerable to health disparities.

Enhancing Cervical Cancer Screening and Treatment in Women Living With HIV in Kenya, the ENHANCE LINKAge Trial

Background In sub-Saharan Africa (SSA), human papillomavirus (HPV) and HIV create a dual burden of disease that causes significant morbidity and mortality in the form of cervical cancer (CC). Women living with HIV (WLWH) have a six-fold higher risk of developing precancerous lesions that persist and progress to CC, which is the leading cause of cancer mortality among women in Kenya. Significant support from the Go Further campaign, represented by donors such as the President's Emergency Plan for AIDS Relief (PEPFAR), the George W. Bush Institute, UNAIDS, Merck, and Roche, to integrate CC screening into HIV clinics represents an exceptional opportunity to scale CC impact across SSA, but only if implementation science evidence is available to inform strategy. Currently, the impact of Go Further has been undermined by fractured linkages to care and insensitive screening methods; in Kenya, less than 2% of WLWH screened have received appropriate treatment. Implementation science studies are needed to better understand and surmount barriers to integrated care in publicly funded HIV clinics. Broad objective This study seeks to explore and innovate strategies to overcome patient-, provider-, and system-level barriers to implementing CC screening and referral guidelines, link WLWH who require further diagnostic testing and/or treatment with effective and accessible care, and document services for accountability and quality improvement. In this proposal, our team will apply our extensive implementation science expertise and partnerships with Kenya Ministry of Health (MOH) to adapt and test evidence-based strategies (e.g., HPV self-testing, care navigators, and the WEMA mHealth app \[tested and scaled in Tanzania\]) that address key multi-level barriers identified through a formative, stakeholder-engaged research phase. Methodology Using the EPIS framework to guide our project, we will: Aim 1a), Explore (engage a multi-disciplinary stakeholder advisory board to co-design the intervention package and prioritize implementation strategies that align with local capacity, opportunities, and motivations; Aim 1b), Prepare (develop tools and strengthen capacity at clinics to implement the strategies; Aim 2), Implement and evaluate the package of implementation strategies via a cluster-randomized stepped wedge trial in 9 clinics (assessing implementation \[provision of CC screening with HPV self-testing\] and effectiveness \[proportion of HPVpositive WLWH who receive subsequent diagnostic triage and/or treatment\] over months 0-12; and Aim 3), assess Sustainability (costs, cost-effectiveness, and transfer of delivery from study to local staff over months 13-18. Significance of the study The overall goal of this study is to employ rigorous empirical methods to adapt and test implementation strategies that expand the scope of HIV care to screen for and treat early precancerous CC lesions in a sustainable, scalable way. Through partnering with Kenya's MOH, this project will have critical institutional support and dissemination capability, and will directly inform public health practice and policy.

Offering HPV Self-Collection in Novel Healthcare Settings to Improve Uptake of Cervical Cancer Screening

This clinical trial evaluates whether offering human papillomavirus (HPV) self-collection for cervical cancer screening at Mayo Clinic Express Care clinics improves uptake of cervical cancer screening and receipt of appropriate follow-up care. Cervical cancer is preventable through vaccination, screening, and treatment of pre-cancerous conditions. However, cervical cancer screening rates have declined over the past 25 years, and an estimated 25% of women are unscreened or overdue for screening. Usual care at Mayo Clinic currently includes annual portal or letter communications in the form of scheduled outreach to request scheduling an appointment for cervical cancer screening, as well as reminders from clinicians during clinic appointments. Cervical cancer screening at Mayo Clinic is most often done with a pelvic speculum exam with cervical swabs collected in the office by a clinician. HPV self-collection is Food and Drug Administration-approved and already used in clinical practice, but offering this method of screening in the novel setting of Express Care clinics that have expanded nighttime and weekend hours may improve rates of cervical cancer screening and receipt of appropriate follow-up care.

MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

Comparing One or Two Doses of the Human Papillomavirus Vaccine for the Prevention of Human Papillomavirus Infection, ESCUDDO Study

This phase IV trial investigates whether one dose of a human papillomavirus vaccine works as well as two doses in preventing human papillomavirus (HPV) infection. Certain types of HPV cause almost all cases of cervical cancer. Vaccines that protect against infection with these types of human papillomavirus may reduce the risk of cervical cancer. Both Gardasil-9 and Cervarix protect against HPV 16 and 18, which cause 70% of all cervical cancers. However, HPV vaccination rates are too low, especially in countries with very high rates of cervical cancer. HPV vaccines are expensive-many countries cannot afford them-more than one dose is needed, and giving multiple doses is difficult. Researchers want to find out if one dose prevents HPV infection. If it does, more people might get the vaccine.