Study for Prevention of Cervical Cancer in Spain (REVIVE)

The REVIVE study aims to analyze the current status of Human Papillomavirus (HPV) vaccination programs and cervical cancer screening strategies in Spain. Its objective is to gain a comprehensive understanding of the effectiveness of these preventive measures, as well as to identify the main barriers to access and the existing inequalities in care. The study will also examine the impact of misinformation on population engagement and on the overall equity of the prevention system.

Despite significant advances in both vaccination and screening efforts, cervical cancer remains a major public health concern in Spain. In 2024 alone, 2,259 new cases were diagnosed, that incidence has remained relatively stable in recent years, even decades. Mortality rates have also shown little change, with over 600 deaths annually, totaling nearly 10,000 in the last 15 years.

To address this, the study plans to include approximately 200 patients diagnosed with cervical cancer in Spain between 2019 and 2024. It is a retrospective, observational, and non-interventional study. Data will be collected from existing medical records and supplemented with a specific questionnaire administered to the participating patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Cancer Screening; HPV Vaccination
• Intervention / Treatment: Biological: Evaluate the effectiveness of current Human Papillomavirus (HPV) vaccination and screening programs in reducing cervical cancer incidence in Spain.

• Study Type: Observational
• Enrollment (Estimated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.

Description

Inclusion Criteria:

• Female patients diagnosed with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix.
• Diagnosis established between 2019 and 2024.

Exclusion Criteria:

• Patients aged below 18 years at diagnosis.
• Diagnosis of other cervical cancer histologies (e.g., neuroendocrine tumors, sarcoma, lymphoma).
• Patents with significant cognitive impairment precluding informed consent for data utilization, where applicable.
• Patients with incomplete medical records relevant to the study variables.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of HPV vaccination and cervical cancer screening among patients diagnosed with cervical cancer in Spain	Proportion of individuals diagnosed with cervical cancer who have previously received the HPV vaccine and/or undergone cervical cancer screening prior to their cervical cancer diagnosis. The objective is to assess the effectiveness of national prevention strategies, identify gaps in vaccine and screening coverage, and understand potential barriers to early detection and vaccination.	2019-2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of HPV vaccination and screening coverage by region and demographic factors	This objective aims to determine the proportion of individuals who have received HPV vaccination and/or undergone cervical cancer screening, stratified by geographic region and key demographic factors such as age and ethnicity. The goal is to identify disparities in preventive healthcare access.	2019-2024
Association between misinformation and socioeconomic factors and the rate of HPV vaccination and screening	This objective seeks to evaluate how misinformation and socioeconomic factors (income level, education, employment status, and healthcare access) influence the rates of HPV vaccination and participation in cervical cancer screening programs.	2019-2024
Reported frequency and nature of barriers to accessing to HPV vaccination and cervical cancer screening	This objective aims to identify and categorize the most commonly reported barriers that individuals face when trying to access to HPV vaccination and screening programs.	2019-2014

Collaborators and Investigators

• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2025
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 24, 2025
• First Submitted That Met QC Criteria: August 7, 2025
• First Posted (Actual): August 8, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Neoplasms; Uterine Cervical Neoplasms
• Other Study ID Numbers: REVIVE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No