Concomitant HPV Vaccination and Screening for Cervical Cancer Prevention in Rwandan Women
Gardasil 9
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Prevention Study
Summary
Study start date: September 1, 2024
Actual date on which the first participant was enrolled.Cervical cancer is a significant health issue in Rwanda, with high rates of new cases and deaths. The disease is largely preventable through the use of the HPV vaccine and regular screening, but these measures are not widely available in many low and middle-income countries, including Rwanda. This study aims to speed up the elimination of cervical cancer in Rwanda by combining HPV vaccination and screening for women aged 23 to 29. The project hopes to reduce the number of new cervical cancer cases and deaths in a cost-effective way, making these prevention methods more sustainable. Participants in this study will receive the Gardasil 9 HPV vaccine and undergo regular screenings to check for cervical cancer. The study will look at whether this combined approach can lower HPV infection rates and improve the overall effectiveness and safety of cervical cancer prevention. Researchers will analyze the incidence of HPV infections and cervical cancer precursors to assess the effectiveness of one-dose and two-dose vaccinations. The study will also consider the convenience and resource usage of this approach, with results compared to initial data collected at the start of the study. The project will take place over two years and involves 100,000 women across four districts in Rwanda.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 23 to 29 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Eligible women will include women within the age range of 23-29, who have not opted out of the screening program and who consent to participate in the study Exclusion Criteria: * Known history of severe allergic reaction or hypersensitivity to any of the components of the HPV vaccine. (For GARDASIL 9: Amorphous aluminium hydroxyphosphate sulphate adjuvant, Sodium chloride, L-histidine, Polysorbate 80, or Sodium borate) * Known history of immune-related disorders * Current acute severe febrile illness, except for minor infections such as a cold, mild upper respiratory infection, or low-grade fever. * Administration of immunoglobulin or blood-derived products within 6 months prior to the scheduled HPV vaccine first dose * Current pregnancy (reported) * Women with a total hysterectomy
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives