Concomitant human papillomavirus (HPV) vaccination and screening for elimination of HPV and cervical cancer.
Laila Sara Arroyo Mühr, Andrea Gini, Emel Yilmaz...
https://pubmed.ncbi.nlm.nih.gov/38693149Actively Recruiting
Phase 4
Age: 22Years - 27Years
FEMALE
ID04910802
Concomitant HPV Vaccination and HPV Screening for Rapid Elimination of HPV Infection and Cervical Cancer in Sweden
Led by Miriam Elfström · Updated on 2021-09-16
150000
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
M
Miriam Elfström
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating whether offering organized HPV vaccination alongside HPV screening to all women aged 22 to 27 in Sweden can speed up the elimination of HPV infection at the population level. Cervical cancer, caused mainly by HPV types targeted by vaccines, remains a serious health issue with many diagnoses and deaths annually in Sweden and worldwide. This study follows global strategies recommended by the World Health Organization to eliminate cervical cancer through vaccination, screening, and treatment. Women aged 22 to 26 will be offered the Gardasil 9 vaccine and HPV screening together. The initial dose of Gardasil 9 will be given at recruitment, followed by a second dose three years later. This approach aims to provide faster protection compared to current vaccination programs that focus mainly on younger girls and boys. The study began with a regional pilot in 2021 and plans to expand to other regions. Participants will have HPV prevalence measured at recruitment and then again at their second and third cervical screening visits, three and six years later. Researchers will also track cases of cervical precancerous changes and cancer, resource use, obstetrical complications, and benign cervical specimen findings at these intervals. Participants will be followed through regular cervical screening appointments as part of the study's long-term assessment of HPV elimination and cervical cancer prevention.
CONDITIONS
Brief Title
Concomitant HPV Vaccination and HPV Screening HPV Infection and Cervical Cancer in Sweden
Who Can Participate
Age: 22Years - 27Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Resident women aged 22 to 26 years
- Have not opted out of the cervical screening program
- Consent to participate in the study
- Willing to attend screening and receive HPV testing
- Offered HPV vaccination regardless of previous vaccination or screening results
You will not qualify if you...
- History of severe allergic reaction or hypersensitivity to any component of the HPV vaccine (including specified adjuvants and ingredients)
- Known immune-related disorders
- Current acute severe febrile illness (minor infections allowed)
- Received immunoglobulin or blood-derived products within 6 months before first vaccine dose
- Current pregnancy
- Women who have had a total hysterectomy
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - 3 years
Participants receive the first dose of Gardasil9 vaccine at recruitment and a second dose 3 years later, alongside HPV screening.
1 vaccination visit at recruitment and 1 follow-up vaccination visit 3 years later, plus cervical screening visits at recruitment, 3 years, and 6 years
Long-term Monitoring
Duration - 3 years
Participants attend cervical screening visits at 3 and 6 years after recruitment to monitor HPV prevalence and cervical health.
Cervical screening visits at 3 years and 6 years after recruitment
Trial Site Locations
Total: 1 location
1
Cancer prevention, screening, and counseling unit, Regional Cancer Center of Stockholm-Gotland
Stockholm, Sweden, 10239
Actively Recruiting
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Research Team
M
Miriam Elfström, PhD
H
Helena Andersson, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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