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RECRUITING
NCT04588402

Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

Sponsor: International Agency for Research on Cancer

View on ClinicalTrials.gov

Summary

This project aims is to monitor the effectiveness of HPV vaccination in real-word conditions, at least 7 years after initiation of HPV vaccination in Sikkim. This study would give an opportunity to provide rapid feedback to the Indian public health authorities about the impact of the HPV vaccine.

Official title: Assessing the Population Level Impact of HPV Vaccination on Prevention of Cervical HPV Infection in Sikkim, India

Key Details

Gender

FEMALE

Age Range

18 Years - 22 Years

Study Type

OBSERVATIONAL

Enrollment

5500

Start Date

2020-10-01

Completion Date

2026-12-31

Last Updated

2026-04-03

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

The study being observational in nature, there is no intervention. The investigators will only collect cervical samples from married women within a specified age range at different intervals.

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons. After signing the informed consent, the participants will fill in a risk factor questionnaire to study the socio-demographic information, sexual history and HPV vaccination history and the determinent of HPV infection. The questionnaire will be administered by a trained social worker or nurse. A gynecologist will collect cervical cells from the participant's cervix during a gynecological examination. The cervical specimen will be examined for presence of specific HPV genotypes and Chlamydia infection.

Locations (1)

Sikkim Manipal Hospital

Gangtok, Sikkim, India