RecruitingNCT04588402

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

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


Sponsor

International Agency for Research on Cancer

Enrollment

5,500 participants

Start Date

Oct 1, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 22 Years

Inclusion Criteria1

  • Women aged 18 to 22 years, resident of Sikkim and married.

Exclusion Criteria5

  • Sample collection should be avoided during active menstruation.
  • Women who do not provide written consent
  • Women who are not able to cooperate in collection of cervical cell sample or respond to questions due to any acute or severe mental and physical illnesses.
  • Women who had undergone hysterectomy.
  • Vaccinated in research project

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Interventions

BIOLOGICALThe 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

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NCT04588402


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