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

NCT04588402 | Unknown

• 1 other identifier: SMIMS/IEC/C/2020-09
• Study Type: observational
• Target: 5,500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Cancer

Outcome Measures

Primary Outcomes (2)

• The reduction in the point prevalence of genotype-specific HPV infection in women within 7 years of initiation of HPV vaccination compared to that at baseline

  The investigators will estimate difference in the prevalence of genotype-specific HPV infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program).

  7 years

• The difference in the point prevalence of chlamydia trachomatis infection in women within 7 years of initiation of HPV vaccination compared to that at baseline

  The investigators will estimate difference in the prevalence of chlamydia trachomatis infection based on cervical samples collected from the married women aged 18 to 22 years at baseline (in the year 2020-21) and again in the year 2025-26 (seven years after the initiation of the HPV vaccination program). The estimate will allow the investigators to understand any change in the background risk of sexually transmitted infection in the population over time.

  7 years

Interventions

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. BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• International Agency for Research on Cancer: lead
• Department of Health and Family welfare, Government of Sikkim: collaborator
• Sikkim Manipal Institute: collaborator
• Rajiv Gandhi Centre for Biotechnology: collaborator

Study Sites (1)

Sikkim Manipal Hospital

Gangtok, Sikkim, 737107, India

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cervical cells

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yogesh Verma, MD

  Sikkim Manipal Inst., Sikkim, India

  PRINCIPAL INVESTIGATOR

• Phumzay Denzongpa, MD

  Dept of H & FW, Govt. of Sikkim, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Partha Basu, MD, PhD

CONTACT

+33 472 738 167; basup@iarc.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2020
• First Posted: October 19, 2020
• Study Start: October 1, 2020
• Primary Completion: June 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)