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

NCT ID: NCT04588402

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-12-31

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.

Detailed Description

The investigators would like to estimate the prevalence of HPV infections based on cervical samples collected from the Sikkimese women aged 18 to 22 years at baseline (i.e. when the study participants are expected to have no benefit of vaccination) and seven years after the launch of the HPV vaccination programme, by which time the initial vaccinated cohorts will be aged 18 to 22 years and many of them will be sexually active. If the vaccination programme continues with the current high coverage rate, the cohort of women in the second age group are expected to be protected due to herd immunity, irrespective of whether any individual woman receives the vaccine or not. Overall effectiveness to protect women aged 18-22 years against targeted and non-targeted HPV infections will be monitored through repeated cervical sample -based surveys.

Conditions

Cervical Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Family welfare, Government of Sikkim

UNKNOWN

Sponsor Role: collaborator

Sikkim Manipal Institute

UNKNOWN

Sponsor Role: collaborator

Rajiv Gandhi Centre for Biotechnology

INDUSTRY

Sponsor Role: collaborator

International Agency for Research on Cancer

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yogesh Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Sikkim Manipal Inst., Sikkim, India

Phumzay Denzongpa, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Sikkim Manipal Hospital

Gangtok, Sikkim, India

Site Status: RECRUITING

Countries

India

Central Contacts

Partha Basu, MD, PhD

Role: CONTACT

basup@iarc.fr

+33 472 738 167

Facility Contacts

Yogesh Verma, MD

Role: primary

Yogeyogeshverma58@gmail.com

Other Identifiers

SMIMS/IEC/C/2020-09

Identifier Type: -

Identifier Source: org_study_id