Clinical trial · Observational
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
NCT04588402CI-TRIAL-00107274HPV-Vac-SrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 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 | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- 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
- timeFrame
- 7 years
- description
- 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).
- measure
- 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
- timeFrame
- 7 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 to 22 years, resident of Sikkim and married. * Pregnancy will not be considered as exclusion criteria. * Sample collection should be avoided during active menstruation. Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.