Clinical trial · Interventional
A Pilot Study on HPV and Cervical Cancer Screening in Mumbai
NCT03229603CI-TRIAL-00030877HPVunknownN/AClinicalTrials.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)
The Study goals are to test feasibility and acceptability of point of care HPV testing with 227 women already accessing an existing cancer screening program in Mumbai, India. Describe HPV infection types in women screened. Compare if the quality of HPV clinician-collected and self-collected samples are equally efficient to detect HPV and cervical cancer precursor lesions. Compare the agreement between HPV GeneXpert and HPV HC2 test on the clinician-collected sample
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 |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cluster of 3000 women | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Cluster of 3000 women
- description
- Cluster will be selected from an existing cervical, breast, and oral cancer screening program in Mumbai, India and its surrounding semi-urban and rural areas.
- interventionNames
- Other: Cluster of 3000 women
Primary outcomes (1)
- measure
- The feasibility of HPV testing as a single visit approach will be summarized using the appropriate descriptive statistics.
- timeFrame
- 3 months
- description
- This will be predominantly for counts and percentages for categorical variables (e.g., number of women screened, number of women with incomplete self-collected specimens). In addition to the numbers of participants, the notes from the providers' debriefing regarding culturally appropriateness of HPV testing will be considered.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Females aged 30 to 55 years (the age when screening for HPV and cervical cancer is recommended) who participate in the TMH cancer screening outreach program. Exclusion Criteria: * Women with a known diagnosis of cancer, any other terminal diagnosis, or who are pregnant
References
Publications (0)
Data not yet available
No reference posted for this study.