Clinical trial · Interventional
Home-Based or Clinic-Based Human Papillomavirus (HPV) Screening
Cytology vs. at Home HPV Screening for Detection of CIN 2,3,CIS
NCT01550783CI-TRIAL-00046307completedN/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)
This randomized clinical trial studies home-based HPV or clinic-based Pap screening for cervical cancer. It is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atypical Squamous Cell of Undetermined Significance | — | UNRESOLVED | — |
| Cervical Carcinoma | Cervical Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Intraepithelial Neoplasia Grade 2/3 | Cervical Intraepithelial Neoplasia Grade 2/3 | ONTOLOGY_EXACT | 0.98 |
| Health Status Unknown | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
| Low Grade Cervical Squamous Intraepithelial Neoplasia | Cervical Squamous Intraepithelial Neoplasia 1 | ALIAS | 0.90 |
| Stage 0 Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical Papanicolaou Test | Other | — | UNRESOLVED |
| Cytology Specimen Collection Procedure | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Screening Method | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (home-based HPV screening)
- description
- Participants collect 2 vaginal specimens using polyester swabs that are then placed in a specimen tube. Specimens are then submitted to the Harborview Medical Center clinical pathology lab. Participants with a positive HPV test result will have a Pap test. Participants with an abnormal Pap test will undergo standard of care as in Group II.
- interventionNames
- Other: Cytology Specimen Collection Procedure
- Other: Questionnaire Administration
- Procedure: Screening Method
- type
- EXPERIMENTAL
- label
- Group II (clinic-based standard of care screening)
- description
- Participants undergo standard of care cervical cancer screening and follow-up. That is, participants undergo Pap testing. Participants with an abnormal Pap test undergo HPV testing, colposcopy, cervical biopsy and/or ECC. Participants with cervical biopsies showing precancerous changes are offered to undergo LEEP or are referred to appropriate care.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Able to provide informed consent in English Exclusion Criteria: * Have had hysterectomy * Currently pregnant * Received treatment of cervical dysplasia with LEEP, cone biopsy, laser procedure or cryotherapy within THREE years * Received colposcopy of cervix within TWO years * Received Pap test within ONE year * Immunocompromised (positive human immunodeficiency virus \[HIV\] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) * Decisionally impaired adults requiring a legally authorized representative
References
Publications (2)
- DERIVEDFeder MA, Kulasingam SL, Kiviat NB, Mao C, Nelson EJ, Winer RL, Whitham HK, Lin J, Hawes SE. Correlates of Human Papillomavirus Vaccination and Association with HPV-16 and HPV-18 DNA Detection in Young Women. J Womens Health (Larchmt). 2019 Oct;28(10):1428-1435. doi: 10.1089/jwh.2018.7340. Epub 2019 Jul 2. PMID 31264912
- DERIVEDMao C, Kulasingam SL, Whitham HK, Hawes SE, Lin J, Kiviat NB. Clinician and Patient Acceptability of Self-Collected Human Papillomavirus Testing for Cervical Cancer Screening. J Womens Health (Larchmt). 2017 Jun;26(6):609-615. doi: 10.1089/jwh.2016.5965. Epub 2017 Mar 23. PMID 28332888