Trial · NCT04472377
HPV Typing Between Self- and Physician-sampled
NCT04472377, Not applicable, Completed, Hygeia Touch Inc.; results first posted 2024-08-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HPV Typing Between Self- and Physician-sampled. Trials, record NCT04472377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04472377
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HPV Typing Between Self- and Physician-sampled
- NCT number
- NCT04472377
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 1,210 participants, actual
- Lead sponsor
- Hygeia Touch Inc.
- Conditions
- Human Papillomavirus Infection, Self Sampling, Vaginal Discharge
- Interventions
- Self sampling kit for collecting discharge from vaginal fornix
- First posted
- 2020-07-15
- Last updated
- 2024-10-03
- Results first posted
- 2024-08-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | 14 days | Rate of the "agreement". The "agreement" is defined as either (1) presence of any high-risk HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of high-risk HPV in physician collected specimen and the patient sampled specimen. |
| Secondary | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | 14 days | Rate of the "agreement". The "agreement" is defined as either (1) presence of any HPV type in physician collected specimen, and the patient sampled specimen, or (2) absence of any HPV in physician collected specimen and the patient sampled specimen. |
| Secondary | Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 14 days | Percentage of the presence of the beta-globin gene. The ratio could be calculated between self-collected and physician-collected specimens. |
| Secondary | Adverse Event From Self Sampling | within one month after sample collection | The number of participants with any adverse event. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adverse Event From Self Sampling | within one month after sample collection | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Self-collected Specimens | Positive | 581 | Participants | |
| Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Physician-sampled Specimens | Positive | 611 | Participants | |
| Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Self-collected Specimens | Negative | 589 | Participants | |
| Agreement in the Detection of High-risk HPV Type in Physician-sampled Specimen and Self-collected Specimen. | Physician-sampled Specimens | Negative | 559 | Participants | |
| Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Self-collected Specimens | Positive | 718 | Participants | |
| Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Physician-sampled Specimens | Positive | 720 | Participants | |
| Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Self-collected Specimens | Negative | 452 | Participants | |
| Agreement in HPV Detection Between Physician Collected Sample and Self-collected Sample | Physician-sampled Specimens | Negative | 450 | Participants | |
| Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | Self-collected Specimens | 1170 | Participants | ||
| Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens | Physician-sampled Specimens | 1170 | Participants |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Study Population | 1,210 | |
| Overall Study | COMPLETED | Study Population | 1,210 | |
| Overall Study | NOT COMPLETED | Study Population | 0 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Perineal pain | Product Issues | Participants With Adverse Events | 7 | 1,210 | |
| other | anxiety | Product Issues | Participants With Adverse Events | 2 | 1,210 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Adverse Events | 0 | 1,210 |
| Total, other adverse events | Participants With Adverse Events | 9 | 1,210 |
| Total, serious adverse events | Participants With Adverse Events | 0 | 1,210 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Self-collected Specimens vs Physician-sampled Specimens: Percentage of a Valid Specimen, According to the Presence of the Beta-globin Gene in Specimens |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04472377
GET https://conductscience.org/api/trials/v1/NCT04472377/registered