Cervical CarcinomaNCT04411849
Multilevel HPV Self-Testing Intervention for the Increase of Cervical Cancer Screening Among Women in Appalachia
A study testing Best Practice, HPV Self-Collection and Informational Intervention in people with Cervical Carcinoma and Human Papillomavirus Infection, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
Trial summary
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. Read more about this study
- Who is it for?
- Ages 30 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus Infection
- What is being tested?
- Best Practice, HPV Self-Collection and Informational Intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 802 participants
- Where
- 4 sitesUnited States
- Study dates
- 27 Aug 2021to 11 Jun 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou [Pap] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years)
- Resident of an Appalachian county
- Not currently pregnant
- Intact cervix
- No history of invasive cervical cancer
- Seen in a participating clinic/health system in last 2 years (i.e., active patient)
- Have a working telephone
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Virginia
Charlottesville, Virginia, 22908
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, 40536
West Virginia University
Morgantown, West Virginia, 26506
About this study
Official title: A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
Read the detailed description
PRIMARY OBJECTIVES:
Determine the effectiveness of the intervention in increasing cervical cancer screening.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.
GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Being tested
- Best Practice, HPV Self-Collection, Informational Intervention, Patient Navigation Program
- Medical subject headings
- Uterine Cervical Neoplasms, Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
HPV Self-CollectionProcedure or surgery
Also called At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-Collection
Receive HPV self-testing intervention
Informational InterventionOther
Receive information about cervical cancer
Patient Navigation ProgramBehavioural
Also called Patient Navigator Program
Receive telephone-based patient navigation
| Study group | Role | What they receive |
|---|---|---|
| Group I (intervention) | Experimental | Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. Receives: Procedure: HPV Self-Collection; Other: Informational Intervention; Behavioral: Patient Navigation Program |
| Group II (usual care continued) | Active comparator | Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. Receives: Other: Best Practice; Other: Informational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Human Papillomavirus (HPV) Intervention
The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system.
Measured: Up to 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start27 Aug 2021
- Primary completion11 Jun 2024
- Study completion11 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 802 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Paul Reiter, Ohio State University Comprehensive Cancer Center
- Investigators
- Paul Reiter, PhD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04411849
- Sponsor's protocol ID
- OSU-20055
- Other IDs
- NCI-2020-01228, P01CA229143
- Status last verified
- Sep 2025
- First submitted
- 28 May 2020
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reiter PL, Shoben AB, Cooper S, Ashcraft AM, McKim Mitchell E, Dignan M, Cromo M, Walunis J, Flinner D, Boatman D, Hauser L, Ruffin MT 4th, Belinson JL, Anderson RT, Kennedy-Rea S, Paskett ED, Katz ML. A Mail-Based HPV Self-Collection Program to Increase Cervical Cancer Screening in Appalachia: Results of a Group Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2025 Jan 9;34(1):159-165. doi: 10.1158/1055-9965.EPI-24-0999.
PubMed 39445831
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel HPV Self-Testing Intervention to Increase Cervical Cancer Screening Among Women in Appalachia
- ClinicalTrials.gov ID
- NCT04411849
- Acronym / sponsor ID
- OSU-20055
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 802 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 11 Jun 2024 (actual)
- Study completion
- 11 Jun 2024 (actual)
- First posted
- 2 Jun 2020 (actual)
- Results
- Posted 4 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial studies how well a multilevel human papillomavirus (HPV) self-testing intervention works in increasing cervical cancer screening among women in Appalachia. Most cases of cervical cancer occur among unscreened and underscreened women. A multilevel HPV self-testing intervention may help to improve cervical cancer screening rates.
Detailed description
PRIMARY OBJECTIVES:
Determine the effectiveness of the intervention in increasing cervical cancer screening.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation.
GROUP II: Participants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (intervention) | Experimental | Procedure: HPV Self-Collection, Other: Informational Intervention, Behavioral: Patient Navigation ProgramParticipants receive the HPV self-testing intervention consisting of mailed HPV self-test devices. Participants also receive an information about cervical cancer. Participants who do not return their self-test within a few weeks receive telephone-based patient navigation. |
| Group II (usual care continued) | Active comparator | Other: Best Practice, Other: Informational InterventionParticipants receive usual care consisting of a reminder letter to get a clinic-based cervical cancer screening test and information about cervical cancer. |
Who may qualify
- Ages
- 30 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Not within recommended cervical cancer screening guidelines for women in this age range (i.e., no Papanicolaou [Pap] test in last 3 years or no Pap test plus clinic-based HPV test in last 5 years)
- Resident of an Appalachian county
- Not currently pregnant
- Intact cervix
- No history of invasive cervical cancer
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Group II (usual care continued) |
| HPV Self-CollectionAlso: At-home HPV Self Collection, HPV Self Collection, Human Papillomavirus Self-CollectionReceive HPV self-testing intervention | Procedure or surgery | Group I (intervention) |
| Informational InterventionReceive information about cervical cancer | Other | Group I (intervention), Group II (usual care continued) |
| Patient Navigation ProgramAlso: Patient Navigator ProgramReceive telephone-based patient navigation | Behavioural | Group I (intervention) |
Primary outcome
Effectiveness of Human Papillomavirus (HPV) Intervention
Time frame: Up to 1 years
The patient-level effectiveness will be whether or not women get "screened" during the project. Will examine the proportion of women screened, and use an intent-to-treat approach. To compare treatment groups (Group 1 versus Group 2), will use generalized linear mixed models (GLMMs) to account for the correlation between women from the same health system.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39445831Reiter PL, Shoben AB, Cooper S, Ashcraft AM, McKim Mitchell E, Dignan M, Cromo M, Walunis J, Flinner D, Boatman D, Hauser L, Ruffin MT 4th, Belinson JL, Anderson RT, Kennedy-Rea S, Paskett ED, Katz ML. A Mail-Based HPV Self-Collection Program to Increase Cervical Cancer Screening in Appalachia: Results of a Group Randomized Trial. Cancer Epidemiol Biomarkers Prev. 2025 Jan 9;34(1):159-165. doi: 10.1158/1055-9965.EPI-24-0999.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Reiter, PhD principal investigator
Ohio State University Comprehensive Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, HPV Self-Collection and Informational Intervention in people with Cervical Carcinoma and Human Papillomavirus Infection, run by Ohio State University Comprehensive Cancer Center at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Human Papillomavirus (HPV) Intervention (time frame: Up to 1 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04411849, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.