Cervical CarcinomaNCT02460237
HPV Self-Test Intervention in Ohio Appalachia
A study testing Disease Screening, Educational Intervention and Informational Intervention in people with Cervical Carcinoma and Human Papillomavirus Infection, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Cervical Carcinoma, Human Papillomavirus Infection
- What is being tested?
- Disease Screening, Educational Intervention and Informational Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 15 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages 30-65
- No Pap test in the last 3 years
- Resident of an Ohio Appalachia county
- Not currently pregnant or was not pregnant in the last 3 months
- No history of invasive cervical cancer
- No history of hysterectomy; women will not be eligible for the pilot randomized controlled trial (RCT) if they participated in the focus groups that helped develop this study (focus groups were institutional review board [IRB] approved as Protocol 2014C0086) or the preliminary device test; we will also require women to read and understand English and have the ability to provide informed consent, which will be inferred upon completion and return of the study eligibility, consent, and Health Insurance Portability and Accountability Act (HIPAA) forms
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.
ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent.
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Being tested
- Disease Screening, Educational Intervention, Informational Intervention, Laboratory Biomarker Analysis, Survey Administration
- Keywords
- HPV
- 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.
Disease ScreeningProcedure or surgery
Also called Disease Screening Procedure, Screening, Screening Intervention
Complete HPV self-test
Educational InterventionOther
Also called Education for Intervention, Intervention, Educational
Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing
Informational InterventionOther
Receive standard instructions and information sheet
Laboratory Biomarker AnalysisOther
Correlative studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (intervention) | Experimental | Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing. Receives: Procedure: Disease Screening; Other: Educational Intervention; Other: Laboratory Biomarker Analysis; Other: Survey Administration |
| Arm II (control) | Active comparator | Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing. Receives: Procedure: Disease Screening; Other: Informational Intervention; Other: Laboratory Biomarker Analysis; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of women who return HPV-self tests
A chi-square test will be used to test for a difference between the two groups.
Measured: Up to 4 weeks from kit distribution
Secondary outcomes (3)
Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Measured: Up to 2 months after notification letters are sent
Prevalence of HPV infection
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Measured: After shipping the specimen, an expected average of 6 weeks
Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing)
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
Measured: After shipping the specimen, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startNov 2015
- Primary completion14 Jun 2016
- Study completion15 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- 103 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- NCT02460237
- Sponsor's protocol ID
- OSU-14282
- Other IDs
- NCI-2015-00726
- Status last verified
- Feb 2018
- First submitted
- 28 May 2015
- Last updated
- 8 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Reiter PL, Shoben AB, McDonough D, Ruffin MT, Steinau M, Unger ER, Paskett ED, Katz ML. Results of a Pilot Study of a Mail-Based Human Papillomavirus Self-Testing Program for Underscreened Women From Appalachian Ohio. Sex Transm Dis. 2019 Mar;46(3):185-190. doi: 10.1097/OLQ.0000000000000944.
PubMed 30461597
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
- ClinicalTrials.gov ID
- NCT02460237
- Acronym / sponsor ID
- OSU-14282
- Conditions
- Cervical Carcinoma, Human Papillomavirus Infection
- Keywords
- HPV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- 14 Jun 2016 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will pilot test a culturally appropriate human papillomavirus (HPV) self-test intervention among women from Ohio Appalachia in order to determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy. The intervention group will receive culturally appropriate materials and the control group will receive standard materials with their HPV self-test device.
Detailed description
PRIMARY OBJECTIVES:
- To determine the feasibility of HPV self-testing as a potential cervical cancer screening strategy and obtain preliminary efficacy data of culturally appropriate materials on self-test use.
OUTLINE:
Participants are randomized to 1 of 2 arms.
ARM I: Participants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing.
ARM II: Participants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing.
Participants are followed up at 4 weeks for return of their HPV self-test device and then for 2 months after notification letters are sent.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (intervention) | Experimental | Procedure: Disease Screening, Other: Educational Intervention, Other: Laboratory Biomarker Analysis, Other: Survey AdministrationParticipants receive a study kit that includes culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing. Participants are asked to complete the HPV self-test and return the test for HPV testing. |
| Arm II (control) | Active comparator | Procedure: Disease Screening, Other: Informational Intervention, Other: Laboratory Biomarker Analysis, Other: Survey AdministrationParticipants receive a study kit that includes standard instructions for using and returning the HPV self-test device and a standard information sheet about HPV and cervical cancer. Participants are asked to complete the HPV self-test and return the test for HPV testing. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 30-65
- No Pap test in the last 3 years
- Resident of an Ohio Appalachia county
- Not currently pregnant or was not pregnant in the last 3 months
- 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 |
|---|---|---|
| Disease ScreeningAlso: Disease Screening Procedure, Screening, Screening InterventionComplete HPV self-test | Procedure or surgery | Arm I (intervention), Arm II (control) |
| Educational InterventionAlso: Education for Intervention, Intervention, EducationalReceive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing | Other | Arm I (intervention) |
| Informational InterventionReceive standard instructions and information sheet | Other | Arm II (control) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Arm I (intervention), Arm II (control) |
| Survey AdministrationAncillary studies | Other | Arm I (intervention), Arm II (control) |
Primary outcome
The proportion of women who return HPV-self tests
Time frame: Up to 4 weeks from kit distribution
A chi-square test will be used to test for a difference between the two groups.
3 secondary outcomes
Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)
Time frame: Up to 2 months after notification letters are sent
Prevalence of HPV infection
Time frame: After shipping the specimen, an expected average of 6 weeks
Specimen adequacy (whether participants self-collected an adequate specimen [yes or no] to allow for HPV testing)
Time frame: After shipping the specimen, an expected average of 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2018.
- Derived from this study: PubMed 30461597Reiter PL, Shoben AB, McDonough D, Ruffin MT, Steinau M, Unger ER, Paskett ED, Katz ML. Results of a Pilot Study of a Mail-Based Human Papillomavirus Self-Testing Program for Underscreened Women From Appalachian Ohio. Sex Transm Dis. 2019 Mar;46(3):185-190. doi: 10.1097/OLQ.0000000000000944.
- The JameslineLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Disease Screening, Educational Intervention and Informational Intervention in people with Cervical Carcinoma and Human Papillomavirus Infection, run by Ohio State University Comprehensive Cancer Center at 1 site 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 6 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 8 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The proportion of women who return HPV-self tests (time frame: Up to 4 weeks from kit distribution). 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 NCT02460237, 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 8 Feb 2018.