- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02460237
HPV Self-Test Intervention in Ohio Appalachia
Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Screening
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm I (intervention)
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.
|
Korrelative undersøgelser
Hjælpestudier
Complete HPV self-test
Andre navne:
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
Andre navne:
|
Aktiv komparator: Arm II (control)
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.
|
Korrelative undersøgelser
Hjælpestudier
Complete HPV self-test
Andre navne:
Receive standard instructions and information sheet
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
The proportion of women who return HPV-self tests
Tidsramme: Up to 4 weeks from kit distribution
|
A chi-square test will be used to test for a difference between the two groups.
|
Up to 4 weeks from kit distribution
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Attendance at a follow-up health care visit after HPV testing notification letters are sent (attended or did not attend)
Tidsramme: Up to 2 months after notification letters are sent
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
Up to 2 months after notification letters are sent
|
Prevalence of HPV infection
Tidsramme: After shipping the specimen, an expected average of 6 weeks
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
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)
Tidsramme: After shipping the specimen, an expected average of 6 weeks
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
After shipping the specimen, an expected average of 6 weeks
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Receipt of a Pap test (received or not received)
Tidsramme: Up to 2 months after receiving notification letters are sent
|
Descriptive statistics (e.g., proportions) will be calculated for the entire sample and by study arm.
|
Up to 2 months after receiving notification letters are sent
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- OSU-14282
- NCI-2015-00726 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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