- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02460237
HPV Self-Test Intervention in Ohio Appalachia
Pilot Testing an HPV Self-Test Intervention: A Novel Strategy for Reducing Cervical Cancer in Appalachia
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43210
- Ohio State University Comprehensive Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Screening
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 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 studier
Hjelpestudier
Complete HPV self-test
Andre navn:
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 navn:
|
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 studier
Hjelpestudier
Complete HPV self-test
Andre navn:
Receive standard instructions and information sheet
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Paul Reiter, PhD, Ohio State University Comprehensive Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- OSU-14282
- NCI-2015-00726 (Registeridentifikator: CTRP (Clinical Trial Reporting Program))
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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