This clinical trial tests HPV self collection kits with or without in person registration navigation to improve at home cervical cancer screening. In the United States more than half of cervical cancers occur in women who are inadequately screened, with disproportionately higher mortality rates in rural areas and among those with limited access to clinic-based screening. Despite highly effective screening methods, nearly one quarter of the U.S. population are not up to date with their screening. The first at-home screening device (Teal Wand) helps address some of these access issues however effective linkages to follow-up care and treatment for women with an abnormal screen are essential to improve cervical cancer outcomes. In person registration navigation may help improve at home cervical cancer screening by ensuring patients have a follow up telehealth appointment to request their screening kit.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07453459.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Michelle Silver
Phone: 314-454-7903
PRIMARY OBJECTIVES:
I. Assess and compare the feasibility of two methods of community-based distribution of human papillomavirus (HPV) self-collection for cervical cancer screening (quick response [QR] code referral process versus [vs.] QR code referral process plus in-person registration navigation) by measuring the return rate of at home, self-collected HPV samples.
II. Identify individuals’ motivations to return kits as well as acceptability and barriers and facilitators of at-home testing (and follow-up if needed) for each distribution method via qualitative interviews.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive information about the self-collection kit along with a QR code they can use to register with Teal and request the telehealth appointment needed to receive their at home cervical cancer screening kit. Patients who complete their telehealth appointment receive text messages, email and phone call reminders to complete their screening and when results are available. Patients who receive abnormal, high-risk (HPV 16/18) results and do not have a provider will be contacted by phone call to connect them with one so they can initiate follow-up care.
ARM II: Patients receive information about the self-collection kit and receive in person navigation assistance to scan the QR code, register with Teal and schedule their telehealth appointment needed to receive their at home cervical cancer screening kit. Patients who complete their telehealth appointment receive text messages, email and phone call reminders to complete their screening and when results are available. Patients who receive abnormal, high-risk (HPV 16/18) results and do not have a provider will be contacted by phone call to connect them with one so they can initiate follow-up care.
After completion of study intervention, patients are followed up at 8 weeks.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorMichelle Silver
