The HOPE study is a randomized clinical trial designed to evaluate a novel approach to screening for cervical cancer. Subjects will be randomized to receive conventional screening with Pap tests or screening with a Home HPV test followed by Pap triage if HPV test is positive for high-risk types. We will be evaluating efficacy, cost effectiveness, and patient acceptability for this new approach.
Potential subjects will be approached who are scheduled for appointments at Roosevelt Women’s clinic, Hall Health clinic, or Harborview Women’s clinic. We will also recruit some subjects by sending letters to UW faculty/staff/students. Potential subjects will receive information about the study prior to their clinic appointment. They will have an opportunity to speak with a research clinician about the trial in detail.
On the day of the clinic visit/enrollment, study research staff will answer any further questions and have the subject sign the study informed consent form.
Subjects will be randomized to one of two arms. Research staff will notify clinician verbally and visually with labels for clinical specimens. Pap tests will be obtained for all study participants. Subjects randomized to the home HPV arm will only have a Pap test performed reflexively if their HPV test is positive.
Research staff will be available to ensure that study samples are properly labeled and sent with appropriate orders to the lab via EPIC.
Results for HPV tests and Pap tests will be sent to clinicians via EPIC with instructions for study follow-up based on protocol.
Subjects in the novel approach arm (home HPV test) will receive a results call from the research clinician.
Research staff will contact subjects between visits for survey completion and reminder of next screening date. Subjects enrolled in home HPV arm will not need to return to clinic for a second screening round unless they need follow-up with a clinician for other issues.
Subjects referred to colposcopy should have procedure and follow-up per standard of care. They will be asked to send a home HPV test in addition to clinic-based test if they are in the novel approach arm.
Subjects will be responsible for the cost of all clinic visits, routine procedures and lab tests except for home HPV test. At the conclusion of the study, some subjects will be offered colposcopy with a research clinician that will be performed at no cost to subject.
Further reading
Balasubramanian A, Kulasingam SL, Baer A, Hughes JP, Myers ER, Mao C, Kiviat NB, Koutsky LA. Accuracy and cost-effectiveness of cervical cancer screening by high-risk human papillomavirus DNA testing of self-collected vaginal samples. J Low Genit Tract Dis. 2010 Jul;14(3):185-95. [pdf] [pubmed]
Leinonen M, Nieminen P, Kotaniemi-Talonen L, Malila N, Tarkkanen J, Laurila P, Anttila A. Age-specific evaluation of primary human papillomavirus screening vs conventional cytology in a randomized setting. J Natl Cancer Inst. 2009 Dec 2;101(23):1612-23. Epub 2009 Nov 9. [pdf] [pubmed]
[link to clinicaltrials.gov]