Flocked swab paired with Roche Cobas 4800 for Cervical Cancers

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
SHE Clinic, Seattle, WA
Cervical Cancers+1 More
Flocked swab paired with Roche Cobas 4800 - Device
Eligibility
18+
Female
What conditions do you have?
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Study Summary

The objective of this study is to evaluate self-collection of vaginal samples for HPV testing as an alternative cervical cancer screening strategy for persons with HIV and/or limited access to care. Self-collection kits will be offered to persons who refuse a Pap smear or are overdue (>=6 months) for cervical cancer screening, with screening uptake recorded as a primary outcome. Kits will be offered in-clinic to individuals who refuse a Pap smear, and individuals overdue for screening will have the option to receive and return kits in the mail. The investigators will additionally administer a phone-based survey to evaluate knowledge about HPV and cervical cancer, barriers and facilitators to screening, and attitudes towards screening. Data from medical records will be abstracted to describe the clinical characteristics of the sample and measure receipt of follow-up procedures. Focus groups will be conducted with clinic administrators, staff, and HIV and women's health experts to evaluate clinic and provider barriers and facilitators to cervical cancer screening. The investigators hypothesize that HPV self-sampling will result in favorable patient-centered outcomes and could reduce disparities in access to screening.

Eligible Conditions

  • Cervical Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 9 Secondary · Reporting Duration: During study year 1

3 weeks from enrollment
Proportion of eligible individuals who return samples with adequate specimens
Proportion of eligible individuals who submit self-sampled specimens
Baseline
Attitudes and preferences for screening
HPV prevalence checklist
Knowledge about HPV and cervical cancer screening
Perceived risk of cervical cancer
Baseline (during clinical and/or study recruitment encounter)
Proportion of eligible individuals who accept self-sampling kits
During study year 1
Provider and/or clinic barriers and facilitators to cervical cancer screening survey
Month 6
Colposcopy results checklist
Receipt of follow-up care
Reflex cytology results checklist
Week 2
Confidence with self-collection
Ease of returning home kits
Recommendation of self-collection
Satisfaction with self-collection

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

HPV self-sampling
1 of 1
Experimental Treatment

50 Total Participants · 1 Treatment Group

Primary Treatment: Flocked swab paired with Roche Cobas 4800 · No Placebo Group · N/A

HPV self-sampling
Device
Experimental Group · 1 Intervention: Flocked swab paired with Roche Cobas 4800 · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during study year 1

Trial Background

Prof. Darcy W Rao, PhD
Principal Investigator
University of Washington
Closest Location: SHE Clinic · Seattle, WA
Photo of Seattle  1Photo of Seattle  2Photo of Seattle  3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Cervical Cancers
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are female.
You have not had a Pap smear in the past 12 months or are overdue for cervical cancer screening.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.