NCT Number: NCT05528237
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.
Interested in participating?
Request Info25 year and older
Female
Interventional
Not applicable
MAX Clinic, Seattle, Washington, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Consenting individuals will insert the sterile flocked swab into the vagina, rotate at least once, and store in the provided dry tube. The sample will be stored at ambient temperature and routed to the lab for HPV testing with Roche Cobas 4800.
Other names: COPAN 552c FLOQSwabs
Time frame: Baseline (during clinical and/or study recruitment encounter)
the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing.
Time frame: 3 weeks from enrollment
the proportion of individuals who agree to self-collection who return samples
Time frame: Within 2 weeks of sample collection
Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I was satisfied with the self-collection experience."
Time frame: Within 2 weeks of sample collection
Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I am sure I got a good sample using the swab."
Time frame: Within 2 weeks of sample collection
Participants will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "I would recommend self-collection to a friend."
Time frame: Within 2 weeks of sample collection
Participants who collected a sample at home will use a 5-point Likert scale (strongly agree, agree, neutral, disagree, strongly disagree) to respond to the statement, "It was easy to return my sample (by mail or to the clinic)."
Time frame: 3 weeks from enrollment
the proportion of returned samples that have valid specimens for HPV testing
Time frame: Baseline
a survey to measure participant's knowledge about HPV and cervical cancer screening
Time frame: Baseline
a survey to measure participant's perceived risk of cervical cancer
Time frame: Baseline
a survey to measure participant's attitudes and preferences for cervical cancer screening
Time frame: Baseline
the distribution of HPV results from all individuals who return a self-sampled specimen
Time frame: Up to 6 months after self-sampling
Among participants who screen positive for hrHPV, measure the proportion who receive indicated follow-up care (cytology and/or colposcopy)
Time frame: Up to 6 months after self-sampling
the results of cytology tests following positive self-sampled HPV results
Time frame: Up to 6 months after self-sampling
the results of colposcopy tests following positive self-sampled HPV results.
Time frame: During study year 1
focus group discussions with clinic administrators, staff and other HIV and women's health experts. These discussions will cover: barriers to clinician-administered screening (i.e., Pap screening and clinician-collected HPV samples); perceived patient barriers to clinician-administered screening and follow-up procedures; perceived facilitators to cervical cancer screening and follow-up; and feasibility of offering HPV self-sampling kits as a potential primary screening strategy.
University of Washington
Other
Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State
Acronym: ACCESS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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