Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Washington
- Enrollment
- 50
- Locations
- 3
- Primary Endpoint
- Proportion of eligible individuals who accept self-sampling kits
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age >=25 and <65 (individuals without diagnosed HIV) or >=30 years (individuals with diagnosed HIV)
- •Female sex at birth
- •Proficient in English or Spanish
- •Refused a Pap smear or are >=6 months overdue for cervical cancer screening
Exclusion Criteria
- •Current pregnancy
- •Complete hysterectomy
- •History of cervical cancer
- •Unable to provide informed consent
Arms & Interventions
HPV self-sampling
Participants will be offered self-collection kits for HPV-based cervical cancer screening.
Intervention: Flocked swab paired with Roche Cobas 4800 (Device)
Outcomes
Primary Outcomes
Proportion of eligible individuals who accept self-sampling kits
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.
Confidence with self-collection
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."
Ease of returning home kits
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)."
Proportion of eligible individuals who submit self-sampled specimens
Time Frame: 3 weeks from enrollment
the proportion of individuals who agree to self-collection who return samples
Satisfaction with self-collection
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."
Recommendation of self-collection
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."
Secondary Outcomes
- Attitudes and preferences for screening(Baseline)
- Proportion of eligible individuals who return samples with adequate specimens(3 weeks from enrollment)
- Perceived risk of cervical cancer(Baseline)
- Provider and/or clinic barriers and facilitators to cervical cancer screening survey(During study year 1)
- Knowledge about HPV and cervical cancer screening(Baseline)
- Reflex cytology results checklist(Up to 6 months after self-sampling)
- HPV prevalence checklist(Baseline)
- Colposcopy results checklist(Up to 6 months after self-sampling)
- Receipt of follow-up care(Up to 6 months after self-sampling)
Investigators
Darcy W Rao, PhD
Acting Assistant Professor: School of Public Health
University of Washington