HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals
- Conditions
- Cervical Cancer
- Interventions
- Device: Flocked swab paired with Roche Cobas 4800
- Registration Number
- NCT05528237
- Lead Sponsor
- University of Washington
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- Female
- Target Recruitment
- 50
- 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
- Current pregnancy
- Complete hysterectomy
- History of cervical cancer
- Unable to provide informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description HPV self-sampling Flocked swab paired with Roche Cobas 4800 Participants will be offered self-collection kits for HPV-based cervical cancer screening.
- Primary Outcome Measures
Name Time Method Proportion of eligible individuals who accept self-sampling kits 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 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 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 3 weeks from enrollment the proportion of individuals who agree to self-collection who return samples
Satisfaction with self-collection 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 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 Outcome Measures
Name Time Method Proportion of eligible individuals who return samples with adequate specimens 3 weeks from enrollment the proportion of returned samples that have valid specimens for HPV testing
Perceived risk of cervical cancer Baseline a survey to measure participant's perceived risk of cervical cancer
Provider and/or clinic barriers and facilitators to cervical cancer screening survey 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.
Knowledge about HPV and cervical cancer screening Baseline a survey to measure participant's knowledge about HPV and cervical cancer screening
Reflex cytology results checklist Up to 6 months after self-sampling the results of cytology tests following positive self-sampled HPV results
HPV prevalence checklist Baseline the distribution of HPV results from all individuals who return a self-sampled specimen
Attitudes and preferences for screening Baseline a survey to measure participant's attitudes and preferences for cervical cancer screening
Colposcopy results checklist Up to 6 months after self-sampling the results of colposcopy tests following positive self-sampled HPV results.
Receipt of follow-up care 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)
Trial Locations
- Locations (3)
MAX Clinic
🇺🇸Seattle, Washington, United States
SHE Clinic
🇺🇸Seattle, Washington, United States
Madison Clinic
🇺🇸Seattle, Washington, United States