HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals (ACCESS)

Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State

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 Overview

• Status: Enrolling by invitation
• Conditions: Cervical Cancer
• Intervention / Treatment: Device: Flocked swab paired with Roche Cobas 4800

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98104
      • Madison Clinic
    • Seattle, Washington, United States, 98103
      • SHE Clinic
    • Seattle, Washington, United States, 98104
      • MAX Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HPV self-sampling; Participants will be offered self-collection kits for HPV-based cervical cancer screening.	Device: Flocked swab paired with Roche Cobas 4800; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible individuals who accept self-sampling kits	the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing.	Baseline (during clinical and/or study recruitment encounter)
Proportion of eligible individuals who submit self-sampled specimens	the proportion of individuals who agree to self-collection who return samples	3 weeks from enrollment
Satisfaction with self-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."	Within 2 weeks of sample collection
Confidence with self-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."	Within 2 weeks of sample collection
Recommendation of self-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."	Within 2 weeks of sample collection
Ease of returning home kits	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)."	Within 2 weeks of sample collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of eligible individuals who return samples with adequate specimens	the proportion of returned samples that have valid specimens for HPV testing	3 weeks from enrollment
Knowledge about HPV and cervical cancer screening	a survey to measure participant's knowledge about HPV and cervical cancer screening	Baseline
Perceived risk of cervical cancer	a survey to measure participant's perceived risk of cervical cancer	Baseline
Attitudes and preferences for screening	a survey to measure participant's attitudes and preferences for cervical cancer screening	Baseline
HPV prevalence checklist	the distribution of HPV results from all individuals who return a self-sampled specimen	Baseline
Receipt of follow-up care	Among participants who screen positive for hrHPV, measure the proportion who receive indicated follow-up care (cytology and/or colposcopy)	Up to 6 months after self-sampling
Reflex cytology results checklist	the results of cytology tests following positive self-sampled HPV results	Up to 6 months after self-sampling
Colposcopy results checklist	the results of colposcopy tests following positive self-sampled HPV results.	Up to 6 months after self-sampling
Provider and/or clinic barriers and facilitators to cervical cancer screening survey	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.	During study year 1

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Darcy Rao, PhD, MPH, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): October 7, 2022

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: HIV; Screening; HPV; Cervical cancer; Self-sampling; Self-collection
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: STUDY00014442; 5KL2TR002317-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified study data will be posted on a repository for use in studies on access to healthcare and sexual and reproductive health, including but not limited to cervical cancer services.
• IPD Sharing Time Frame: Data will be available within 6 months of study end date.
• IPD Sharing Access Criteria: Investigators interested in using study data will need to contact the investigator and sign a data use agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No