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

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

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.

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.

the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing.

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."

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."

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."

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)."

Among participants who screen positive for hrHPV, measure the proportion who receive indicated follow-up care (cytology and/or colposcopy)

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.

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

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.

Investigators interested in using study data will need to contact the investigator and sign a data use agreement.