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

NCT05528237 | Enrolling By Invitation FDA Device

• 2 other identifiers: STUDY000144425KL2TR002317-05
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

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.

Conditions

Cervical Cancer

Keywords

Screening; Self-collection; Self-sampling; Cervical cancer; HPV; HIV

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (9)

• Proportion of eligible individuals who return samples with adequate specimens

  3 weeks from enrollment

• Knowledge about HPV and cervical cancer screening

  Baseline

• Perceived risk of cervical cancer

  Baseline

• Attitudes and preferences for screening

  Baseline

• HPV prevalence checklist

  Baseline

Study Arms (1)

HPV self-sampling

EXPERIMENTAL

Participants will be offered self-collection kits for HPV-based cervical cancer screening.

Device: Flocked swab paired with Roche Cobas 4800

Interventions

Flocked swab paired with Roche Cobas 4800 DEVICE

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.

Also known as: COPAN 552c FLOQSwabs

HPV self-sampling

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current pregnancy
• Complete hysterectomy
• History of cervical cancer
• Unable to provide informed consent

Sponsors & Collaborators

• University of Washington: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (3)

SHE Clinic

Seattle, Washington, 98103, United States

Location

Madison Clinic

Seattle, Washington, 98104, United States

Location

MAX Clinic

Seattle, Washington, 98104, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Darcy Rao, PhD, MPH

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Assistant Professor: School of Public Health

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: August 18, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 7, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available within 6 months of study end date.
• Access Criteria: Investigators interested in using study data will need to contact the investigator and sign a data use agreement.

Locations

US (3)