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

Cervical Cancer Clinical Trial

— ACCESS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05528237
• Other study ID #: STUDY00014442
• Secondary ID: 5KL2TR002317-05
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: October 7, 2022

Study information

• Verified date: August 2022
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: October 7, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Madison Clinic	Seattle	Washington
United States	MAX Clinic	Seattle	Washington
United States	SHE Clinic	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	Knowledge about HPV and cervical cancer screening	a survey to measure participant's knowledge about HPV and cervical cancer screening	Baseline
Secondary	Perceived risk of cervical cancer	a survey to measure participant's perceived risk of cervical cancer	Baseline
Secondary	Attitudes and preferences for screening	a survey to measure participant's attitudes and preferences for cervical cancer screening	Baseline
Secondary	HPV prevalence checklist	the distribution of HPV results from all individuals who return a self-sampled specimen	Baseline
Secondary	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
Secondary	Reflex cytology results checklist	the results of cytology tests following positive self-sampled HPV results	Up to 6 months after self-sampling
Secondary	Colposcopy results checklist	the results of colposcopy tests following positive self-sampled HPV results.	Up to 6 months after self-sampling
Secondary	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