Clinical trial NCT05528237: HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals
Official title: Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cervical Cancer
Keywords: Screening
Self-collection
Self-sampling
Cervical cancer
HPV
HIV
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-09-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of eligible individuals who accept self-sampling kits
timeFrame: Baseline (during clinical and/or study recruitment encounter)
measure: Proportion of eligible individuals who submit self-sampled specimens
timeFrame: 3 weeks from enrollment
measure: Satisfaction with self-collection
timeFrame: Within 2 weeks of sample collection
measure: Confidence with self-collection
timeFrame: Within 2 weeks of sample collection
measure: Recommendation of self-collection
timeFrame: Within 2 weeks of sample collection
measure: Ease of returning home kits
timeFrame: Within 2 weeks of sample collection
Secondary outcomes:
measure: Proportion of eligible individuals who return samples with adequate specimens
timeFrame: 3 weeks from enrollment
measure: Knowledge about HPV and cervical cancer screening
timeFrame: Baseline
measure: Perceived risk of cervical cancer
timeFrame: Baseline
measure: Attitudes and preferences for screening
timeFrame: Baseline
measure: HPV prevalence checklist
timeFrame: Baseline
measure: Receipt of follow-up care
timeFrame: Up to 6 months after self-sampling
measure: Reflex cytology results checklist
timeFrame: Up to 6 months after self-sampling
measure: Colposcopy results checklist
timeFrame: Up to 6 months after self-sampling
measure: Provider and/or clinic barriers and facilitators to cervical cancer screening survey
timeFrame: During study year 1
Other outcomes:
Locations:
city: Seattle
country: United States
facility: SHE Clinic
state: Washington
city: Seattle
country: United States
facility: Madison Clinic
state: Washington
city: Seattle
country: United States
facility: MAX Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Darcy Rao, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: