HPV Self-sampling to Improve Access to Cervical Cancer Screening for Persons With HIV and/or Underserved Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Flocked swab paired with Roche Cobas 4800.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: from 25 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Advancing Cervical Cancer Screening Through Self-Sampling (ACCESS): A Pilot Study of HPV Self-sampling for Cervical Cancer Prevention in Washington State
Overview
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.
Interventions
- 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.
Primary outcome measures
- Proportion of eligible individuals who accept self-sampling kits [Time frame: Baseline (during clinical and/or study recruitment encounter)]
- Proportion of eligible individuals who submit self-sampled specimens [Time frame: 3 weeks from enrollment]
- Satisfaction with self-collection [Time frame: Within 2 weeks of sample collection]
- Confidence with self-collection [Time frame: Within 2 weeks of sample collection]
- Recommendation of self-collection [Time frame: Within 2 weeks of sample collection]
- Ease of returning home kits [Time frame: Within 2 weeks of sample collection]
Secondary outcome measures (9)
- Proportion of eligible individuals who return samples with adequate specimens [Time frame: 3 weeks from enrollment]
- Knowledge about HPV and cervical cancer screening [Time frame: Baseline]
- Perceived risk of cervical cancer [Time frame: Baseline]
- Attitudes and preferences for screening [Time frame: Baseline]
- HPV prevalence checklist [Time frame: Baseline]
- Receipt of follow-up care [Time frame: Up to 6 months after self-sampling]
- Reflex cytology results checklist [Time frame: Up to 6 months after self-sampling]
- Colposcopy results checklist [Time frame: Up to 6 months after self-sampling]
- Provider and/or clinic barriers and facilitators to cervical cancer screening survey [Time frame: During study year 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 3 centers
- SHE Clinic — Seattle
- Madison Clinic — Seattle
- MAX Clinic — Seattle
Identifiers
NCT: NCT05528237 · STUDY00014442 · 5KL2TR002317-05