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

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Device: Flocked swab paired with Roche Cobas 4800


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV self-sampling<br>Participants will be offered self-collection kits for HPV-based cervical cancer screening. | Device: Flocked swab paired with Roche Cobas 4800<br>* 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.<br>* Other names: COPAN 552c FLOQSwabs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Self-collection, Self-sampling, Cervical cancer, HPV, HIV