Cervical Cancer
Conditions
Keywords
Screening, Self-collection, Self-sampling, Cervical cancer, HPV, HIV
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.
Interventions
DEVICEFlocked 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.
Sponsors
National Center for Advancing Translational Sciences (NCATS)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible individuals who accept self-sampling kits | Baseline (during clinical and/or study recruitment encounter) | the proportion of eligible individuals due or overdue for screening who agree to collect a vaginal sample for HPV testing. |
| Proportion of eligible individuals who submit self-sampled specimens | 3 weeks from enrollment | the proportion of individuals who agree to self-collection who return samples |
| Satisfaction with self-collection | Within 2 weeks of sample 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. |
| Confidence with self-collection | Within 2 weeks of sample 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. |
| Recommendation of self-collection | Within 2 weeks of sample 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. |
| Ease of returning home kits | Within 2 weeks of sample collection | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflex cytology results checklist | Up to 6 months after self-sampling | the results of cytology tests following positive self-sampled HPV results |
| Proportion of eligible individuals who return samples with adequate specimens | 3 weeks from enrollment | the proportion of returned samples that have valid specimens for HPV testing |
| Provider and/or clinic barriers and facilitators to cervical cancer screening survey | During study year 1 | 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. |
| Colposcopy results checklist | Up to 6 months after self-sampling | the results of colposcopy tests following positive self-sampled HPV results. |
| Knowledge about HPV and cervical cancer screening | Baseline | a survey to measure participant's knowledge about HPV and cervical cancer screening |
| Perceived risk of cervical cancer | Baseline | a survey to measure participant's perceived risk of cervical cancer |
| Attitudes and preferences for screening | Baseline | a survey to measure participant's attitudes and preferences for cervical cancer screening |
| HPV prevalence checklist | Baseline | the distribution of HPV results from all individuals who return a self-sampled specimen |
| Receipt of follow-up care | Up to 6 months after self-sampling | Among participants who screen positive for hrHPV, measure the proportion who receive indicated follow-up care (cytology and/or colposcopy) |
Countries
United States
Outcome results
None listed