Cervical Cancer, Human Papillomavirus Infection
Conditions
Keywords
Screening, Human Papillomavirus Infection, Self-Testing
Brief summary
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. This study is a supplement to increase representation of Asian and Asian American women in a pragmatic clinical trial that evaluates if mailing and testing self-sampled kits for high-risk human papillomavirus (HPV) can cost-effectively increase screening participation among underserved minority women in a safety-net health system.
Detailed description
Regularly attending for Pap test cervical cancer screening in a clinic is often unfeasible and/or unacceptable to many women and persons with a cervix. Using mailed self-sampling kits to test for high-risk human papillomavirus (HPV), the virus that causes cervical cancer, may overcome multiple barriers to clinic-based screening. The parent study (NCT03898167) is a randomized controlled trial to compare the effectiveness of three outreach interventions to increase primary screening participation and clinical follow-up among underscreened women a in a safety net health system. The three strategies that will be evaluated are: 1) telephone recall; 2) telephone recall with mailed self-sample HPV testing kits; and 3) telephone recall with mailed self-sample HPV testing kits and patient navigation. A supplemental accrual of Asian/Asian American persons (target n=240) was added to increase representation of this subpopulation in the parent trial.
Interventions
BEHAVIORALTelephone Recall
Participants receive a scripted telephone recall from a trained patient navigator.
BEHAVIORALMailed HPV Self-Sampling Kit
Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.
BEHAVIORALPatient Navigation
Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.
Sponsors
National Institute on Minority Health and Health Disparities (NIMHD)
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Asian ethnicity reported in the electronic health record * no history of hysterectomy or cervical cancer * no Pap test in the past 3.5 years or Pap/HPV co-test in the past 5.5 years * patient of Harris Health System in Harris County (Houston), Texas * have at least 2 visits to ambulatory care within Harris Health System in the past 5 years * be currently enrolled in a healthcare coverage or financial assistance plan accepted by Harris Health System or have been enrolled in a Harris Health coverage plan in the past 12 months
Exclusion criteria
* no valid telephone contact information * unable to communicate in English, Vietnamese or Spanish * currently pregnant * history of cervical dysplasia in the past 3.5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary screening participation | [Time Frame: within 6 months of randomization | completion and return of a mailed self-sample HPV testing kit that is adequate for testing (i.e., does not produce unsatisfactory results) or attendance for clinic-based screening |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Screening tests results | Time Frame: within 6 months of randomization | Results of HPV test using self-collected samples (positive, negative, or inadequate) |
| completion of clinical follow-up among women with an abnormal screening test result | Time Frame: within 12 months of screening test result | Electronic medical record (EMR)-confirmed attendance for colposcopy among participants who had a positive test by clinic-based screening; EMR- confirmed attendance for colposcopy or subsequent clinic-based screening among those who had a positive test by self-sampling |
Other
| Measure | Time frame | Description |
|---|---|---|
| Detection of cervical precancer | [Time Frame: within 12 months of screening test result] | Histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) |
| Treatment of cervical precancer | [Time Frame: within 6 months of diagnosis] | Treatment of histologically-confirmed cervical intraepithelial neoplasia grade II or greater (CIN2+) per American Society for Colposcopy and Cervical Pathology guidelines |
Countries
United States
Outcome results
None listed