A Randomized Controlled Trial of Mailed Self-Sample HPV Testing to Increase Cervical Cancer Screening Participation Among Minority/Underserved Women in an Integrated Safety Net Healthcare System Asian/Asian American Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Baylor College of Medicine
- Enrollment
- 111
- Locations
- 1
- Primary Endpoint
- Primary screening participation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
Telephone Recall
Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System
Intervention: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit
Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope
Intervention: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit
Participants receive a scripted telephone recall from a patient navigator on behalf of Harris Health System and receive a mailed HPV self-sampling kit with a prepaid return envelope
Intervention: Mailed HPV Self-Sampling Kit (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
Intervention: Telephone Recall (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
Intervention: Mailed HPV Self-Sampling Kit (Behavioral)
Mailed HPV Self-Sampling Kit + Patient Navigation
Participants receive a scripted telephone recall and mailed self-sampling kit with a pre-paid return envelope. Within 3-5 days of the kit's mail-out, participants will receive a telephone call from a patient navigator to provide one-on-one education.
Intervention: Patient Navigation (Behavioral)
Outcomes
Primary Outcomes
Primary screening participation
Time Frame: [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 Outcomes
- Screening tests results(Time Frame: within 6 months of randomization)
- completion of clinical follow-up among women with an abnormal screening test result(Time Frame: within 12 months of screening test result)
Investigators
Jane Montealegre
Associate Professor
M.D. Anderson Cancer Center