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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Baylor College of Medicine
- Enrollment
- 2,474
- 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. This study 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. 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. This study 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.
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
- •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 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 pre-paid 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 pre-paid 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: within 6 months of randomization
cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.
Secondary Outcomes
- Screening Tests Results(within 6 months of randomization)
- Completion of Clinical Follow-up Among Women With an Abnormal Screening Test Result(Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.)
Investigators
Jane Montealegre
Associate Professor
M.D. Anderson Cancer Center