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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cervical Cancer
- Sponsor
- Baylor College of Medicine
- Enrollment
- 2474
- Locations
- 1
- Primary Endpoint
- Primary Screening Participation
- Status
- Completed
- Last Updated
- 8 months ago
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.
Investigators
Jane Montealegre
Associate Professor
M.D. Anderson Cancer Center
Eligibility Criteria
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
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.)