Prospective Evaluation of Self-Testing to Increase Screening

Not Applicable

Completed

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Primary Screening Participation	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 Outcome Measures

Name	Time	Method
Screening Tests Results	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	Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.	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