Prospective Evaluation of Self-Testing to Increase Screening

Baylor College of Medicine2,474 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Enrollment

2,474

Conditions

Cervical Cancer Human Papillomavirus Infection

Interventions

Telephone RecallBEHAVIORAL

Participants receive a scripted telephone recall from a trained patient navigator.

Mailed HPV Self-Sampling KitBEHAVIORAL

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.

Patient NavigationBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Harris Health System

Houston, Texas, United States

Outcomes

Primary Outcomes

Primary Screening Participation

cervical cancer screening participation within 6 months, defined as return of a mailed HPV self-collection kit or attendance for clinic-based screening.

Time frame: within 6 months of randomization

Secondary Outcomes

Screening Tests Results

Results of HPV test using self-collected samples (positive, negative, or inadequate)

Time frame: within 6 months of randomization

Completion of Clinical Follow-up Among Women With an Abnormal 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

Time frame: Attendance to clinical follow up was assessed within 12 months of screening test result, up to 18 months post randomization.

Data from ClinicalTrials.gov

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