Prospective Evaluation of Self-Testing to Increase Screening (PRESTIS)

Baylor College of Medicine

Status: Completed

Conditions: Human Papillomavirus Infection; Cervical Cancer

Treatments: Behavioral: Mailed HPV Self-Sampling Kit; Behavioral: Telephone Recall; Behavioral: Patient Navigation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03898167

R01MD013715 (U.S. NIH Grant/Contract)

R01MD013715-04S2 (U.S. NIH Grant/Contract)

H-44944

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,474 patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,474 participants in 3 patient groups

Telephone Recall

Active Comparator group

Description:

Participants receive a scripted telephone recall from a trained patient navigator on behalf of Harris Health System.

Treatment:

Behavioral: Telephone Recall

Mailed HPV Self-Sampling Kit

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone Recall

Behavioral: Mailed HPV Self-Sampling Kit

Mailed HPV Self-Sampling Kit + Patient Navigation

Experimental group

Description:

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.

Treatment:

Behavioral: Patient Navigation

Behavioral: Telephone Recall

Behavioral: Mailed HPV Self-Sampling Kit