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Prospective Evaluation of Self-Testing to Increase Screening

NCT03898167 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2474

Last updated 2025-09-04

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Telephone Recall

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

BEHAVIORAL

Mailed HPV Self-Sampling Kit

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.

BEHAVIORAL

Patient Navigation

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.

Sponsors & Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

    collaborator NIH

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Jane R Montealegre, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-02-13
Primary Completion
2024-03-01
Completion
2025-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898167 on ClinicalTrials.gov