CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,474 enrolled
Drug / intervention
Telephone Recall +2 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03898167
NCT03898167N/ACompleted

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

Baylor College of Medicine·interventional·Posted Apr 1, 2019·Updated Sep 4, 2025

In Brief

A clinical study evaluating Telephone Recall, Mailed HPV Self-Sampling Kit, and 1 other intervention for Cervical Cancer and Human Papillomavirus Infection. Completed, enrolled 2,474 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedApr 1, 2019
Enrollment StartFeb 13, 2020
Primary CompletionMar 1, 2024
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.3 years ago

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.