Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
FEMALE
Healthy Volunteers
ID06416150

Reducing Urban Cervical Cancer Disparities Using a Tailored Mobile Health Intervention to Improve Colposcopy Attendance in Underserved Women

Led by Fox Chase Cancer Center · Updated on 2024-10-26

546

Participants Needed

3

Research Sites

170 weeks

Total Duration

On this page

Sponsors

F

Fox Chase Cancer Center

Lead Sponsor

R

Rutgers, The State University of New Jersey

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the Health Enhancement Resource System (HERS), a mobile health intervention designed to improve follow-up attendance after abnormal cervical cancer screening results among urban, underserved women. The study targets women referred for colposcopy after abnormal cervical tests and aims to address the persistent disparities in cervical cancer mortality by increasing attendance at follow-up appointments. This hybrid Type 1 effectiveness-implementation trial adapts a prior telephone counseling intervention to a text message-based system combined with optional health coaching. Participants are randomized to receive either Standard of Care or the HERS intervention, which includes text message appointment reminders and barrier counseling. Women who miss their appointments may receive supplemental telephone health coaching calls. The study uses a sequential, multiple assignment, randomized trial (SMART) design over multiple stages, including baseline colposcopy and a 12-month follow-up appointment, with interventions adjusted based on attendance. Text messages and coaching calls are scheduled flexibly, and participants receive barriers assessments via text or online surveys depending on their group. Participants complete surveys at baseline and one week after appointments, with barriers assessments and qualitative interviews conducted with both patients and providers. The primary outcome is attendance at the baseline colposcopy appointment within three months. The study takes place at three urban clinic sites serving predominantly low-income, minority women and includes ongoing monitoring through the 12-month follow-up and exit interviews to assess intervention impact and implementation.

CONDITIONS

Official Title

Reducing Urban Cervical Cancer Disparities

Who Can Participate

Age: 18Years - 90Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be female and between 18 and 90 years old
  • Have a referral for colposcopic evaluation at the study clinics
  • Be able to communicate easily in English
  • Have a cell phone capable of receiving text messages
  • Be competent to provide consent
Not Eligible

You will not qualify if you...

  • Be pregnant at the time of recruitment
  • Have current evidence or a history of invasive cervical cancer
  • Require follow-up care but not colposcopy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

2

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

3

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States, 19111

Actively Recruiting

Loading map...

Research Team

S

Suzanne M Miller, PhD

E

Erin K Tagai, PhD, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

13

Similar Trials

Study of 177Lu-BetaBart, an Anti-B7-H3 Antibody, for Safety ...

Castration-Resistant Prostate Cancer (CRPC)

Actively Recruiting

4 locations

Evaluation of 18F-T2 PET/CT Imaging for Detecting CAIX Posit...

Clear Cell Renal Cell Cancer (ccRCC)

Actively Recruiting

1 location

A Phase 1/2 Study of MDNA11, a Beta-only Interleukin-2, Alon...

Advanced Solid Tumor

Actively Recruiting

27 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here