Actively Recruiting
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
Eligibility Criteria
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
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
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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
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
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