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A Tailored mHealth Intervention to Enhance Colposcopy Attendance in Patients at Risk for Cervical Cancer
Trial Status: active
This clinical trial tests how well a new mobile health (mHealth) text messaging program, Health Enhancement Resource System (HERS), works in disadvantaged patients at risk for cervical cancer. Cervical cancer is a slow-growing cancer that may not have symptoms but can be found with regular pap tests (a procedure in which cells are scraped from the cervix and looked at under a microscope). However, there is a large and unequal treatment gap among urban, underserved women. These women persistently have lower rates of attendance at follow-up appointments for abnormal test results, along with persistently greater rates of invasive cervical cancer incidence and mortality. Using HERS may help low-income women at risk for cervical cancer to attend follow-up appointments after an abnormal cervical test result, which may help them better understand how prevention and treatment can help them stay healthy by making it easier for them to keep their appointments.
Inclusion Criteria
18 to 90 years of age (screening is still recommended for some women over 65—depending on screening and medical history and proceeds until age 90 in the study’s clinic recruitment sites)
Referral for colposcopic evaluation at the clinic sites
Able to communicate with ease in English or Spanish
Have a cell phone with texting ability
Competent to give consent
Healthcare team providers and clinic staff are eligible for qualitative interviews if they are a physician, nurse, or staff member that provides or supports colposcopy services to patients, or if they are an attending or other staff member in a practice who provide referrals to the colposcopy clinics
Exclusion Criteria
Are pregnant at the time of recruitment
Display current evidence or have a history of positive invasive carcinoma of the cervix
Require follow-up but not a colposcopy. Specifically, women will be excluded if they require follow-up (e.g., repeat
pap test in 1 year) but not colposcopy as the intervention targets those at greatest risk for cervical cancer; 40% of patients in our clinics requiring follow-up are recommended to receive colposcopy
Additional locations may be listed on ClinicalTrials.gov for NCT06416150.
I. Evaluate the effectiveness of the Health Enhancement Resource System (HERS) intervention.
II. Qualitatively assess the contextual factors (patient factors, healthcare team resources, and organizational factors) affecting HERS implementation outcomes and potential for scalability and sustainability.
III. Explore patient-level moderators of the relationship between the HERS intervention and attendance at the baseline colposcopy appointment.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients receive high standard care consisting of a telephone call approximately one month before the
appointment to confirm the appointment date for the baseline colposcopy appointment, followed by a notification letter including scheduled appointment date and clinic contact information should the clinic be unable to reach the patient by telephone. Patients will receive another telephone call before their 12-month follow-up appointments to remind patients about their upcoming appointment and schedule/reschedule if needed.
ARM II: Patients receive HERS text messages appointment reminders before their baseline colposcopy appointment, as well as their 12-month follow-up appointments and patient identified colposcopy-related barriers messages prior to the scheduled target appointment.
AIM III: Patients receive HERS text messages appointment reminders before their baseline colposcopy appointment, as well as their 12-month follow-up appointments and patient identified colposcopy-related barriers messages prior to the scheduled target appointment. Patients that miss their scheduled appointments or reschedule their appointment two or more times also receive health coaching phone calls to review the patients identified barriers and will help the patient identify resources and strategies to overcome barriers on study.
Patients who miss their scheduled baseline or 12 month appointment will have their barriers reassessed. Patients in Arm I will be assigned to Arm II. Patients in Arm II or II will be rerandomized to Arm II or Arm III.
