Reducing Urban Cervical Cancer Disparities Using a Tailored mHealth Intervention to Enhance Colposcopy Attendance

PROJECT SUMMARY/ABSTRACT Cervical cancer is one of the most preventable cancers and when diagnosed early and appropriately treated, the likelihood of survival is close to 100%. However, nonattendance at abnormal follow-up appointments reaches 63% among Black and Hispanic women. Cervical cancer prevention and timely diagnosis requires that patients be monitored over time. Existing intervention protocols to promote attendance have significant limitations given a limited focus on Black and Hispanic patients and reduced sustainability in resource-limited settings. To fill this void, we propose a tailored mHealth intervention targeting follow-up attendance for abnormal test feedback at 3 clinic sites serving predominately Black and Hispanic women. We propose a hybrid Type 1 effectiveness-implementation trial that is theoretically-guided by the Cognitive-Social Health Information Processing model and the Exploration, Planning, Implementation and Sustainment Implementation Framework to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based counseling for women and supplemental telephone-based Health Coaching for women who miss their appointment. Using a sequential, multiple assignment, randomized trial (SMART) design and stakeholder-engaged approach our aims are to: (1) conduct a randomized control trial (RCT) using the SMART design to evaluate the efficacy of HERS; (2) qualitatively assess the contextual factors (patient factors, healthcare team resources, and organizational factors) affecting HERS implementation outcomes and potential for scalability and sustainability; and (3) explore patient-level moderators of the relationship between the HERS intervention and attendance at the colposcopy appointment. Women (N=546) scheduled for initial or repeat colposcopy following an abnormal test result will be recruited and randomized to one of 2 conditions (HERS text messages or Standard of Care) and, through the SMART design, will remain in their assigned group or re-randomized to HERS or HERS + Health Coaching, depending on initial appointment attendance. The primary outcome is attendance at the baseline colposcopy and the secondary outcome is long-term follow-up at 12-months. Additional research questions will evaluate the best initial intervention (e.g., Standard of Care or HERS) for increasing attendance at the baseline and 12-month follow-up appointments. In-depth interviews with healthcare stakeholders and exit interviews with patients will assess the impact of team and healthcare system context on the HERS implementation. Finally, exploratory analyses seek to identify moderators of intervention effect (e.g., demographic characteristics, health literacy) at baseline and 12-month follow-up appointments to evaluate which patients should receive the HERS intervention as a first-line intervention rather than Standard of Care.