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 urban, underserved minority 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 urban, underserved minority women and reduced sustainability in resource-
limited settings. To fill this void, we propose a tailored mHealth intervention available in both English and Spanish
targeting follow-up attendance for abnormal test feedback at 3 urban clinic sites serving predominately low-
income minority 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 barriers 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., race/ethnicity, Spanish or English language, 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.
