Reducing Urban Cervical Cancer Disparities

Summary

This study uses a hybrid Type 1 effectiveness-implementation trial 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.

Conditions

• Cervical Cancer
• Papilloma Viral Infection

Interventions

BEHAVIORAL

Stage 1 SOC

Participants will 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.

BEHAVIORAL

Stage 1 HERS

Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.

BEHAVIORAL

Stage 2 HERS

Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.

BEHAVIORAL

Stage 2 HERS+HC

Participants will receive another barriers assessment and another round of text message barriers counseling as well as health coaching (HC) after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.

BEHAVIORAL

Stage 3 SOC

Participants will receive a telephone call before their 12-month follow-up appointments to remind participants about their upcoming appointment and schedule/reschedule if needed.

BEHAVIORAL

Stage 3 HERS

Participants will receive text message appointment reminders and barriers messages. Text messages will be sent on a prescheduled basis over the course of 2 weeks preceding the scheduled target appointment.

BEHAVIORAL

Stage 3 HERS+HC

Participants will receive text message barriers counseling as well as HC after their missed appointment. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.

BEHAVIORAL

Stage 4 HERS

Participants will receive another barriers assessment and another round of text message appointment reminders and barriers messages.

BEHAVIORAL

Stage 4 HERS+HC

Participants will receive another barriers assessment and another round of text message barriers counseling as well as HC. Participants that miss their scheduled appointment will receive a HC call within 2 business days. HC calls will be flexibly scheduled based on the preference of the patients and limited to 15 minutes or less.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey

  collaborator OTHER

• Thomas Jefferson University

  collaborator OTHER

• Temple University

  collaborator OTHER

• University of South Carolina

  collaborator OTHER

• Fox Chase Cancer Center

  lead OTHER

Principal Investigators

• Suzanne M Miller, PhD · Fox Chase Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-08-28

Primary Completion

2027-04-30

Completion

2027-12-31

Countries

• United States

Study Locations