Empowering Latinas to Obtain Guideline Concordant Screenings

The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat Brease Cancer (BC) screening.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Screening
• Intervention / Treatment: Other: Educate; Other: Empower

Detailed Description

To further test the added benefits of the empower approach relative to traditional educate approaches. Past community research among Latinas has primarily focused on one-time BC screening among intervention participants. The design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent Latinas may "boost" intervention effects throughout their networks.

The investigator's goal is to further test the added benefits of the empower approach relative to traditional educate approaches. Past community research among Latinas has primarily focused on one-time BC screening among intervention participants. The investigator's novel design builds on past studies by integrating social network analysis (SNA) and implementation science (IS) into a longitudinal randomized clinical trial (RCT). The investigator will compare the long-term effects of interventions by examining guideline-concordant initial and repeat BC screening. The investigator will estimate the widespread effects of interventions by prospectively collecting data from network members not involved in the RCT. The investigator will also explore "active ingredients" that underlie intervention effects, including psychosocial, IS and network mechanisms. Overall, the investigator will demonstrate whether and how non-adherent Latinas may "boost" intervention effects throughout their networks.

Aim 1: Among 400 non-adherent Latinas, the investigator will compare intervention effects on BC screening, using an individual RCT in a federally qualified health center (FQHC). The investigator will use the US Preventative Services Task Force (USPSTF) guidelines - i.e., 50-74 year-olds should obtain mammograms every 2 years.

Aim 2: Among 200 network members of non-adherent Latinas, the investigator will compare intervention effects on BC screening, based on the USPSTF guidelines.

Aim 3: The investigator will explore mechanisms of change underlying intervention effects on BC screening using IS measures, descriptive SNA, and structural equation models. If study arms are comparable, the investigator will examine which mechanisms may predict multilevel intervention effects across approaches.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yamile Molina, PhD; Phone Number: 312-355-2679; Email: ymolin2@uic.edu
• Study Contact Backup: Name: Jocelyn Perez; Phone Number: 312-996-6337; Email: jocelynp@uic.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • University of Illinois Health
      • Contact: Jocelyn Perez; Phone Number: 312-996-6337; Email: jocelynp@uic.edu
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Mile Square Health Center
      • Contact: Jocelyn Perez; Phone Number: 312-996-6337; Email: jocelynp@uic.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

Aim 1. (1) female biological sex; (2) identification as Latinas; (3) non-adherence to USPSTF guidelines (52-74 years old, no mammogram in past 2 years, no previous BC diagnosis); (4) no previous history of health volunteerism; and (5) not a network member enrolled in Aim 2.

Aim 2. (1) female biological sex; (2) eligibility to obtain BC screenings by USPSTF guidelines (i.e., 50-74 years old, no personal BC history); (3) referral from non-adherent Latinas; (4) no previous history of health volunteerism; and (5) no participation in the RCT (not an Aim 1 participant, no Session #3 attendance).

Exclusion Criteria:

Aim 1: (1) Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Aim 2: (1) Not meeting at least one of the aforementioned Aim 1 inclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Educate (Education + Navigation) Sessions; Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening, Community Health Workers (CHW) testimonials, empirical data, individual action plans for BC screening Session 2 &3 Health knowledge (diet and physical activity guidelines), barriers and preferred solutions to dietary and physical activity change, CHW testimonials, empirical data, individual action plans for diet	Other: Educate; Education sessions
Other: Empower (Empowerment + Navigation) Sessions; Session 1 BC knowledge, BC disparities, USPSTF guidelines, barriers and preferred solutions to BC screening CHW testimonials, Empirical data, Individual action plans for BC screening Sessions 2 & 3 BC screening as leading by example, BC promotion strategies that reflect personal and network members' preferences, opportunities to volunteer/be a part of tight-knit initiatives, partnerships with navigators/CHWs to serve as "bridges" for network members CHW testimonials , resource guides for BC promotion, individual action plans for promoting BC, role playing activities (session 2) Participant testimonials, participant relays empirical data, group discussion and plans for promoting BC (session 3)	Other: Empower; Empowerment sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-adherent Latinas in the empowerment arm are more likely to obtain initial and repeat BC screening than non-adherent Latinas in the education arem	Compare the number of participants in the non-adherent Latina empowerment arm that obtain guideline-concordant initial and repeat BC screening with the the number of non-adherent Latinas in the education arm	4 years
Network members in the empowerment arm will be more likely to obtain guideline-concordant initial and repeat BC screening than network members in the educate arm	Compare the number of network members in the empowerment arm that obtain guideline-concordant initial and repeat BC screening with the number of non-adherent network members in the education arm	4 years
Non-adherent Latinas greater BC knowledge and stronger motivation to be a role model will mediate the greater BC screening rates among non-adherent Latinas in the empower arm relative to the educate arm	Compare the number of non-adherent Latinas greater BC knowledge and stronger motivation to be a role model and medicate greater BC screening rates in the empowerment arm than the non-adherent Latinas in the education arm	4 years
Non-adherent Latinas' greater capacity to promote BC will mediate the greater BC screening rates among network members in the empower arm relative to the educate arm	Compare the number of non-adherent Latinas greater capacity to promote BC and medicate greater BC screening rates among network members in the empowerment arm than the non-adherent Latinas in the education arm	4 years

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: April 23, 2023
• First Submitted That Met QC Criteria: April 23, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2022-0531

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No