Empowering Latinas to Obtain Guideline Concordant Screenings

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Empowering Latinas to Obtain Guideline Concordant Screenings

Conditions
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Breast Cancer Screening

Intervention / Treatment
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* Other: Educate
* Other: Empower


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare intervention effects on BC screening among 400 non-adherent Latinas in a 1:1 empower/educate ratio (n=200 per group)
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Educate (Education + Navigation) Sessions<br>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<br>* Education sessions<br>|
| Other: Empower (Empowerment + Navigation) Sessions<br>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<br>* Empowerment sessions<br>|

What is the study measuring?
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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 |