Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention

Trial Title: Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention

NCT ID: NCT05524480

Condition: Cancer Prevention

Conditions: Official terms:
Uterine Cervical Neoplasms

Conditions: Keywords:
Implementation Intervention
Cervical Cancer
Breast Cancer
HPV Vaccination

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Twenty community health centers (CHCs) will be recruited and randomized to either the SEMM-Dissemination and Implementation Assistance arm or the SEMM-Usual Implementation Practice arm.

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Salud en Mis Manos - Dissemination and Implementation Assistance
Description: The experimental arm will utilize the multi-component and multifaceted implementation strategy, SEMM-DIA. This includes elements like 1) A program orientation session (virtual or in-person), 2) Technical Assistance for implementers, such as SEMM Program Manager/ Coordinator and LHWs, 3) SEMM program materials (including LHW Training curriculum, in-reach/ outreach materials, patient tracking forms), and 4) Virtual community support (Project ECHO series).
Arm group label: Salud en Mis Manos - Dissemination and Implementation Assistance

Other name: SEMM-DIA

Intervention type: Behavioral
Intervention name: Salud en Mis Manos- Usual Implementation Practice
Description: The control arm will undertake SEMM- Usual Implementation Practice, which includes utilizing all existing SEMM program materials (MOPs, LHW Training Curriculum, etc.) which will be shared with clinic staff in PDF form.
Arm group label: Salud en Mis Manos - Usual Implementation Practice

Other name: SEMM

Summary: The proposed study will develop and test an implementation strategy called Salud en Mis Manos-Dissemination and Implementation Assistance (SEMM-DIA) which is an internet-accessible cross-platform that includes additional implementation support strategies to increase the reach, effectiveness, and implementation of an evidence-based breast and cervical cancer screening and HPV vaccination program for Latinas (SEMM).

Detailed description: This study tests a multicomponent and multifaceted implementation strategy, SEMM-DIA and serves as a model for developing other implementation strategies designed to build the capacity of clinic leadership, intervention champions, and LHWs to plan, manage, and deliver SEMM. Investigators will examine the effect of SEMM-DIA program implementation in a randomized group trial comparing the impact of SEMM-DIA vs. SEMM- Usual Implementation Practice on the reach, effectiveness, implementation, and cost-effectiveness of SEMM in safety-net clinics.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Organization inclusion criteria: - Clinic or community health center (CHC) with LHWs serving Latina populations. - Expressed intent to participate in the implementation of SEMM. - Serve low-income populations with low or no-cost screening and vaccination. - Provide comprehensive primary health care services. SEMM Participant Inclusion criteria: - Latinas who self-identify as Hispanic/Latina. - Latinas who have at least one unmet breast or cervical cancer prevention need, following Electronic Clinical Quality Measures. - (1) Latinas aged 21-64 years who have not had a Pap test in the past 3 years, and (2) Latinas aged 30-64 who have not had a HPV test in the past 5 years (CMS eCQM ID: CMS124v9). - (3) Latinas aged 51-74 years who have not had a mammogram in the past 2 years (CMS eCQM ID: CMS125v9). - (4) Latinas aged 18-26 years who have not initiated HPV vaccination. - Note: Some women will have more than one unmet need (e.g., HPV vaccination and pap test), so they will be included in more than one non-adherent group. Exclusion Criteria: Organization exclusion criteria: - Clinics/Community Health Centers not located in Texas. SEMM Participant Exclusion criteria: - Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.

Gender: Female

Minimum age: 18 Years

Maximum age: 74 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: The University of Texas Health Science Center at Houston

Address:
City: Houston
Zip: 77030
Country: United States

Contact:
Last name: Lara Savas, PhD

Phone: 713-500-9638
Email: lara.staub@uth.tmc.edu

Contact backup:
Last name: Angelita Alaniz, MPH
Email: angelita.alaniz@uth.tmc.edu

Investigator:
Last name: Maria E Fernandez, PhD
Email: Principal Investigator

Start date: February 2, 2024

Completion date: September 30, 2024

Lead sponsor:
Agency: The University of Texas Health Science Center, Houston
Agency class: Other

Collaborator:
Agency: Centers for Disease Control and Prevention
Agency class: U.S. Fed

Source: The University of Texas Health Science Center, Houston

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05524480