NCT05524480

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

Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,000 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cancer Prevention

Interventions

Type	Name	Description
BEHAVIORAL	Salud en Mis Manos - Dissemination and Implementation Assistance	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).
BEHAVIORAL	Salud en Mis Manos- Usual Implementation Practice	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.

Timeline

• Start date: 2024-10-02
• Primary completion: 2025-06-01
• Completion: 2025-09-30
• First posted: 2022-09-01
• Last updated: 2024-12-12

Locations

1 site across 1 country: United States