Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

The multi-component and multi-faceted implementation strategy SEMM-DIA

The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.

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).

Salud en Mis Manos - Dissemination and Implementation Assistance

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.

Salud en Mis Manos- Usual Implementation Practice

Lara Savas, PhD

Angelita Alaniz, MPH

Maria E Fernandez, PhD

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).

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.

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.

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

Reach will assess several factors: Among eligible women, what number participate in SEMM education sessions?

Investigators will assess mammogram completion outcomes using EHR data collection. All participants identified as eligible for a mammogram between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.

Investigators will assess Pap completion outcomes using EHR data collection. All participants identified as eligible for a Pap or HPV screening test between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.

Investigators will assess HPV vaccination initiation or completion outcomes using EHR data collection. All participants identified as eligible for an HPV vaccination between program implementation start and end (regardless if identified via in-reach or outreach) will serve as the denominator.

Investigators will assess the level of implementation from baseline to 8-month follow-up using manager assessments.

Investigators will assess the level of implementation from baseline to 8-month follow-up using LHW assessments.

Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with LHWs.

Investigators will assess the level of implementation from baseline to 8-month follow-up using in-depth end-of-study interviews with managers.

Investigators will assess implementation fidelity using participant tracking forms (completed by LHWs) to understand their level of fidelity associated with implementing the program.

Investigators will assess implementation fidelity using end-of-study in-depth interviews with LHWs to understand their level of fidelity associated with implementing the program.

Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record time spent in education sessions.

Investigators will assess implementation dose using SEMM participant tracking forms collected for SEMM participants, which record # of navigation calls needed to overcome barriers to complete needed services (mammogram, Pap/HPV test, and HPV vaccination).

The purpose of the economic analysis is to produce information on the cost-effectiveness of SEMM-DIA in community and clinic practice settings. Investigators will determine the current market value of all ingredients associated with the planning and implementation of the dissemination interventions (from study start to 8-month follow-up), including training and other costs of adapting the intervention to specific sites.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention	NCT05524480	Cancer Preventi...	Salud en Mis Ma... Salud en Mis Ma...	18 Years - 74 Years	The University of Texas Health Science Center, Houston
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention	NCT05524480	Cancer Preventi...	Salud en Mis Ma... Salud en Mis Ma...	18 Years - 74 Years	The University of Texas Health Science Center, Houston

Spots Global Cancer Trial Database for implementation intervention