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

The University of Texas System (UT)

Status: Invitation-only

Conditions: Cancer Prevention

Treatments: Behavioral: Salud en Mis Manos - Dissemination and Implementation Assistance; Behavioral: Salud en Mis Manos- Usual Implementation Practice

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05524480

HSC-SPH-20-1117

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,000 estimated patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,000 participants in 2 patient groups

Salud en Mis Manos - Dissemination and Implementation Assistance

Experimental group

Description:

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

Treatment:

Behavioral: Salud en Mis Manos - Dissemination and Implementation Assistance

Salud en Mis Manos - Usual Implementation Practice

Active Comparator group

Description:

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

Treatment:

Behavioral: Salud en Mis Manos- Usual Implementation Practice