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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Reach is measured by the proportion of women who participate in SEMM education sessions among those that are eligible in the clinic (among all eligible patients) & in the community (the number of participants that receive SEMM education). [Time frame: 4-month follow up]
• Reach is measured by the proportion of women who participate in SEMM education sessions among those that are eligible in the clinic (among all eligible patients) & in the community (the number of participants that receive SEMM education). [Time frame: 8-month follow up]
• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients. [Time frame: Baseline]
• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients. [Time frame: 4-month follow-up]
• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients. [Time frame: 8-month follow-up]
• Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients. [Time frame: Baseline]
• Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients. [Time frame: 4-month follow-up]
• Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients. [Time frame: 8-month follow-up]
• Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients. [Time frame: Baseline]
• Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients. [Time frame: 4-month follow-up]

Secondary outcome measures (1)

• Cost effectiveness of SEMM-DIA in community and clinic practice settings [Time frame: 8-month follow up]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT05524480 · HSC-SPH-20-1117

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗