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

NCT05524480 | Enrolling By Invitation

• 1 other identifier: HSC-SPH-20-1117
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer Prevention

Keywords

Implementation Intervention; Cervical Cancer; Breast Cancer; HPV Vaccination

Outcome Measures

Primary Outcomes (21)

• 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).

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

  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).

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

  8-month follow up

• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.

  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.

  Baseline

• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.

  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.

  4-month follow-up

• Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Baseline

• Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.

  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.

  4-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.

  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.

  8-month follow-up

• The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)

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

  8-month follow-up

• The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)

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

  8-month follow-up

• The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)

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

  8-month follow-up

• The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)

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

  8-month follow-up

• Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.

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

  4-month follow-up

• Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.

  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.

  8-month follow-up

• Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).

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

  4-month follow up

• Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).

  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).

  4-month follow up

• Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).

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

  8-month follow up

• Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).

  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).

  8-month follow up

Secondary Outcomes (1)

• Cost effectiveness of SEMM-DIA in community and clinic practice settings

  8-month follow up

Study Arms (2)

Salud en Mis Manos - Dissemination and Implementation Assistance

EXPERIMENTAL

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

Behavioral: Salud en Mis Manos - Dissemination and Implementation Assistance

Salud en Mis Manos - Usual Implementation Practice

ACTIVE COMPARATOR

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

Behavioral: Salud en Mis Manos- Usual Implementation Practice

Interventions

Salud en Mis Manos - Dissemination and Implementation Assistance BEHAVIORAL

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).

Also known as: SEMM-DIA

Salud en Mis Manos - Dissemination and Implementation Assistance

Salud en Mis Manos- Usual Implementation Practice BEHAVIORAL

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.

Also known as: SEMM

Salud en Mis Manos - Usual Implementation Practice

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• \- Clinics/Community Health Centers not located in Texas.
• \- Latinas with a prior or current cancer diagnosis due to modified cancer screening surveillance guidelines for cancer survivors.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lara Savas, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Maria E Fernandez, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: September 1, 2022
• Study Start: October 2, 2024
• Primary Completion: June 1, 2025
• Study Completion: September 30, 2025
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)