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Enrolling by Invitation

NCT Number: NCT05524480

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

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).

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Key information

Conditions

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

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: SEMM-DIA

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.

Other names: SEMM

Primary outcomes

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

  2. 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

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

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

    Time frame: Baseline

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

    Time frame: 4-month follow-up

    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.

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

    Time frame: 8-month follow-up

    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.

  6. 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

    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.

  7. 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

    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. 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

    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.

  9. 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

    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.

  10. 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

    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.

  11. 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: 8-month follow-up

    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.

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

    Time frame: 8-month follow-up

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

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

    Time frame: 8-month follow-up

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

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

    Time frame: 8-month follow-up

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

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

    Time frame: 8-month follow-up

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

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

    Time frame: 4-month follow-up

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

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

    Time frame: 8-month follow-up

    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.

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

    Time frame: 4-month follow up

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

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

    Time frame: 4-month follow up

    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).

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

    Time frame: 8-month follow up

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

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

    Time frame: 8-month follow up

    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).

Secondary outcomes

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

    Time frame: 8-month follow up

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2022
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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