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NCT05524480

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

Enrolling by Invitation
NAAges 18–74InterventionalPrevention
The University of Texas Health Science Center, Houston
~2,000 participants
Updated 2024-12-12 on ClinicalTrials.gov
What's tested:Salud en Mis Manos - Dissemination and Implementation AssistanceSalud en Mis Manos- Usual Implementation Practice

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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).
Measured over 4-month follow up
+20 more outcomes measured

Conditions

Cancer Prevention

Explore related trials

Breast CarcinomaCervical CarcinomaHuman Papillomavirus Infection

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Lara Savas, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
  • Maria E Fernandez, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial 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).4-month follow up

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

  • 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).8-month follow up

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

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

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

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

  • Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.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.

  • Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.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.

  • Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.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.

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

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

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

  • The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)8-month follow-up

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

  • The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)8-month follow-up

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

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

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

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

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

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

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

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

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