Clinical trial NCT05524480: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cancer Prevention
Keywords: Implementation Intervention
Cervical Cancer
Breast Cancer
HPV Vaccination
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2022-09-01
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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).

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.

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.

Primary outcomes:
measure: 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).
timeFrame: 4-month follow up
measure: 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).
timeFrame: 8-month follow up
measure: Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
timeFrame: Baseline
measure: Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
timeFrame: 4-month follow-up
measure: Effectiveness (for screening) as measured by the percentage of women who complete mammogram screening among all eligible patients.
timeFrame: 8-month follow-up
measure: Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
timeFrame: Baseline
measure: Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
timeFrame: 4-month follow-up
measure: Effectiveness (for screening) as measured by the percentage of women who complete cervical cancer screening (Pap or HPV screening test) among all eligible patients.
timeFrame: 8-month follow-up
measure: Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
timeFrame: Baseline
measure: Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
timeFrame: 4-month follow-up
measure: Effectiveness (for HPV vaccination) as measured by the percentage of female patients who initiate or complete an HPV vaccination among all eligible patients.
timeFrame: 8-month follow-up
measure: The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (1)
timeFrame: 8-month follow-up
measure: The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (2)
timeFrame: 8-month follow-up
measure: The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (3)
timeFrame: 8-month follow-up
measure: The level of Implementation will be assessed the extent to which SEMM has been carried out per clinic. (4)
timeFrame: 8-month follow-up
measure: Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
timeFrame: 4-month follow-up
measure: Implementation (fidelity) as measured by the degree to which SEMM program components are implemented by LHWs as prescribed.
timeFrame: 8-month follow-up
measure: Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
timeFrame: 4-month follow up
measure: Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
timeFrame: 4-month follow up
measure: Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (time spent in education sessions).
timeFrame: 8-month follow up
measure: Implementation dose is described as the average dose of SEMM received by participants/delivered by LHWs (# of navigation calls).
timeFrame: 8-month follow up
Secondary outcomes:
measure: Cost effectiveness of SEMM-DIA in community and clinic practice settings
timeFrame: 8-month follow up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Lara Savas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas Health Science Center, Houston
name: Maria E Fernandez, PhD
role: PRINCIPAL_INVESTIGATOR
References: