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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05524480
Status
Enrolling By Invitation

Conditions

  • Cancer Prevention

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 74 Years
Healthy Volunteers
Accepted

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).
  • 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.

Study Details

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).

Key Dates

Start date
Oct 2, 2024
Status verified
Dec 2024
Primary completion
Jun 1, 2025
Completion
Sep 30, 2025

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Salud en Mis Manos - Dissemination and Implementation Assistance
    The multi-component and multi-faceted implementation strategy SEMM-DIA
  • Active Comparator: Salud en Mis Manos - Usual Implementation Practice
    The SEMM-Usual Implementation Practice arm includes all existing SEMM program materials.

Primary Outcome 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). [ Time Frame: 4-month follow up ]

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030-

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