Cancer PreventionNCT05524480
Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention
A study testing Salud en Mis Manos - Dissemination and Implementation Assistance and Salud en Mis Manos- Usual Implementation Practice in people with Cancer Prevention, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cancer Prevention
- What is being tested?
- Salud en Mis Manos - Dissemination and Implementation Assistance and Salud en Mis Manos- Usual Implementation Practice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2024to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics
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).
Read the 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.
- Conditions
- Cancer Prevention
- Being tested
- Salud en Mis Manos - Dissemination and Implementation Assistance, Salud en Mis Manos- Usual Implementation Practice
- Keywords
- Implementation Intervention, Cervical Cancer, Breast Cancer, HPV Vaccination
- Medical subject headings
- Uterine Cervical Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salud en Mis Manos - Dissemination and Implementation AssistanceBehavioural
Also called SEMM-DIA
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 PracticeBehavioural
Also called SEMM
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 group | Role | What they receive |
|---|---|---|
| Salud en Mis Manos - Dissemination and Implementation Assistance | Experimental | The multi-component and multi-faceted implementation strategy SEMM-DIA Receives: 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. Receives: Behavioral: Salud en Mis Manos- Usual Implementation Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 8-month follow up
Secondary outcomes (1)
Cost effectiveness of SEMM-DIA in community and clinic practice settings
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.
Measured: 8-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start2 Oct 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PreventionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Lara Savas, The University of Texas Health Science Center, Houston
- Investigators
- Lara Savas, PhD, Principal investigator, The University of Texas Health Science Center, HoustonMaria E Fernandez, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524480
- Sponsor's protocol ID
- HSC-SPH-20-1117
- Status last verified
- Dec 2024
- First submitted
- 23 Aug 2022
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating the Implementation of a Breast and Cervical Cancer Screening and HPV Vaccination Intervention for Under-served Hispanics
- ClinicalTrials.gov ID
- NCT05524480
- Acronym / sponsor ID
- HSC-SPH-20-1117
- Conditions
- Cancer Prevention
- Keywords
- Implementation Intervention, Cervical Cancer, Breast Cancer, HPV Vaccination
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Salud en Mis Manos - Dissemination and Implementation Assistance | Experimental | Behavioral: Salud en Mis Manos - Dissemination and Implementation AssistanceThe multi-component and multi-faceted implementation strategy SEMM-DIA |
| Salud en Mis Manos - Usual Implementation Practice | Active comparator | Behavioral: Salud en Mis Manos- Usual Implementation PracticeThe SEMM-Usual Implementation Practice arm includes all existing SEMM program materials. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salud en Mis Manos - Dissemination and Implementation AssistanceAlso: SEMM-DIAThe 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). | Behavioural | Salud en Mis Manos - Dissemination and Implementation Assistance |
| Salud en Mis Manos- Usual Implementation PracticeAlso: SEMMThe 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. | Behavioural | Salud en Mis Manos - Usual Implementation Practice |
Primary outcome
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?
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?
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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).
1 secondary outcome
Cost effectiveness of SEMM-DIA in community and clinic practice settings
Time frame: 8-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salud en Mis Manos - Dissemination and Implementation Assistance and Salud en Mis Manos- Usual Implementation Practice in people with Cancer Prevention, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.