xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05987059</url>
    </required_header>
    <id_info>
      <org_study_id>MH-CIP Project IMPACT</org_study_id>
      <nct_id>NCT05987059</nct_id>
    </id_info>
    <brief_title>Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT</brief_title>
    <official_title>Involving Communities in Addressing the Maternal Health Crisis: Making an IMPACT</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Morehouse School of Medicine</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Morehouse School of Medicine</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        With support from the National Heart, Lung, and Blood Institute, The Center for Maternal&#xD;
        Health Equity at Morehouse School of Medicine is conducting a research study to test the&#xD;
        implementation of Pre-Pregnancy Counseling in community-based settings.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Severe racial disparities in pregnancy-related cardiovascular morbidity and mortality are&#xD;
        preventable and warrant timely community-engaged action. Black women are 3 times more likely&#xD;
        to die from a pregnancy-related cause, as compared to white women10 -in part, due to higher&#xD;
        rates of cardiovascular risk during pregnancy. More than 80% of pregnancy-related deaths in&#xD;
        the U.S. are preventable. Preconception counseling has been shown to improve maternal health&#xD;
        for all women, with clear benefits to address cardiovascular risk factors of obesity,&#xD;
        diabetes, hypertension. In order to have impact, evidence-based preconception counseling&#xD;
        programs must be delivered through community settings that have a mission to reach at-risk&#xD;
        populations of women. Healthy Start/community-based settings are appropriate for this, as&#xD;
        they serve an at-risk population of Black women in many locations nationally. The&#xD;
        investigators have engaged with Healthy Start and similar community-based settings in&#xD;
        Georgia, South Carolina, to identify preconception counseling interventions that are&#xD;
        evidence-based and feasible for their staff and community members. This community-engaged&#xD;
        approach identified Screening, Brief Intervention, and Referral to Treatment (SBIRT)&#xD;
        interventions as feasible and acceptable to both staff and patients. In the pilot-test of&#xD;
        their SBIRT model approach (Project IMPACT intervention), the investigators demonstrated&#xD;
        capacity to screen for pregnancy risks and provide early intervention to n = 23 at-risk&#xD;
        persons of reproductive age who wanted to get pregnant within the year. The investigators&#xD;
        will build on their pilot work to conduct a hybrid effectiveness/implementation trial (type 2&#xD;
        hybrid) with n = 10 sites serving low-income African American men and women in Georgia, NC,&#xD;
        SC, and TN. The investigators will use EPIS as an overarching framework to guide progress&#xD;
        across the four phases (exploration, preparation, implementation and sustainment). In Aim 1&#xD;
        (EPIS Preparation phase), the investigators will work with their community partners to tailor&#xD;
        the implementation strategy packages (Aim 1a) and their Project IMPACT intervention (Aim 1b)&#xD;
        to the context of 10 sites across 4 states -- this tailoring will address contextual&#xD;
        determinants of successful implementation from the Pragmatic Robust Implementation and&#xD;
        Sustainability Model (PRISM). In Aim 2 (EPIS Implementation phase), we will test an Enhanced&#xD;
        vs. Standard implementation strategy package of structured follow-up on the number of&#xD;
        pre-conception counseling visits completed and will test any structured follow-up vs. no&#xD;
        structured follow-up on readiness to change for key cardiovascular risk factors. In Aim 3&#xD;
        (EPIS Sustainment phase), the investigators will work with their community sites to&#xD;
        co-develop an implementation and sustainment guide for the most effective strategy bundle&#xD;
        from Aim 2. This work has potential to impact racial disparities in pregnancy-related&#xD;
        morbidity/mortality and to advance our collective scientific understanding of the relative&#xD;
        benefits of alternate implementation strategy packages.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2028</completion_date>
    <primary_completion_date type="Anticipated">March 2028</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>The proposed study will be a Type 2 hybrid effectiveness-implementation RCT with individual level randomization to two arms (standard and enhanced implementation strategy packages and control data captured at baseline. An expected 10 community-based organizations will participate in the study. A hybrid type 2 design is ideal because there are effectiveness studies conducted on preconception counseling conducted in clinical settings, but there is still a dearth of evidence on both effectiveness and implementation of preconception counseling in community-based settings and specifically with Black women and in Black-led organizations. The hybrid type 2 design would allow for continued evaluation of the effectiveness of the intervention and could capitalize on the implementation occurring to evaluate the impact of implementation strategies.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Implementation</measure>
      <time_frame>3.5 years</time_frame>
      <description>The number of pre-conception counseling sessions received by community members in the standard and enhanced intervention arms will be captured at 6 months. The proposed range for the primary implementation outcome will be 0-7 visits/contacts.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effectiveness</measure>
      <time_frame>3.5 years</time_frame>
      <description>1) 0-10 readiness ruler (inclusive of all 5 stages of change) for eating 4-5 fruits and vegetables/day&#xD;
  The stage of change score will be captured at baseline, 3 and 6 months. A simple 3-item survey will be texted to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the baseline control participants.&#xD;
  In addition to readiness measures, participants will complete a survey assessing social determinants of health (e.g., PRAPARE assessment measures and initial anthropometric measures).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Effectiveness</measure>
      <time_frame>3.5 years</time_frame>
      <description>2) 0-10 readiness ruler (inclusive of all 5 stages of change) for at least 150 of moderate or 75 minutes of vigorous physical activity/week&#xD;
  The stage of change score will be captured at baseline, 3 and 6 months. A simple 3-item survey will be texted to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the baseline control participants.&#xD;
  In addition to readiness measures, participants will complete a survey assessing social determinants of health (e.g., PRAPARE assessment measures and initial anthropometric measures).</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Preconception Health</condition>
    <arm_group>
      <arm_group_label>Standard Structured Follow-Up</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Mailed informational flyer(s) on prioritized cardiovascular risks</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhanced Structured Follow-Up</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>text or phone message(s) focused on the same prioritized risks + mailed informational flyer(s). These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>SBIRT Intervention</intervention_name>
      <description>Project IMPACT intervention will follow a Screening, Brief Intervention, and Referral to Treatment (SBIRT) Model. In the proposed study, staff at community sites will deliver a tailored SBIRT model for people seeking to get pregnant as our &quot;Project IMPACT intervention&quot;. SBIRT was originally developed as a public health model designed to provide universal screening, secondary prevention (detecting risky or hazardous substance use before the onset of abuse or dependence), early intervention, and treatment for people who have problematic or hazardous alcohol problems within primary care and other health care settings. Morehouse School of Medicine (MSM) has adapted this SBIRT model for people who are seeking to get pregnant to assess their risks and provide early intervention to at-risk people of reproductive age who want to get pregnant. Brief preconception counseling interventions addressing multiple behavioral risk factors have been found to be effective in prior studies.</description>
      <arm_group_label>Enhanced Structured Follow-Up</arm_group_label>
      <arm_group_label>Standard Structured Follow-Up</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Self-identify as Black/ African-American&#xD;
  &#xD;
            -  Fluent English-Speaker&#xD;
  &#xD;
            -  Not pregnant at the time of enrollment&#xD;
  &#xD;
            -  Own a phone&#xD;
  &#xD;
            -  Receive services at the community-based site&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Natalie D. Hernandez, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Associate Professor</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Latrice Rollins, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Erin S. Harris, BA</last_name>
      <phone>404-756-5736</phone>
      <email>eharris@msm.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Madison Haiman, MSW</last_name>
      <phone>623-521-0947</phone>
      <email>mdsmith@msm.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Morehouse School of Medicine</name>
        <address>
          <city>Atlanta</city>
          <state>Georgia</state>
          <zip>30310</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Costanza-Chock S. Design justice: Community-led practices to build the worlds we need. The MIT Press; 2020.</citation>
    </reference>
    <reference>
      <citation>Wallerstein N, Duran B, Oetzel JG, Minkler M. On community-based participatory research. Community-based participatory research for health: Advancing social and health equity. 2017;3:3-16.</citation>
    </reference>
    <reference>
      <citation>Aguilar-Gaxiola S, Ahmed SM, Anise A, Azzahir A, Baker KE, Cupito A, Eder M, Everette TD, Erwin K, Felzien M, Freeman E, Gibbs D, Greene-Moton E, Hernandez-Cancio S, Hwang A, Jones F, Jones G, Jones M, Khodyakov D, Michener JL, Milstein B, Oto-Kent DS, Orban M, Pusch B, Shah M, Shaw M, Tarrant J, Wallerstein N, Westfall JM, Williams A, Zaldivar R. Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Health: Organizing Committee for Assessing Meaningful Community Engagement in Health &amp; Health Care Programs &amp; Policies. NAM Perspect. 2022 Feb 14;2022:10.31478/202202c. doi: 10.31478/202202c. eCollection 2022. No abstract available.</citation>
      <PMID>35891775</PMID>
    </reference>
    <reference>
      <citation>Surgo Ventures - The US Maternal Vulnerability Index (MVI). mvi.surgoventures.org. Published 2021. Accessed February 2023. https://mvi.surgoventures.org/</citation>
    </reference>
    <reference>
      <citation>Armstrong-Mensah E, Dada D, Bowers A, Muhammad A, Nnoli C. Geographic, Health Care Access, Racial Discrimination, and Socioeconomic Determinants of Maternal Mortality in Georgia, United States. Int J MCH AIDS. 2021;10(2):278-286. doi: 10.21106/ijma.524. Epub 2021 Dec 13.</citation>
      <PMID>34938596</PMID>
    </reference>
    <reference>
      <citation>Maternal, Child, and Infant Health. Mecknc.gov. Published 2019. Accessed February 4, 2023. https://www.mecknc.gov/HealthDepartment/HealthStatistics/Pages/MaternalChildInfantHealth.aspx</citation>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05987059
  org study id: MH-CIP Project IMPACT
  nct id: NCT05987059
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  With support from the National Heart, Lung, and Blood Institute, The Center for Maternal
        Health Equity at Morehouse School of Medicine is conducting a research study to test the
        implementation of Pre-Pregnancy Counseling in community-based settings.
  Severe racial disparities in pregnancy-related cardiovascular morbidity and mortality are
        preventable and warrant timely community-engaged action. Black women are 3 times more likely
        to die from a pregnancy-related cause, as compared to white women10 -in part, due to higher
        rates of cardiovascular risk during pregnancy. More than 80% of pregnancy-related deaths in
        the U.S. are preventable. Preconception counseling has been shown to improve maternal health
        for all women, with clear benefits to address cardiovascular risk factors of obesity,
        diabetes, hypertension. In order to have impact, evidence-based preconception counseling
        programs must be delivered through community settings that have a mission to reach at-risk
        populations of women. Healthy Start/community-based settings are appropriate for this, as
        they serve an at-risk population of Black women in many locations nationally. The
        investigators have engaged with Healthy Start and similar community-based settings in
        Georgia, South Carolina, to identify preconception counseling interventions that are
        evidence-based and feasible for their staff and community members. This community-engaged
        approach identified Screening, Brief Intervention, and Referral to Treatment (SBIRT)
        interventions as feasible and acceptable to both staff and patients. In the pilot-test of
        their SBIRT model approach (Project IMPACT intervention), the investigators demonstrated
        capacity to screen for pregnancy risks and provide early intervention to n = 23 at-risk
        persons of reproductive age who wanted to get pregnant within the year. The investigators
        will build on their pilot work to conduct a hybrid effectiveness/implementation trial (type 2
        hybrid) with n = 10 sites serving low-income African American men and women in Georgia, NC,
        SC, and TN. The investigators will use EPIS as an overarching framework to guide progress
        across the four phases (exploration, preparation, implementation and sustainment). In Aim 1
        (EPIS Preparation phase), the investigators will work with their community partners to tailor
        the implementation strategy packages (Aim 1a) and their Project IMPACT intervention (Aim 1b)
        to the context of 10 sites across 4 states -- this tailoring will address contextual
        determinants of successful implementation from the Pragmatic Robust Implementation and
        Sustainability Model (PRISM). In Aim 2 (EPIS Implementation phase), we will test an Enhanced
        vs. Standard implementation strategy package of structured follow-up on the number of
        pre-conception counseling visits completed and will test any structured follow-up vs. no
        structured follow-up on readiness to change for key cardiovascular risk factors. In Aim 3
        (EPIS Sustainment phase), the investigators will work with their community sites to
        co-develop an implementation and sustainment guide for the most effective strategy bundle
        from Aim 2. This work has potential to impact racial disparities in pregnancy-related
        morbidity/mortality and to advance our collective scientific understanding of the relative
        benefits of alternate implementation strategy packages.
  allocation: Non-Randomized
  intervention model: Factorial Assignment
  intervention model description: The proposed study will be a Type 2 hybrid effectiveness-implementation RCT with individual level randomization to two arms (standard and enhanced implementation strategy packages and control data captured at baseline. An expected 10 community-based organizations will participate in the study. A hybrid type 2 design is ideal because there are effectiveness studies conducted on preconception counseling conducted in clinical settings, but there is still a dearth of evidence on both effectiveness and implementation of preconception counseling in community-based settings and specifically with Black women and in Black-led organizations. The hybrid type 2 design would allow for continued evaluation of the effectiveness of the intervention and could capitalize on the implementation occurring to evaluate the impact of implementation strategies.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Implementation
  time frame: 3.5 years
  description: The number of pre-conception counseling sessions received by community members in the standard and enhanced intervention arms will be captured at 6 months. The proposed range for the primary implementation outcome will be 0-7 visits/contacts.
  measure: Effectiveness
  time frame: 3.5 years
  description: 1) 0-10 readiness ruler (inclusive of all 5 stages of change) for eating 4-5 fruits and vegetables/day
  The stage of change score will be captured at baseline, 3 and 6 months. A simple 3-item survey will be texted to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the baseline control participants.
  In addition to readiness measures, participants will complete a survey assessing social determinants of health (e.g., PRAPARE assessment measures and initial anthropometric measures).
  measure: Effectiveness
  time frame: 3.5 years
  description: 2) 0-10 readiness ruler (inclusive of all 5 stages of change) for at least 150 of moderate or 75 minutes of vigorous physical activity/week
  The stage of change score will be captured at baseline, 3 and 6 months. A simple 3-item survey will be texted to patients at 3 and 6 months to help minimize missing data. The stage of change score will be captured for control subjects in year 1 and intervention subjects during the implementation phase. All participants from both implementation strategies will be combined into one group, and this group will be compared to the baseline control participants.
  In addition to readiness measures, participants will complete a survey assessing social determinants of health (e.g., PRAPARE assessment measures and initial anthropometric measures).
  arm group label: Standard Structured Follow-Up
  arm group type: Experimental
  description: Mailed informational flyer(s) on prioritized cardiovascular risks
  arm group label: Enhanced Structured Follow-Up
  arm group type: Experimental
  description: text or phone message(s) focused on the same prioritized risks + mailed informational flyer(s). These will be in addition to the SBIRT intervention delivered by Healthy Start and other similar community organization staff that all participants will receive.
  intervention type: Behavioral
  intervention name: SBIRT Intervention
  description: Project IMPACT intervention will follow a Screening, Brief Intervention, and Referral to Treatment (SBIRT) Model. In the proposed study, staff at community sites will deliver a tailored SBIRT model for people seeking to get pregnant as our "Project IMPACT intervention". SBIRT was originally developed as a public health model designed to provide universal screening, secondary prevention (detecting risky or hazardous substance use before the onset of abuse or dependence), early intervention, and treatment for people who have problematic or hazardous alcohol problems within primary care and other health care settings. Morehouse School of Medicine (MSM) has adapted this SBIRT model for people who are seeking to get pregnant to assess their risks and provide early intervention to at-risk people of reproductive age who want to get pregnant. Brief preconception counseling interventions addressing multiple behavioral risk factors have been found to be effective in prior studies.
  arm group label: Enhanced Structured Follow-Up
  arm group label: Standard Structured Follow-Up
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Natalie D. Hernandez, PhD
  role: Principal Investigator
  affiliation: Associate Professor
  last name: Latrice Rollins, PhD
  role: Principal Investigator
  affiliation: Assistant Professor
  last name: Erin S. Harris, BA
  phone: 404-756-5736
  email: eharris@msm.edu
  last name: Madison Haiman, MSW
  phone: 623-521-0947
  email: mdsmith@msm.edu
  facility: 
  country: United States
  citation: Costanza-Chock S. Design justice: Community-led practices to build the worlds we need. The MIT Press; 2020.
  citation: Wallerstein N, Duran B, Oetzel JG, Minkler M. On community-based participatory research. Community-based participatory research for health: Advancing social and health equity. 2017;3:3-16.
  citation: Aguilar-Gaxiola S, Ahmed SM, Anise A, Azzahir A, Baker KE, Cupito A, Eder M, Everette TD, Erwin K, Felzien M, Freeman E, Gibbs D, Greene-Moton E, Hernandez-Cancio S, Hwang A, Jones F, Jones G, Jones M, Khodyakov D, Michener JL, Milstein B, Oto-Kent DS, Orban M, Pusch B, Shah M, Shaw M, Tarrant J, Wallerstein N, Westfall JM, Williams A, Zaldivar R. Assessing Meaningful Community Engagement: A Conceptual Model to Advance Health Equity through Transformed Systems for Health: Organizing Committee for Assessing Meaningful Community Engagement in Health & Health Care Programs & Policies. NAM Perspect. 2022 Feb 14;2022:10.31478/202202c. doi: 10.31478/202202c. eCollection 2022. No abstract available.
  PMID: 35891775
  citation: Surgo Ventures - The US Maternal Vulnerability Index (MVI). mvi.surgoventures.org. Published 2021. Accessed February 2023. https://mvi.surgoventures.org/
  citation: Armstrong-Mensah E, Dada D, Bowers A, Muhammad A, Nnoli C. Geographic, Health Care Access, Racial Discrimination, and Socioeconomic Determinants of Maternal Mortality in Georgia, United States. Int J MCH AIDS. 2021;10(2):278-286. doi: 10.21106/ijma.524. Epub 2021 Dec 13.
  PMID: 34938596
  citation: Maternal, Child, and Infant Health. Mecknc.gov. Published 2019. Accessed February 4, 2023. https://www.mecknc.gov/HealthDepartment/HealthStatistics/Pages/MaternalChildInfantHealth.aspx
  responsible party type: Sponsor
  sharing ipd: No