<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/NCT04489667</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300005613</org_study_id>
    <secondary_id>1R01MH124633-01</secondary_id>
    <nct_id>NCT04489667</nct_id>
  </id_info>
  <brief_title>HIV + Service Delivery and Telemedicine Through Effective PROs</brief_title>
  <acronym>HIV+STEP</acronym>
  <official_title>HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</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>
      This study will examine the impact of using a multicomponent intervention (patient reported&#xD;
      outcomes, training, and telemedicine) to assist with the management of Mental Health (MH) and&#xD;
      Substance Use Disorders (SUD) among people living with HIV (PLWH) engaged in care at UAB HIV&#xD;
      Clinic, University of Alabama Family Clinic (Birmingham, AL), Thrive Federally Qualified&#xD;
      Health Services Center (Huntsville), Health Services Center (Anniston), and Medical Advocacy&#xD;
      and Outreach (Montgomery). The study will employ a hybrid type 2 implementation design.&#xD;
      Because this intervention will be employed as the new standard of care at participating&#xD;
      sites, all PLWH receiving care at the sites will receive this intervention. Patient-reported&#xD;
      outcomes (PROs) will be integrated into routine care to screen PLWH for substance use and&#xD;
      mental health disorders during routine clinical encounters. Training will be delivered to&#xD;
      frontline clinicians so that they receive targeted knowledge on best practices for treatment&#xD;
      of MH and SUD along with clinic-specific protocols for response to PROs on MH and SUD&#xD;
      including treatment and referrals. Telemedicine services for MH and SUD will be offered to&#xD;
      patients in need of expanded access to services due to a lack of clinic-level resources or&#xD;
      additional barriers to traditional clinic visits such transportation, stigma, or substance&#xD;
      using behaviors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Not considered a clinical trial&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 19, 2021</start_date>
  <completion_date type="Anticipated">January 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2026</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of patients completing PROs</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will quantify the percentage of patients completing a PRO related to mental health or substance use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients completing PROs</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will quantify the percentage of patients completing a PRO related to mental health or substance use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients completing PROs</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will quantify the percentage of patients completing a PRO related to mental health or substance use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients completing PROs</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will quantify the percentage of patients completing a PRO related to mental health or substance use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients completing PROs</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will quantify the percentage of patients completing a PRO related to mental health or substance use</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of staff participating in training</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will use attendance logs to determine how many staff at each site complete training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of staff participating in training</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will use attendance logs to determine how many staff at each site complete training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of staff participating in training</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will use attendance logs to determine how many staff at each site complete training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of staff participating in training</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will use attendance logs to determine how many staff at each site complete training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of staff participating in training</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will use attendance logs to determine how many staff at each site complete training</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving a referral to a mental health or substance use service</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will use EMR and scheduling data to determine the number of referrals generated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving a referral to a mental health or substance use service</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will use EMR and scheduling data to determine the number of referrals generated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving a referral to a mental health or substance use service</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will use EMR and scheduling data to determine the number of referrals generated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving a referral to a mental health or substance use service</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will use EMR and scheduling data to determine the number of referrals generated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving a referral to a mental health or substance use service</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will use EMR and scheduling data to determine the number of referrals generated</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving mental health or substance use service based on attendance</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will use EMR and scheduling data to determine the number of visits attended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving mental health or substance use service based on attendance</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will use EMR and scheduling data to determine the number of visits attended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving mental health or substance use service based on attendance</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will use EMR and scheduling data to determine the number of visits attended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving mental health or substance use service based on attendance</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will use EMR and scheduling data to determine the number of visits attended</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of patients receiving mental health or substance use service based on attendance</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will use EMR and scheduling data to determine the number of visits attended</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage engaged in HIV care</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will determine the number of participants engage in HIV care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage engaged in HIV care</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will determine the number of participants engage in HIV care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage engaged in HIV care</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will determine the number of participants engage in HIV care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage engaged in HIV care</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will determine the number of participants engage in HIV care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage engaged in HIV care</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will determine the number of participants engage in HIV care</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage receiving antiretroviral therapy for HIV</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will determine the number of participants receiving HIV treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage receiving antiretroviral therapy for HIV</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will determine the number of participants receiving HIV treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage receiving antiretroviral therapy for HIV</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will determine the number of participants receiving HIV treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage receiving antiretroviral therapy for HIV</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will determine the number of participants receiving HIV treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage receiving antiretroviral therapy for HIV</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will determine the number of participants receiving HIV treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving a Viral Load Suppression</measure>
    <time_frame>Baseline through Year 1</time_frame>
    <description>We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of &lt;20 copies per milliliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving a Viral Load Suppression</measure>
    <time_frame>Year 1 through Year 2</time_frame>
    <description>We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of &lt;20 copies per milliliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving a Viral Load Suppression</measure>
    <time_frame>Year 2 through Year 3</time_frame>
    <description>We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of &lt;20 copies per milliliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving a Viral Load Suppression</measure>
    <time_frame>Year 3 through Year 4</time_frame>
    <description>We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of &lt;20 copies per milliliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Achieving a Viral Load Suppression</measure>
    <time_frame>Year 4 through Year 5</time_frame>
    <description>We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of &lt;20 copies per milliliter</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>HIV/AIDS</condition>
  <condition>Mental Health Issue</condition>
  <condition>Substance Use Disorders</condition>
  <arm_group>
    <arm_group_label>+STEP Implementation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All patients will receive +STEP as new standard of care at their clinic. This intervention will include staff training, PROs as part of routine care to screen for substance use and mental health disorders, and telemedicine for health care delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>+STEP Implementation</intervention_name>
    <description>All patients receiving care at five RWHAP-funded clinics will receive the intervention (+STEP), in which patient-reported outcomes (PROs) on mental health and substance use disorder (SUD) will be integrated into routine care, targeted training will be provided for frontline clinicians on best practices for mental health and SUD treatment, and telemedicine for mental health and SUD will be offered to patients in need of expanded access to services.</description>
    <arm_group_label>+STEP Implementation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older and receiving HIV care at one of the five participating sites&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below 18 years of age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ellen Eaton, MD, MSPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham (UAB)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Services Center</name>
      <address>
        <city>Anniston</city>
        <state>Alabama</state>
        <zip>36202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Alabama Family Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thrive Federally Qualified Health Services Center</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Advocacy and Outreach (MAO)</name>
      <address>
        <city>Montgomery</city>
        <state>Alabama</state>
        <zip>36111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unity Wellness Center</name>
      <address>
        <city>Opelika</city>
        <state>Alabama</state>
        <zip>36801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kozak MS, Mugavero MJ, Ye J, Aban I, Lawrence ST, Nevin CR, Raper JL, McCullumsmith C, Schumacher JE, Crane HM, Kitahata MM, Saag MS, Willig JH. Patient reported outcomes in routine care: advancing data capture for HIV cohort research. Clin Infect Dis. 2012 Jan 1;54(1):141-7. doi: 10.1093/cid/cir727. Epub 2011 Oct 31.</citation>
    <PMID>22042879</PMID>
  </reference>
  <reference>
    <citation>Mehrotra A, Huskamp HA, Souza J, Uscher-Pines L, Rose S, Landon BE, Jena AB, Busch AB. Rapid Growth In Mental Health Telemedicine Use Among Rural Medicare Beneficiaries, Wide Variation Across States. Health Aff (Millwood). 2017 May 1;36(5):909-917. doi: 10.1377/hlthaff.2016.1461.</citation>
    <PMID>28461359</PMID>
  </reference>
  <reference>
    <citation>Ickovics JR, Hamburger ME, Vlahov D, Schoenbaum EE, Schuman P, Boland RJ, Moore J; HIV Epidemiology Research Study Group. Mortality, CD4 cell count decline, and depressive symptoms among HIV-seropositive women: longitudinal analysis from the HIV Epidemiology Research Study. JAMA. 2001 Mar 21;285(11):1466-74. doi: 10.1001/jama.285.11.1466.</citation>
    <PMID>11255423</PMID>
  </reference>
  <reference>
    <citation>Springer SA, Dushaj A, Azar MM. The impact of DSM-IV mental disorders on adherence to combination antiretroviral therapy among adult persons living with HIV/AIDS: a systematic review. AIDS Behav. 2012 Nov;16(8):2119-43. doi: 10.1007/s10461-012-0212-3.</citation>
    <PMID>22644066</PMID>
  </reference>
  <reference>
    <citation>Sohail M, Rastegar J, Long D, Rana A, Levitan EB, Reed-Pickens H, Batey DS, Ross-Davis K, Gaddis K, Tarrant A, Parmar J, Raper JL, Mugavero MJ. Data for Care (D4C) Alabama: Clinic-Wide Risk Stratification With Enhanced Personal Contacts for Retention in HIV Care via the Alabama Quality Management Group. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3:S192-S198. doi: 10.1097/QAI.0000000000002205.</citation>
    <PMID>31764254</PMID>
  </reference>
  <reference>
    <citation>Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26.</citation>
    <PMID>22203646</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>January 27, 2022</last_update_submitted>
  <last_update_submitted_qc>January 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Ellen Eaton</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Telemedicine</keyword>
  <keyword>Patient reported outcomes</keyword>
  <keyword>Focused training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Substance-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The proposed project will comply with the NIH Data Sharing Policy, thus all data collected will be made available to outside investigators. To maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information). When possible, collaborative use of the data will be encouraged in order to enhance the quality of secondary analyses. Data will be made available as either a SPSS or Excel dataset, or as a tab-delimited ASCII file. Methods will be described through published papers, and relevant software and/or procedures documents.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>All data collected for this protocol will be made available to outside investigators in a timely fashion (defined by the NIH as no later than the acceptance of the primary outcome paper for publication)</ipd_time_frame>
    <ipd_access_criteria>Requests for data will be handled on a case-by-case basis in consultation with the Co-Investigators and members of the team.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04489667
org study id: IRB-300005613
secondary id: 1R01MH124633-01
nct id: NCT04489667
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the impact of using a multicomponent intervention (patient reported
      outcomes, training, and telemedicine) to assist with the management of Mental Health (MH) and
      Substance Use Disorders (SUD) among people living with HIV (PLWH) engaged in care at UAB HIV
      Clinic, University of Alabama Family Clinic (Birmingham, AL), Thrive Federally Qualified
      Health Services Center (Huntsville), Health Services Center (Anniston), and Medical Advocacy
      and Outreach (Montgomery). The study will employ a hybrid type 2 implementation design.
      Because this intervention will be employed as the new standard of care at participating
      sites, all PLWH receiving care at the sites will receive this intervention. Patient-reported
      outcomes (PROs) will be integrated into routine care to screen PLWH for substance use and
      mental health disorders during routine clinical encounters. Training will be delivered to
      frontline clinicians so that they receive targeted knowledge on best practices for treatment
      of MH and SUD along with clinic-specific protocols for response to PROs on MH and SUD
      including treatment and referrals. Telemedicine services for MH and SUD will be offered to
      patients in need of expanded access to services due to a lack of clinic-level resources or
      additional barriers to traditional clinic visits such transportation, stigma, or substance
      using behaviors.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Percentage of patients completing PROs
time frame: Baseline through Year 1
description: We will quantify the percentage of patients completing a PRO related to mental health or substance use
measure: Percentage of patients completing PROs
time frame: Year 1 through Year 2
description: We will quantify the percentage of patients completing a PRO related to mental health or substance use
measure: Percentage of patients completing PROs
time frame: Year 2 through Year 3
description: We will quantify the percentage of patients completing a PRO related to mental health or substance use
measure: Percentage of patients completing PROs
time frame: Year 3 through Year 4
description: We will quantify the percentage of patients completing a PRO related to mental health or substance use
measure: Percentage of patients completing PROs
time frame: Year 4 through Year 5
description: We will quantify the percentage of patients completing a PRO related to mental health or substance use
measure: Percentage of staff participating in training
time frame: Baseline through Year 1
description: We will use attendance logs to determine how many staff at each site complete training
measure: Percentage of staff participating in training
time frame: Year 1 through Year 2
description: We will use attendance logs to determine how many staff at each site complete training
measure: Percentage of staff participating in training
time frame: Year 2 through Year 3
description: We will use attendance logs to determine how many staff at each site complete training
measure: Percentage of staff participating in training
time frame: Year 3 through Year 4
description: We will use attendance logs to determine how many staff at each site complete training
measure: Percentage of staff participating in training
time frame: Year 4 through Year 5
description: We will use attendance logs to determine how many staff at each site complete training
measure: Percentage of patients receiving a referral to a mental health or substance use service
time frame: Baseline through Year 1
description: We will use EMR and scheduling data to determine the number of referrals generated
measure: Percentage of patients receiving a referral to a mental health or substance use service
time frame: Year 1 through Year 2
description: We will use EMR and scheduling data to determine the number of referrals generated
measure: Percentage of patients receiving a referral to a mental health or substance use service
time frame: Year 2 through Year 3
description: We will use EMR and scheduling data to determine the number of referrals generated
measure: Percentage of patients receiving a referral to a mental health or substance use service
time frame: Year 3 through Year 4
description: We will use EMR and scheduling data to determine the number of referrals generated
measure: Percentage of patients receiving a referral to a mental health or substance use service
time frame: Year 4 through Year 5
description: We will use EMR and scheduling data to determine the number of referrals generated
measure: Percentage of patients receiving mental health or substance use service based on attendance
time frame: Baseline through Year 1
description: We will use EMR and scheduling data to determine the number of visits attended
measure: Percentage of patients receiving mental health or substance use service based on attendance
time frame: Year 1 through Year 2
description: We will use EMR and scheduling data to determine the number of visits attended
measure: Percentage of patients receiving mental health or substance use service based on attendance
time frame: Year 2 through Year 3
description: We will use EMR and scheduling data to determine the number of visits attended
measure: Percentage of patients receiving mental health or substance use service based on attendance
time frame: Year 3 through Year 4
description: We will use EMR and scheduling data to determine the number of visits attended
measure: Percentage of patients receiving mental health or substance use service based on attendance
time frame: Year 4 through Year 5
description: We will use EMR and scheduling data to determine the number of visits attended
measure: Percentage engaged in HIV care
time frame: Baseline through Year 1
description: We will determine the number of participants engage in HIV care
measure: Percentage engaged in HIV care
time frame: Year 1 through Year 2
description: We will determine the number of participants engage in HIV care
measure: Percentage engaged in HIV care
time frame: Year 2 through Year 3
description: We will determine the number of participants engage in HIV care
measure: Percentage engaged in HIV care
time frame: Year 3 through Year 4
description: We will determine the number of participants engage in HIV care
measure: Percentage engaged in HIV care
time frame: Year 4 through Year 5
description: We will determine the number of participants engage in HIV care
measure: Percentage receiving antiretroviral therapy for HIV
time frame: Baseline through Year 1
description: We will determine the number of participants receiving HIV treatment
measure: Percentage receiving antiretroviral therapy for HIV
time frame: Year 1 through Year 2
description: We will determine the number of participants receiving HIV treatment
measure: Percentage receiving antiretroviral therapy for HIV
time frame: Year 2 through Year 3
description: We will determine the number of participants receiving HIV treatment
measure: Percentage receiving antiretroviral therapy for HIV
time frame: Year 3 through Year 4
description: We will determine the number of participants receiving HIV treatment
measure: Percentage receiving antiretroviral therapy for HIV
time frame: Year 4 through Year 5
description: We will determine the number of participants receiving HIV treatment
measure: Number of Patients Achieving a Viral Load Suppression
time frame: Baseline through Year 1
description: We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
measure: Number of Patients Achieving a Viral Load Suppression
time frame: Year 1 through Year 2
description: We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
measure: Number of Patients Achieving a Viral Load Suppression
time frame: Year 2 through Year 3
description: We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
measure: Number of Patients Achieving a Viral Load Suppression
time frame: Year 3 through Year 4
description: We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
measure: Number of Patients Achieving a Viral Load Suppression
time frame: Year 4 through Year 5
description: We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
arm group label: +STEP Implementation
arm group type: Other
description: All patients will receive +STEP as new standard of care at their clinic. This intervention will include staff training, PROs as part of routine care to screen for substance use and mental health disorders, and telemedicine for health care delivery.
intervention type: Other
intervention name: +STEP Implementation
description: All patients receiving care at five RWHAP-funded clinics will receive the intervention (+STEP), in which patient-reported outcomes (PROs) on mental health and substance use disorder (SUD) will be integrated into routine care, targeted training will be provided for frontline clinicians on best practices for mental health and SUD treatment, and telemedicine for mental health and SUD will be offered to patients in need of expanded access to services.
arm group label: +STEP Implementation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ellen Eaton, MD, MSPH
role: Principal Investigator
affiliation: University of Alabama at Birmingham (UAB)
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kozak MS, Mugavero MJ, Ye J, Aban I, Lawrence ST, Nevin CR, Raper JL, McCullumsmith C, Schumacher JE, Crane HM, Kitahata MM, Saag MS, Willig JH. Patient reported outcomes in routine care: advancing data capture for HIV cohort research. Clin Infect Dis. 2012 Jan 1;54(1):141-7. doi: 10.1093/cid/cir727. Epub 2011 Oct 31.
PMID: 22042879
citation: Mehrotra A, Huskamp HA, Souza J, Uscher-Pines L, Rose S, Landon BE, Jena AB, Busch AB. Rapid Growth In Mental Health Telemedicine Use Among Rural Medicare Beneficiaries, Wide Variation Across States. Health Aff (Millwood). 2017 May 1;36(5):909-917. doi: 10.1377/hlthaff.2016.1461.
PMID: 28461359
citation: Ickovics JR, Hamburger ME, Vlahov D, Schoenbaum EE, Schuman P, Boland RJ, Moore J; HIV Epidemiology Research Study Group. Mortality, CD4 cell count decline, and depressive symptoms among HIV-seropositive women: longitudinal analysis from the HIV Epidemiology Research Study. JAMA. 2001 Mar 21;285(11):1466-74. doi: 10.1001/jama.285.11.1466.
PMID: 11255423
citation: Springer SA, Dushaj A, Azar MM. The impact of DSM-IV mental disorders on adherence to combination antiretroviral therapy among adult persons living with HIV/AIDS: a systematic review. AIDS Behav. 2012 Nov;16(8):2119-43. doi: 10.1007/s10461-012-0212-3.
PMID: 22644066
citation: Sohail M, Rastegar J, Long D, Rana A, Levitan EB, Reed-Pickens H, Batey DS, Ross-Davis K, Gaddis K, Tarrant A, Parmar J, Raper JL, Mugavero MJ. Data for Care (D4C) Alabama: Clinic-Wide Risk Stratification With Enhanced Personal Contacts for Retention in HIV Care via the Alabama Quality Management Group. J Acquir Immune Defic Syndr. 2019 Dec;82 Suppl 3:S192-S198. doi: 10.1097/QAI.0000000000002205.
PMID: 31764254
citation: Powell BJ, McMillen JC, Proctor EK, Carpenter CR, Griffey RT, Bunger AC, Glass JE, York JL. A compilation of strategies for implementing clinical innovations in health and mental health. Med Care Res Rev. 2012 Apr;69(2):123-57. doi: 10.1177/1077558711430690. Epub 2011 Dec 26.
PMID: 22203646
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Ellen Eaton
investigator title: Assistant Professor
mesh term: Substance-Related Disorders
sharing ipd: Yes
ipd description: The proposed project will comply with the NIH Data Sharing Policy, thus all data collected will be made available to outside investigators. To maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information). When possible, collaborative use of the data will be encouraged in order to enhance the quality of secondary analyses. Data will be made available as either a SPSS or Excel dataset, or as a tab-delimited ASCII file. Methods will be described through published papers, and relevant software and/or procedures documents.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: All data collected for this protocol will be made available to outside investigators in a timely fashion (defined by the NIH as no later than the acceptance of the primary outcome paper for publication)
ipd access criteria: Requests for data will be handled on a case-by-case basis in consultation with the Co-Investigators and members of the team.