HIV + Service Delivery and Telemedicine Through Effective PROs (HIV+STEP)
Primary Purpose
HIV/AIDS, Mental Health Issue, Substance Use Disorders
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
+STEP Implementation
Sponsored by
About this trial
This is an interventional screening trial for HIV/AIDS focused on measuring Telemedicine, Patient reported outcomes, Focused training
Eligibility Criteria
Inclusion Criteria:
- 18 years or older and receiving HIV care at one of the five participating sites
Exclusion Criteria:
- Below 18 years of age
Sites / Locations
- Health Services Center
- University of Alabama Family Clinic
- Thrive Federally Qualified Health Services Center
- Medical Advocacy and Outreach (MAO)
- Unity Wellness Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
+STEP Implementation
Arm 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.
Outcomes
Primary Outcome Measures
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Percentage of staff participating in training
We will use attendance logs to determine how many staff at each site complete training
Percentage of staff participating in training
We will use attendance logs to determine how many staff at each site complete training
Percentage of staff participating in training
We will use attendance logs to determine how many staff at each site complete training
Percentage of staff participating in training
We will use attendance logs to determine how many staff at each site complete training
Percentage of staff participating in training
We will use attendance logs to determine how many staff at each site complete training
Percentage of patients receiving a referral to a mental health or substance use service
We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving a referral to a mental health or substance use service
We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving a referral to a mental health or substance use service
We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving a referral to a mental health or substance use service
We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving a referral to a mental health or substance use service
We will use EMR and scheduling data to determine the number of referrals generated
Percentage of patients receiving mental health or substance use service based on attendance
We will use EMR and scheduling data to determine the number of visits attended
Percentage of patients receiving mental health or substance use service based on attendance
We will use EMR and scheduling data to determine the number of visits attended
Percentage of patients receiving mental health or substance use service based on attendance
We will use EMR and scheduling data to determine the number of visits attended
Percentage of patients receiving mental health or substance use service based on attendance
We will use EMR and scheduling data to determine the number of visits attended
Percentage of patients receiving mental health or substance use service based on attendance
We will use EMR and scheduling data to determine the number of visits attended
Secondary Outcome Measures
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Number of Patients Achieving a Viral Load Suppression
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
Number of Patients Achieving a Viral Load Suppression
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
Number of Patients Achieving a Viral Load Suppression
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
Number of Patients Achieving a Viral Load Suppression
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
Number of Patients Achieving a Viral Load Suppression
We will determine the number of participants who have achieved Viral Load suppression, s defined by a Viral load of <20 copies per milliliter
Full Information
NCT ID
NCT04489667
First Posted
June 24, 2020
Last Updated
January 27, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT04489667
Brief Title
HIV + Service Delivery and Telemedicine Through Effective PROs
Acronym
HIV+STEP
Official Title
HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Not considered a clinical trial
Study Start Date
March 19, 2021 (Anticipated)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV/AIDS, Mental Health Issue, Substance Use Disorders
Keywords
Telemedicine, Patient reported outcomes, Focused training
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
+STEP Implementation
Arm Type
Other
Arm 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(s)
+STEP Implementation
Intervention 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.
Primary Outcome Measure Information:
Title
Percentage of patients completing PROs
Description
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Time Frame
Baseline through Year 1
Title
Percentage of patients completing PROs
Description
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Time Frame
Year 1 through Year 2
Title
Percentage of patients completing PROs
Description
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Time Frame
Year 2 through Year 3
Title
Percentage of patients completing PROs
Description
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Time Frame
Year 3 through Year 4
Title
Percentage of patients completing PROs
Description
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Time Frame
Year 4 through Year 5
Title
Percentage of staff participating in training
Description
We will use attendance logs to determine how many staff at each site complete training
Time Frame
Baseline through Year 1
Title
Percentage of staff participating in training
Description
We will use attendance logs to determine how many staff at each site complete training
Time Frame
Year 1 through Year 2
Title
Percentage of staff participating in training
Description
We will use attendance logs to determine how many staff at each site complete training
Time Frame
Year 2 through Year 3
Title
Percentage of staff participating in training
Description
We will use attendance logs to determine how many staff at each site complete training
Time Frame
Year 3 through Year 4
Title
Percentage of staff participating in training
Description
We will use attendance logs to determine how many staff at each site complete training
Time Frame
Year 4 through Year 5
Title
Percentage of patients receiving a referral to a mental health or substance use service
Description
We will use EMR and scheduling data to determine the number of referrals generated
Time Frame
Baseline through Year 1
Title
Percentage of patients receiving a referral to a mental health or substance use service
Description
We will use EMR and scheduling data to determine the number of referrals generated
Time Frame
Year 1 through Year 2
Title
Percentage of patients receiving a referral to a mental health or substance use service
Description
We will use EMR and scheduling data to determine the number of referrals generated
Time Frame
Year 2 through Year 3
Title
Percentage of patients receiving a referral to a mental health or substance use service
Description
We will use EMR and scheduling data to determine the number of referrals generated
Time Frame
Year 3 through Year 4
Title
Percentage of patients receiving a referral to a mental health or substance use service
Description
We will use EMR and scheduling data to determine the number of referrals generated
Time Frame
Year 4 through Year 5
Title
Percentage of patients receiving mental health or substance use service based on attendance
Description
We will use EMR and scheduling data to determine the number of visits attended
Time Frame
Baseline through Year 1
Title
Percentage of patients receiving mental health or substance use service based on attendance
Description
We will use EMR and scheduling data to determine the number of visits attended
Time Frame
Year 1 through Year 2
Title
Percentage of patients receiving mental health or substance use service based on attendance
Description
We will use EMR and scheduling data to determine the number of visits attended
Time Frame
Year 2 through Year 3
Title
Percentage of patients receiving mental health or substance use service based on attendance
Description
We will use EMR and scheduling data to determine the number of visits attended
Time Frame
Year 3 through Year 4
Title
Percentage of patients receiving mental health or substance use service based on attendance
Description
We will use EMR and scheduling data to determine the number of visits attended
Time Frame
Year 4 through Year 5
Secondary Outcome Measure Information:
Title
Percentage engaged in HIV care
Description
We will determine the number of participants engage in HIV care
Time Frame
Baseline through Year 1
Title
Percentage engaged in HIV care
Description
We will determine the number of participants engage in HIV care
Time Frame
Year 1 through Year 2
Title
Percentage engaged in HIV care
Description
We will determine the number of participants engage in HIV care
Time Frame
Year 2 through Year 3
Title
Percentage engaged in HIV care
Description
We will determine the number of participants engage in HIV care
Time Frame
Year 3 through Year 4
Title
Percentage engaged in HIV care
Description
We will determine the number of participants engage in HIV care
Time Frame
Year 4 through Year 5
Title
Percentage receiving antiretroviral therapy for HIV
Description
We will determine the number of participants receiving HIV treatment
Time Frame
Baseline through Year 1
Title
Percentage receiving antiretroviral therapy for HIV
Description
We will determine the number of participants receiving HIV treatment
Time Frame
Year 1 through Year 2
Title
Percentage receiving antiretroviral therapy for HIV
Description
We will determine the number of participants receiving HIV treatment
Time Frame
Year 2 through Year 3
Title
Percentage receiving antiretroviral therapy for HIV
Description
We will determine the number of participants receiving HIV treatment
Time Frame
Year 3 through Year 4
Title
Percentage receiving antiretroviral therapy for HIV
Description
We will determine the number of participants receiving HIV treatment
Time Frame
Year 4 through Year 5
Title
Number of Patients Achieving a Viral Load Suppression
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
Time Frame
Baseline through Year 1
Title
Number of Patients Achieving a Viral Load Suppression
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
Time Frame
Year 1 through Year 2
Title
Number of Patients Achieving a Viral Load Suppression
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
Time Frame
Year 2 through Year 3
Title
Number of Patients Achieving a Viral Load Suppression
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
Time Frame
Year 3 through Year 4
Title
Number of Patients Achieving a Viral Load Suppression
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
Time Frame
Year 4 through Year 5
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older and receiving HIV care at one of the five participating sites
Exclusion Criteria:
Below 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Eaton, MD, MSPH
Organizational Affiliation
University of Alabama at Birmingham (UAB)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Services Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36202
Country
United States
Facility Name
University of Alabama Family Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Thrive Federally Qualified Health Services Center
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Medical Advocacy and Outreach (MAO)
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36111
Country
United States
Facility Name
Unity Wellness Center
City
Opelika
State/Province
Alabama
ZIP/Postal Code
36801
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing 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 Sharing 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.
Citations:
PubMed Identifier
22042879
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.
Results Reference
background
PubMed Identifier
28461359
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.
Results Reference
background
PubMed Identifier
11255423
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.
Results Reference
background
PubMed Identifier
22644066
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.
Results Reference
background
PubMed Identifier
31764254
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.
Results Reference
background
PubMed Identifier
22203646
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.
Results Reference
background
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HIV + Service Delivery and Telemedicine Through Effective PROs
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