HIV + Service Delivery and Telemedicine Through Effective PROs (HIV+STEP)

HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)

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.

Study Overview

• Status: Withdrawn
• Conditions: HIV/AIDS; Substance Use Disorders; Mental Health Issue
• Intervention / Treatment: Other: +STEP Implementation

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36202
      • Health Services Center
    • Birmingham, Alabama, United States, 35233
      • University of Alabama Family Clinic
    • Huntsville, Alabama, United States, 35801
      • Thrive Federally Qualified Health Services Center
    • Montgomery, Alabama, United States, 36111
      • Medical Advocacy and Outreach (MAO)
    • Opelika, Alabama, United States, 36801
      • Unity Wellness Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years or older and receiving HIV care at one of the five participating sites

Exclusion Criteria:

• Below 18 years of age

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: +STEP Implementation; 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.

Other: +STEP Implementation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients completing PROs	We will quantify the percentage of patients completing a PRO related to mental health or substance use	Baseline through Year 1
Percentage of patients completing PROs	We will quantify the percentage of patients completing a PRO related to mental health or substance use	Year 1 through Year 2
Percentage of patients completing PROs	We will quantify the percentage of patients completing a PRO related to mental health or substance use	Year 2 through Year 3
Percentage of patients completing PROs	We will quantify the percentage of patients completing a PRO related to mental health or substance use	Year 3 through Year 4
Percentage of patients completing PROs	We will quantify the percentage of patients completing a PRO related to mental health or substance use	Year 4 through Year 5
Percentage of staff participating in training	We will use attendance logs to determine how many staff at each site complete training	Baseline through Year 1
Percentage of staff participating in training	We will use attendance logs to determine how many staff at each site complete training	Year 1 through Year 2
Percentage of staff participating in training	We will use attendance logs to determine how many staff at each site complete training	Year 2 through Year 3
Percentage of staff participating in training	We will use attendance logs to determine how many staff at each site complete training	Year 3 through Year 4
Percentage of staff participating in training	We will use attendance logs to determine how many staff at each site complete training	Year 4 through Year 5
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	Baseline through Year 1
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	Year 1 through Year 2
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	Year 2 through Year 3
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	Year 3 through Year 4
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	Year 4 through Year 5
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	Baseline through Year 1
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	Year 1 through Year 2
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	Year 2 through Year 3
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	Year 3 through Year 4
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	Year 4 through Year 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Baseline through Year 1
Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 1 through Year 2
Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 2 through Year 3
Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 3 through Year 4
Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 4 through Year 5
Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Baseline through Year 1
Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 1 through Year 2
Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 2 through Year 3
Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 3 through Year 4
Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 4 through Year 5
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	Baseline through Year 1
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	Year 1 through Year 2
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	Year 2 through Year 3
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	Year 3 through Year 4
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	Year 4 through Year 5

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Ellen Eaton, MD, MSPH, University of Alabama at Birmingham (UAB)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): March 19, 2021
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: July 24, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine; Patient reported outcomes; Focused training
• Additional Relevant MeSH Terms: Blood-Borne Infections; Urogenital Diseases; Genital Diseases; Mental Disorders; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Chemically-Induced Disorders; Slow Virus Diseases; HIV Infections; Substance-Related Disorders; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: IRB-300005613; 1R01MH124633-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No