HIV + Service Delivery and Telemedicine Through Effective PROs

NCT04489667 | Withdrawn

• 2 other identifiers: IRB-3000056131R01MH124633-01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Substance Use Disorders; HIV/AIDS; Mental Health Issue

Keywords

Telemedicine; Patient reported outcomes; Focused training

Outcome Measures

Primary Outcomes (20)

• 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 Outcomes (15)

• Percentage engaged in HIV care

  Baseline through Year 1

• Percentage engaged in HIV care

  Year 1 through Year 2

• Percentage engaged in HIV care

  Year 2 through Year 3

• Percentage engaged in HIV care

  Year 3 through Year 4

• Percentage engaged in HIV care

  Year 4 through Year 5

Study Arms (1)

+STEP Implementation

OTHER

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

Interventions

+STEP Implementation OTHER

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.

+STEP Implementation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Below 18 years of age

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• University of Alabama at Birmingham: lead

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Substance-Related Disorders

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ellen Eaton, MD, MSPH

  University of Alabama at Birmingham (UAB)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: July 28, 2020
• Study Start: March 19, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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)
• 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.

Locations

US (5)