Clinical trial NCT04489667: HIV + Service Delivery and Telemedicine Through Effective PROs
Official title: HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: HIV/AIDS
Mental Health Issue
Substance Use Disorders
Keywords: Telemedicine
Patient reported outcomes
Focused training
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-07-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Percentage of patients completing PROs
timeFrame: Baseline through Year 1
measure: Percentage of patients completing PROs
timeFrame: Year 1 through Year 2
measure: Percentage of patients completing PROs
timeFrame: Year 2 through Year 3
measure: Percentage of patients completing PROs
timeFrame: Year 3 through Year 4
measure: Percentage of patients completing PROs
timeFrame: Year 4 through Year 5
measure: Percentage of staff participating in training
timeFrame: Baseline through Year 1
measure: Percentage of staff participating in training
timeFrame: Year 1 through Year 2
measure: Percentage of staff participating in training
timeFrame: Year 2 through Year 3
measure: Percentage of staff participating in training
timeFrame: Year 3 through Year 4
measure: Percentage of staff participating in training
timeFrame: Year 4 through Year 5
measure: Percentage of patients receiving a referral to a mental health or substance use service
timeFrame: Baseline through Year 1
measure: Percentage of patients receiving a referral to a mental health or substance use service
timeFrame: Year 1 through Year 2
measure: Percentage of patients receiving a referral to a mental health or substance use service
timeFrame: Year 2 through Year 3
measure: Percentage of patients receiving a referral to a mental health or substance use service
timeFrame: Year 3 through Year 4
measure: Percentage of patients receiving a referral to a mental health or substance use service
timeFrame: Year 4 through Year 5
measure: Percentage of patients receiving mental health or substance use service based on attendance
timeFrame: Baseline through Year 1
measure: Percentage of patients receiving mental health or substance use service based on attendance
timeFrame: Year 1 through Year 2
measure: Percentage of patients receiving mental health or substance use service based on attendance
timeFrame: Year 2 through Year 3
measure: Percentage of patients receiving mental health or substance use service based on attendance
timeFrame: Year 3 through Year 4
measure: Percentage of patients receiving mental health or substance use service based on attendance
timeFrame: Year 4 through Year 5
Secondary outcomes:
measure: Percentage engaged in HIV care
timeFrame: Baseline through Year 1
measure: Percentage engaged in HIV care
timeFrame: Year 1 through Year 2
measure: Percentage engaged in HIV care
timeFrame: Year 2 through Year 3
measure: Percentage engaged in HIV care
timeFrame: Year 3 through Year 4
measure: Percentage engaged in HIV care
timeFrame: Year 4 through Year 5
measure: Percentage receiving antiretroviral therapy for HIV
timeFrame: Baseline through Year 1
measure: Percentage receiving antiretroviral therapy for HIV
timeFrame: Year 1 through Year 2
measure: Percentage receiving antiretroviral therapy for HIV
timeFrame: Year 2 through Year 3
measure: Percentage receiving antiretroviral therapy for HIV
timeFrame: Year 3 through Year 4
measure: Percentage receiving antiretroviral therapy for HIV
timeFrame: Year 4 through Year 5
measure: Number of Patients Achieving a Viral Load Suppression
timeFrame: Baseline through Year 1
measure: Number of Patients Achieving a Viral Load Suppression
timeFrame: Year 1 through Year 2
measure: Number of Patients Achieving a Viral Load Suppression
timeFrame: Year 2 through Year 3
measure: Number of Patients Achieving a Viral Load Suppression
timeFrame: Year 3 through Year 4
measure: Number of Patients Achieving a Viral Load Suppression
timeFrame: Year 4 through Year 5
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Health Services Center
state: Alabama
city: Birmingham
country: United States
facility: University of Alabama Family Clinic
state: Alabama
city: Huntsville
country: United States
facility: Thrive Federally Qualified Health Services Center
state: Alabama
city: Montgomery
country: United States
facility: Medical Advocacy and Outreach (MAO)
state: Alabama
city: Opelika
country: United States
facility: Unity Wellness Center
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham (UAB)
name: Ellen Eaton, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
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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: 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.