HIV + Service Delivery and Telemedicine Through Effective PROs

HIV/AIDS Clinical Trial

— HIV+STEP  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04489667
• Other study ID #: IRB-300005613
• Secondary ID: 1R01MH124633-01
• Status: Withdrawn
• Phase: N/A
• Start date: March 19, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: January 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Below 18 years of age

Related Conditions & MeSH terms

• HIV/AIDS
• Mental Health Issue
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Health Services Center	Anniston	Alabama
United States	University of Alabama Family Clinic	Birmingham	Alabama
United States	Thrive Federally Qualified Health Services Center	Huntsville	Alabama
United States	Medical Advocacy and Outreach (MAO)	Montgomery	Alabama
United States	Unity Wellness Center	Opelika	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Baseline through Year 1
Secondary	Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 1 through Year 2
Secondary	Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 2 through Year 3
Secondary	Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 3 through Year 4
Secondary	Percentage engaged in HIV care	We will determine the number of participants engage in HIV care	Year 4 through Year 5
Secondary	Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Baseline through Year 1
Secondary	Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 1 through Year 2
Secondary	Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 2 through Year 3
Secondary	Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 3 through Year 4
Secondary	Percentage receiving antiretroviral therapy for HIV	We will determine the number of participants receiving HIV treatment	Year 4 through Year 5
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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