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

February 16, 2026 updated by: Ellen Eaton, University of Alabama at Birmingham

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients completing PROs
Time Frame: Baseline through Year 1
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
Time Frame: Year 1 through Year 2
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
Time Frame: Year 2 through Year 3
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
Time Frame: Year 3 through Year 4
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
Time Frame: Year 4 through Year 5
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
Time Frame: Baseline through Year 1
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
Time Frame: Year 1 through Year 2
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
Time Frame: Year 2 through Year 3
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
Time Frame: Year 3 through Year 4
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
Time Frame: Year 4 through Year 5
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
Time Frame: Baseline through Year 1
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
Time Frame: Year 1 through Year 2
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
Time Frame: Year 2 through Year 3
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
Time Frame: Year 3 through Year 4
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
Time Frame: Year 4 through Year 5
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
Time Frame: Baseline through Year 1
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
Time Frame: Year 1 through Year 2
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
Time Frame: Year 2 through Year 3
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
Time Frame: Year 3 through Year 4
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
Time Frame: Year 4 through Year 5
We will use EMR and scheduling data to determine the number of visits attended
Year 4 through Year 5

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage engaged in HIV care
Time Frame: Baseline through Year 1
We will determine the number of participants engage in HIV care
Baseline through Year 1
Percentage engaged in HIV care
Time Frame: Year 1 through Year 2
We will determine the number of participants engage in HIV care
Year 1 through Year 2
Percentage engaged in HIV care
Time Frame: Year 2 through Year 3
We will determine the number of participants engage in HIV care
Year 2 through Year 3
Percentage engaged in HIV care
Time Frame: Year 3 through Year 4
We will determine the number of participants engage in HIV care
Year 3 through Year 4
Percentage engaged in HIV care
Time Frame: Year 4 through Year 5
We will determine the number of participants engage in HIV care
Year 4 through Year 5
Percentage receiving antiretroviral therapy for HIV
Time Frame: Baseline through Year 1
We will determine the number of participants receiving HIV treatment
Baseline through Year 1
Percentage receiving antiretroviral therapy for HIV
Time Frame: Year 1 through Year 2
We will determine the number of participants receiving HIV treatment
Year 1 through Year 2
Percentage receiving antiretroviral therapy for HIV
Time Frame: Year 2 through Year 3
We will determine the number of participants receiving HIV treatment
Year 2 through Year 3
Percentage receiving antiretroviral therapy for HIV
Time Frame: Year 3 through Year 4
We will determine the number of participants receiving HIV treatment
Year 3 through Year 4
Percentage receiving antiretroviral therapy for HIV
Time Frame: Year 4 through Year 5
We will determine the number of participants receiving HIV treatment
Year 4 through Year 5
Number of Patients Achieving a Viral Load Suppression
Time Frame: Baseline through Year 1
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
Time Frame: Year 1 through Year 2
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
Time Frame: Year 2 through Year 3
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
Time Frame: Year 3 through Year 4
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
Time Frame: Year 4 through Year 5
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Alabama at Birmingham

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ellen Eaton, MD, MSPH, University of Alabama at Birmingham (UAB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 19, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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