HIV/AIDSHIV+STEPNCT04489667
HIV + Service Delivery and Telemedicine Through Effective PROs
A study testing +STEP Implementation in people with HIV/AIDS and Mental Health Issue, run by University of Alabama at Birmingham.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV/AIDS, Mental Health Issue, Substance Use Disorders
- What is being tested?
- +STEP Implementation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 19 Mar 2021to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older and receiving HIV care at one of the five participating sites
Who cannot join
- Below 18 years of age
About this study
Official title: 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.
- Conditions
- HIV/AIDS, Mental Health Issue, Substance Use Disorders
- Being tested
- +STEP Implementation
- Keywords
- Telemedicine, Patient reported outcomes, Focused training
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
+STEP ImplementationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| +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. Receives: Other: +STEP Implementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients completing PROs
We will quantify the percentage of patients completing a PRO related to mental health or substance use
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Year 4 through Year 5
Secondary outcomes (15)
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Measured: Baseline through Year 1
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Measured: Year 1 through Year 2
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Measured: Year 2 through Year 3
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Measured: Year 3 through Year 4
Percentage engaged in HIV care
We will determine the number of participants engage in HIV care
Measured: Year 4 through Year 5
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Measured: Baseline through Year 1
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Measured: Year 1 through Year 2
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Measured: Year 2 through Year 3
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Measured: Year 3 through Year 4
Percentage receiving antiretroviral therapy for HIV
We will determine the number of participants receiving HIV treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Year 4 through Year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start19 Mar 2021 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Why it stopped: Not considered a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ellen Eaton, University of Alabama at Birmingham
- Investigators
- Ellen Eaton, MD, MSPH, Principal investigator, University of Alabama at Birmingham (UAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489667
- Sponsor's protocol ID
- IRB-300005613
- Other IDs
- 1R01MH124633-01
- Acronym
- HIV+STEP
- Status last verified
- Feb 2026
- First submitted
- 24 Jun 2020
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 22042879Mehrotra 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.
PubMed 28461359Ickovics 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.
PubMed 11255423Springer 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.
PubMed 22644066Sohail 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.
PubMed 31764254Powell 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.
PubMed 22203646
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HIV + Service Delivery and Telemedicine Through Effective PROs (+STEP)
- ClinicalTrials.gov ID
- NCT04489667
- Acronym / sponsor ID
- HIV+STEP / IRB-300005613
- Conditions
- HIV/AIDS, Mental Health Issue, Substance Use Disorders
- Keywords
- Telemedicine, Patient reported outcomes, Focused training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not considered a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 19 Mar 2021 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| +STEP Implementation | Other | Other: +STEP ImplementationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older and receiving HIV care at one of the five participating sites
Key exclusion criteria (1 listed)
- Below 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| +STEP ImplementationAll 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. | Other | +STEP Implementation |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
15 secondary outcomes
Percentage engaged in HIV care
Time frame: Baseline through Year 1
Percentage engaged in HIV care
Time frame: Year 1 through Year 2
Percentage engaged in HIV care
Time frame: Year 2 through Year 3
Percentage engaged in HIV care
Time frame: Year 3 through Year 4
Percentage engaged in HIV care
Time frame: Year 4 through Year 5
Percentage receiving antiretroviral therapy for HIV
Time frame: Baseline through Year 1
Percentage receiving antiretroviral therapy for HIV
Time frame: Year 1 through Year 2
Percentage receiving antiretroviral therapy for HIV
Time frame: Year 2 through Year 3
Percentage receiving antiretroviral therapy for HIV
Time frame: Year 3 through Year 4
Percentage receiving antiretroviral therapy for HIV
Time frame: Year 4 through Year 5
Number of Patients Achieving a Viral Load Suppression
Time frame: Baseline through Year 1
Number of Patients Achieving a Viral Load Suppression
Time frame: Year 1 through Year 2
Number of Patients Achieving a Viral Load Suppression
Time frame: Year 2 through Year 3
Number of Patients Achieving a Viral Load Suppression
Time frame: Year 3 through Year 4
Number of Patients Achieving a Viral Load Suppression
Time frame: Year 4 through Year 5
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Background: PubMed 22042879Kozak 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.
- Background: PubMed 28461359Mehrotra 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.
- Background: PubMed 11255423Ickovics 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.
- Background: PubMed 22644066Springer 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.
- Background: PubMed 31764254Sohail 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.
- Background: PubMed 22203646Powell 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Eaton, MD, MSPH principal investigator
University of Alabama at Birmingham (UAB)
Questions about this trial
What is this clinical trial studying?
A study testing +STEP Implementation in people with HIV/AIDS and Mental Health Issue, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients completing PROs (time frame: Baseline through Year 1). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04489667, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.