Opioid UsePARTNERUPNCT05108935
Providing PrEP, Hepatitis C Treatment, and MOUD Through Telemedicine at Greensboro SSP
A study testing Suboxone, Truvada and Mavyret in people with Opioid Use and Opioid Use Disorder, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Use Disorder, Risk Reduction
- What is being tested?
- Suboxone, Truvada and Mavyret
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Feb 2022to 30 Mar 2023
- 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
- Participant in SSP
- History of self-report injection opioid use in the past 6 months
- Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months
- Not currently taking PrEP
- HIV negative
Show all 14Show fewer
- Not pregnant
- Either a history of sharing injection or drug preparation equipment or risk of sexual acquisition of HIV* in the past 6 months
- Individuals are considered at risk of sexual acquisition of HIV if they answer yes to any of the items in the below question: In the last 6 months, have any of the following applied to you?
- Traded sex for money or drugs
- Had a sexual partner who is HIV positive
- Did not consistently use condoms when having sex
- Had a bacterial sexually transmitted infections (like gonorrhea, chlamydia, or syphilis)
- No medical contraindications for these medications such as history of renal failure or bone diseases
Who cannot join
- Have altered mental status in which participant cannot sign a consent form
- Receive a positive pregnancy test (will be checked at screening visit)
- Receive a positive HIV test at enrollment (will be checked at screening visit)
- Have evidence of renal failure (will be checked at screening visit)
- Have a history of hepatitis B (will be checked at screening visit)
- Becoming incarcerated during the study
Show all 10Show fewer
- Additional considerations:
- The following are not exclusion criteria for the study overall, but will affect which treatment(s) they can receive:
- Are currently receiving some form of MOUD (buprenorphine, naltrexone, methadone) - this makes them ineligible for MOUD treatment through the study, but they can still receive PrEP and/or hepatitis C treatment
- Have received treatment for hepatitis C prior to enrollment - this makes them ineligible for hepatitis C treatment through study, but they can still receive PrEP and/or MOUD
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke Department of Population Health Sciences
Durham, North Carolina, 27701
NC Survivors Union
Greensboro, North Carolina, 27403
About this study
Official title: Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP site in Greensboro, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Read the detailed description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention and/or hepatitis C treatment for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
To assess uptake and persistence to bup/nx, PrEP, and hepatitis C treatment as part of a comprehensive telemedicine-based harm reduction program among people who inject drugs using SSPs.
To assess feasibility and acceptability of implementing a telemedicine-based care harm reduction program among program implementers To assess feasibility and acceptability of participating in a telemedicine-based harm reduction program among users
The study population is people who inject drugs, specifically opioids, and who access services at an SSP in Greensboro, NC. The study team will enroll 30 people who inject drugs accessing the participating SSP. Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
Enrollment visit:
The study coordinator will administer a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.
Follow up visits:
Follow-up visits will be conducted via telemedicine at the SSP.
Participants on any combination of treatment including MOUD:
For the first month (Month 1), telemedicine visits will be weekly with each to ensure that participants are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly.
For participants on any combination of treatment NOT including MOUD:
Participants will attend telemedicine follow up visits at month 3 and month 6 to check in and provide labs.
All participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation. All participants will also be asked to participate in qualitative interviews on their experiences with the program at month 1 and month 6.
By the end of the study, we hope to determine the following:
- The proportion of persons who demonstrate no or minimal opioid use 1a. Defined as completing Month 3 and Month 6 visits with self-reported opioid use on ≤4 days in the past month and/or 2
- The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6
- Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
- Retention or persistence in care 4a. Defined as the proportion who remain on treatment (all or any combination of MOUD, PrEP, and hepatitis C treatment) at Month 3 and Month 6 4b. We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.
- Organizational facilitators and barriers to establishing a telehealth program in an SSP 5a. We will iteratively collect programmatic data and document challenges and problem-solving that occurs throughout the implementation period of providing bup/nx, PrEP, and/or hepatitis C treatment. We will identify and describe organizational factors using the framework of the Implementation Research Logic Model.
- Patient perspectives on telehealth delivery of PrEP, MOUD, and/or hepatitis C treatment via SSP 6a. Analysis of interview data at Month 1 and Month 6 to measure attitudes toward PrEP, MOUD, and hepatitis C treatment in general, and on delivery of treatment via telehealth and at the SSP 6b. Analysis of questionnaire data at baseline, Month 3, and Month 6
- Conditions
- Opioid Use, Opioid Use Disorder, Risk Reduction, Hiv, Hepatitis C
- Being tested
- Suboxone, Truvada, Mavyret
- Keywords
- opioid, medication for opioid use disorder, Drug user health hub, syringe services program, syringe exchange, PrEP, HIV prevention, retention in care, Suboxone, Hepatitis C treatment, hepatitis C, Opioid use disorder, feasibility, acceptability
- Medical subject headings
- Opioid-Related Disorders, Risk Reduction Behavior, Acquired Immunodeficiency Syndrome, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuboxoneDrug
Also called Buprenorphine Naloxone
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
TruvadaDrug
Also called Pre-Exposure Prophylaxis (PrEP)
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
MavyretDrug
Also called Hepatitis C treatment
Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
| Study group | Role | What they receive |
|---|---|---|
| Medication and telemedicine follow up | Experimental | Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. Receives: Drug: Suboxone; Drug: Truvada; Drug: Mavyret |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion who demonstrate no or minimal opioid use.
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Measured: 3 months
Proportion who demonstrate no or minimal opioid use.
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Measured: 6 months
Proportion who remain HIV negative.
Measured via negative HIV test.
Measured: 3 months
Proportion who remain HIV negative.
Measured via negative HIV test.
Measured: 6 months
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
Measured via negative hepatitis C test.
Measured: 6 months
Persistence in care
Defined as the proportion who remain on treatment.
Measured: 3 months
Persistence in care
Defined as the proportion who remain on treatment.
Measured: 6 months
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measured: month 1
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measured: month 6
Ease/difficulty of accessing the telemedicine video platform
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measured: month 1
Acceptability of medical care via a telemedicine video platform
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Measured: 6 month
Participant satisfaction with the program
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Measured: 1 month
Participant satisfaction with the program
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measured: month 6
Participant perceived usefulness of the program
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Measured: month 1
Participant perceived usefulness of the program
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Measured: month 6
Motivators and barriers affecting program persistence
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measured: month 6
Motivators and barriers affecting medication adherence and persistence
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start17 Feb 2022
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for AIDS Research (CFAR), National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Sponsor
- Investigators
- Mehri McKellar, MD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05108935
- Sponsor's protocol ID
- Pro00104147_1
- Other IDs
- 5P30AI064518-17
- Acronym
- PARTNERUP
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2021
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Providing A Resource: Telemedicine at Needle Exchanges to Reach Under-served Populations - Greensboro
- ClinicalTrials.gov ID
- NCT05108935
- Acronym / sponsor ID
- PARTNERUP / Pro00104147_1
- Conditions
- Opioid Use, Opioid Use Disorder, Risk Reduction, Hiv, Hepatitis C
- Keywords
- opioid, medication for opioid use disorder, Drug user health hub, syringe services program, syringe exchange, PrEP, HIV prevention, retention in care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Center for AIDS Research (CFAR), National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 5 Nov 2021 (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.
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention, and/or hepatitis C treatment for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The initial visit will be conducted in person or remotely via telemedicine given COVID-19 protocols at the SSP site in Greensboro, North Carolina (NC); follow-up visits will be conducted via telemedicine.
Detailed description
The purpose of this study is to provide medication for opioid use disorder (MOUD) with buprenorphine and naloxone, or bup/nx, pre-exposure prophylaxis (PrEP) for HIV prevention and/or hepatitis C treatment for persons who inject opioids accessing syringe services programs (SSPs), as part of a comprehensive harm reduction program, and assess the acceptability and feasibility of using telemedicine to implement the program.
The study objectives are the following:
To assess uptake and persistence to bup/nx, PrEP, and hepatitis C treatment as part of a comprehensive telemedicine-based harm reduction program among people who inject drugs using SSPs.
To assess feasibility and acceptability of implementing a telemedicine-based care harm reduction program among program implementers To assess feasibility and acceptability of participating in a telemedicine-based harm reduction program among users
The study population is people who inject drugs, specifically opioids, and who access services at an SSP in Greensboro, NC. The study team will enroll 30 people who inject drugs accessing the participating SSP. Participants will be enrolled in the study for 6 months. At the end of the study, they will be referred to MOUD and PrEP providers identified in the community.
Data collection
Enrollment visit:
The study coordinator will administer a baseline survey to collect demographics, HIV risk behaviors, and substance use history. Participants will undergo laboratory testing at the SSP to determine eligibility and enrolled participants will be prescribed bup/nx and PrEP free of charge.
Follow up visits:
Follow-up visits will be conducted via telemedicine at the SSP.
Participants on any combination of treatment including MOUD:
For the first month (Month 1), telemedicine visits will be weekly with each to ensure that participants are stable on the appropriate bup/nx dose. Starting at Month 2, the telemedicine visits will take place monthly.
For participants on any combination of treatment NOT including MOUD:
Participants will attend telemedicine follow up visits at month 3 and month 6 to check in and provide labs.
All participants will be asked to complete a questionnaire at Month 3 and Month 6 which include questions on HIV risk and drug use, as well as adherence evaluation. All participants will also be asked to participate in qualitative interviews on their experiences with the program at month 1 and month 6.
By the end of the study, we hope to determine the following:
- The proportion of persons who demonstrate no or minimal opioid use 1a. Defined as completing Month 3 and Month 6 visits with self-reported opioid use on ≤4 days in the past month and/or 2
- The proportion of persons who remain HIV negative. 2a.Measured via negative HIV test at Month 3 and Month 6
- Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
- Retention or persistence in care 4a. Defined as the proportion who remain on treatment (all or any combination of MOUD, PrEP, and hepatitis C treatment) at Month 3 and Month 6 4b. We will also examine whether participants are more apt to remain on paired/combined therapy compared to individual treatment.
- Organizational facilitators and barriers to establishing a telehealth program in an SSP 5a. We will iteratively collect programmatic data and document challenges and problem-solving that occurs throughout the implementation period of providing bup/nx, PrEP, and/or hepatitis C treatment. We will identify and describe organizational factors using the framework of the Implementation Research Logic Model.
- Patient perspectives on telehealth delivery of PrEP, MOUD, and/or hepatitis C treatment via SSP 6a. Analysis of interview data at Month 1 and Month 6 to measure attitudes toward PrEP, MOUD, and hepatitis C treatment in general, and on delivery of treatment via telehealth and at the SSP 6b. Analysis of questionnaire data at baseline, Month 3, and Month 6
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication and telemedicine follow up | Experimental | Drug: Suboxone, Drug: Truvada, Drug: MavyretEnrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18 years or older
- Participant in SSP
- History of self-report injection opioid use in the past 6 months
- Willing to take bup/nx, PrEP, and/or hepatitis C treatment for 6 months
- Not currently taking PrEP
Key exclusion criteria (10 listed)
- Have altered mental status in which participant cannot sign a consent form
- Receive a positive pregnancy test (will be checked at screening visit)
- Receive a positive HIV test at enrollment (will be checked at screening visit)
- Have evidence of renal failure (will be checked at screening visit)
- Have a history of hepatitis B (will be checked at screening visit)
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 |
|---|---|---|
| SuboxoneAlso: Buprenorphine NaloxoneEnrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. | Drug | Medication and telemedicine follow up |
| TruvadaAlso: Pre-Exposure Prophylaxis (PrEP)Enrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. | Drug | Medication and telemedicine follow up |
| MavyretAlso: Hepatitis C treatmentEnrolled participants will be prescribed PrEP Mavyret and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up. | Drug | Medication and telemedicine follow up |
Primary outcome
Proportion who demonstrate no or minimal opioid use.
Time frame: 3 months
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Proportion who demonstrate no or minimal opioid use.
Time frame: 6 months
Defined as self-reported opioid use on ≤4 days in the past month and/or 2 or more consecutive negative urine tests.
Proportion who remain HIV negative.
Time frame: 3 months
Measured via negative HIV test.
Proportion who remain HIV negative.
Time frame: 6 months
Measured via negative HIV test.
Among participants who undergo hepatitis C treatment, the hepatitis C cure rate
Time frame: 6 months
Measured via negative hepatitis C test.
Persistence in care
Time frame: 3 months
Defined as the proportion who remain on treatment.
Persistence in care
Time frame: 6 months
Defined as the proportion who remain on treatment.
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Time frame: month 1
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Ease/difficulty of visiting a SSP to meet with a provider via telemedicine
Time frame: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Ease/difficulty of accessing the telemedicine video platform
Time frame: month 1
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Acceptability of medical care via a telemedicine video platform
Time frame: 6 month
Exploratory method, conducted in the form of individual interviews to document the personal experiences of each participant (qualitative method)
Participant satisfaction with the program
Time frame: 1 month
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Participant satisfaction with the program
Time frame: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Participant perceived usefulness of the program
Time frame: month 1
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Participant perceived usefulness of the program
Time frame: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant (qualitative method)
Motivators and barriers affecting program persistence
Time frame: month 6
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Motivators and barriers affecting medication adherence and persistence
Time frame: 6 months
Exploratory method, conducted in the form of individual interviews to document the personal experiences and opinions of each participant over time (qualitative method)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Individual participant dataSharing planned: No. We will not share IPD with other researchers.
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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.
Mehri McKellar, MD principal investigator
Duke Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suboxone, Truvada and Mavyret in people with Opioid Use and Opioid Use Disorder, run by Duke University at 2 sites in United States.
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 14 inclusion and 10 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: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion who demonstrate no or minimal opioid use. (time frame: 3 months). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2023.