HIVNCT04426656
The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
A study testing Phone application in people with HIV and Pre-exposure Prophylaxis, run by University of North Carolina, Chapel Hill at 1 site in China.
Trial summary
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). Read more about this study
- Who is it for?
- Ages 18 to 99 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Pre-exposure Prophylaxis
- What is being tested?
- Phone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 8 Jul 2020to 2 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.
- Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.
- AND, they must report :
- Having a smartphone with WeChat installed.
- Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND
- At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:
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- Unprotected (condomless) anal intercourse with male partner(s)
- More than two male partners (regardless of condom use and HIV serostatus)
- Reported STI, such as syphilis, Herpes Simplex Virus-2 (HSV-2), gonorrhea, chlamydia, chancroid, or lymphogranuloma venereum.
- Reported use of post-exposure prophylaxis (PEP)
- Have a sexual partner living with HIV
Who cannot join
- Part 1: Individuals who report any following status will be excluded from participating Part 1:
- HIV-positive
- Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders.
- Part 2:
- HIV-positive (self-report or lab-confirmed)
- Currently taking oral PrEP based on self-report
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- Symptoms of acute HIV infection within the prior 30 days
- Contradictions to taking oral PrEP
- Personal diagnosis or family history of hemophilia
- Chronic Hepatitis B (self-report)
- Participating in another research study related to HIV and antiretroviral therapy or other intervention study
- Having serious chronic disease, including metabolic diseases (such as diabetes), neurological, and psychiatric disorders
- Mental health issues which may compromise participant adherence or safety, including memory loss, cognitive impairment, intellectual disability, or communication disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.
Read the detailed description
This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.
Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.
In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.
Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.
- Conditions
- HIV, Pre-exposure Prophylaxis
- Being tested
- Phone application
- Keywords
- HIV, PrEP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone applicationBehavioural
Also called mini-app
The mini-app (used in Part 2) has four main functions:
- a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
- an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
- an asynchronous message function that allows users to chat with a study staff (C.Li); and
- a user profile page where users can manage all HIV test orders.
| Study group | Role | What they receive |
|---|---|---|
| Part 2 Standard of Care | No intervention | Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services. |
| Part 2 mini-app | Experimental | In addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period. Receives: Behavioral: Phone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intention to Use PrEP Score
Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.
Measured: Baseline and up to 12 weeks
Number of Participants Who Initiate PrEP by Week 8
Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
Measured: Up to 8 weeks
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Measured: Baseline
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Measured: Week 4
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Measured: Week 8
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Measured: Week 12
Secondary outcomes (6)
Change in PrEP Knowledge Score at Week 4, 8 and 12
Individual's understanding of PrEP, measured by a 5-item True/False quiz. Values range from 0-5. Higher score indicates better PrEP knowledge.
Measured: Baseline and up to 12 weeks
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Willingness to pay for PrEP ranging from 0-100% of monthly income. Amount spent will be assessed at Baseline, Weeks 4, 8, and 12.
Measured: Up to 12 weeks
Change in PrEP Self-Efficacy Score
Self-Efficacy will be assessed at Baseline, Weeks 4, 8, and 12 using an 8-item PrEP self-efficacy scale. Values range from 0-5. Higher scores indicate higher self-efficacy to use PrEP.
Measured: Baseline and up to 12 weeks
Change in PrEP Attitude Score
Individual's attitude towards PrEP, measured by a 5-item scale. Values range from 0-5. Higher scores indicate more positive attitude toward PrEP. The PrEP Attitude will be assessed at Baseline, Weeks 4, 8, and 12.
Measured: Baseline and up to 12 weeks
Change in PrEP Stigma Score
Individual's perceived stigma related to PrEP, measured by 5-item PrEP stigma scale. Values range from 0-5. Higher score indicates higher perceived stigma related to PrEP. The PrEP Stigma will be assessed at Baseline, Weeks 4, 8, and 12.
Measured: Baseline and up to 12 weeks
Number of Participants Who Ordered At-home HIV/Syphilis Tests
Number of participants who ordered at-home HIV/syphilis tests through the mini-app based on the study record. Values range from 0 to greater than 0. Higher indicates higher frequency of participants who ordered HIV/syphilis tests completed through the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start8 Jul 2020
- Primary completion2 Apr 2021
- Study completion2 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Mixed methods study, including a 2-arm randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chunyan Li, MS, Principal investigator, University of North CarolinaJoseph D Tucker, MD, Study director, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426656
- Sponsor's protocol ID
- 19-3481
- Other IDs
- R01AI114310
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2020
- Last updated
- 2 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Li C, Xiong Y, Maman S, Matthews DD, Fisher EB, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Li L, Tucker JD, Muessig KE. An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study. PLoS One. 2023 Nov 13;18(11):e0285036. doi: 10.1371/journal.pone.0285036. eCollection 2023.
PubMed 37956177Li C, Xiong Y, Muessig KE, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Matthews DD, Fisher EB, Li L, Tucker JD. Community-engaged mHealth intervention to increase uptake of HIV pre-exposure prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: study protocol for a pilot randomised controlled trial. BMJ Open. 2022 May 10;12(5):e055899. doi: 10.1136/bmjopen-2021-055899.
PubMed 35537794
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 12001 - The Development of a Mobile-based App to Increase Uptake of Pre-Exposure Prophylaxis (PrEP) by Men Who Have Sex With Men in China
- ClinicalTrials.gov ID
- NCT04426656
- Acronym / sponsor ID
- 19-3481
- Conditions
- HIV, Pre-exposure Prophylaxis
- Keywords
- HIV, PrEP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 8 Jul 2020 (actual)
- Primary completion
- 2 Apr 2021 (actual)
- Study completion
- 2 Apr 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 2 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to use a mini-application on the popular Chinese social media mobile platform, WeChat, to improve HIV pre-exposure prophylaxis (PrEP) uptake among at-risk men who have sex with men (MSM). UNC investigators will work in close partnership with a well-established HIV special hospital and the local MSM community to understand key barriers to PrEP use, and develop a mobile-based intervention to increase PrEP uptake among young MSM in Guangzhou, China.
Detailed description
This study includes two parts. Before the start of Part 1, a mini-app prototype for promoting HIV pre-exposure prophylaxis (PrEP) uptake will have been developed from a prior MSM community-driven hackathon contest. PrEP is an antiretroviral medicines-based prevention strategy against HIV infection, which has been proved save and effective.
Part 1 includes in-depth interviews with 40 HIV-negative young MSM (18 and above) with a brief survey to collect demographic data. The interview topics include PrEP-related perceptions and feedback on the design of a mini-app prototype. Findings from Part 1 will inform refining the mini-app before the start of Part 2.
In Part 2, a small two-arm randomized control trial with 70 young MSM (18 and above) will be conducted to evaluate the preliminary efficacy of the mini-app in improving PrEP-related perceptions and actual PrEP uptake, compared to a control group of standard of care.
Participants in Part 2 will be followed up for 12 weeks (8 week intervention and after-intervention follow-up at 12th week). A subgroup of participants (n=15) from both the intervention arm and the control arm will receive two rounds of in-depth interviews, separately at the 4th and 8th week, to share their experience of using the app and changed perceptions and/or behaviors related to PrEP.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Mixed methods study, including a 2-arm randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Part 2 Standard of Care | No intervention | –Participants will receive written HIV prevention materials including basic facts of PrEP, recommendations for HIV/STI(sexually transmitted infections) testing and referrals to local HIV/STI testing sites and prevention services. |
| Part 2 mini-app | Experimental | Behavioral: Phone applicationIn addition to the standard of care, participants in the mini-app arm will have access to the mini-app (i.e. the intervention) during the whole study period. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Part 1: HIV-negative men who have sex with men (MSM): must self-report: being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, identify as a Chinese citizen, own a smartphone, able to being willing to sign written informed consent and participate in the study as procedures required.
- Part 2: HIV-negative men who have sex with men (MSM): same characteristics as in Part 1.
- Having a smartphone with WeChat installed.
- Being assigned male sex at birth, HIV-negative, age 18 and above, ever having had anal sex with another man, currently reside in Guangzhou, China, identifying as a Chinese citizen, able to sign written informed consent and participate in the study as procedures require. AND
- At least one criterion associated with high risk of HIV infection in the past 6 months prior to enrollment as follows:
Key exclusion criteria (13 listed)
- Part 1: Individuals who report any following status will be excluded from participating Part 1:
- Part 2:
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 |
|---|---|---|
| Phone applicationAlso: mini-appThe mini-app (used in Part 2) has four main functions: 1. a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese; 2. an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time); 3. an asynchronous message function that allows users to chat with a study staff (C.Li); and 4. a user profile page where users can manage all HIV test orders. | Behavioural | Part 2 mini-app |
Primary outcome
Change in Intention to Use PrEP Score
Time frame: Baseline and up to 12 weeks
Individual perceived likelihood to start using PrEP, measured by a one-item question with a bipolar response scale (-3 to 3). Higher score indicates higher intention to use.
Number of Participants Who Initiate PrEP by Week 8
Time frame: Up to 8 weeks
Individual's self-reported whether starting use of PrEP medication (binary: Yes/No)
Number of Participants at Different Change Stages to PrEP Initiation at Baseline
Time frame: Baseline
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Number of Participants at Different Change Stages to PrEP Initiation at Week 4
Time frame: Week 4
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Number of Participants at Different Change Stages to PrEP Initiation at Week 8
Time frame: Week 8
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
Number of Participants at Different Change Stages to PrEP Initiation at Week 12
Time frame: Week 12
Individual's stages in the changing process towards starting using PrEP, which includes pre-contemplation (no interest in using PrEP), contemplation (interested in using PrEP but no action taken), preparation (plan to start PrEP and have taken initial actions), action (have started using PrEP), and maintenance (stay adherent to PrEP regimen). Each stage will be assessed by 1 or 2 questions (Yes/No) to determine which stage the individual is currently at.
6 secondary outcomes
Change in PrEP Knowledge Score at Week 4, 8 and 12
Time frame: Baseline and up to 12 weeks
Number of Participants Who Are Willing to Pay a Specified Percentage of Monthly Income for PrEP
Time frame: Up to 12 weeks
Change in PrEP Self-Efficacy Score
Time frame: Baseline and up to 12 weeks
Change in PrEP Attitude Score
Time frame: Baseline and up to 12 weeks
Change in PrEP Stigma Score
Time frame: Baseline and up to 12 weeks
Number of Participants Who Ordered At-home HIV/Syphilis Tests
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37956177Li C, Xiong Y, Maman S, Matthews DD, Fisher EB, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Li L, Tucker JD, Muessig KE. An instant messaging mobile phone application for promoting HIV pre-exposure prophylaxis uptake among Chinese gay, bisexual and other men who have sex with men: A mixed methods feasibility and piloting randomized controlled trial study. PLoS One. 2023 Nov 13;18(11):e0285036. doi: 10.1371/journal.pone.0285036. eCollection 2023.
- Derived from this study: PubMed 35537794Li C, Xiong Y, Muessig KE, Tang W, Huang H, Mu T, Tong X, Yu J, Yang Z, Sherer R, Hazra A, Lio J, Matthews DD, Fisher EB, Li L, Tucker JD. Community-engaged mHealth intervention to increase uptake of HIV pre-exposure prophylaxis (PrEP) among gay, bisexual and other men who have sex with men in China: study protocol for a pilot randomised controlled trial. BMJ Open. 2022 May 10;12(5):e055899. doi: 10.1136/bmjopen-2021-055899.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Chunyan Li, MS principal investigator
University of North Carolina
Joseph D Tucker, MD study director
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone application in people with HIV and Pre-exposure Prophylaxis, run by University of North Carolina, Chapel Hill at 1 site in China.
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 11 inclusion and 13 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 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Yes. Results are posted in the registry (first posted 2 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intention to Use PrEP Score (time frame: Baseline and up to 12 weeks). The study lists 6 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 NCT04426656, which also lists 2 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 2 Mar 2022.