HIV InfectionsNCT03435887
Piloting At-birth Point of Care HIV Testing Strategies in Kenya
A study testing Alere q HIV-1/2 Detect for point of care infant testing and GeneXpert HIV-1 Qual for point of care infant testing in people with HIV Infections, run by University of Kansas Medical Center at 5 sites in 2 countries.
Trial summary
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Alere q HIV-1/2 Detect for point of care infant testing and GeneXpert HIV-1 Qual for point of care infant testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,999 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 2 Dec 2016to 30 Apr 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-positive pregnant women enrolled in PMTCT services or who deliver at the study hospitals and/or mothers with exposed infants presenting for EID prior to 24 weeks
- Provide informed consent
Who cannot join
- HIV-positive pregnant women less than 18 years of age
- HIV-positive pregnant women unable to provide informed consent
- HIV-exposed infants presenting for HIV testing at > 24 weeks
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Kenya4 sites
Kisumu County Hospital
Kisumu
Kombewa District Hospital
Kombewa
Tudor Sub-County Hospital
Mombasa
Rift Valley Provincial General Hospital
Nakuru
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.
Read the detailed description
Testing HIV-exposed infants by polymerase chain reaction (PCR) testing at 6 weeks is often not early enough to mitigate the substantial mortality peak that occurs around 2-3 months of age. Initial testing at birth would foster more rapid identification of infants with intrauterine (IU) infection and speed up the initiation of antiretroviral therapy (ART) for HIV-positive infants. Consequently, Kenya introduced new early infant diagnosis guidelines recommending at-birth (0-2 weeks) virologic testing in addition to the SOC tests at 6 weeks (6 - <24 weeks), 6 months and 12 months. POC testing performed in the clinic setting can potentially further reduce the time to diagnosis. Investigators will pilot test the implementation, performance, and cost-effectiveness of two POC test systems (Xpert HIV-1 Qual, Alere q HIV-1/2 Detect) in samples from neonates (at-birth test) and older infants (6-week test) in four government hospitals in Kenya.
In the formative phase of the study, interviews will be conducted with parents, providers and community members regarding benefits and concerns about the implementation of at-birth and POC testing. Interviews with parents (pregnant women living with HIV and their partners if available) will focus on the impact for the child and family. Interviews with providers who would carry out POC testing at each site (maternity nurses, mentor mothers, hospital laboratory staff) will highlight issues of training, logistics and implementation. Interviews with community members (parents of HIV-exposed infants, community health workers, community leaders) in surrounding communities will elicit attitudes and suggestions regarding the potential for POC HIV testing in hard to access communities. Investigators will develop a codebook with typical exemplars for each theme, calculating the frequency and distribution of themes within the larger topic areas. The study team will rapidly review themes to inform the POC pilot.
In the intervention phase the investigators will pilot at-birth and POC infant testing strategies in four hospitals over a continuous 12-month enrollment period. Sites will be randomized to pilot Xpert HIV-1 Qual (n=2) or Alere q HIV-1/2 Detect (n=2), both targeting the at-birth and 6-week testing points. A second blood sample will be collected at each time point to be tested by SOC laboratory-based HIV DNA PCR, which will correspond with the Kenya government's 2016 guidelines that recommend adding an at-birth test to the EID schedule. At-birth samples will ideally be collected within 24 hours of delivery and results communicated to the mother with counseling prior to discharge from maternity. The expected due dates of exposed infant will be tracked to encourage mothers who deliver outside the hospital to return for infant testing within two weeks postnatal. Infants enrolled in this pilot will be tracked until HIV results at birth and 6 weeks postnatal have been provided by POC and standard PCR, or until ART is initiated for HIV-positive infants. Investigators will assess user uptake, age at notification of HIV test results, age of ART initiation among HIV+ infants, POC machine performance, costs, and user experiences (providers will participate in a monthly focus group to discuss challenges and solutions) to inform the feasibility and optimal implementation of Kenya's 2016 at-birth test recommendation and of the mobile POC test systems for the improvement of EID outcomes.
- Conditions
- HIV Infections
- Being tested
- Alere q HIV-1/2 Detect for point of care infant testing, GeneXpert HIV-1 Qual for point of care infant testing, HIV DNA PCR testing (Standard of Care)
- Keywords
- Point of Care Testing, HIV, Pediatric HIV-exposed infants, at-birth testing, early infant diagnosis, Kenya
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alere q HIV-1/2 Detect for point of care infant testingBehavioural
The investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit.
GeneXpert HIV-1 Qual for point of care infant testingBehavioural
The investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to <24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.
HIV DNA PCR testing (Standard of Care)Behavioural
This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.
| Study group | Role | What they receive |
|---|---|---|
| Alere q HIV-1/2 Detect for point of care infant testing | Active comparator | POC testing with Alere q HIV-1/2 Detect at birth and 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing Receives: Behavioral: Alere q HIV-1/2 Detect for point of care infant testing; Behavioral: HIV DNA PCR testing (Standard of Care) |
| GeneXpert HIV-1 Qual for point of care infant testing | Active comparator | POC testing with GeneXpert HIV-1 Qual at-birth and at 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing Receives: Behavioral: GeneXpert HIV-1 Qual for point of care infant testing; Behavioral: HIV DNA PCR testing (Standard of Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of infants tested at birth
The proportion of infants receiving HIV testing (POC and/or PCR) during the birth testing window
Measured: 0-4 weeks
Proportion of infants tested at 6-weeks
The proportion of infants receiving HIV testing (POC and/or PCR) during the 6 week window
Measured: 4-12 weeks postpartum
Secondary outcomes (6)
Completeness of POC and SOC tests
Proportions of birth and 6-week tests with results returned and notified to mother
Measured: up to 24 weeks postnatal
Efficiency of POC and SOC tests
Measures include turnaround time (TAT) associated with key steps in POC or SOC testing: TAT from specimen collection to result availability, TAT from result availability to mother notification of results, and overall TAT from specimen collection to mother notification.
Measured: up to 24 weeks postnatal
Retention in EID services
Complete retention will be measured as the proportion of infants receiving a completed sequence of at-birth test result notification, 6-week-postnatal test result notification, and antiretroviral therapy (ART) initiation if HIV-positive.
Measured: up to 24 weeks postnatal
POC system implementation
Number of POC tests performed successfully, versus indeterminate results or failed tests, on each platform.
Number of missed opportunities to engage infants with POC testing due to documented machine breakdown, machine error, or cartridge stockout.
Measured: Month 12
Costs
Costs of implementing each POC strategy into an existing system compared to HIV DNA PCR will be quantified, including up-front purchase of machines and accessory equipment; site-specific training and secure equipment storage; purchase of test cartridges, including delivery and customs fees; and machine repair.
Measured: Month 12
Infant age at notification of HIV test results (birth and 6 week)
Infant age when mother is notified of at-birth (0-2 weeks postnatal) and 6 week (4-8 wks) POC and SOC test results
Measured: 0-8 weeks postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start2 Dec 2016
- Primary completion1 Jul 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sarah Kessler, PhD, MPH, University of Kansas Medical Center
- Investigators
- Sarah Kessler, PhD, Principal investigator, University of Kansas Medical CenterRaphael Lwembe, PhD, Principal investigator, Kenya Medical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435887
- Sponsor's protocol ID
- STUDY00140399
- Other IDs
- R01HD076673-04S2
- Status last verified
- Jul 2020
- First submitted
- 8 Jan 2018
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sandbulte MR, Gautney BJ, Maloba M, Wexler C, Brown M, Mabachi N, Goggin K, Lwembe R, Nazir N, Odeny TA, Finocchario-Kessler S. Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya. Pilot Feasibility Stud. 2019 Jan 25;5:18. doi: 10.1186/s40814-019-0402-0. eCollection 2019.
PubMed 30701079Wexler C, Maloba M, Brown M, Mabachi N, Goggin K, Gautney B, Odeny B, Finocchario-Kessler S. Factors affecting acceptance of at-birth point of care HIV testing among providers and parents in Kenya: A qualitative study. PLoS One. 2019 Nov 22;14(11):e0225642. doi: 10.1371/journal.pone.0225642. eCollection 2019.
PubMed 31756242Wexler C, Kamau Y, Halder R, Brown M, Maloba M, Mabachi N, Sandbulte M, Gautney B, Goggin K, Odeny T, Finocchario-Kessler S. "Closing the Gap": Provider Recommendations for Implementing Birth Point of Care HIV Testing. AIDS Behav. 2019 Apr;23(4):1073-1083. doi: 10.1007/s10461-018-2363-3.
PubMed 30542834Wexler C, Kamau Y, Muchoki E, Babu S, Maosa N, Maloba M, Brown M, Goggin K, Mabachi N, Gautney B, Finocchario-Kessler S. Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research. Implement Sci Commun. 2021 Aug 11;2(1):89. doi: 10.1186/s43058-021-00188-9.
PubMed 34380567
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Piloting At-birth Point of Care HIV Testing Strategies in Kenya
- ClinicalTrials.gov ID
- NCT03435887
- Acronym / sponsor ID
- STUDY00140399
- Conditions
- HIV Infections
- Keywords
- Point of Care Testing, HIV, Pediatric HIV-exposed infants, at-birth testing, early infant diagnosis, Kenya
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,999 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Dec 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 19 Feb 2018 (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.
Innovative strategies to expedite HIV diagnosis among exposed infants, including at-birth testing and two portable point-of-care (POC) diagnostic systems, will be piloted using an implementation framework. The programmatic impact of these tools on early infant diagnosis (EID) will be measured in comparison with parallel standard of care (SOC) HIV DNA PCR testing initiated at 6 weeks of age.
Detailed description
Testing HIV-exposed infants by polymerase chain reaction (PCR) testing at 6 weeks is often not early enough to mitigate the substantial mortality peak that occurs around 2-3 months of age. Initial testing at birth would foster more rapid identification of infants with intrauterine (IU) infection and speed up the initiation of antiretroviral therapy (ART) for HIV-positive infants. Consequently, Kenya introduced new early infant diagnosis guidelines recommending at-birth (0-2 weeks) virologic testing in addition to the SOC tests at 6 weeks (6 - <24 weeks), 6 months and 12 months. POC testing performed in the clinic setting can potentially further reduce the time to diagnosis. Investigators will pilot test the implementation, performance, and cost-effectiveness of two POC test systems (Xpert HIV-1 Qual, Alere q HIV-1/2 Detect) in samples from neonates (at-birth test) and older infants (6-week test) in four government hospitals in Kenya.
In the formative phase of the study, interviews will be conducted with parents, providers and community members regarding benefits and concerns about the implementation of at-birth and POC testing. Interviews with parents (pregnant women living with HIV and their partners if available) will focus on the impact for the child and family. Interviews with providers who would carry out POC testing at each site (maternity nurses, mentor mothers, hospital laboratory staff) will highlight issues of training, logistics and implementation. Interviews with community members (parents of HIV-exposed infants, community health workers, community leaders) in surrounding communities will elicit attitudes and suggestions regarding the potential for POC HIV testing in hard to access communities. Investigators will develop a codebook with typical exemplars for each theme, calculating the frequency and distribution of themes within the larger topic areas. The study team will rapidly review themes to inform the POC pilot.
In the intervention phase the investigators will pilot at-birth and POC infant testing strategies in four hospitals over a continuous 12-month enrollment period. Sites will be randomized to pilot Xpert HIV-1 Qual (n=2) or Alere q HIV-1/2 Detect (n=2), both targeting the at-birth and 6-week testing points. A second blood sample will be collected at each time point to be tested by SOC laboratory-based HIV DNA PCR, which will correspond with the Kenya government's 2016 guidelines that recommend adding an at-birth test to the EID schedule. At-birth samples will ideally be collected within 24 hours of delivery and results communicated to the mother with counseling prior to discharge from maternity. The expected due dates of exposed infant will be tracked to encourage mothers who deliver outside the hospital to return for infant testing within two weeks postnatal. Infants enrolled in this pilot will be tracked until HIV results at birth and 6 weeks postnatal have been provided by POC and standard PCR, or until ART is initiated for HIV-positive infants. Investigators will assess user uptake, age at notification of HIV test results, age of ART initiation among HIV+ infants, POC machine performance, costs, and user experiences (providers will participate in a monthly focus group to discuss challenges and solutions) to inform the feasibility and optimal implementation of Kenya's 2016 at-birth test recommendation and of the mobile POC test systems for the improvement of EID outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alere q HIV-1/2 Detect for point of care infant testing | Active comparator | Behavioral: Alere q HIV-1/2 Detect for point of care infant testing, Behavioral: HIV DNA PCR testing (Standard of Care)POC testing with Alere q HIV-1/2 Detect at birth and 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing |
| GeneXpert HIV-1 Qual for point of care infant testing | Active comparator | Behavioral: GeneXpert HIV-1 Qual for point of care infant testing, Behavioral: HIV DNA PCR testing (Standard of Care)POC testing with GeneXpert HIV-1 Qual at-birth and at 6-weeks postnatal in parallel with standard of care HIV DNA PCR testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HIV-positive pregnant women enrolled in PMTCT services or who deliver at the study hospitals and/or mothers with exposed infants presenting for EID prior to 24 weeks
- Provide informed consent
Key exclusion criteria (3 listed)
- HIV-positive pregnant women less than 18 years of age
- HIV-positive pregnant women unable to provide informed consent
- HIV-exposed infants presenting for HIV testing at > 24 weeks
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 |
|---|---|---|
| Alere q HIV-1/2 Detect for point of care infant testingThe investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit. | Behavioural | Alere q HIV-1/2 Detect for point of care infant testing |
| GeneXpert HIV-1 Qual for point of care infant testingThe investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to <24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit. | Behavioural | GeneXpert HIV-1 Qual for point of care infant testing |
| HIV DNA PCR testing (Standard of Care)This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital. | Behavioural | Alere q HIV-1/2 Detect for point of care infant testing, GeneXpert HIV-1 Qual for point of care infant testing |
Primary outcome
Proportion of infants tested at birth
Time frame: 0-4 weeks
The proportion of infants receiving HIV testing (POC and/or PCR) during the birth testing window
Proportion of infants tested at 6-weeks
Time frame: 4-12 weeks postpartum
The proportion of infants receiving HIV testing (POC and/or PCR) during the 6 week window
6 secondary outcomes
Completeness of POC and SOC tests
Time frame: up to 24 weeks postnatal
Efficiency of POC and SOC tests
Time frame: up to 24 weeks postnatal
Retention in EID services
Time frame: up to 24 weeks postnatal
POC system implementation
Time frame: Month 12
Costs
Time frame: Month 12
Infant age at notification of HIV test results (birth and 6 week)
Time frame: 0-8 weeks postnatal
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 14 Jul 2020.
- Background: PubMed 30701079Sandbulte MR, Gautney BJ, Maloba M, Wexler C, Brown M, Mabachi N, Goggin K, Lwembe R, Nazir N, Odeny TA, Finocchario-Kessler S. Infant HIV testing at birth using point-of-care and conventional HIV DNA PCR: an implementation feasibility pilot study in Kenya. Pilot Feasibility Stud. 2019 Jan 25;5:18. doi: 10.1186/s40814-019-0402-0. eCollection 2019.
- Results publication: PubMed 31756242Wexler C, Maloba M, Brown M, Mabachi N, Goggin K, Gautney B, Odeny B, Finocchario-Kessler S. Factors affecting acceptance of at-birth point of care HIV testing among providers and parents in Kenya: A qualitative study. PLoS One. 2019 Nov 22;14(11):e0225642. doi: 10.1371/journal.pone.0225642. eCollection 2019.
- Results publication: PubMed 30542834Wexler C, Kamau Y, Halder R, Brown M, Maloba M, Mabachi N, Sandbulte M, Gautney B, Goggin K, Odeny T, Finocchario-Kessler S. "Closing the Gap": Provider Recommendations for Implementing Birth Point of Care HIV Testing. AIDS Behav. 2019 Apr;23(4):1073-1083. doi: 10.1007/s10461-018-2363-3.
- Derived from this study: PubMed 34380567Wexler C, Kamau Y, Muchoki E, Babu S, Maosa N, Maloba M, Brown M, Goggin K, Mabachi N, Gautney B, Finocchario-Kessler S. Implementing at-birth, point-of-care HIV testing in Kenya: a qualitative study using the Consolidated Framework for Implementation Research. Implement Sci Commun. 2021 Aug 11;2(1):89. doi: 10.1186/s43058-021-00188-9.
- Individual participant dataSharing planned: No
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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.
Sarah Kessler, PhD principal investigator
University of Kansas Medical Center
Raphael Lwembe, PhD principal investigator
Kenya Medical Research Institute
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alere q HIV-1/2 Detect for point of care infant testing and GeneXpert HIV-1 Qual for point of care infant testing in people with HIV Infections, run by University of Kansas Medical Center at 5 sites in 2 countries.
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 2 inclusion and 3 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 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kenya, 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 of infants tested at birth (time frame: 0-4 weeks). The study lists 2 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 NCT03435887, which also lists 4 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 14 Jul 2020.