Sexually Transmitted InfectionNCT04446611

Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes (Philani Ndiphile)

A study testing First antenatal care + test-of-cure and First antenatal care + week 30-34 gestation (no test-of-cure) in people with Sexually Transmitted Infection and HIV/AIDS, run by Foundation for Professional Development (Pty) Ltd at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness
What is being tested?: First antenatal care + test-of-cure and First antenatal care + week 30-34 gestation (no test-of-cure)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,247 participants
Where: 1 siteSouth Africa
Study dates: 29 Mar 2021to 28 Feb 2025
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Age≥18 years
Currently pregnant based on positive urine pregnancy test
Attending first ANC visit for current pregnancy
Gestational age <20 weeks (Amended to <27 weeks, after 328 participants (14%) had been enrolled, to mitigate COVID-19 delays and align with similar studies)
Agreeing to nurse-collected specimens
Resident in Buffalo City Municipality (BCM)

Show all 9Show fewer

Intent to deliver in one of the four midwife obstetric units (MOUs) in BCM
Gestational age will be confirmed via ultrasound
1) born to mothers that provided informed consent to participate in study, 2) provision of updated verbal consent by mother to collect and test specimens for STIs

Who cannot join

Planning to relocate during pregnancy or deliver in an MOU outside of BCM
Unknown HIV status (e.g. refusal, invalid test result)
Currently participating in another ANC/HIV study
When the ultrasound confirms ≥27 weeks gestation at first ANC

Trial locations and contacts

1 site in 1 country.

South Africa1 site

Buffalo City Metro
East London, Eastern Cape, 5217

Other trials in South Africa

About this study

Official title: Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes

This study aims to evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae (NG), Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) among pregnant women, and reduce adverse birth outcomes. In turn it aims to evaluate the cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per sexually transmitted infection (STI) and disability-adjusted life-year (DALY) averted. Furthermore, this study will incorporate a vaginal microbiome sub-study aimed to investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women.

Aim 1 and 2: The intervention includes diagnostic testing at a woman's first antenatal care visit using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection with either a test-of-cure three weeks post-treatment (arm 1) or a repeat test at 30-34 weeks gestation (arm 2) compared to the standard of care, i.e. syndromic management (arm 3).

Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes

Read the detailed description

Prevalence of STIs is high among pregnant women in South Africa and most infections remain untreated. Untreated infections impact on pregnancy and birth outcomes. Good diagnostic and point-of-care (POC) tests are available, such as the GeneXpert platform. The health impact, cost-effectiveness and approaches to optimization of STI diagnostic screening during pregnancy are unknown.

In order to 1) identify optimal, cost-effective screening strategies that decrease the burden of STIs during pregnancy and reduce adverse birth outcomes, 2) informs evidence to WHO's guidelines to introduce aetiologic STI screening globally and 3) elucidate the role of the vaginal microbiome in STI treatment outcomes, the investigators propose three Specific Aims:

Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse birth outcomes
Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted
Investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women

STI screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis will be offered to HIV-infected and non-infected women (age >18 years) whom present for first antenatal care services. An effectiveness-implementation hybrid type 1 three-arm (1:1:1) randomized controlled trial (RCT), will be employed to evaluate different screening strategies to decrease the burden of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis among pregnant women, and reduce adverse birth outcomes.

The costs of the different STI screening strategies relative to control will be estimated based on literature review and performance/implementation characteristics and compared, in addition to the costs of managing adverse birth outcomes. Decision analytic modelling will estimate the cost-effectiveness per STI, and DALY averted (Aim 2).

Depending on the randomization arm, participants will be scheduled to be seen various times throughout pregnancy by the study team; antenatal care visits will be conducted in line with national policy. All post-partum mothers and infants will be asked to be seen at the first post-delivery clinic visit.

Conditions: Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes, Vaginal Microbiome, Neisseria Gonorrhoeae
Being tested: First antenatal care + test-of-cure, First antenatal care + week 30-34 gestation (no test-of-cure)
Keywords: Sexually transmitted infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Antenatal care, HIV/AIDS, Birth outcomes, South Africa, Vaginal microbiome, Pregnancy, Diagnostic testing
Medical subject headings: Sexually Transmitted Diseases, Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

First antenatal care + test-of-cureDiagnostic test
Single point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.
First antenatal care + week 30-34 gestation (no test-of-cure)Diagnostic test
Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.

Study groups in NCT04446611
Study group	Role	What they receive
Test at 1st ANC + Test-of-Cure (Treatment 1)	Experimental	Single point-in-time diagnostic screening plus test-of-cure three weeks post-treatment Receives: Diagnostic Test: First antenatal care + test-of-cure
Test at 1st ANC + 30-34 gestation (Treatment 2)	Experimental	Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation Receives: Diagnostic Test: First antenatal care + week 30-34 gestation (no test-of-cure)
Syndromic Management (Control)	No intervention	Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.

What is being measured

The primary outcome is the main question the study is designed to answer.

Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms
Adverse birth outcomes as defined by the proportion of participants (pregnant women) with live birth who experienced preterm birth (born alive before 37 completed weeks of gestation) or low birth weight (less than 2500g) as recorded in the maternity case records
Measured: Recorded within 2 weeks of delivery

Secondary outcomes (2)

Incidence of Preterm Birth Among Study Arms Measured in Pregnant Women Who Had a Live Birth
The frequency of live births before 37 completed weeks of gestation (among pregnant women enrolled who had a live birth), as validated by ultrasound dating at first antenatal visit
Measured: Recorded within 2 weeks of delivery
Incidence of Low Birthweight Among Study Arms Measured in Pregnant Women Who Had a Live Birth
The frequency of mothers with live births who delivered an infant with birth weight < 2500g, as recorded in the maternity case records
Measured: Recorded within 2 weeks of delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202128 Feb 2025

First posted25 Jun 2020
Study start29 Mar 2021
Primary completion31 Dec 2024
Study completion28 Feb 2025

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 (3)Papers the sponsor has linked to this study.
Other trials for Sexually Transmitted InfectionStudies 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: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: The intervention will incorporate diagnostic testing using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection at first antenatal care (ANC) (study aims 1 and 2) with either a test-of-cure (arm 1) or 30 weeks repeat testing as follow-up (arm 2) compared to the standard of care (arm 3), i.e. syndromic management as per the South African guidelines. It is thus a 3-arm (1:1:1) control trial with additional components of vaginal microbiome analysis, economic evaluation and qualitative insights.
Masking: None (open label)
Enrolment: 2,247 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04446611
Sponsor's protocol ID: R01AI149339
Other IDs: R01AI149339
Status last verified: Jul 2026
First submitted: 15 Apr 2020
Last updated: 17 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Onyema C, Babalola CM, Klausner J. Clinician-observed genital lesions among pregnant women in a high HIV/sexually transmitted infection prevalence setting. Int J STD AIDS. 2026 Sep 9:9564624261487933. doi: 10.1177/09564624261487933. Online ahead of print.
PubMed 42715544
Medina-Marino A, Babalola CM, Mdingi MM, Wilson ML, Mukomana F, Muzny CA, Taylor CM, Gigi RM, Jung H, Low N, Peters RP, Klausner JD. Antenatal Screening for Sexually Transmitted Infections to Reduce Preterm Birth or Low Birthweight (Philani Ndiphile Study): A Randomized Three-Group Trial. medRxiv [Preprint]. 2026 Apr 21:2026.04.15.26350805. doi: 10.64898/2026.04.15.26350805.
PubMed 42078373
Medina-Marino A, Cleary S, Muzny CA, Taylor C, Tamhane A, Ngwepe P, Bezuidenhout C, Facente SN, Mlisana K, Peters RPH, Klausner JD. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. Trials. 2022 May 24;23(1):441. doi: 10.1186/s13063-022-06400-y.
PubMed 35610666

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy

All Sexually Transmitted Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study of STI Screening to Prevent Adverse Birth and New-born Outcomes
ClinicalTrials.gov ID: NCT04446611
Acronym / sponsor ID: R01AI149339
Conditions: Sexually Transmitted Infection, HIV/AIDS, Cost-effectiveness, Birth Outcomes, Vaginal Microbiome, Neisseria Gonorrhoeae
Keywords: Sexually transmitted infection, Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, Antenatal care, HIV/AIDS, Birth outcomes, South Africa
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,247 participants (actual)
Lead sponsor: Foundation for Professional Development (Pty) LtdUniversity, hospital or other
Collaborators: University of Southern California, National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), University of Cape Town, University of Alabama at Birmingham, Louisiana State University Health Sciences Center in New Orleans
Study start: 29 Mar 2021 (actual)
Primary completion: 31 Dec 2024 (actual)
Study completion: 28 Feb 2025 (actual)
First posted: 25 Jun 2020 (actual)
Results: Posted 17 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim 3: Case-control study to investigate role vaginal microbiome in STI treatment outcomes

Detailed description

Evaluate different screening strategies to decrease the burden of Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis among pregnant women and reduce adverse birth outcomes
Evaluate cost per pregnant woman screened and treated, cost of adverse birth outcomes, and cost-effectiveness per STI and disability-adjusted life-year (DALY) averted
Investigate the relationship between the vaginal microbiome and persistent Chlamydial infections in pregnant women

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: The intervention will incorporate diagnostic testing using the Xpert® platform with same-day treatment for Neisseria gonorrhoeae, Chlamydia trachomatis and Trichomonas vaginalis infection at first antenatal care (ANC) (study aims 1 and 2) with either a test-of-cure (arm 1) or 30 weeks repeat testing as follow-up (arm 2) compared to the standard of care (arm 3), i.e. syndromic management as per the South African guidelines. It is thus a 3-arm (1:1:1) control trial with additional components of vaginal microbiome analysis, economic evaluation and qualitative insights.

Arm	Type	Receives
Test at 1st ANC + Test-of-Cure (Treatment 1)	Experimental	Diagnostic Test: First antenatal care + test-of-cureSingle point-in-time diagnostic screening plus test-of-cure three weeks post-treatment
Test at 1st ANC + 30-34 gestation (Treatment 2)	Experimental	Diagnostic Test: First antenatal care + week 30-34 gestation (no test-of-cure)Repeated diagnostic screening at first antenatal care and 30-34 weeks gestation
Syndromic Management (Control)	No intervention	–Syndromic management (standard of care) at every antenatal care visit per South African National Guidelines.

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Age≥18 years
Currently pregnant based on positive urine pregnancy test
Attending first ANC visit for current pregnancy
Gestational age <20 weeks (Amended to <27 weeks, after 328 participants (14%) had been enrolled, to mitigate COVID-19 delays and align with similar studies)
Agreeing to nurse-collected specimens

Key exclusion criteria (4 listed)

Planning to relocate during pregnancy or deliver in an MOU outside of BCM
Unknown HIV status (e.g. refusal, invalid test result)
Currently participating in another ANC/HIV study
When the ultrasound confirms ≥27 weeks gestation at first ANC

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
First antenatal care + test-of-cureSingle point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.	Diagnostic test	Test at 1st ANC + Test-of-Cure (Treatment 1)
First antenatal care + week 30-34 gestation (no test-of-cure)Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.	Diagnostic test	Test at 1st ANC + 30-34 gestation (Treatment 2)

Primary outcome

Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms
Time frame: Recorded within 2 weeks of delivery
Adverse birth outcomes as defined by the proportion of participants (pregnant women) with live birth who experienced preterm birth (born alive before 37 completed weeks of gestation) or low birth weight (less than 2500g) as recorded in the maternity case records

2 secondary outcomes

Incidence of Preterm Birth Among Study Arms Measured in Pregnant Women Who Had a Live Birth
Time frame: Recorded within 2 weeks of delivery
Incidence of Low Birthweight Among Study Arms Measured in Pregnant Women Who Had a Live Birth
Time frame: Recorded within 2 weeks of delivery

Results and safety

Results posted to the registry on 17 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Screen Once at 1st ANC + Test-of-Cure (Treatment 1)	754	703
Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2)	738	706
Syndromic Management (Control)	755	710

Primary outcome: Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms

Time frame: Recorded within 2 weeks of delivery. Count of participants. Unit: Participants

Measure	Screen Once at 1st ANC + Test-of-Cure (Treatment 1) n = 625	Screen Twice at 1st ANC + 30-34 Gestation (Treatment 2) n = 642	Syndromic Management (Control) n = 643
Value	143	132	149

Population analysed: Participants (pregnant women) with live births - The proportion of participants with live births) who experienced preterm birth or low birth weight. Calculated as number with adverse birth outcome (number)/total number who experienced a live birth delivery.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment through 2 weeks post-delivery. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test at 1st ANC + Test-of-Cure (Treatment 1)	47 of 754 (6.2%)	0 of 754 (0%)	0 of 754
Test at 1st ANC + 30-34 Gestation (Treatment 2)	38 of 738 (5.1%)	0 of 738 (0%)	1 of 738
Syndromic Management (Control)	46 of 755 (6.1%)	0 of 755 (0%)	0 of 755

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42715544Onyema C, Babalola CM, Klausner J. Clinician-observed genital lesions among pregnant women in a high HIV/sexually transmitted infection prevalence setting. Int J STD AIDS. 2026 Sep 9:9564624261487933. doi: 10.1177/09564624261487933. Online ahead of print.
Derived from this study: PubMed 42078373Medina-Marino A, Babalola CM, Mdingi MM, Wilson ML, Mukomana F, Muzny CA, Taylor CM, Gigi RM, Jung H, Low N, Peters RP, Klausner JD. Antenatal Screening for Sexually Transmitted Infections to Reduce Preterm Birth or Low Birthweight (Philani Ndiphile Study): A Randomized Three-Group Trial. medRxiv [Preprint]. 2026 Apr 21:2026.04.15.26350805. doi: 10.64898/2026.04.15.26350805.
Derived from this study: PubMed 35610666Medina-Marino A, Cleary S, Muzny CA, Taylor C, Tamhane A, Ngwepe P, Bezuidenhout C, Facente SN, Mlisana K, Peters RPH, Klausner JD. Sexually transmitted infection screening to prevent adverse birth and newborn outcomes: study protocol for a randomized-controlled hybrid-effectiveness trial. Trials. 2022 May 24;23(1):441. doi: 10.1186/s13063-022-06400-y.
Individual participant dataSharing planned: Yes

Related trials for Sexually Transmitted Infection

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy

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.

Andrew Medina-Marino, PhD, MPH principal investigator

Foundation for Professional Development

Jeffrey Klausner, MD, MPH principal investigator

USC Keck School of Medicine - University of Southern California

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 4 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 17 Jul 2026. 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 South Africa. 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 17 Jul 2026). 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?

Frequency of Adverse Birth Outcomes Among Pregnant Women With a Live Birth Across Study Arms (time frame: Recorded within 2 weeks of delivery). 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 NCT04446611, which also lists 3 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 17 Jul 2026.