CompletedNCT01582711iAdhereUpdated Mar 13, 2025Results posted

Study 33: Adherence to Latent Tuberculosis Infection Treatment 3HP SAT Versus 3HP DOT

A Phase 3 interventional study of Self Administered Therapy (SAT) and SMS reminders in Latent Tuberculosis Infection, sponsored by Centers for Disease Control and Prevention. Completed at 12 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-13.

Sponsored by Centers for Disease Control and Prevention · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 1,002
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The study is an open label, multicenter, randomized (three arms: DOT (standard control), SAT, SAT with SMS reminders) controlled clinical trial. The trial is conducted in patients diagnosed with latent tuberculosis infection (LTBI) who are recommended for treatment. The primary objective is to evaluate adherence to a three-month (12-dose) regimen of weekly rifapentine and isoniazid (3RPT/INH) given by directly observed therapy (DOT) compared to self-administered therapy (SAT). The secondary objectives:

To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders
To evaluate the timing of doses and patterns of adherence to once weekly RPT/INH among participants who complete treatment and those who discontinue therapy prior to completion.
To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study.
To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually)
To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms
To collect patient-specific cost data related to the 3 treatment arms
To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.

Read the detailed description

The World Health Organization (WHO) estimates that approximately 2.3 billion people are infected with Mycobacterium tuberculosis. Approximately 1.7 million people die of TB each year, the second most common infectious cause of death in the world. In order to improve TB control worldwide, an affordable, effective, short course treatment for latent TB infection (LTBI) is a global priority.

Candidates for LTBI treatment are those persons with a positive TST or IGRA, particularly if they also have risk factors for progressing to active TB, including individuals likely to be recently infected. The Prevent TB Study (TBTC Study 26) was an open-label, randomized, phase III controlled clinical trial with over 8,000 high risk TST reactors enrolled. The study compared rifapentine and INH (3RPT/INH) given once-weekly by directly observed treatment (DOT) for 3 months (12 doses) compared with 9 months of daily, self-administered INH. The results demonstrated the safety and efficacy of the shorter regimen. Moreover, the once weekly therapy had significantly higher treatment completion rates than the standard 9 INH regimen.

One of the most effective strategies for assuring adherence with therapy is to have each dose of medication directly administered by a health care worker who observes and records the ingestion of the drugs. DOT for active TB has been successfully used in many settings to improve treatment completion, however cost and logistical constraints of DOT remain. The estimated cost of giving 12 weekly DOT doses to all LTBI patients is likely prohibitive for TB control programs worldwide. This may lead to a decreased uptake of the new regimen or implementation using SAT where adherence has not been studied. Therefore, to apply the Prevent TB study results more broadly, a new study evaluating treatment completion of 3 RPT/INH given as SAT is conducted.

Medication adherence is defined by whether patients take a treatment as prescribed. The effectiveness of any treatment is determined largely by adherence. In clinical practice and research, indirect measures of adherence are commonly used. Indirect measures of adherence include patient self-report, evaluation of pharmacy dispensation records, pill counts, and the use of electronic prescription bottle monitors. Patient self-reported adherence is accurate when non-adherence is reported but tends to overestimate true adherence. Self-report is not discerning enough to be utilized as a sole measure of adherence in research settings where adherence is the primary outcome. Pill counts have been utilized successfully in research and clinical settings for real-time assessment but also tend to overestimate adherence. Electronic drug monitors such as the Medication Event Monitoring System (MEMS) are the best available tools to assess the timing and patterns of adherence. This study uses a combination of indirect measures including MEMS, pill counts, and self-report to provide the most accurate assessment of adherence to once weekly, self-administered RPT/INH.

The number of cellular phone users globally has increased dramatically in the last decade. Cell phones and SMS reminders have been used successfully in randomized controlled clinical trials to improve adherence to vaccines, HIV medications, and asthma treatment. SMS appear to be cost-effective ways to reach patients in remote locations. This study examines effect of SMS on medication adherence.

The goal of this open label clinical trial is to compare the adherence to 3RPT/INH given by DOT versus SAT or SAT with a weekly SMS reminder. The primary assessment of adherence will be treatment completion which is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of initiation. Secondary objectives include evaluating the patterns of adherence in participants who fail to complete, determining the feasibility and impact of using SMS reminders on treatment completion with SAT, evaluating the tolerability and any adverse events associated with each treatment arm, monitoring for the development of active TB, determining the drug susceptibility for participants who develop active TB, and measuring important patient-related expenditures associated with each study arm. The trial will be conducted in patients diagnosed with LTBI and recommended for treatment.

Conditions studied

Latent Tuberculosis Infection

Browse trials for

Keywords

LTBI
LTB
Latent TB
TB infection

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 1,002 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Males and non-pregnant, non-nursing females
Age > 18 years
Weight > 45kg and considered appropriate to receive RPT 900mg and INH 900mg once weekly by the local site investigator
Willingness to provide signed informed consent.
Clinical indication for LTBI treatment such as: 1) persons with a positive tuberculin skin test (TST) as defined by CDC criteria or a positive interferon-gamma release assay (IGRA) defined per the manufacturers' guidelines AND one of the following: close contact to someone with culture confirmed TB, HIV infection, or > 2 cm2 of pulmonary parenchymal fibrosis on chest X-ray and no prior history of TB treatment; 2) TST or IGRA converters defined as a documented change from negative to positive within a two-year period; 3) Persons with any other clinical indication for LTBI treatment as locally defined including persons with a negative TST and/or IGRA (e.g. HIV-infected close contacts to an active pulmonary TB cases)

Exclusion criteria

Exclusion Criteria:

Confirmed or suspected active TB
Contacts to a source case with known resistance to isoniazid or rifampin
Persons with a history (by written documentation or self-report) of ever receiving > 1 week of treatment for active or latent TB, regardless of whether the course was completed, because adherence may be different in people who previously took TB treatment
Persons who are not considered candidates for SAT by the local investigator
History of sensitivity or intolerance to isoniazid or rifamycins
Serum alanine aminotransferase (ALT, SGPT) > 5x upper limit of normal among persons in whom an ALT is determined
Persons with HIV-infection who 1) have a CD4 \< 350 or 2) are currently receiving or planning to receive antiretroviral therapy in the first 120 days after study initiation (e.g., HIV-1 protease inhibitors, nucleoside or non-nucleoside reverse transcriptase inhibitors, CCR5 inhibitors or integrase inhibitors)

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 1,002 participants (actual)

Study arms

Active comparator
3HP Directly Observed Therapy (DOT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) under Directly Observed Therapy (DOT)
Drug: isoniazid and rifapentine
Experimental
3HP Self Administered Therapy (SAT)
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT)
Behavioral: Self Administered Therapy (SAT) · Drug: isoniazid and rifapentine
Experimental
3HP SAT with SMS Reminders
900mg of isoniazid plus 900mg of rifapentine given weekly for 3 months (12 weeks, 12 doses) as patient Self Administered Therapy (SAT). In addition, patient receives phone Short Message Service (SMS) reminders weekly.
Behavioral: Self Administered Therapy (SAT) · Behavioral: SMS reminders · Drug: isoniazid and rifapentine

Interventions

BehavioralSelf Administered Therapy (SAT)
Self Administered Therapy (SAT)
Also known as: SAT
BehavioralSMS reminders
Short Message Service (SMS) text reminders
Also known as: SMS, phone text reminder
Drugisoniazid and rifapentine
rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
Also known as: PRIFTIN, RPT, P, INH, I

What researchers measure

Primary outcomes

Treatment Completion Rate.
To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.
Time frame: Up to 16 weeks from start of treatment.

Secondary outcomes

Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders
To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders
Time frame: Up to 16 weeks from start of treatment.
The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS
The number and proportion of participants who adhered (completed treatment) based on pill count and self-report, considered to be standard of care (SOC) vs. the number of participants who completed treatment based on SOC plus MEMS cap.
Time frame: Up to 16 weeks from start of treatment.
Availability and Acceptability
To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study.
Time frame: Up to 16 weeks from start of treatment.
Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death
To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually)
Time frame: Up to 16 weeks from start of treatment.
Number and Percentage of Participants Reason for Failure to Complete Treatment
To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms (both combined and individually) including discontinuation due to: * non-adherence * any adverse event (AE) * a diagnosis of active TB * other reasons
Time frame: Up to 16 weeks from start of treatment.
Patient-specific Cost
To collect patient-specific cost data related to the DOT and SAT arms
Time frame: Up to 20 weeks from start of treatment.
Antituberculosis Drug Resistance
To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.
Time frame: Up to 16 weeks from start of treatment.

Results

Posted Mar 13, 2025

Participant flow

Participant flow — Overall Study
Milestone	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Started	337	337	328
Completed	337	337	328
Not completed	0	0	0

Outcome measures

PrimaryTreatment Completion Rate.

To compare the treatment completion rates between participants randomized to DOT vs SAT without reminders and DOT versus SAT with weekly SMS reminders. Treatment completion is defined as taking at least 90% of the doses (11/12 doses of each drug) within 16 weeks of treatment initiation.

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Treatment Completion Rate.
Participants	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Treatment Completion Rate.	294	248	250

SecondaryTreatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders

To compare the treatment completion rates between participants randomized to SAT without reminders versus SAT with weekly SMS reminders

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders
Participants	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Treatment Completion Rates Between Participants Randomized to SAT Without Reminders Versus SAT With Weekly SMS Reminders	248	250

SecondaryThe Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS

The number and proportion of participants who adhered (completed treatment) based on pill count and self-report, considered to be standard of care (SOC) vs. the number of participants who completed treatment based on SOC plus MEMS cap.

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

The Percentage of Participants Who Completed Treatment Based on SOC vs SOC Plus MEMS
Participants	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Treatment completion proportion based on pill count/self-report	294	271	266
Treatment completion proportion based on pill count/self-report and MEMS cap	294	248	249

SecondaryAvailability and Acceptability

To determine the availability and acceptability of using SMS reminders among all patients consenting to participate in the study.

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Availability and Acceptability
Participants	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders	3HP Directly Observed Therapy (DOT)
Proportion of Participants have cell SMS phone (Availability)	34	29	28
Proportion of Participants willing to use SMS (Acceptability) (eSAT arm ONLY)	0	229	0

SecondaryNumber and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death

To determine the toxicity and tolerability by comparing the rates of any drug-related grade 3 or 4 adverse events or death between the DOT arm and the SAT arms (both combined and individually)

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death
Participants	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Number and Percentage of Participants With Drug-related Grade 3 or 4 Adverse Events or Death	23	23	29

SecondaryNumber and Percentage of Participants Reason for Failure to Complete Treatment

To compare the frequency, timing, and causes for failure to complete treatment between the DOT arm and the SAT arms (both combined and individually) including discontinuation due to: * non-adherence * any adverse event (AE) * a diagnosis of active TB * other reasons

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Number and Percentage of Participants Reason for Failure to Complete Treatment
Participants	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Study therapy not started	3	7	4
Drug toxicities causing permanent discontinuation	12	18	14
Failure to complete minimum number of PP doses	4	7	9
Not advisable to continue study drugs	2	5	2
Refused further study therapy	6	7	11
Patient became pregnant	2	1	2
Other	9	12	11
Unknown/Missing	2	6	6

SecondaryPatient-specific Cost

To collect patient-specific cost data related to the DOT and SAT arms

Time frame:: Up to 20 weeks from start of treatment.
Reported as:: Median · U.S. Dollar

Patient-specific Cost
U.S. Dollar	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (Combined SAT and SAT With Reminders)
Patient-specific Cost	361.50 (125 to 425)	257.82 (90 to 340)

SecondaryAntituberculosis Drug Resistance

To describe the pattern of antituberculosis drug resistance among Mycobacterium tuberculosis strains cultured from participants who develop active TB.

Time frame:: Up to 16 weeks from start of treatment.
Reported as:: Count of participants · Participants

Antituberculosis Drug Resistance
Participants	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
Developed TB but not drug resistant	0	0	1
Antituberculosis Drug Resistant	0	0	0

Adverse events

Collected over Adverse event data were collected for the duration of study treatment (up to 16 weeks) + 14 days (for late toxicity). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
3HP Directly Observed Therapy (DOT)	0/337 (0%)	11/337 (3.3%)	42/337 (12.5%)
3HP Self Administered Therapy (SAT)	0/337 (0%)	5/337 (1.5%)	54/337 (16%)
3HP SAT With SMS Reminders	1/328 (0.3%)	6/328 (1.8%)	56/328 (17.1%)

Most frequent serious events

Most frequent serious events
Event	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
unrelated to study drugGeneral disorders	8/337	5/337	4/328
Acute gastroenteritisGastrointestinal disorders	1/337	0/337	1/328
fatigueGeneral disorders	0/337	0/337	1/328
Systemic Drug ReactionGeneral disorders	1/337	0/337	0/328
rheumatoid arthritis flareGeneral disorders	1/337	0/337	0/328

Most frequent other events

Most frequent other events
Event	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders
OtherGeneral disorders	27/337	36/337	50/328
Systemic Drug ReactionGeneral disorders	13/337	15/337	14/328
HepatitisGeneral disorders	1/337	3/337	5/328
ThrombocytopeniaGeneral disorders	0/337	0/337	1/328
NeutropeniaGeneral disorders	1/337	0/337	0/328

Baseline characteristics

Age, Continuous
Age, Continuous(years)	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders	Total
Median	36 (27 to 48)	36 (27 to 48)	38 (27 to 49)	36 (27 to 49)

Sex: Female, Male
Sex: Female, Male(Participants)	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders	Total
Female	153	161	168	482
Male	184	176	160	520

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders	Total
American Indian or Alaska Native	0	0	0	0
Asian	68	62	70	200
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	84	91	75	250
White	171	175	172	518
More than one race	14	9	11	34
Unknown or Not Reported	0	0	0	0

Region of Enrollment
Region of Enrollment(participants)	3HP Directly Observed Therapy (DOT)	3HP Self Administered Therapy (SAT)	3HP SAT With SMS Reminders	Total
United States	261	262	251	774
China	15	14	16	45
South Africa	26	29	28	83
Spain	35	32	33	100

Study locations

12 sites

University of California, San Francisco
San Francisco, California 94110, United States
Denver Public Health Department
Denver, Colorado 80204, United States
Washington DC Veterans Affairs Medical Center
Washington, District of Columbia 20422, United States
Columbia University College of Physicians and Surgeons and New York City Department of Health
New York, New York 10032, United States
Duke University
Durham, North Carolina 27713, United States
Vanderbilt University Medical Center and Nashville Metro Public Health Department
Nashville, Tennessee 37232-0146, United States
University of North Texas Health Science Center at Fort Worth
Fort Worth, Texas 76104-4802, United States
Audie L. Murphy VA Hospital
San Antonio, Texas 78229-4404, United States
South Texas - Department of State Health Services
San Antonio, Texas 78229-4404, United States
TB and Chest service of Hong Kong
Hong Kong, China
Wits Health Consortium
Soweto, South Africa
Agencia de Salut Publica - Barcelona, Spain and UNTHSC
Barcelona, 08023, Spain

References and documents

Publications

Sterling TR, Villarino ME, Borisov AS, Shang N, Gordin F, Bliven-Sizemore E, Hackman J, Hamilton CD, Menzies D, Kerrigan A, Weis SE, Weiner M, Wing D, Conde MB, Bozeman L, Horsburgh CR Jr, Chaisson RE; TB Trials Consortium PREVENT TB Study Team. Three months of rifapentine and isoniazid for latent tuberculosis infection. N Engl J Med. 2011 Dec 8;365(23):2155-66. doi: 10.1056/NEJMoa1104875. PubMed 22150035 ↗
Centers for Disease Control and Prevention (CDC). Recommendations for use of an isoniazid-rifapentine regimen with direct observation to treat latent Mycobacterium tuberculosis infection. MMWR Morb Mortal Wkly Rep. 2011 Dec 9;60(48):1650-3. PubMed 22157884 ↗
Shepardson D, Marks SM, Chesson H, Kerrigan A, Holland DP, Scott N, Tian X, Borisov AS, Shang N, Heilig CM, Sterling TR, Villarino ME, Mac Kenzie WR. Cost-effectiveness of a 12-dose regimen for treating latent tuberculous infection in the United States. Int J Tuberc Lung Dis. 2013 Dec;17(12):1531-7. doi: 10.5588/ijtld.13.0423. PubMed 24200264 ↗
Sterling TR, Moro RN, Borisov AS, Phillips E, Shepherd G, Adkinson NF, Weis S, Ho C, Villarino ME; Tuberculosis Trials Consortium. Flu-like and Other Systemic Drug Reactions Among Persons Receiving Weekly Rifapentine Plus Isoniazid or Daily Isoniazid for Treatment of Latent Tuberculosis Infection in the PREVENT Tuberculosis Study. Clin Infect Dis. 2015 Aug 15;61(4):527-35. doi: 10.1093/cid/civ323. Epub 2015 Apr 22. PubMed 25904367 ↗
Moro RN, Scott NA, Vernon A, Tepper NK, Goldberg SV, Schwartzman K, Leung CC, Schluger NW, Belknap RW, Chaisson RE, Narita M, Machado ES, Lopez M, Sanchez J, Villarino ME, Sterling TR. Exposure to Latent Tuberculosis Treatment during Pregnancy. The PREVENT TB and the iAdhere Trials. Ann Am Thorac Soc. 2018 May;15(5):570-580. doi: 10.1513/AnnalsATS.201704-326OC. PubMed 29393655 ↗
Belknap R, Holland D, Feng PJ, Millet JP, Cayla JA, Martinson NA, Wright A, Chen MP, Moro RN, Scott NA, Arevalo B, Miro JM, Villarino ME, Weiner M, Borisov AS; TB Trials Consortium iAdhere Study Team. Self-administered Versus Directly Observed Once-Weekly Isoniazid and Rifapentine Treatment of Latent Tuberculosis Infection: A Randomized Trial. Ann Intern Med. 2017 Nov 21;167(10):689-697. doi: 10.7326/M17-1150. Epub 2017 Nov 7. PubMed 29114781 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01582711
Lead sponsor: Centers for Disease Control and Prevention
Responsible party: Sponsor
First posted: Apr 23, 2012
Start date: Sep 2012
Primary completion: Oct 2014
Completion: Oct 2014
Results posted: Mar 13, 2025
Last update: Mar 13, 2025

Study contacts

Andrey S Borisov, MD, MPH

study director · U.S. Centers for Disease Control and Prevention (CDC), Atlanta, USA.

Robert Belknap, MD

study chair · Division of Infectious Diseases, University of Colorado, Denver, USA.

Robert Belknap, MD

principal investigator · Division of Infectious Diseases, University of Colorado, Denver, USA.

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

Centers for Disease Control and Prevention

Start the discussion