TuberculosisNCT02520973
Screening for TB in Pregnancy. on HIV-Infected Pregnant Women
A study testing Sputum sample in people with Tuberculosis, run by Johns Hopkins University at 1 site in South Africa.
Trial summary
Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Sputum sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,400 participants
- Where
- 1 siteSouth Africa
- Study dates
- May 2015to 30 Jun 2017
- 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 seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL
- Pregnancy confirmed by urine pregnancy test or clinical exam
- Estimated gestational age of 13 weeks or older
- Age 18 years or greater
- Willing to provide verbal consent
Who cannot join
- Currently diagnosed with TB
- Completed TB treatment within the last 6 months
- Inability to communicate in one of the study languages.
- Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants
Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .
- Conditions
- Tuberculosis
- Being tested
- Sputum sample
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sputum sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Universal screening | Experimental | All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen Receives: Other: Sputum sample |
| Symptom- directed screening | Active comparator | Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB Receives: Other: Sputum sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women diagnosed with TB
- Proportion of women who are diagnosed with TB in each arm
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Responsible party
- Sponsor
- Investigators
- Richard Chaisson, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02520973
- Sponsor's protocol ID
- 00039194
- Status last verified
- Aug 2017
- First submitted
- 9 Mar 2015
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for TB in Pregnancy A Supplement to: The Effect of Tuberculosis and Its Treatment on HIV-Infected Pregnant Women and Their Infants
- ClinicalTrials.gov ID
- NCT02520973
- Acronym / sponsor ID
- 00039194
- Conditions
- Tuberculosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,400 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Witwatersrand, South Africa
- Study start
- May 2015
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 13 Aug 2015 (estimated)
- 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.
Pregnant women who develop active Tuberculosis (TB) are at increased risk of poor maternal and infant outcomes. Our data from South Africa show that up to 3% of HIV-infected pregnant women have active TB , many with advanced disease, contributing to the 40% of maternal mortality associated with TB or HIV in South Africa . Screening for TB in pregnant women in this setting is therefore essential to reduce maternal mortality. Symptom-directed screening for TB has been recommended by the World Health Organization and by the South African National Department of Health; however, no implementation framework is in place to operationalize the guidelines. Symptom-based testing is an efficient process that limits use of diagnostic tests, but may miss many cases. In Soweto, we found that 0.7% (700/100,000) of HIV-infected women had active TB when a symptom-based strategy was employed once, but in Klerksdorp we found that 3.3% (3,300/100,000) had active TB when universal testing, regardless of symptoms, was performed; most TB cases were newly diagnosed among women who reported no symptoms .
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Universal screening | Experimental | Other: Sputum sampleAll HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen |
| Symptom- directed screening | Active comparator | Other: Sputum sampleOnly symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL
- Pregnancy confirmed by urine pregnancy test or clinical exam
- Estimated gestational age of 13 weeks or older
- Age 18 years or greater
- Willing to provide verbal consent
Key exclusion criteria (4 listed)
- Currently diagnosed with TB
- Completed TB treatment within the last 6 months
- Inability to communicate in one of the study languages.
- Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.
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 |
|---|---|---|
| Sputum sample | Other | Symptom- directed screening, Universal screening |
Primary outcome
Proportion of women diagnosed with TB
Time frame: One year
1. Proportion of women who are diagnosed with TB in each arm
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 18 Aug 2017.
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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.
Richard Chaisson, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sputum sample in people with Tuberculosis, run by Johns Hopkins University at 1 site in South Africa.
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 5 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 18 Aug 2017. 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?
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 women diagnosed with TB (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.