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Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

Primary Purpose

Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Sputum sample
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Tuberculosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. HIV seropositive by two rapid tests, or documented history of a positive Enzyme Immunoassay EIAs, or HIV RNA >1000 copies/mL
  2. Pregnancy confirmed by urine pregnancy test or clinical exam
  3. Estimated gestational age of 13 weeks or older
  4. Age 18 years or greater
  5. Willing to provide verbal consent

Exclusion Criteria:

  1. Currently diagnosed with TB
  2. Completed TB treatment within the last 6 months
  3. Inability to communicate in one of the study languages.
  4. Lack of comprehension of the study based on inability to meet basic understanding questions during the screening process.

Sites / Locations

  • Perinatal HIV Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Universal screening

Symptom- directed screening

Arm Description

All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen

Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB

Outcomes

Primary Outcome Measures

Proportion of women diagnosed with TB
1. Proportion of women who are diagnosed with TB in each arm

Secondary Outcome Measures

Full Information

First Posted
March 9, 2015
Last Updated
August 15, 2017
Sponsor
Johns Hopkins University
Collaborators
University of Witwatersrand, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT02520973
Brief Title
Screening for TB in Pregnancy. on HIV-Infected Pregnant Women
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
June 30, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Witwatersrand, South Africa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Universal screening
Arm Type
Experimental
Arm Description
All HIV + pregnant women will be asked to give a sputum sample for TB prior to TB symptom screen
Arm Title
Symptom- directed screening
Arm Type
Active Comparator
Arm Description
Only symptomatic HIV+ pregnant women will be asked to give a sputum sample for TB
Intervention Type
Other
Intervention Name(s)
Sputum sample
Primary Outcome Measure Information:
Title
Proportion of women diagnosed with TB
Description
1. Proportion of women who are diagnosed with TB in each arm
Time Frame
One year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Chaisson, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Perinatal HIV Research Unit
City
Klerksdorp
State/Province
Northwest
Country
South Africa

12. IPD Sharing Statement

Learn more about this trial

Screening for TB in Pregnancy. on HIV-Infected Pregnant Women

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