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Evaluation of PTB Screening in ANC in Lusaka, Zambia

Primary Purpose

Pulmonary Tuberculosis

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
TB screening Questionnaire
Sputum smear and culture (only in HIV negative women who are symptomatic)
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Tuberculosis focused on measuring tuberculosis, HIV, pregnancy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Pregnant women
  • 18 years or older
  • HIV-negative women with any TB symptoms or HIV-infected women regardless of TB symptoms
  • Attending first ANC visit at one of program clinics

Exclusion Criteria:

  • HIV negative without any TB symptoms

Sites / Locations

  • Centre for Infectious Disease Research in Zambia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HIV negative pregnant women

HIV positive pregnant women

Arm Description

Pregnant women who are HIV negative attending their first ANC visit

Pregnant women who are HIV positive accessing antenatal care.

Outcomes

Primary Outcome Measures

number of positive pulmonary tuberculosis (PTB) tests
The prevalence of culture confirmed PTB among HIV positive and HIV negative pregnant women will be measured to determine if there is a substantial amount of undiagnosed TB in the HIV positive population accessing antenatal care.

Secondary Outcome Measures

Sensitivity and specificity of symptom-based TB screening
To determine the sensitivity and specificity of symptom based TB screening (compared to TB culture), enrollees will have TB symptoms assessed by administration of a questionnaire. Culture will then be performed on all HIV infected pregnant women, with or without symptoms, and on all symptomatic HIV negative women.

Full Information

First Posted
January 31, 2014
Last Updated
September 13, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centre for Infectious Disease Research in Zambia
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1. Study Identification

Unique Protocol Identification Number
NCT02053129
Brief Title
Evaluation of PTB Screening in ANC in Lusaka, Zambia
Official Title
Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Centre for Infectious Disease Research in Zambia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot pulmonary TB screening program done in three antenatal care clinics in Lusaka, Zambia to determine the prevalence of culture-confirmed pulmonary tuberculosis and to determine the sensitivity and specificity of symptom-based TB screening.
Detailed Description
5000 pregnant women attending antenatal clinics will be evaluated by piloting a TB symptom questionnaire as part of the general health screening done at each visit. Due to the atypical and subclinical presentation of TB in HIV infected patients, culture will be performed on all HIV-infected pregnant women, with or without symptoms, and on all symptomatic HIVnegative women. Referrals for TB treatment in accordance with current national guidelines will be offered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis
Keywords
tuberculosis, HIV, pregnancy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5033 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV negative pregnant women
Arm Type
Other
Arm Description
Pregnant women who are HIV negative attending their first ANC visit
Arm Title
HIV positive pregnant women
Arm Type
Other
Arm Description
Pregnant women who are HIV positive accessing antenatal care.
Intervention Type
Other
Intervention Name(s)
TB screening Questionnaire
Other Intervention Name(s)
Pilot TB symptom questionnaire
Intervention Description
All subjects will be screened with the questionnaire which assesses TB symptoms.
Intervention Type
Other
Intervention Name(s)
Sputum smear and culture (only in HIV negative women who are symptomatic)
Intervention Description
specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines
Primary Outcome Measure Information:
Title
number of positive pulmonary tuberculosis (PTB) tests
Description
The prevalence of culture confirmed PTB among HIV positive and HIV negative pregnant women will be measured to determine if there is a substantial amount of undiagnosed TB in the HIV positive population accessing antenatal care.
Time Frame
1 day of screening (first antenatal visit)
Secondary Outcome Measure Information:
Title
Sensitivity and specificity of symptom-based TB screening
Description
To determine the sensitivity and specificity of symptom based TB screening (compared to TB culture), enrollees will have TB symptoms assessed by administration of a questionnaire. Culture will then be performed on all HIV infected pregnant women, with or without symptoms, and on all symptomatic HIV negative women.
Time Frame
1 day of screening visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pregnant women 18 years or older HIV-negative women with any TB symptoms or HIV-infected women regardless of TB symptoms Attending first ANC visit at one of program clinics Exclusion Criteria: HIV negative without any TB symptoms
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stewart Reid, MD
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nzali Kancheya, MMED, MPH
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Saag, MD
Organizational Affiliation
Professor, University of Alabama
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
German Henostroza, MD
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Annika Kruuner, MD
Organizational Affiliation
Centre for Infectious Disease Research in Zambia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Infectious Disease Research in Zambia
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Citations:
Citation
Global tuberculosis control: Epidemiology, Strategy, Financing. WHO report 2009. 2009, World Health Organization: Geneva, Switzerland.
Results Reference
background
PubMed Identifier
19622990
Citation
Black V, Brooke S, Chersich MF. Effect of human immunodeficiency virus treatment on maternal mortality at a tertiary center in South Africa: a 5-year audit. Obstet Gynecol. 2009 Aug;114(2 Pt 1):292-299. doi: 10.1097/AOG.0b013e3181af33e6.
Results Reference
background
PubMed Identifier
12640889
Citation
Mwaba P, Maboshe M, Chintu C, Squire B, Nyirenda S, Sunkutu R, Zumla A. The relentless spread of tuberculosis in Zambia--trends over the past 37 years (1964-2000). S Afr Med J. 2003 Feb;93(2):149-52.
Results Reference
background
Citation
WHO. TB Country Profile for Zambia: Surveillance and Epidemiology. 2009 [cited; Available from: http://apps.who.int/globalatlas/predefinedReports/TB/PDF_Files/zmb.pdf
Results Reference
background
PubMed Identifier
19440346
Citation
Ayles H, Schaap A, Nota A, Sismanidis C, Tembwe R, De Haas P, Muyoyeta M, Beyers N; Peter Godfrey-Faussett for the ZAMSTAR Study Team. Prevalence of tuberculosis, HIV and respiratory symptoms in two Zambian communities: implications for tuberculosis control in the era of HIV. PLoS One. 2009;4(5):e5602. doi: 10.1371/journal.pone.0005602. Epub 2009 May 19.
Results Reference
background
PubMed Identifier
12628525
Citation
Tripathy SN, Tripathy SN. Tuberculosis and pregnancy. Int J Gynaecol Obstet. 2003 Mar;80(3):247-53. doi: 10.1016/s0020-7292(02)00393-4.
Results Reference
background
PubMed Identifier
9142060
Citation
Murray CJ, Lopez AD. Mortality by cause for eight regions of the world: Global Burden of Disease Study. Lancet. 1997 May 3;349(9061):1269-76. doi: 10.1016/S0140-6736(96)07493-4.
Results Reference
background
PubMed Identifier
9432391
Citation
Harries AD, Parry C, Nyongonya Mbewe L, Graham SM, Daley HM, Maher D, Salaniponi FM, Nyangulu DS. The pattern of tuberculosis in Queen Elizabeth Central Hospital, Blantyre, Malawi: 1986-1995. Int J Tuberc Lung Dis. 1997 Aug;1(4):346-51.
Results Reference
background
PubMed Identifier
11579249
Citation
Khan M, Pillay T, Moodley JM, Connolly CA; Durban Perinatal TB HIV-1 Study Group. Maternal mortality associated with tuberculosis-HIV-1 co-infection in Durban, South Africa. AIDS. 2001 Sep 28;15(14):1857-63. doi: 10.1097/00002030-200109280-00016.
Results Reference
background
Citation
WHO. Fact Sheet- Women and TB; 2009. 2009 [cited; Available from: http://www.stoptb.org/resource_center/assets/factsheets/womenandtb.pdf
Results Reference
background
PubMed Identifier
11847922
Citation
Pillay T, Khan M, Moodley J, Adhikari M, Padayatchi N, Naicker V, Pillay DG, Coovadia HM. The increasing burden of tuberculosis in pregnant women, newborns and infants under 6 months of age in Durban, KwaZulu-Natal. S Afr Med J. 2001 Nov;91(11):983-7.
Results Reference
background
Citation
Celine R. Gounder, M., ScM*, Nikolas Wada, MPH*, Caroline Kensler, MHS*, Avy Violari, MD**, Richard E. Chaisson, MD*, James McIntyre, MBChB, FRCOG***, Neil Martinson, MBChB, MPH*,**, Provider-Initiated Screening for Tuberculosis (TB) among Pregnant Women in Antenatal Clinics in Soweto, South Africa, in 17th Conference on Retroviruses and Opportunistic Infections. 2010: San Francisco, CA. February 16 - 19 2010.
Results Reference
background
PubMed Identifier
16645548
Citation
Kali PB, Gray GE, Violari A, Chaisson RE, McIntyre JA, Martinson NA. Combining PMTCT with active case finding for tuberculosis. J Acquir Immune Defic Syndr. 2006 Jul;42(3):379-81. doi: 10.1097/01.qai.0000218434.20404.9c.
Results Reference
background
PubMed Identifier
17578786
Citation
Gupta A, Nayak U, Ram M, Bhosale R, Patil S, Basavraj A, Kakrani A, Philip S, Desai D, Sastry J, Bollinger RC; Byramjee Jeejeebhoy Medical College-Johns Hopkins University Study Group. Postpartum tuberculosis incidence and mortality among HIV-infected women and their infants in Pune, India, 2002-2005. Clin Infect Dis. 2007 Jul 15;45(2):241-9. doi: 10.1086/518974. Epub 2007 Jun 4.
Results Reference
background
PubMed Identifier
10460099
Citation
Ahmed Y, Mwaba P, Chintu C, Grange JM, Ustianowski A, Zumla A. A study of maternal mortality at the University Teaching Hospital, Lusaka, Zambia: the emergence of tuberculosis as a major non-obstetric cause of maternal death. Int J Tuberc Lung Dis. 1999 Aug;3(8):675-80.
Results Reference
background
PubMed Identifier
8190429
Citation
Margono F, Mroueh J, Garely A, White D, Duerr A, Minkoff HL. Resurgence of active tuberculosis among pregnant women. Obstet Gynecol. 1994 Jun;83(6):911-4. doi: 10.1097/00006250-199406000-00001.
Results Reference
background
PubMed Identifier
1209197
Citation
Bjerkedal T, Bahna SL, Lehmann EH. Course and outcome of pregnancy in women with pulmonary tuberculosis. Scand J Respir Dis. 1975;56(5):245-50.
Results Reference
background
PubMed Identifier
9643636
Citation
Figueroa-Damian R, Arredondo-Garcia JL. Pregnancy and tuberculosis: influence of treatment on perinatal outcome. Am J Perinatol. 1998 May;15(5):303-6. doi: 10.1055/s-2007-993948.
Results Reference
background
PubMed Identifier
7911094
Citation
Jana N, Vasishta K, Jindal SK, Khunnu B, Ghosh K. Perinatal outcome in pregnancies complicated by pulmonary tuberculosis. Int J Gynaecol Obstet. 1994 Feb;44(2):119-24. doi: 10.1016/0020-7292(94)90064-7.
Results Reference
background
PubMed Identifier
14998501
Citation
Pillay T, Khan M, Moodley J, Adhikari M, Coovadia H. Perinatal tuberculosis and HIV-1: considerations for resource-limited settings. Lancet Infect Dis. 2004 Mar;4(3):155-65. doi: 10.1016/S1473-3099(04)00939-9.
Results Reference
background
Citation
Amita Gupta, N.G., Sandesh Patil, Pradeep Sambarey, Sandhya Khadse, Anju Kagal, Suvarna Joshi, Arun Jamkar, Robert Bollinger, and the SWEN India Study Group1Johns, Maternal TB is associated with increased risk of HIV mother-to-child transmission, in 17th Conference on Retroviruses and Opportunistic Infections. 2010: San Francisco, CA. February 16 - 19 2010
Results Reference
background
Links:
URL
http://www.unc.edu
Description
University of North Carolina website

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Evaluation of PTB Screening in ANC in Lusaka, Zambia

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