Evaluation of PTB Screening in ANC in Lusaka, Zambia

NCT02053129 | Completed

• 1 other identifier: CIDRZ 1217/IRB12-0417
• Study Type: interventional
• Target: 5,033
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Tuberculosis

Keywords

tuberculosis; HIV; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day of screening (first antenatal visit)

Secondary Outcomes (1)

• Sensitivity and specificity of symptom-based TB screening

  1 day of screening visit

Study Arms (2)

HIV negative pregnant women

OTHER

Pregnant women who are HIV negative attending their first ANC visit

Other: TB screening Questionnaire

HIV positive pregnant women

OTHER

Pregnant women who are HIV positive accessing antenatal care.

Other: TB screening Questionnaire; Other: Sputum smear and culture (only in HIV negative women who are symptomatic)

Interventions

TB screening Questionnaire OTHER

All subjects will be screened with the questionnaire which assesses TB symptoms.

Also known as: Pilot TB symptom questionnaire

HIV negative pregnant women; HIV positive pregnant women

Sputum smear and culture (only in HIV negative women who are symptomatic) OTHER

specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines

HIV positive pregnant women

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women
• 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

You may not qualify if:

• HIV negative without any TB symptoms

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Centre for Infectious Disease Research in Zambia: collaborator

Study Sites (1)

Centre for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (21)

• Global tuberculosis control: Epidemiology, Strategy, Financing. WHO report 2009. 2009, World Health Organization: Geneva, Switzerland.

  BACKGROUND

• 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.

  PMID: 19622990 BACKGROUND

• 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.

  PMID: 12640889 BACKGROUND

• WHO. TB Country Profile for Zambia: Surveillance and Epidemiology. 2009 [cited; Available from: http://apps.who.int/globalatlas/predefinedReports/TB/PDF_Files/zmb.pdf

  BACKGROUND

• 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.

  PMID: 19440346 BACKGROUND

• 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.

  PMID: 12628525 BACKGROUND

• 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.

  PMID: 9142060 BACKGROUND

• 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.

  PMID: 9432391 BACKGROUND

• 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.

  PMID: 11579249 BACKGROUND

• WHO. Fact Sheet- Women and TB; 2009. 2009 [cited; Available from: http://www.stoptb.org/resource_center/assets/factsheets/womenandtb.pdf

  BACKGROUND

• 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.

  PMID: 11847922 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 16645548 BACKGROUND

• 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.

  PMID: 17578786 BACKGROUND

• 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.

  PMID: 10460099 BACKGROUND

• 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.

  PMID: 8190429 BACKGROUND

• 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.

  PMID: 1209197 BACKGROUND

• 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.

  PMID: 9643636 BACKGROUND

• 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.

  PMID: 7911094 BACKGROUND

• 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.

  PMID: 14998501 BACKGROUND

• 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

  BACKGROUND

Related Links

• University of North Carolina website

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Interventions

Culture Techniques; Single Person

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Stewart Reid, MD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Nzali Kancheya, MMED, MPH

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Michael Saag, MD

  Professor, University of Alabama

  PRINCIPAL INVESTIGATOR

• German Henostroza, MD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

• Annika Kruuner, MD

  Centre for Infectious Disease Research in Zambia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 3, 2014
• Study Start: November 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2013
• Last Updated: September 15, 2017

Record last verified: 2014-12

Locations

ZA (1)