Evaluation of PTB Screening in ANC in Lusaka, Zambia

Pulmonary Tuberculosis Clinical Trial

Official title:

Pilot Evaluation of Pulmonary Tuberculosis Screening in Antenatal Clinics in Lusaka, Zambia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053129
• Other study ID #: CIDRZ 1217/IRB12-0417
• Status: Completed
• Phase: N/A
• First received: January 31, 2014
• Last updated: September 13, 2017
• Start date: November 2011
• Est. completion date: December 2013

Study information

• Verified date: December 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5033
• Est. completion date: December 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

Intervention

Other:
• TB screening Questionnaire
All subjects will be screened with the questionnaire which assesses TB symptoms.
• Sputum smear and culture (only in HIV negative women who are symptomatic)
specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines

Locations

Country	Name	City	State
Zambia	Centre for Infectious Disease Research in Zambia	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centre for Infectious Disease Research in Zambia

Country where clinical trial is conducted

Zambia, 

References & Publications (21)

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. — View 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

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. — View 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. — View 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):292-9. doi: 10.1097/AOG.0b013e3181af33e6. — View 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.

Figueroa-Damian R, Arredondo-Garcia JL. Pregnancy and tuberculosis: influence of treatment on perinatal outcome. Am J Perinatol. 1998 May;15(5):303-6. — View Citation

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

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. Epub 2007 Jun 4. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

Tripathy SN, Tripathy SN. Tuberculosis and pregnancy. Int J Gynaecol Obstet. 2003 Mar;80(3):247-53. — View Citation

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

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

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	1 day of screening visit

External Links

•   University of North Carolina website