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AzTrials

Pulmonary TuberculosisNCT02053129

Evaluation of PTB Screening in ANC in Lusaka, Zambia

A study testing TB screening Questionnaire and Sputum smear and culture (only in HIV negative women who are symptomatic) in people with Pulmonary Tuberculosis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
Conditions the study is for
Pulmonary Tuberculosis
What is being tested?
TB screening Questionnaire and Sputum smear and culture (only in HIV negative women who are symptomatic)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,033 participants
Where
1 siteZambia
Study dates
Nov 2011to Dec 2013
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 to 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • HIV negative without any TB symptoms

Trial locations and contacts

1 site in 1 country.

Zambia1 site

  • Centre for Infectious Disease Research in Zambia

    Lusaka

Other trials in Zambia

About this study

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

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.

Read the 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.

Being tested
TB screening Questionnaire, Sputum smear and culture (only in HIV negative women who are symptomatic)
Keywords
tuberculosis, HIV, pregnancy
Medical subject headings
Tuberculosis, Pulmonary, Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TB screening QuestionnaireOther

    Also called Pilot TB symptom 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)Other

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

Study groups in NCT02053129
Study groupRoleWhat they receive
HIV negative pregnant womenOtherPregnant women who are HIV negative attending their first ANC visit
Receives: Other: TB screening Questionnaire
HIV positive pregnant womenOtherPregnant women who are HIV positive accessing antenatal care.
Receives: Other: TB screening Questionnaire; Other: Sputum smear and culture (only in HIV negative women who are symptomatic)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 day of screening (first antenatal visit)

Secondary outcomes (1)

  1. 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.

    Measured: 1 day of screening visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2014 (estimated)
  2. Study startNov 2011
  3. Primary completionOct 2012
  4. Study completionDec 2013

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,033 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02053129
Sponsor's protocol ID
CIDRZ 1217/IRB12-0417
Status last verified
Dec 2014
First submitted
31 Jan 2014
Last updated
15 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

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

  • 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.

    PubMed 19622990

  • 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.

    PubMed 12640889

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

  • 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.

    PubMed 19440346

  • 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.

    PubMed 12628525

  • 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.

    PubMed 9142060

  • 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.

    PubMed 9432391

  • 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.

    PubMed 11579249

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

  • 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.

    PubMed 11847922

  • 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.

  • 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.

    PubMed 16645548

  • 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.

    PubMed 17578786

  • 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.

    PubMed 10460099

Questions about this trial

What is this clinical trial studying?

A study testing TB screening Questionnaire and Sputum smear and culture (only in HIV negative women who are symptomatic) in people with Pulmonary Tuberculosis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.

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 4 inclusion and 1 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 15 Sep 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 Zambia. 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?

number of positive pulmonary tuberculosis (PTB) tests (time frame: 1 day of screening (first antenatal visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02053129, which also lists 21 linked publications.

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 15 Sep 2017.

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