TuberculosisNCT02043067
Enhanced TB Screening to Determine the Prevalence and Incidence of TB in Patients With HIV
An observational study of Tuberculosis, run by University of North Carolina, Chapel Hill at 1 site in Zambia.
Trial summary
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB). Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Comprehensive TB screening
- How many people
- 400 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2011to May 2013
- Phase
- Observational
- 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 16 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not currently being treated for TB.
Who may be able to join
- Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent
- Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs
- Not have taken any TB treatment in the past 3 months
- Willing to provide locator information and allow study staff to contact by phone or visit them at home if required
Who cannot join
- Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
Read the detailed description
Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB. Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB. As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care. This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated). In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.
- Conditions
- Tuberculosis
- Being tested
- Comprehensive TB screening
- Keywords
- TB, HIV, Extensively resistant TB, Extra pulmonary TB
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive TB screeningOther
All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
| Study group | Role | What they receive |
|---|---|---|
| new HIV clinic enrollees | All new enrollees to a Lusaka HIV clinic will receive a full TB work-up. Receives: Other: Comprehensive TB screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of undiagnosed TB in those with HIV.
Among the cohort of 400 new enrollees at the clinic, all will be tested for TB at the specified time points using enhanced TB screening. Initial diagnosis will use smear microscopy and culture. Chest X-ray will be performed on the second day of enrollment. Presumptive Diagnosis: As culture results will take several days or weeks to become available, a presumptive diagnosis will be made based on history and physical exam, symptoms, smear microscopy and chest radiography results. All patients who are smear-positive by at least one sample will be diagnosed with TB per national guidelines. Patients who are smear-negative or suspected of extra-pulmonary TB based on clinical or radiographic findings may be treated empirically for TB at the discretion of a clinical or medical officer. Sputum samples will also be sent for testing at the end of the study with the Xpert MTB/RIF assay.
Measured: Enrollment screening visit
Secondary outcomes (1)
Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
To account for patients who are censored prior to 12 months of follow-up, the incidence of TB will be calculated as a rate. Each patient will contribute follow-up time until they are censored, are diagnosed with TB, or have been in the study for 12 months. Patients who were diagnosed with TB at enrollment will not be included.
Measured: enrollment, 3, 6, 9 and 12 month visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2014 (estimated)
- Study startOct 2011
- Primary completionSep 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Stewart Reid, MD, Principal investigator, CIDRZ; University of North Carolina at Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043067
- Sponsor's protocol ID
- CIDRZ 1226/IRB12-0416
- Status last verified
- Dec 2014
- First submitted
- 16 Jan 2014
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Harris JB, Hatwiinda SM, Randels KM, Chi BH, Kancheya NG, Jham MA, Samungole KV, Tambatamba BC, Cantrell RA, Levy JW, Kimerling ME, Reid SE. Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Jul;12(7):773-9.
PubMed 18544203Moore D, Liechty C, Ekwaru P, Were W, Mwima G, Solberg P, Rutherford G, Mermin J. Prevalence, incidence and mortality associated with tuberculosis in HIV-infected patients initiating antiretroviral therapy in rural Uganda. AIDS. 2007 Mar 30;21(6):713-9. doi: 10.1097/QAD.0b013e328013f632.
PubMed 17413692Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis. 2004 Jun;8(6):792-5.
PubMed 15182152Day JH, Charalambous S, Fielding KL, Hayes RJ, Churchyard GJ, Grant AD. Screening for tuberculosis prior to isoniazid preventive therapy among HIV-infected gold miners in South Africa. Int J Tuberc Lung Dis. 2006 May;10(5):523-9.
PubMed 16704034Lawn SD, Myer L, Bekker LG, Wood R. Burden of tuberculosis in an antiretroviral treatment programme in sub-Saharan Africa: impact on treatment outcomes and implications for tuberculosis control. AIDS. 2006 Aug 1;20(12):1605-12. doi: 10.1097/01.aids.0000238406.93249.cd.
PubMed 16868441Wood R, Middelkoop K, Myer L, Grant AD, Whitelaw A, Lawn SD, Kaplan G, Huebner R, McIntyre J, Bekker LG. Undiagnosed tuberculosis in a community with high HIV prevalence: implications for tuberculosis control. Am J Respir Crit Care Med. 2007 Jan 1;175(1):87-93. doi: 10.1164/rccm.200606-759OC. Epub 2006 Sep 14.
PubMed 16973982Wise J. Southern Africa is moving swiftly to combat the threat of XDR-TB. Bull World Health Organ. 2006 Dec;84(12):924-5. No abstract available.
PubMed 17242824Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0.
PubMed 9989714Hernandez-Garduno E, Cook V, Kunimoto D, Elwood RK, Black WA, FitzGerald JM. Transmission of tuberculosis from smear negative patients: a molecular epidemiology study. Thorax. 2004 Apr;59(4):286-90. doi: 10.1136/thx.2003.011759.
PubMed 15047946Kimerling ME, Schuchter J, Chanthol E, Kunthy T, Stuer F, Glaziou P, Ee O. Prevalence of pulmonary tuberculosis among HIV-infected persons in a home care program in Phnom Penh, Cambodia. Int J Tuberc Lung Dis. 2002 Nov;6(11):988-94.
PubMed 12475145Ba F, Rieder HL. A comparison of fluorescence microscopy with the Ziehl-Neelsen technique in the examination of sputum for acid-fast bacilli. Int J Tuberc Lung Dis. 1999 Dec;3(12):1101-5.
PubMed 10599014Mugusi F, Villamor E, Urassa W, Saathoff E, Bosch RJ, Fawzi WW. HIV co-infection, CD4 cell counts and clinical correlates of bacillary density in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2006 Jun;10(6):663-9.
PubMed 16776454Siddiqi K, Lambert ML, Walley J. Clinical diagnosis of smear-negative pulmonary tuberculosis in low-income countries: the current evidence. Lancet Infect Dis. 2003 May;3(5):288-96. doi: 10.1016/s1473-3099(03)00609-1.
PubMed 12726978Bakari M, Arbeit RD, Mtei L, Lyimo J, Waddell R, Matee M, Cole BF, Tvaroha S, Horsburgh CR, Soini H, Pallangyo K, von Reyn CF. Basis for treatment of tuberculosis among HIV-infected patients in Tanzania: the role of chest x-ray and sputum culture. BMC Infect Dis. 2008 Mar 6;8:32. doi: 10.1186/1471-2334-8-32.
PubMed 18325120Swaminathan S, Paramasivan CN, Kumar SR, Mohan V, Venkatesan P. Unrecognised tuberculosis in HIV-infected patients: sputum culture is a useful tool. Int J Tuberc Lung Dis. 2004 Jul;8(7):896-8.
PubMed 15260283
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced TB Screening to Determine the Prevalence and Incidence of TB in a Cohort of HIV Clinic Patients in Lusaka, Zambia
- ClinicalTrials.gov ID
- NCT02043067
- Acronym / sponsor ID
- CIDRZ 1226/IRB12-0416
- Conditions
- Tuberculosis
- Keywords
- TB, HIV, Extensively resistant TB, Extra pulmonary TB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Centers for Disease Control and Prevention
- Study start
- Oct 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 23 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of tuberculosis (TB).
Detailed description
Zambia is a high burden country for both HIV and TB infection and HIV clinic enrollees are a high-risk group for active TB. Current Zambian Ministry of Health screening protocols are symptom-based even though active case-finding studies in HIV-infected populations have shown that symptoms are not always predictive of active TB. As a result, there may be a significant amount of un-diagnosed TB among HIV-infected Zambians even in the context of accessing HIV care. This study will examine an enhanced protocol to systematically screen a cohort of 400 new HIV clinic enrollees for prevalence and 1-year incidence of TB using symptoms, light and fluorescence microscopy, chest radiography and TB culture of sputum and extra-pulmonary fluids (when indicated). In addition, the sensitivity, specificity and cost-effectiveness of each diagnostic tool will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new HIV clinic enrollees | – | Other: Comprehensive TB screeningAll new enrollees to a Lusaka HIV clinic will receive a full TB work-up. |
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Four hundred new enrollees at the Kalingalinga HIV Care and Treatment Clinic who are not currently being treated for TB.
Key inclusion criteria (4 listed)
- Persons with HIV/AIDS, 16 years of age or older, who are enrolling at the Kalingalinga ART clinic and are able and willing to provide informed consent
- Antiretroviral therapy-naïve except for short-course therapy through prevention of mother-to-child-transmission programs
- Not have taken any TB treatment in the past 3 months
- Willing to provide locator information and allow study staff to contact by phone or visit them at home if required
Key exclusion criteria (1 listed)
- Any condition, including active drug or alcohol use, which in the opinion of the investigators, would interfere with adherence to study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive TB screeningAll enrollees will receive a comprehensive TB screening regardless of symptom presentation. | Other | new HIV clinic enrollees |
Primary outcome
Prevalence of undiagnosed TB in those with HIV.
Time frame: Enrollment screening visit
Among the cohort of 400 new enrollees at the clinic, all will be tested for TB at the specified time points using enhanced TB screening. Initial diagnosis will use smear microscopy and culture. Chest X-ray will be performed on the second day of enrollment. Presumptive Diagnosis: As culture results will take several days or weeks to become available, a presumptive diagnosis will be made based on history and physical exam, symptoms, smear microscopy and chest radiography results. All patients who are smear-positive by at least one sample will be diagnosed with TB per national guidelines. Patients who are smear-negative or suspected of extra-pulmonary TB based on clinical or radiographic findings may be treated empirically for TB at the discretion of a clinical or medical officer. Sputum samples will also be sent for testing at the end of the study with the Xpert MTB/RIF assay.
1 secondary outcome
Incidence of TB in a cohort of HIV clinic patients screened as 'TB negative'.
Time frame: enrollment, 3, 6, 9 and 12 month visits.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Background: PubMed 18544203Harris JB, Hatwiinda SM, Randels KM, Chi BH, Kancheya NG, Jham MA, Samungole KV, Tambatamba BC, Cantrell RA, Levy JW, Kimerling ME, Reid SE. Early lessons from the integration of tuberculosis and HIV services in primary care centers in Lusaka, Zambia. Int J Tuberc Lung Dis. 2008 Jul;12(7):773-9.
- Background: PubMed 17413692Moore D, Liechty C, Ekwaru P, Were W, Mwima G, Solberg P, Rutherford G, Mermin J. Prevalence, incidence and mortality associated with tuberculosis in HIV-infected patients initiating antiretroviral therapy in rural Uganda. AIDS. 2007 Mar 30;21(6):713-9. doi: 10.1097/QAD.0b013e328013f632.
- Background: PubMed 15182152Mohammed A, Ehrlich R, Wood R, Cilliers F, Maartens G. Screening for tuberculosis in adults with advanced HIV infection prior to preventive therapy. Int J Tuberc Lung Dis. 2004 Jun;8(6):792-5.
- Background: PubMed 16704034Day JH, Charalambous S, Fielding KL, Hayes RJ, Churchyard GJ, Grant AD. Screening for tuberculosis prior to isoniazid preventive therapy among HIV-infected gold miners in South Africa. Int J Tuberc Lung Dis. 2006 May;10(5):523-9.
- Background: PubMed 16868441Lawn SD, Myer L, Bekker LG, Wood R. Burden of tuberculosis in an antiretroviral treatment programme in sub-Saharan Africa: impact on treatment outcomes and implications for tuberculosis control. AIDS. 2006 Aug 1;20(12):1605-12. doi: 10.1097/01.aids.0000238406.93249.cd.
- Background: PubMed 16973982Wood R, Middelkoop K, Myer L, Grant AD, Whitelaw A, Lawn SD, Kaplan G, Huebner R, McIntyre J, Bekker LG. Undiagnosed tuberculosis in a community with high HIV prevalence: implications for tuberculosis control. Am J Respir Crit Care Med. 2007 Jan 1;175(1):87-93. doi: 10.1164/rccm.200606-759OC. Epub 2006 Sep 14.
- Background: PubMed 17242824Wise J. Southern Africa is moving swiftly to combat the threat of XDR-TB. Bull World Health Organ. 2006 Dec;84(12):924-5. No abstract available.
- Background: PubMed 9989714Behr MA, Warren SA, Salamon H, Hopewell PC, Ponce de Leon A, Daley CL, Small PM. Transmission of Mycobacterium tuberculosis from patients smear-negative for acid-fast bacilli. Lancet. 1999 Feb 6;353(9151):444-9. doi: 10.1016/s0140-6736(98)03406-0.
- Background: PubMed 15047946Hernandez-Garduno E, Cook V, Kunimoto D, Elwood RK, Black WA, FitzGerald JM. Transmission of tuberculosis from smear negative patients: a molecular epidemiology study. Thorax. 2004 Apr;59(4):286-90. doi: 10.1136/thx.2003.011759.
- Background: PubMed 12475145Kimerling ME, Schuchter J, Chanthol E, Kunthy T, Stuer F, Glaziou P, Ee O. Prevalence of pulmonary tuberculosis among HIV-infected persons in a home care program in Phnom Penh, Cambodia. Int J Tuberc Lung Dis. 2002 Nov;6(11):988-94.
- Background: PubMed 10599014Ba F, Rieder HL. A comparison of fluorescence microscopy with the Ziehl-Neelsen technique in the examination of sputum for acid-fast bacilli. Int J Tuberc Lung Dis. 1999 Dec;3(12):1101-5.
- Background: PubMed 16776454Mugusi F, Villamor E, Urassa W, Saathoff E, Bosch RJ, Fawzi WW. HIV co-infection, CD4 cell counts and clinical correlates of bacillary density in pulmonary tuberculosis. Int J Tuberc Lung Dis. 2006 Jun;10(6):663-9.
- University of North Carolina websiteLink provided by the sponsor.
Related trials for Tuberculosis
RecruitingPhase 4
Short-term Antibiotic Therapy in Mycobacterium Avium Complex Pulmonary Disease
Mycobacterium Avium Complex Pulmonary Disease
RecruitingObservational study
Paradoxical Tuberculosis Reactions in Patients Without HIV Infection
Tuberculosis
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
RecruitingPhase 1/2
A Study of Daily Rifapentine Combined With Isoniazid (1HP) for Tuberculosis Prevention in Children Less Than 13 Years of Age With and Without HIV
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stewart Reid, MD principal investigator
CIDRZ; University of North Carolina at Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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?
Prevalence of undiagnosed TB in those with HIV. (time frame: Enrollment screening 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 NCT02043067, which also lists 27 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.