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HIV InfectionsNCT00346476

Characteristics and Prevalence of Tuberculosis and HIV in Masiphumelele Township, Cape Town, South Africa

An observational study of HIV Infections and Tuberculosis, run by CIPRA SA at 2 sites in South Africa.

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

The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. Read more about this study

Who is it for?
Ages 15 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Infections, Tuberculosis
How many people
1,250 participants
Where
2 sitesSouth Africa
Study dates
Apr 2006to Dec 2010
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 15 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: HIV and TB infected and uninfected individuals

Who may be able to join

  • Willing to comply with study requirements
  • Parent or guardian willing to provide informed consent, if applicable
  • Inclusion Criteria for Participants in First Part of the Study:
  • Live in Masiphumelele Township, Cape Town, South Africa for at least 1 week
  • Inclusion Criteria for Participants in Second Part of the Study:
  • Live in Masiphumelele Township, Cape Town, South Africa
  • Registered TB patient at the study site

Who cannot join

  • Currently incarcerated
  • Exclusion Criteria for Participants in Second Part of the Study:
  • No Mycobacterium tuberculosis specimen obtained from the participant for genetic analysis

Trial locations and contacts

2 sites in 1 country.

South Africa2 sites

  • Desmond Tutu HIV Centre Department of Medicine

    Cape Town, Western Cape, 7925

  • Desmond Tutu HIV Centre Department of Medicine

    Cape Town, 8005

Other trials in South Africa

About this study

Official title: A Study of the Effects of Antiretroviral Therapy on Rates and Transmission of Tuberculosis

The purpose of this study is to determine the number of people infected with tuberculosis (TB) in the Masiphumelele Township of Cape Town, South Africa, a community with high rates of TB and HIV. This study will also examine the genetics of TB and the relationships among active TB infection, new HIV infections, and HIV disease progression.

Read the detailed description

TB is the most common opportunistic infection and the single most common cause of death in HIV infected people in Africa today. Latent TB infection has been known to revert to active TB following new infection in HIV infected people; also, TB has been shown to accelerate the progression of HIV disease. These epidemiologic relationships between TB and HIV and the high prevalence of these diseases in sub-Saharan Africa make studying TB and HIV infected populations in this region of the world important. The Masiphumelele Township of Cape Town, South Africa, with its high rates of TB and HIV, is representative of many poor communities in Africa. The purpose of this study is to observe people from the Masiphumelele Township over a 5-year period to assess the prevalence of TB and HIV infections in a random sample of people and the clinical and genetic characteristics of active TB infection.

This study has two parts: a random cross-sectional survey and a clinical and genetic assessment of TB patients. Participants in the random survey will only be involved with the study for a maximum of 2 days. The purpose of the first part of the study is to compare the prevalence of active TB and the prevalence of HIV infection in a random sample of people from the Masiphumelele Township. In this part of the study, children and adults will be randomly selected from the township population to determine the prevalence of active TB and the prevalence of HIV infection in this group of people. Fieldworkers will identify eligible participants in the township and will ask them to visit the clinic that day or the next. At the clinic, participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. A sputum sample will be collected from each participant with a nebulizer; each participant will also be given a sputum sample bottle and will be asked to collect an early morning sputum sample on the next day that will be returned to the clinic.

The second part of the study will enroll TB patients. Participants in this part of this study will be followed for the course of their TB treatment for at least 6 months. The purpose of the second part of the study is to assess changes through time of the clustering and transmission of TB among HIV infected and uninfected people in the Masiphumelele Township. This assessment will include examining the diversity of TB strains in this population and determining the relationship between recurrent cases of TB and HIV infection. All sputum samples indicating TB infections that were previously collected from participants will undergo genetic testing by restriction fragment length polymorphism (RFLP) analysis. Participants will be asked to complete a demographics and TB history questionnaire and provide a saliva sample for anonymous HIV testing. Participants will also be interviewed about treatment they have received for TB, their responses to this treatment, and whether they are currently on highly active antiretroviral therapy (HAART) for the treatment of HIV infection.

Participants who are found to be infected with TB during the first part of the study will be offered TB treatment through the clinic and will be invited to participate in the second part of this study. Participants who are found to be infected with HIV during the study will be referred to further treatment and evaluation.

Keywords
TB, Transmission, Genetic Diversity, Genetic Testing, RFLP
Medical subject headings
HIV Infections, Tuberculosis

What participants receive

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

Study groups in NCT00346476
Study groupRoleWhat they receive
ParticipantsIndividuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV

What is being measured

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

  1. Number of Participants With Microbiologically Confirmed Tuberculosis Infection

    Measured: At Year 5

  2. Number of Participants With HIV Infection

    Measured: At Year 5

Secondary outcomes (4)

  1. Changes in Clustering and Transmission of TB Among HIV Infected and Uninfected Participants

    Measured: Year 1 to Year 5

  2. Changes in the Clustering and Transmission of TB Among HIV Infected and Uninfected Participants After the Introduction of HAART

    Measured: Year 1 to Year 5

  3. Diversity of TB Strains Among HIV Infected Participants Receiving HAART, HIV Infected Participants Not Receiving HAART, and HIV Uninfected Participants

    Measured: Year 1 to Year 5

  4. Number of Recurrent Cases of TB Attributable to Endogenous Reactivation Versus Exogenous Re-infection in Both HIV Infected and Uninfected Participants

    Measured: At Year 5

Timeline

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

  1. First posted30 Jun 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
Ecologic or community
Time perspective
Prospective
Enrolment
1,250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00346476
Sponsor's protocol ID
CIPRA-SA Project 3B
Other IDs
U19AI053217
Status last verified
Feb 2011
First submitted
28 Jun 2006
Last updated
11 Feb 2011
Data monitoring committee
No

Publications

  • Aaron L, Saadoun D, Calatroni I, Launay O, Memain N, Vincent V, Marchal G, Dupont B, Bouchaud O, Valeyre D, Lortholary O. Tuberculosis in HIV-infected patients: a comprehensive review. Clin Microbiol Infect. 2004 May;10(5):388-98. doi: 10.1111/j.1469-0691.2004.00758.x.

    PubMed 15113314

  • Badri M, Ehrlich R, Wood R, Pulerwitz T, Maartens G. Association between tuberculosis and HIV disease progression in a high tuberculosis prevalence area. Int J Tuberc Lung Dis. 2001 Mar;5(3):225-32.

    PubMed 11326821

  • Friedland G, Harries A, Coetzee D. Implementation issues in tuberculosis/HIV program collaboration and integration: 3 case studies. J Infect Dis. 2007 Aug 15;196 Suppl 1:S114-23. doi: 10.1086/518664.

    PubMed 17624820

  • Kwara A, Flanigan TP, Carter EJ. Highly active antiretroviral therapy (HAART) in adults with tuberculosis: current status. Int J Tuberc Lung Dis. 2005 Mar;9(3):248-57.

    PubMed 15786886

  • Maher D, Harries A, Getahun H. Tuberculosis and HIV interaction in sub-Saharan Africa: impact on patients and programmes; implications for policies. Trop Med Int Health. 2005 Aug;10(8):734-42. doi: 10.1111/j.1365-3156.2005.01456.x.

    PubMed 16045459

  • Perkins MD, Cunningham J. Facing the crisis: improving the diagnosis of tuberculosis in the HIV era. J Infect Dis. 2007 Aug 15;196 Suppl 1:S15-27. doi: 10.1086/518656.

    PubMed 17624822

  • Wood R, Maartens G, Lombard CJ. Risk factors for developing tuberculosis in HIV-1-infected adults from communities with a low or very high incidence of tuberculosis. J Acquir Immune Defic Syndr. 2000 Jan 1;23(1):75-80. doi: 10.1097/00126334-200001010-00010.

    PubMed 10708059

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Tuberculosis, run by CIPRA SA at 2 sites in South Africa.

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 7 inclusion and 3 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 11 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Africa. 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?

Yes. Results are posted in the registry (first posted 9 Feb 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Participants With Microbiologically Confirmed Tuberculosis Infection (time frame: At Year 5). The study lists 2 primary outcomes in all. 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 NCT00346476, which also lists 7 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 11 Feb 2011.

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