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

An observational study of HIV Infections and Tuberculosis, run by CIPRA SA.

Completed

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

Trial summary

The purpose of this study is to estimate the amount of HIV and tuberculosis (TB) infection in individuals 15 years and older in the Masiphumelele township of Cape Town, South Africa. Data collected in this study will be used to predict the effect of introducing anti-HIV therapy in this community. 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: 762 participants
Where: No sites listed yet
Study dates: Feb 2005to Feb 2006
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: Residents of the Masiphumelele township of Cape Town, South Africa

Who may be able to join

Resident of the Masiphumelele township for at least 1 week prior to study entry
Willing to provide informed consent
Willing to comply with study requirements

Who cannot join

None listed.

About this study

Official title: Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township

Read the detailed description

TB is the most common opportunistic infection among HIV infected people, and is the most common cause of death in HIV infected people in Africa. The Masiphumelele township of Cape Town, South Africa, with its high rates of TB and HIV, is representative of many poor communities of Africa. Via random sampling, this study will assess the prevalence of HIV and TB infections in the Masiphumelele township. Knowledge gained from this study will be used to predict if introducing antiretroviral therapy will reduce the prevalence of TB in this community.

Selection and enrollment of participants will last about 4 months. Potential participants will be visited in their homes by fieldworkers, who will explain the study. Participants will be invited to either go to the clinic on the day of the fieldworker's visit or to go on a different day. Participants who go to the clinic on the day of the visit will have two sputum samples collected with a nebulizer. Participants who do not go to the clinic on the visit day will be given a sputum sample bottle and will be asked to collect a sputum sample in the early morning the day before their clinic appointment. At the clinic appointment, another sputum sample will be collected from these participants. Direct smear acid-fast bacilli and Mycobacterium tuberculosis cultures will be done on both sputum samples. Participants who test positive for TB will be referred for TB treatment at the clinic. Participants will also be asked to complete a study questionnaire and will undergo an anonymous oral HIV test at the clinic visit.

Conditions: HIV Infections, Tuberculosis
Medical subject headings: HIV Infections, Tuberculosis

What is being measured

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

Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis
Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.
Measured: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit

Secondary outcomes (1)

Number of Participants With a Positive HIV Test
Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.
Measured: HIV status at the time of the study visit

Timeline

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

Feb 2005Feb 2006

First posted15 Nov 2004 (estimated)
Study startFeb 2005
Primary completionAug 2005
Study completionFeb 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
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: Ecologic or community
Time perspective: Prospective
Enrolment: 762 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00096681
Sponsor's protocol ID: CIPRA-SA Project 3A
Other IDs: U19AI053217, CIPRA, Project 3A
Status last verified: Feb 2011
First submitted: 12 Nov 2004
Last updated: 14 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
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, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002 Jun 15;359(9323):2059-64. doi: 10.1016/S0140-6736(02)08904-3.
PubMed 12086758

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Protocol for Cross-Sectional Survey of Acid-Fast Bacilli (AFB) Smear Positive and/or Culture Positive Tuberculosis in the Masiphumelele Township
ClinicalTrials.gov ID: NCT00096681
Acronym / sponsor ID: CIPRA-SA Project 3A
Conditions: HIV Infections, Tuberculosis
Study type: Observational
Recruitment status: Completed
Enrolment: 762 participants (actual)
Lead sponsor: CIPRA SAResearch network
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Study start: Feb 2005
Primary completion: Aug 2005 (actual)
Study completion: Feb 2006 (actual)
First posted: 15 Nov 2004 (estimated)
Results: Posted 17 Feb 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Ecologic or community
Time perspective: Prospective

Who may qualify

Ages: 15 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
Study population: Residents of the Masiphumelele township of Cape Town, South Africa

Key inclusion criteria (3 listed)

Resident of the Masiphumelele township for at least 1 week prior to study entry
Willing to provide informed consent
Willing to comply with study requirements

Key exclusion criteria (0 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis
Time frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit
Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.

1 secondary outcome

Number of Participants With a Positive HIV Test
Time frame: HIV status at the time of the study visit

Results and safety

Results posted to the registry on 17 Feb 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants From the Community	762	762

Primary outcome: Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis

Time frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit. Number. Unit: Participants

Measure	Participants From the Community n = 762
Value	23

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants From the Community	0 of 762 (0%)	0 of 762 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15113314Aaron 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.
Background: PubMed 12086758Badri M, Wilson D, Wood R. Effect of highly active antiretroviral therapy on incidence of tuberculosis in South Africa: a cohort study. Lancet. 2002 Jun 15;359(9323):2059-64. doi: 10.1016/S0140-6736(02)08904-3.

Related trials for HIV Infections

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HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
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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.

Linda Gail Bekker, MBChB, FCP, PhD study chair

Department of Medicine, University of Cape Town

James McIntyre, MBChB, MRCOG principal investigator

University of the Witwatersrand and Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Tuberculosis, run by CIPRA SA.

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 3 inclusion and 0 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 14 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

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 17 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 Pulmonary Tuberculosis (time frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study 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 NCT00096681, which also lists 2 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 14 Mar 2011.