NCT00096681

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
762

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2005

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2004

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2005

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
5 years until next milestone

Results Posted

Study results publicly available

February 17, 2011

Completed
Last Updated

March 14, 2011

Status Verified

February 1, 2011

Enrollment Period

6 months

First QC Date

November 12, 2004

Results QC Date

January 14, 2011

Last Update Submit

February 17, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit

Secondary Outcomes (1)

  • Number of Participants With a Positive HIV Test

    HIV status at the time of the study visit

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Residents of the Masiphumelele township of Cape Town, South Africa

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 15113314BACKGROUND
  • 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.

    PMID: 12086758BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Sputum samples

MeSH Terms

Conditions

HIV InfectionsTuberculosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and Mycoses

Results Point of Contact

Title
Prof LG Bekker
Organization
Desmond Tutu HIV Centre

Study Officials

  • Linda Gail Bekker, MBChB, FCP, PhD

    Department of Medicine, University of Cape Town

    STUDY CHAIR
  • James McIntyre, MBChB, MRCOG

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK

Study Record Dates

First Submitted

November 12, 2004

First Posted

November 15, 2004

Study Start

February 1, 2005

Primary Completion

August 1, 2005

Study Completion

February 1, 2006

Last Updated

March 14, 2011

Results First Posted

February 17, 2011

Record last verified: 2011-02