Trial Outcomes & Findings for Prevalence of HIV and Tuberculosis in Masiphumelele Township, Cape Town, South Africa (NCT NCT00096681)

NCT ID: NCT00096681

Last Updated: 2011-03-14

Results Overview

Confirmed Pulmonary Tuberculosis based on the sputum smear and culture results. The sputum sample was obtained at the once off study visit.

Recruitment status

COMPLETED

Target enrollment

762 participants

Primary outcome timeframe

Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit

Results posted on

2011-03-14

Participant Flow

Participant milestones

Participant milestones
Measure
Participants From the Community
The number of participants from the community who attended the clinic for a once off study visit
Overall Study
STARTED
762
Overall Study
COMPLETED
762
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Participants From the Community
n=762 Participants
The number of participants from the community who attended the clinic for a once off study visit
Age, Categorical
<=18 years
26 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
726 Participants
n=5 Participants
Age, Categorical
>=65 years
10 Participants
n=5 Participants
Age Continuous
30 years
STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male
Female
422 Participants
n=5 Participants
Sex: Female, Male
Male
340 Participants
n=5 Participants
Region of Enrollment
South Africa
762 participants
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Participants From the Community
n=762 Participants
The number of participants from the community who attended the clinic for a once off study visit
Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis
23 Participants

SECONDARY outcome

Timeframe: HIV status at the time of the study visit

Prevalence of HIV in the community based on a positive oral mucosal transudate sample obtained at the once off study visit.

Outcome measures

Outcome measures
Measure
Participants From the Community
n=762 Participants
The number of participants from the community who attended the clinic for a once off study visit
Number of Participants With a Positive HIV Test
174 Participants

Adverse Events

Participants From the Community

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof LG Bekker

Desmond Tutu HIV Centre

Phone: +2721 633 6599

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place