HIV Infections, Tuberculosis
Conditions
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.
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.
Interventions
None listed
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
CIPRA SA
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Positive HIV Test | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Participants From the Community The number of participants from the community who attended the clinic for a once off study visit | 762 |
| Total | 762 |
Baseline characteristics
| Characteristic | Participants From the Community |
|---|---|
| Age, Categorical <=18 years | 26 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 726 Participants |
| Age Continuous | 30 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment South Africa | 762 participants |
| Sex: Female, Male Female | 422 Participants |
| Sex: Female, Male Male | 340 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 762 |
| serious Total, serious adverse events | 0 / 762 |
Outcome results
Primary
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.
Time frame: Pulmonary Tuberculosis diagnosed from sputum sample obtained at the study visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants From the Community | Number of Participants With Microbiologically Confirmed Pulmonary Tuberculosis | 23 Participants |
Secondary
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.
Time frame: HIV status at the time of the study visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Participants From the Community | Number of Participants With a Positive HIV Test | 174 Participants |