TO ACCESS THE INDIVIDUAL-LEVEL EFFECTS OF HIV AND ANTIRETROVIRAL THERAPY
Conditions
Keywords
EVALUATING TUBERCULOSIS
Brief summary
The overarching objective/aim of the study is to assess pulmonary TB treatment and longer-term outcomes among people with and without HIV in African population in order to inform policy and practice around TB treatment and create a platform for additional TB research in Zambia
Detailed description
The TB-SRN study will be a prospective observational non-interventional study open to enrollment for individuals ≥15 years of age diagnosed with active pulmonary TB that is either bacteriologically confirmed or clinically diagnosed in HIV-positive and HIV-negative participants. The enrollment will be consecutively, regardless of drug resistance and HIV status. When the sample size of 300 consecutively enrolled TB patients is reached per site, we will enroll additionally drug-resistant TB patients (defined as GeneXpert MTB/RIF positive) until will reach a target of 150 drug resistant TB patients at each site. TB treatment will be managed according to and by the existing standard of care/systems, but those who provide informed consent and agree to participate will contribute other study-related data, which may require additional radiograph(s), laboratory tests, and healthcare-related outcomes measures beyond those collected during routine care. Participants may be co-enrolled in an affiliated or external observational or interventional study
Interventions
None listed
Sponsors
Centre for Infectious Disease Research in Zambia
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
15 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Be ≥15 years of age * Clinically diagnosed pulmonary TB and initiated/to be initiated on anti-TB treatment, as determined by medical providers through standard of care, on the basis of either. * Microbiologically confirmed pulmonary TB based on sputum or other respiratory samples with either
Exclusion criteria
* Have plans to follow-up for TB care at a site distant from the enrollment site, imminent plans to move from his/her current area of residence, or plans to return to a distant area of residence, which would interfere with the participant's ability to complete all study visits (through the 12-month post-treatment visit). * 1\. Received \>1 week of TB treatment within the prior 30 days, excluding TB preventive therapy * 3\. Have substantial cognitive impairment that in the opinion of the site investigator or designee may interfere with the ability to give reliable informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants achieving successful pulmonary tuberculosis treatment outcome at the end of TB treatment | 4 YEARS | The proportion of participants who achieve a successful pulmonary tuberculosis treatment outcome at the end of the TB treatment period. Treatment success will be defined according to the study-prespecified TB treatment outcome definitions and will be compared between participants with and without HIV. |
Countries
Zambia
Outcome results
None listed