Research Studies

Area

Locations
Countries
Funders
Principal Investigators
Research Partners
Researches Involved
Year
  • Methodological approach: This is an observational cohort study. Pulmonary TB patients will be enrolled at the time of TB diagnosis and prospectively followed for at least two years after TB treatment initiation with optional prolonged follow-up. Study visits will be performed in the study clinics or if necessary at the participant’s home at predefined time points after TB treatment initiation. Clinical assessments, biological sample collections and collection of socio-economic data will be performed according to the pre-defined schedule of events.

    Key Findings: 

    Outputs/Outcomes: This project aims to advance the understanding of the clinical, microbiologic, and host immune factors affecting the long-term sequelae of pulmonary tuberculosis; to identify the most important factors that contribute to lung impairment, including the immunological response and genetic predisposition of the host and differences in the biology of the pathogen; to determine occurrence of reversible and irreversible costs and socioeconomic consequences for patients; and to facilitate novel interventions to restore and preserve overall health, well-being and financial protection in patients with TB.

    Related resources: https://www.tbsequel.org/

    Timeline: September 2017-December 2021
    Research Partners: Instituto Nacional de Saúde (INS), Karolinska Institutet, Stockholm, Sweden, Klinikum der LMU (KUM), Munich, Medical Research Council (MRC) Unit The Gambia at LSHTM, Fajara, The Gambia, Ministry of Health, Mozambique, NIMR-Mbeya Medical Research Center (NIMR-MMRC), Mbeya in Tanzania, Research Center Borstel (RCB), Borstel, University of the Witwatersrand (WITS), Johannesburg in South Africa, World Health Organisation, Geneva, Switzerland
    Locations: South Africa, The Gambia, Mozambique, Tanzania
  • Methodological approach: Randomized control trial: participants who received 6 months IPT were followed for 12 months and the 3HP arms were followed for 24 months.

    Key Findings: A single course of weekly rifapentine and isoniazid for three months (3HP) provides lasting protection against TB and does not need to be repeated year after year. Adherence was higher among 3HP groups than among patients taking 6 months IPT. Treatment completion was better amongst 3HP arms than the 6H arm.

    Outputs/Outcomes: N/A 

    Related resources:

    Timeline: November 2016 to November 2019
    Research Partners: Centro de Investigação de Saúde de Manhiça (CISM) in Mozambique, Global One Health initiative in Ethiopia, Perinatal HIV Research Unit (PHRU) in South Africa, The Ohio State University, Global One Health initiative in Ethiopia
    Locations: South Africa, Mozambique and Ethiopia
  • Methodological approach: A formative phase was used to identify gaps in the TB contact tracing cascade using (CHWs) and develop an intervention.  Implementation research using quality improvement methods to implement and evaluate a more focused approach to TB contact tracing using CHWs and mHealth. Cost-effectiveness analysis, in-depth interviews and focus group discussions used to assess feasibility and utility of the intervention.

    Key Findings: 

    Outputs/Outcomes:

    • Incremental number of TB cases identified and treated in health facilities
    • Cost per TB case detected
    • Utility of the intervention 

    Related resources: A policy brief highlighting barriers and recommendations to TB contact tracing using CHWs was developed by the study team at the request of the South African TB Think Tank.

    Timeline: May 2016 – December 2019
    Research Partners: Johns Hopkins University, University of Pretoria
    Locations: Gauteng, KwaZulu-Natal, North West
  • Methodological approach: A longitudinal (prospective cohort) study was conducted at South African gold mines to identify miners who have been working in the mines for at least 15 years but have no evidence of TB infection and were HIV positive. Miners were screened for eligibility and chest radiographs were reviewed to exclude current or prior TB, and medical records were also reviewed to confirm HIV status. Enrolment was offered to HIV-positive individuals with no prior or current TB and blood was collected for QFT, plasma, peripheral blood mononuclear cells (PBMC) processing, whole blood bactericidal assay (WBA) and transcriptomics. In addition to QFT for LTBI, tuberculin skin test (TST) was also done. Sputum was collected for culture testing to identify subclinical TB cases. To assess the stability of the resistant phenotype, miners who were QFT negative at enrolment were followed up six and 12 months post enrolment and further bloods were taken for plasma, PBMC processing, transcriptomics and WBA from those not started on TB treatment. Tests for LTBI (QFT and TST) was repeated at each follow up visit. Embedded within the longitudinal study was a case control study to identify gene expression and immunological profiles associated with being TB-uninfected

    Key Findings: Still analysing and completing lab tests

    Outputs/Outcomes: This work offers innovative approaches to understanding the mechanisms that underlie resistance and susceptibility to Mtb infection in HIV infected individuals which may point to novel approaches to TB vaccine and therapeutic strategies that incorporate host-directed therapies (HDT) to subvert immune evasion by Mtb.

    Related resources:

    Timeline: 2016 – 2021
    Research Partners: Case Western Reserve University, The Aurum Institute , University of Washington
    Locations: Gold mines, Orkney - North West Carletonville - Gauteng
  • Methodological approach: A data quality methodology was applied, with a baseline data quality assessment (DQA) of DR-TB records conducted in 2017. Following the baseline, a data quality improvement process (QIP) was applied to the 2015 - 2017 records as the intervention methodology. In addition a quality assurance (QA) audit of the updated records was used to measure the intervention (data QIP). We use data completeness, Concordance and Validity as components to measure data quality.

    Key Findings: Data quality improvement for approximately 6 500 records updated between 2015 - 2017. The data show 90% - 100% data completeness of primary data elements between the patient clinical folder (PCF) and EDRWeb; 100% agreement between PCF and EDRWeb with kappa (k) statistic = 1.0; Sensitivity and positive predictive values (PPV) 100% between 2015 - 17 records.

    Outputs/Outcomes: This project has provided excellent quality data in support of full registration for Bedaquiline (BDQ) at the United States Food and Drug Agency (USFDA), European Medicines Agency (EMA) and South African Health Products Regulatory Authority (SAHPRA).

    Related resources: Data quality abstraction and EDRWeb updating SOP, EDRWeb sampling SOP, Consolidated DQA report (2015-17), Baseline DQA report shared with funder for submission to FDA, EMA, SAHPRA Data Quality journal article submitted for publication to Public Health Action (PHA).

    Timeline: 2015 - 2020
    Locations: Eastern Cape, KZN, Gauteng, WC