EDCTP portfolio: Tuberculosis
index
The Stop TB/HIV at One study is assessing technologies to allow diagnosis of HIV and TB in a single visit.
Efficient diagnosis of HIV and TB
HIV infections greatly accelerate progression from latent TB to active TB disease. Globally, around 10% of new TB cases are among people living with HIV, and in 2016, 374,000 people with HIV and TB co-infections died – 86% of them in Africa. TB remains the leading cause of death of people with HIV.
Diagnosis of HIV is relatively straightforward, as simple and affordable point-of-care tests are available. Detection of TB is more challenging – national surveillance programmes are thought to miss a third of new cases. In particular, TB can be difficult to detect in people living with HIV, leading to delayed diagnosis and initiation of treatment.
The challenge
The Stop TB/HIV at One study aims to develop new approaches for diagnosing HIV and TB rapidly and cost-effectively. Current approaches for TB detection are not suitable for rapid and large-scale screening. Smear microscopy is time-consuming and misses a significant number of cases, and is particularly poor at identifying TB in people with HIV, who may not be able to generate a sputum sample for analysis. Molecular tests and X rays require equipment that may not be available at clinics.
To overcome these shortcomings, new point-of-care diagnostic tools are being developed. The Stop TB/HIV at One study is evaluating a range of tools for diagnosing HIV and TB. Based on the performance of these tests, it will then develop new approaches for use of these tests, or diagnostic algorithms, to enable health care workers to detect TB and HIV in the shortest possible time and at the lowest possible cost.
The performance of these new diagnostic algorithms will then be evaluated in real-life settings in Nigeria and Ethiopia.
The project
Rapid detection of TB is essential to ensure rapid initiation of treatment, which improves patient outcomes and reduces the risk of disease transmission. Earlier identification of TB and prompt treatment could prevent most TB-related deaths in people with HIV infections. However, detection of TB is challenging, particularly in people with HIV. New tests, and careful design of testing strategies, could provide diagnostic algorithms that are practical for use in health centres with limited facilities and cost-effectively improve timely detection of both HIV and TB.
Impact
“
crucial in
widening African
children’s access
to antiretrovirals
”
Bringing antiretroviral drugs to children
The CHAPAS trials have ensured that many more children with HIV have benefited
from life-saving antiretrovirals.
EDCTP portfolio: HIV & HIV-associated infections
The challenge
HIV infections greatly accelerate progression from latent TB to active TB disease. Globally, around 10% of new TB cases are among people living with HIV, and in 2016, 374,000 people with HIV and TB co-infections died – 86% of them in Africa. TB remains the leading cause of death of people with HIV.
Diagnosis of HIV is relatively straightforward, as simple and affordable point-of-care tests are available. Detection of TB is more challenging – national surveillance programmes are thought to miss a third of new cases. In particular, TB can be difficult to detect in people living with HIV, leading to delayed diagnosis and initiation of treatment.
The Stop TB/HIV at One study aims to develop new approaches for diagnosing HIV and TB rapidly and cost-effectively. Current approaches for TB detection are not suitable for rapid and large-scale screening. Smear microscopy is time-consuming and misses a significant number of cases, and is particularly poor at identifying TB in people with HIV, who may not be able to generate a sputum sample for analysis. Molecular tests and X rays require equipment that may not be available at clinics.
To overcome these shortcomings, new point-of-care diagnostic tools are being developed. The Stop TB/HIV at One study is evaluating a range of tools for diagnosing HIV and TB. Based on the performance of these tests, it will then develop new approaches for use of these tests, or diagnostic algorithms, to enable health care workers to detect TB and HIV in the shortest possible time and at the lowest possible cost.
The performance of these new diagnostic algorithms will then be evaluated in real-life settings in Nigeria and Ethiopia.
The project
The later CHAPAS-3 trial compared the efficacy and safety of three fixed-dose combinations including two without stavudine (found to have some long-term side effects in adults, leading to a recommendation that its use be discontinued in children). The trial the first of its kind in Africa studied nearly 500 children at four sites in two African countries.
Rapid detection of TB is essential to ensure rapid initiation of treatment, which improves patient outcomes and reduces the risk of disease transmission. Earlier identification of TB and prompt treatment could prevent most TB-related deaths in people with HIV infections. However, detection of TB is challenging, particularly in people with HIV. New tests, and careful design of testing strategies, could provide diagnostic algorithms that are practical for use in health centres with limited facilities and cost-effectively improve timely detection of both HIV and TB.
ratios forfixed-dose combinations and on appropriatedosage according to weight.
The CHAPAS-3 trial confirmed the effectiveness of fixed-dose combinations, providing further impetus to the rollout of antiretrovirals to children. Its evidence on abacavir informed the WHO recommendation of abacavir-containing combinations for first-line therapy in children. Trial data have also been used to support applications for regulatory approval for new scored efavirenz tablets.
Impact
L’homme RF et al. Nevirapine, stavudine and lamivudine pharmacokinetics in African children on paediatric fixed-dose combination tablets. AIDS. 2008;22(5):557–65.
Mulenga V et al. Abacavir, zidovudine, or stavudine as paediatric tablets for African HIVinfected children (CHAPAS-3): an open-label, parallel-group, randomised controlled trial. Lancet Infect Dis. 2016;16(2):169–79.
WHO. Guidelines on the use of antiretroviral drugs for treating and preventing HIV infection: recommendations for a public health approach. 2010.
WHO. Consolidated guidelines on the use of antiretroviral drugs
for treating and preventing
HIV infection: Recommendations for a public health approach
(second edition). 2016
Projects: Children with HIV in Africa Pharmacokinetics and Adherence of Simple Antiretroviral Regimens (CHAPAS): CHAPAS-1 and -3
Project lead: Professor Chifumbe Chintu, University Teaching Hospital, Zambia (CHAPAS-1); Dr Veronica Mulenga, University Teaching Hospital, Zambia (CHAPAS-3)
Target population(s): Children with HIV
Sample size: 71 (CHAPAS-1); 480 (CHAPAS-3)
Countries involved: Ireland, the Netherlands, the UK, the USA, Zambia (CHAPAS-1); Uganda, Zambia (CHAPAS-3)
Project duration: 2005–2009 (CHAPAS-1); 2010 –2011 (CHAPAS-3)
EDCTP funding: €1.2M (CHAPAS-1); €4.6M (CHAPAS-3)
Total project funding: €1.2M (CHAPAS-1); €5.0M