Conference Material > Abstract
Lissouba P, Huerga H, Rucker C
Epicentre Scientific Day Paris 2021. 2021 June 10
BACKGROUND
The novel point-of-care urine-based FujiLAM test is promising for diagnosis of tuberculosis. We assessed the diagnostic yield of FujiLAM in HIV patients and the feasibility of using the test.
METHODS
We conducted a prospective diagnostic study and a mixed-methods feasibility and acceptability study in 4 countries: Uganda, Kenya,
Mozambique and South Africa. The diagnostic study included 2 groups of ambulatory HIV-positive adults: 1) with TB symptoms, 2) with advanced HIV disease and no TB symptoms. Patients received FujiLAM and AlereLAM, Xpert MTB/RIF, culture and chest X-ray. The feasibility study included test’ users, key informants and patients who participated through standard questionnaires, individual interviews and group discussions.
RESULTS
We included 1117 patients in the diagnostic study: 712 with TB symptoms (Group 1) and 405 with advanced HIV disease and no TB
symptoms (Group 2). TB was confirmed in 9.2% (63/685) and 4.1% (16/395) in Group 1 and 2, respectively. FujiLAM diagnostic yield among patients with confirmed TB was 63.2% and 43.8% in Group 1 and 2, respectively. FujiLAM diagnostic yield by CD4 count was: 75.0% in CD4<200, 77.8% in CD4 200-349, 31.3% in CD4≥350 (Group 1) and 46.7% in CD4<200 (Group 2). Most of the test users (including lay health workers) found FujiLAM easy to perform. The main concern was the multiple timed steps involved. Invalid results were obtained if test cartridges were dropped or performed on blood stained or cloudy urine. Most patients viewed urine sampling
positively and easier than sputum provision.
CONCLUSIONS
FujiLAM detects TB in a high proportion of the HIV patients with confirmed TB who have symptoms of TB and low CD4 counts, and in
a considerable proportion of those asymptomatic. The test is easy to perform at point-of-care. Urine sampling is well accepted by patients. These results encourage the future use of the FujiLAM assay.
KEY MESSAGES: The novel urine-based FujiLAM is a useful and easy to use point-of care test for TB diagnosis in HIV-positive patients. Urine sampling is well accepted.
This abstract is not to be quoted for publication.
The novel point-of-care urine-based FujiLAM test is promising for diagnosis of tuberculosis. We assessed the diagnostic yield of FujiLAM in HIV patients and the feasibility of using the test.
METHODS
We conducted a prospective diagnostic study and a mixed-methods feasibility and acceptability study in 4 countries: Uganda, Kenya,
Mozambique and South Africa. The diagnostic study included 2 groups of ambulatory HIV-positive adults: 1) with TB symptoms, 2) with advanced HIV disease and no TB symptoms. Patients received FujiLAM and AlereLAM, Xpert MTB/RIF, culture and chest X-ray. The feasibility study included test’ users, key informants and patients who participated through standard questionnaires, individual interviews and group discussions.
RESULTS
We included 1117 patients in the diagnostic study: 712 with TB symptoms (Group 1) and 405 with advanced HIV disease and no TB
symptoms (Group 2). TB was confirmed in 9.2% (63/685) and 4.1% (16/395) in Group 1 and 2, respectively. FujiLAM diagnostic yield among patients with confirmed TB was 63.2% and 43.8% in Group 1 and 2, respectively. FujiLAM diagnostic yield by CD4 count was: 75.0% in CD4<200, 77.8% in CD4 200-349, 31.3% in CD4≥350 (Group 1) and 46.7% in CD4<200 (Group 2). Most of the test users (including lay health workers) found FujiLAM easy to perform. The main concern was the multiple timed steps involved. Invalid results were obtained if test cartridges were dropped or performed on blood stained or cloudy urine. Most patients viewed urine sampling
positively and easier than sputum provision.
CONCLUSIONS
FujiLAM detects TB in a high proportion of the HIV patients with confirmed TB who have symptoms of TB and low CD4 counts, and in
a considerable proportion of those asymptomatic. The test is easy to perform at point-of-care. Urine sampling is well accepted by patients. These results encourage the future use of the FujiLAM assay.
KEY MESSAGES: The novel urine-based FujiLAM is a useful and easy to use point-of care test for TB diagnosis in HIV-positive patients. Urine sampling is well accepted.
This abstract is not to be quoted for publication.
Journal Article > CommentaryFull Text
Eur Respir J. 2020 March 1; Volume 55 (Issue 3); DOI:10.1183/13993003.01935-2019
Guglielmetti L, Huerga H, Khan UT, Varaine T
Eur Respir J. 2020 March 1; Volume 55 (Issue 3); DOI:10.1183/13993003.01935-2019
Journal Article > LetterFull Text
Lancet Global Health. 2023 April 1; Volume 11 (Issue 4); e502.; DOI:10.1016/S2214-109X(23)00115-8
Huerga H, Gupta-Wright A, Muyindike WR, Hewison CCH, Casenghi M, et al.
Lancet Global Health. 2023 April 1; Volume 11 (Issue 4); e502.; DOI:10.1016/S2214-109X(23)00115-8
Journal Article > ResearchFull Text
Public Health Action. 2022 June 21; Volume 12 (Issue 2); 96-101.; DOI:10.5588/pha.22.0002
Kirakosyan O, Melikyan N, Falcao J, Khachatryan N, Atshemyan H, et al.
Public Health Action. 2022 June 21; Volume 12 (Issue 2); 96-101.; DOI:10.5588/pha.22.0002
BACKGROUND
Direct-acting antivirals (DAAs) are not widely used for patients with chronic hepatitis C virus (HCV) infection and multidrug- or rifampicin-resistant TB (MDR/RR-TB). We describe the implementation aspects of a new integrated model of care in Armenia and the perceptions of the healthcare staff and patients.
METHODS
We used qualitative methods, including a desktop review and semi-structured individual interviews with healthcare staff and with patients receiving HCV and MDR/RR-TB treatment.
RESULTS
The new integrated model resulted in simplified management of HCV and MDR/RR-TB at public TB facilities. Training on HCV was provided for TB clinic staff. All MDR/RR-TB patients were systematically offered HCV testing and those diagnosed with HCV, offered treatment with DAAs. Treatment monitoring was performed by TB staff in coordination with a hepatologist. The staff interviewed had a positive opinion of the new model. They suggested that additional training should be provided. Most patients were fully satisfied with the care received. Some were concerned about the increased pill burden.
CONCLUSION
Integrating HCV treatment into MDR/ RR-TB care was feasible and appreciated by patients and staff. This new model facilitated HCV diagnosis and treatment among people with MDR/RR-TB. Our results encourage piloting this model in other settings.
Direct-acting antivirals (DAAs) are not widely used for patients with chronic hepatitis C virus (HCV) infection and multidrug- or rifampicin-resistant TB (MDR/RR-TB). We describe the implementation aspects of a new integrated model of care in Armenia and the perceptions of the healthcare staff and patients.
METHODS
We used qualitative methods, including a desktop review and semi-structured individual interviews with healthcare staff and with patients receiving HCV and MDR/RR-TB treatment.
RESULTS
The new integrated model resulted in simplified management of HCV and MDR/RR-TB at public TB facilities. Training on HCV was provided for TB clinic staff. All MDR/RR-TB patients were systematically offered HCV testing and those diagnosed with HCV, offered treatment with DAAs. Treatment monitoring was performed by TB staff in coordination with a hepatologist. The staff interviewed had a positive opinion of the new model. They suggested that additional training should be provided. Most patients were fully satisfied with the care received. Some were concerned about the increased pill burden.
CONCLUSION
Integrating HCV treatment into MDR/ RR-TB care was feasible and appreciated by patients and staff. This new model facilitated HCV diagnosis and treatment among people with MDR/RR-TB. Our results encourage piloting this model in other settings.
Journal Article > ResearchFull Text
Int J Tuberc Lung Dis. 2017 March 1; Volume 21 (Issue 3); 314-319.; DOI:10.5588/ijtld.16.0661
Huerga H, Bastard M, Kamene M, Wanjala S, Arnold A, et al.
Int J Tuberc Lung Dis. 2017 March 1; Volume 21 (Issue 3); 314-319.; DOI:10.5588/ijtld.16.0661
SETTING
In March 2006, the first multidrug-resistant tuberculosis (MDR-TB) treatment programme was implemented in Kenya.
OBJECTIVE
To describe patients' treatment outcomes and adverse events.
DESIGN
A retrospective case note review of patients started on MDR-TB treatment at two Médecins Sans Frontières-supported sites and the national referral hospital of Kenya was undertaken. Sites operated an ambulatory model of care. Patients were treated for a minimum of 24 months with at least 4-5 drugs for the intensive phase of treatment, including an injectable agent.
RESULTS
Of 169 patients, 25.6% were human immunodeficiency virus (HIV) positive and 89.3% were culture-positive at baseline. Adverse events occurred in 67.4% of patients: 45.9% had nausea/vomiting, 43.9% electrolyte disturbance, 41.8% dyspepsia and 31.6% hypothyroidism. The median time to culture conversion was 2 months. Treatment outcomes were as follows: 76.6% success, 14.5% deaths, 8.3% lost to follow-up and 0.7% treatment failure. HIV-positive individuals (adjusted odds ratio [aOR] 3.51, 95% confidence interval [CI] 1.12-11.03) and women (aOR 2.73, 95%CI 1.01-7.39) had a higher risk of unfavourable outcomes, while the risk was lower in those with culture conversion at 6 months (aOR 0.11, 95%CI 0.04-0.32).
CONCLUSION
In Kenya, where an ambulatory model of care is used for MDR-TB treatment, treatment success was high, despite high rates of HIV. Almost half of the patients experienced electrolyte disturbance and one third had hypothyroidism; this supports the view that systematic regular biochemical monitoring is needed in Kenya.
In March 2006, the first multidrug-resistant tuberculosis (MDR-TB) treatment programme was implemented in Kenya.
OBJECTIVE
To describe patients' treatment outcomes and adverse events.
DESIGN
A retrospective case note review of patients started on MDR-TB treatment at two Médecins Sans Frontières-supported sites and the national referral hospital of Kenya was undertaken. Sites operated an ambulatory model of care. Patients were treated for a minimum of 24 months with at least 4-5 drugs for the intensive phase of treatment, including an injectable agent.
RESULTS
Of 169 patients, 25.6% were human immunodeficiency virus (HIV) positive and 89.3% were culture-positive at baseline. Adverse events occurred in 67.4% of patients: 45.9% had nausea/vomiting, 43.9% electrolyte disturbance, 41.8% dyspepsia and 31.6% hypothyroidism. The median time to culture conversion was 2 months. Treatment outcomes were as follows: 76.6% success, 14.5% deaths, 8.3% lost to follow-up and 0.7% treatment failure. HIV-positive individuals (adjusted odds ratio [aOR] 3.51, 95% confidence interval [CI] 1.12-11.03) and women (aOR 2.73, 95%CI 1.01-7.39) had a higher risk of unfavourable outcomes, while the risk was lower in those with culture conversion at 6 months (aOR 0.11, 95%CI 0.04-0.32).
CONCLUSION
In Kenya, where an ambulatory model of care is used for MDR-TB treatment, treatment success was high, despite high rates of HIV. Almost half of the patients experienced electrolyte disturbance and one third had hypothyroidism; this supports the view that systematic regular biochemical monitoring is needed in Kenya.
Journal Article > Short ReportFull Text
Clin Infect Dis. 2019 November 2; Volume 71 (Issue 2); 415-418.; DOI:10.1093/cid/ciz1084
Seung KJ, Khan PY, Franke MF, Ahmed SM, Aiylchiev S, et al.
Clin Infect Dis. 2019 November 2; Volume 71 (Issue 2); 415-418.; DOI:10.1093/cid/ciz1084
Delamanid should be effective against highly resistant strains of Mycobacterium tuberculosis, but uptake has been slow globally. In the endTB (expand new drug markets for TB) Observational Study, which enrolled a large, heterogeneous cohorts of patients receiving delamanid as part of a multidrug regimen, 80% of participants experienced sputum culture conversion within 6 months.
Journal Article > LetterFull Text
Am J Respir Crit Care Med. 2016 October 15; Volume 194 (Issue 8); 1028-1029.; DOI:10.1164/rccm.201605-1080LE
Varaine FFV, Guglielmetti L, Huerga H, Bonnet MMB, Kiria N, et al.
Am J Respir Crit Care Med. 2016 October 15; Volume 194 (Issue 8); 1028-1029.; DOI:10.1164/rccm.201605-1080LE
Journal Article > ResearchFull Text
Journal of Clinical Tuberculosis and Other Mycobacterial Diseases. 2022 May 1; Volume 27; 100316.; DOI: 10.1016/j.jctube.2022.100316
Rucker SCM, Lissouba P, Akinyi M, Lubega AV, Stewart RC, et al.
Journal of Clinical Tuberculosis and Other Mycobacterial Diseases. 2022 May 1; Volume 27; 100316.; DOI: 10.1016/j.jctube.2022.100316
BACKGROUND
The novel urine-based FujiLAM test identifies tuberculosis in HIV-positive patients but may be challenging to use at point-of-care (POC).
OBJECTIVES
We assessed the feasibility and acceptability of using the FujiLAM test at the point of care in outpatient settings.
METHODS
We conducted a mixed-methods study in four outpatient settings in Kenya, Mozambique, South Africa, and Uganda between November 2020 and September 2021. The test was performed at POC in existing clinic laboratories and consultation spaces. We performed direct observations in the four health facilities, individual questionnaires, proficiency testing evaluations, and individual interviews among healthcare workers performing the FujiLAM test (healthcare workers), and group discussions with programme managers.
RESULTS
Overall, 18/19 (95%) healthcare workers and 14/14 (100%) managers agreed to participate in the study. Most assessed healthcare workers, including lay health workers (10/11; 91%), met the minimum required theoretical knowledge and practical skill in performing the FujiLAM test. Most healthcare workers (17/18; 94%) found the FujiLAM test overall “Easy/Very easy” to perform. Some challenges were mentioned: many timed steps (5/18; 28%); ensuring correct incubation period (5/18; 28%); test result readability (4/18; 22%); and difficulties with cartridge buttons (3/18; 17%). Half of the healthcare workers regularly performing the test (4/7; 57%) found it “Easy” to integrate into routine activities. Most healthcare workers and managers believed that any healthcare worker could perform the test after adequate training.
CONCLUSIONS
Implementing the FujiLAM test in outpatient POC settings is feasible and acceptable to healthcare workers and managers. This test can be performed in various clinic locations by any healthcare worker. The timed, multi-step test procedure is challenging and may affect the workload in resource-constrained health facilities.
The novel urine-based FujiLAM test identifies tuberculosis in HIV-positive patients but may be challenging to use at point-of-care (POC).
OBJECTIVES
We assessed the feasibility and acceptability of using the FujiLAM test at the point of care in outpatient settings.
METHODS
We conducted a mixed-methods study in four outpatient settings in Kenya, Mozambique, South Africa, and Uganda between November 2020 and September 2021. The test was performed at POC in existing clinic laboratories and consultation spaces. We performed direct observations in the four health facilities, individual questionnaires, proficiency testing evaluations, and individual interviews among healthcare workers performing the FujiLAM test (healthcare workers), and group discussions with programme managers.
RESULTS
Overall, 18/19 (95%) healthcare workers and 14/14 (100%) managers agreed to participate in the study. Most assessed healthcare workers, including lay health workers (10/11; 91%), met the minimum required theoretical knowledge and practical skill in performing the FujiLAM test. Most healthcare workers (17/18; 94%) found the FujiLAM test overall “Easy/Very easy” to perform. Some challenges were mentioned: many timed steps (5/18; 28%); ensuring correct incubation period (5/18; 28%); test result readability (4/18; 22%); and difficulties with cartridge buttons (3/18; 17%). Half of the healthcare workers regularly performing the test (4/7; 57%) found it “Easy” to integrate into routine activities. Most healthcare workers and managers believed that any healthcare worker could perform the test after adequate training.
CONCLUSIONS
Implementing the FujiLAM test in outpatient POC settings is feasible and acceptable to healthcare workers and managers. This test can be performed in various clinic locations by any healthcare worker. The timed, multi-step test procedure is challenging and may affect the workload in resource-constrained health facilities.
Journal Article > ResearchFull Text
PLOS One. 2012 March 12; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0032140
Nackers F, Huerga H, Espie E, Aloo AO, Bastard M, et al.
PLOS One. 2012 March 12; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0032140
Good adherence to treatment is crucial to control tuberculosis (TB). Efficiency and feasibility of directly observed therapy (DOT) under routine program conditions have been questioned. As an alternative, Médecins sans Frontières introduced self-administered therapy (SAT) in several TB programs. We aimed to measure adherence to TB treatment among patients receiving TB chemotherapy with fixed dose combination (FDC) under SAT at the Homa Bay district hospital (Kenya). A second objective was to compare the adherence agreement between different assessment tools.
Journal Article > ResearchFull Text
Nat Commun. 2024 May 9; Volume 15 (Issue 1); 3927.; DOI:10.1038/s41467-024-48077-8
Kho S, Seung KJ, Huerga H, Bastard M, Khan PY, et al.
Nat Commun. 2024 May 9; Volume 15 (Issue 1); 3927.; DOI:10.1038/s41467-024-48077-8
Sputum culture reversion after conversion is an indicator of tuberculosis (TB) treatment failure. We analyze data from the endTB multi-country prospective observational cohort (NCT03259269) to estimate the frequency (primary endpoint) among individuals receiving a longer (18-to-20 month) regimen for multidrug- or rifampicin-resistant (MDR/RR) TB who experienced culture conversion. We also conduct Cox proportional hazard regression analyses to identify factors associated with reversion, including comorbidities, previous treatment, cavitary disease at conversion, low body mass index (BMI) at conversion, time to conversion, and number of likely-effective drugs. Of 1,286 patients, 54 (4.2%) experienced reversion, a median of 173 days (97-306) after conversion. Cavitary disease, BMI < 18.5, hepatitis C, prior treatment with second-line drugs, and longer time to initial culture conversion were positively associated with reversion. Reversion was uncommon. Those with cavitary disease, low BMI, hepatitis C, prior treatment with second-line drugs, and in whom culture conversion is delayed may benefit from close monitoring following conversion.