Journal Article > ResearchFull Text
PLOS One. 2017 June 8; Volume 12 (Issue 6); DOI:10.1371/journal.pone.0176581
Zhang C, Ruan Y, Cheng J, Zhao F, Xia Y, et al.
PLOS One. 2017 June 8; Volume 12 (Issue 6); DOI:10.1371/journal.pone.0176581
To calculate the yield and cost per diagnosed tuberculosis (TB) case for three World Health Organization screening algorithms and one using the Chinese National TB program (NTP) TB suspect definitions, using data from a TB prevalence survey of people aged 65 years and over in China, 2013.
Conference Material > Video (panel)
Kalon S, Iyer AS, Zarli K
MSF Scientific Days Asia 2021. 2021 August 25
Conference Material > Abstract
Arago M, Mangue M, Cumbi N, Zamudio AG, Loarec A, et al.
MSF Scientific Days International 2021: Innovation. 2021 May 20
WHAT CHALLENGE OR OPPORTUNITY DID YOU TRY TO ADDRESS? WERE EXISTING SOLUTIONS NOT AVAILABLE OR NOT GOOD ENOUGH?
Ototoxicity is an unfortunate side-effect of second-line injectable drugs for drug-resistant tuberculosis (DRTB), including aminoglycosides and peptides. Worldwide, up to 15% of patients on treatment regimens containing these drugs develop a degree of ototoxicity. Patients who experience ototoxicity are generally switched to an oral treatment regimen. Although regular audiological evaluations are recommended for patients receiving these drugs, there is limited access to these services, and few patients with noticeable hearing problems are referred for confirmation and follow-up.
WHY DOES THIS CHALLENGE OR OPPORTUNITY MATTER – WHY SHOULD MSF ADDRESS IT?
Before the introduction of this digital tool, the MSF DRTB project in Mozambique had to refer patients to the Central Hospital in Maputo. This limited the number of patients screened and referred for testing, curtailing the potential to switch treatment early for those showing mild-to-moderate hearing loss.
DESCRIBE YOUR INNOVATION AND WHAT MAKES IT INNOVATIVE
In 2018, the team piloted a way to simplify monitoring of hearing using a clinically approved mobile tablet-based tool that has been found to be comparable with traditional audiometry measurements in children and adults. MSF acquired three kits of CE-marked and FDA-certified iOS-based audiometry kits from SHOEBOX® Audiometry systems. The units were comprised of calibrated headphones and tablet-based software that have acceptable accuracy (±10dB) with 90% sensitivity and specificity. The portable units were deployed in rotation in six health centres over two years; a total of 673 audiometry tests were performed in MSF-supported public health centres in Maputo. Patients were tested at baseline during their first consultation and then monthly while on treatment regimens that included injectable drugs.
WHO WILL BENEFIT (WHOSE LIFE / WORK WILL IT IMPROVE?) AND WERE THEY INVOLVED IN THE DESIGN?
The 2018 Mozambique National TB Committee approved treatment without injectable drugs in patients who had any degree of hearing impairment before the initiation of treatment. Patients screened using the digital tool directly benefitted from switching to oral DRTB treatment if they exhibited any hearing loss, without requiring hospital referral.
WHAT OBJECTIVES DID YOU SET FOR THE PROJECT – WHAT DID YOU WANT TO ACHIEVE AND HOW DID YOU DEFINE AND MEASURE SUCCESS (IMPROVED SERVICE, LOWER COST, BETTER EFFICIENCY, BETTER USER EXPERIENCE, ETC.)?
We describe the implementation and use of a mobile audiometry system for patients with treatment-related ototoxicity in the MSF DRTB project in Mozambique, and consider its potential for easily assessing hearing deterioration in this cohort.
WHAT DATA DID YOU COLLECT TO MEASURE THE INNOVATION AGAINST THESE INDICATORS AND HOW DID YOU COLLECT IT? INCLUDE IF YOU DECIDED TO CHANGE THE INDICATORS AND WHY
Routinely collected data were evaluated.
WERE THERE ANY LIMITATIONS TO THE DATA YOU COLLECTED, HOW YOU COLLECTED IT OR HOW YOU ANALYSED IT, OR WERE THERE ANY UNFORESEEN FACTORS THAT MAY HAVE INTERFERED WITH YOUR RESULTS?
Data were analysed retrospectively from routine records and may not be exhaustive. Separate analysis of baseline and follow-up was not possible.
WHAT RESULTS DID YOU GET?
Of the 673 audiometry tests conducted using the digital tool, 480 (71%) showed normal hearing, 65 (10%) mild hearing loss, 81 (12%) moderate hearing loss, and 47 (7%) severe-to-profound hearing loss.
COMPARING THE RESULTS FROM YOUR DATA ANALYSIS TO YOUR OBJECTIVES, EXPLAIN WHY YOU CONSIDER YOUR INNOVATION A SUCCESS OR FAILURE?
This decentralised approach does not need specialised setup, which may lead to increased screening, proper follow-up, and more potential for early switching of drug regimens.
TO WHAT EXTENT DID THE INNOVATION BENEFIT PEOPLE’S LIVES / WORK?
Decreasing the need for hospital referrals improved time and transport costs for patients.
IS THERE ANYTHING THAT YOU WOULD DO DIFFERENTLY IF YOU WERE TO DO THE WORK AGAIN?:
A cost-benefit analysis to compare the mobile audiometry system to referrals would be beneficial for programmatic decisions.
WHAT ARE THE NEXT STEPS FOR THE INNOVATION ITSELF (SCALE UP, IMPLEMENTATION, FURTHER DEVELOPMENT, DISCONTINUED)?
In December 2019, the project was phased out as there was a protocol change in which injectable drugs were replaced with more potent and fully oral regimens that made monitoring for ototoxicity unnecessary for most patients.
IS THE INNOVATION TRANSFERABLE OR ADAPTABLE TO OTHER SETTINGS OR DOMAINS?
The tools adapted are clinically approved for screening activities for any programmes that deal with hearing loss.
WHAT BROADER IMPLICATIONS ARE THERE FROM THE INNOVATION FOR MSF AND / OR OTHERS (CHANGE IN PRACTICE, CHANGE IN POLICY, CHANGE IN GUIDELINES, PARADIGM SHIFT)?
The project demonstrates the potential to improve follow-up and detect complications early for patients who take ototoxic medications.
WHAT OTHER LEARNINGS FROM YOUR WORK ARE IMPORTANT TO SHARE?
User-friendly and automated audiometry systems that are mobile and do not require audiologists or sound-insulated booths could be extremely useful to various medical projects using potentially ototoxic drugs such as aminoglycosides. They may also be beneficial for environmental projects with noise and toxic pollutions. The high cost of the license could present a limitation necessitating a cost-benefit analysis before contemplating scale-up.
ETHICS
This description and evaluation of an innovation project involved human participants or their data, and has had ethics oversight from Monica Rull, Medical Director, Operational Centre Geneva, MSF.
Ototoxicity is an unfortunate side-effect of second-line injectable drugs for drug-resistant tuberculosis (DRTB), including aminoglycosides and peptides. Worldwide, up to 15% of patients on treatment regimens containing these drugs develop a degree of ototoxicity. Patients who experience ototoxicity are generally switched to an oral treatment regimen. Although regular audiological evaluations are recommended for patients receiving these drugs, there is limited access to these services, and few patients with noticeable hearing problems are referred for confirmation and follow-up.
WHY DOES THIS CHALLENGE OR OPPORTUNITY MATTER – WHY SHOULD MSF ADDRESS IT?
Before the introduction of this digital tool, the MSF DRTB project in Mozambique had to refer patients to the Central Hospital in Maputo. This limited the number of patients screened and referred for testing, curtailing the potential to switch treatment early for those showing mild-to-moderate hearing loss.
DESCRIBE YOUR INNOVATION AND WHAT MAKES IT INNOVATIVE
In 2018, the team piloted a way to simplify monitoring of hearing using a clinically approved mobile tablet-based tool that has been found to be comparable with traditional audiometry measurements in children and adults. MSF acquired three kits of CE-marked and FDA-certified iOS-based audiometry kits from SHOEBOX® Audiometry systems. The units were comprised of calibrated headphones and tablet-based software that have acceptable accuracy (±10dB) with 90% sensitivity and specificity. The portable units were deployed in rotation in six health centres over two years; a total of 673 audiometry tests were performed in MSF-supported public health centres in Maputo. Patients were tested at baseline during their first consultation and then monthly while on treatment regimens that included injectable drugs.
WHO WILL BENEFIT (WHOSE LIFE / WORK WILL IT IMPROVE?) AND WERE THEY INVOLVED IN THE DESIGN?
The 2018 Mozambique National TB Committee approved treatment without injectable drugs in patients who had any degree of hearing impairment before the initiation of treatment. Patients screened using the digital tool directly benefitted from switching to oral DRTB treatment if they exhibited any hearing loss, without requiring hospital referral.
WHAT OBJECTIVES DID YOU SET FOR THE PROJECT – WHAT DID YOU WANT TO ACHIEVE AND HOW DID YOU DEFINE AND MEASURE SUCCESS (IMPROVED SERVICE, LOWER COST, BETTER EFFICIENCY, BETTER USER EXPERIENCE, ETC.)?
We describe the implementation and use of a mobile audiometry system for patients with treatment-related ototoxicity in the MSF DRTB project in Mozambique, and consider its potential for easily assessing hearing deterioration in this cohort.
WHAT DATA DID YOU COLLECT TO MEASURE THE INNOVATION AGAINST THESE INDICATORS AND HOW DID YOU COLLECT IT? INCLUDE IF YOU DECIDED TO CHANGE THE INDICATORS AND WHY
Routinely collected data were evaluated.
WERE THERE ANY LIMITATIONS TO THE DATA YOU COLLECTED, HOW YOU COLLECTED IT OR HOW YOU ANALYSED IT, OR WERE THERE ANY UNFORESEEN FACTORS THAT MAY HAVE INTERFERED WITH YOUR RESULTS?
Data were analysed retrospectively from routine records and may not be exhaustive. Separate analysis of baseline and follow-up was not possible.
WHAT RESULTS DID YOU GET?
Of the 673 audiometry tests conducted using the digital tool, 480 (71%) showed normal hearing, 65 (10%) mild hearing loss, 81 (12%) moderate hearing loss, and 47 (7%) severe-to-profound hearing loss.
COMPARING THE RESULTS FROM YOUR DATA ANALYSIS TO YOUR OBJECTIVES, EXPLAIN WHY YOU CONSIDER YOUR INNOVATION A SUCCESS OR FAILURE?
This decentralised approach does not need specialised setup, which may lead to increased screening, proper follow-up, and more potential for early switching of drug regimens.
TO WHAT EXTENT DID THE INNOVATION BENEFIT PEOPLE’S LIVES / WORK?
Decreasing the need for hospital referrals improved time and transport costs for patients.
IS THERE ANYTHING THAT YOU WOULD DO DIFFERENTLY IF YOU WERE TO DO THE WORK AGAIN?:
A cost-benefit analysis to compare the mobile audiometry system to referrals would be beneficial for programmatic decisions.
WHAT ARE THE NEXT STEPS FOR THE INNOVATION ITSELF (SCALE UP, IMPLEMENTATION, FURTHER DEVELOPMENT, DISCONTINUED)?
In December 2019, the project was phased out as there was a protocol change in which injectable drugs were replaced with more potent and fully oral regimens that made monitoring for ototoxicity unnecessary for most patients.
IS THE INNOVATION TRANSFERABLE OR ADAPTABLE TO OTHER SETTINGS OR DOMAINS?
The tools adapted are clinically approved for screening activities for any programmes that deal with hearing loss.
WHAT BROADER IMPLICATIONS ARE THERE FROM THE INNOVATION FOR MSF AND / OR OTHERS (CHANGE IN PRACTICE, CHANGE IN POLICY, CHANGE IN GUIDELINES, PARADIGM SHIFT)?
The project demonstrates the potential to improve follow-up and detect complications early for patients who take ototoxic medications.
WHAT OTHER LEARNINGS FROM YOUR WORK ARE IMPORTANT TO SHARE?
User-friendly and automated audiometry systems that are mobile and do not require audiologists or sound-insulated booths could be extremely useful to various medical projects using potentially ototoxic drugs such as aminoglycosides. They may also be beneficial for environmental projects with noise and toxic pollutions. The high cost of the license could present a limitation necessitating a cost-benefit analysis before contemplating scale-up.
ETHICS
This description and evaluation of an innovation project involved human participants or their data, and has had ethics oversight from Monica Rull, Medical Director, Operational Centre Geneva, MSF.
Journal Article > ResearchFull Text
BMC Health Serv Res. 2021 December 6; Volume 21 (Issue 1); 1314.; DOI:10.1186/s12913-021-07323-1
Schausberger B, Mmema N, Dlamini V, Dube L, Aung A, et al.
BMC Health Serv Res. 2021 December 6; Volume 21 (Issue 1); 1314.; DOI:10.1186/s12913-021-07323-1
BACKGROUND
Traditional healing plays an important role in healthcare in Eswatini, and innovative collaborations with traditional healers may enable hard-to-reach men to access HIV and tuberculosis diagnostic services. This study explored attitudes towards integration of traditional healers into the provision of HIV self-testing kits and sputum collection containers.
METHODS
A qualitative study was conducted in 2019-2020 in Shiselweni region, Eswatini. Eight male traditional healers were trained on HIV and tuberculosis care including distribution of HIV self-testing kits and sputum collection containers. Attitudes towards the intervention were elicited through in-depth interviews with the eight traditional healers, ten clients, five healthcare workers and seven focus group discussions with community members. Interviews and group discussions were conducted in SiSwati, audio-recorded, translated and transcribed into English. Data were coded inductively and analysed thematically.
RESULTS
81 HIV self-testing kits and 24 sputum collection containers were distributed by the healers to 99 clients, with 14% of participants reporting a reactive HIV self-test result. The distribution of sputum containers did not result in any tuberculosis diagnoses, as samples were refused at health centres. Traditional healers perceived themselves as important healthcare providers, and after training, were willing and able to distribute HIV self-test kits and sputum containers to clients. Many saw themselves as peers who could address barriers to health-seeking among Swazi men that reflected hegemonic masculinities and patriarchal attitudes. Traditional healers were considered to provide services that were private, flexible, efficient and non-judgemental, although some clients and community members expressed concerns over confidentiality breaches. Attitudes among health workers were mixed, with some calling for greater collaboration with traditional healers and others expressing doubts about their potential role in promoting HIV and tuberculosis services. Specifically, many health workers did not accept sputum samples collected outside health facilities.
CONCLUSIONS
Offering HIV self-testing kits and sputum containers through traditional healers led to high HIV yields, but no TB diagnoses. The intervention was appreciated by healers' clients, due to the cultural literacy of traditional healers and practical considerations. Scaling-up this approach could bridge testing gaps if traditional healers are supported, but procedures for receiving sputum samples at health facilities need further strengthening.
Traditional healing plays an important role in healthcare in Eswatini, and innovative collaborations with traditional healers may enable hard-to-reach men to access HIV and tuberculosis diagnostic services. This study explored attitudes towards integration of traditional healers into the provision of HIV self-testing kits and sputum collection containers.
METHODS
A qualitative study was conducted in 2019-2020 in Shiselweni region, Eswatini. Eight male traditional healers were trained on HIV and tuberculosis care including distribution of HIV self-testing kits and sputum collection containers. Attitudes towards the intervention were elicited through in-depth interviews with the eight traditional healers, ten clients, five healthcare workers and seven focus group discussions with community members. Interviews and group discussions were conducted in SiSwati, audio-recorded, translated and transcribed into English. Data were coded inductively and analysed thematically.
RESULTS
81 HIV self-testing kits and 24 sputum collection containers were distributed by the healers to 99 clients, with 14% of participants reporting a reactive HIV self-test result. The distribution of sputum containers did not result in any tuberculosis diagnoses, as samples were refused at health centres. Traditional healers perceived themselves as important healthcare providers, and after training, were willing and able to distribute HIV self-test kits and sputum containers to clients. Many saw themselves as peers who could address barriers to health-seeking among Swazi men that reflected hegemonic masculinities and patriarchal attitudes. Traditional healers were considered to provide services that were private, flexible, efficient and non-judgemental, although some clients and community members expressed concerns over confidentiality breaches. Attitudes among health workers were mixed, with some calling for greater collaboration with traditional healers and others expressing doubts about their potential role in promoting HIV and tuberculosis services. Specifically, many health workers did not accept sputum samples collected outside health facilities.
CONCLUSIONS
Offering HIV self-testing kits and sputum containers through traditional healers led to high HIV yields, but no TB diagnoses. The intervention was appreciated by healers' clients, due to the cultural literacy of traditional healers and practical considerations. Scaling-up this approach could bridge testing gaps if traditional healers are supported, but procedures for receiving sputum samples at health facilities need further strengthening.
Journal Article > ResearchFull Text
Public Health Action. 2016 September 21; Volume 6 (Issue 3); 193-198.; DOI:10.5588/pha.16.0043
Shirodkar S, Anande L, Dalal A, Desai C, Correa G, et al.
Public Health Action. 2016 September 21; Volume 6 (Issue 3); 193-198.; DOI:10.5588/pha.16.0043
SETTING
While surgery for pulmonary tuberculosis (PTB) is considered an important adjunct for specific cases, including drug-resistant tuberculosis, operational evidence on its feasibility and effectiveness is limited.
OBJECTIVE
To describe surgical outcomes and programmatic challenges of providing surgery for PTB in Mumbai, India.
DESIGN
A descriptive study of routinely collected data of surgical interventions for PTB from 2010 to 2014 in two Mumbai hospitals, one public, one private.
RESULTS
Of 85 patients, 5 (6%) died and 17 (20%) had complications, with wound infection being the most frequent. Repeat operation was required in 12 (14%) patients. Most procedures were performed on an emergency basis, and eligibility was established late in the course of treatment. Median time from admission to surgery was 51 days. Drug susceptibility test (DST) patterns and final treatment outcomes were not systematically collected.
CONCLUSION
In a high-burden setting such as Mumbai, important data on surgery for PTB were surprisingly limited in both the private and public sectors. Eligibility for surgery was established late, culture and DST were not systematically offered, the interval between admission and surgery was long and TB outcomes were not known. Systematic data collection would allow for proper evaluation of surgery as adjunctive therapy for all forms of TB under programmatic conditions.
While surgery for pulmonary tuberculosis (PTB) is considered an important adjunct for specific cases, including drug-resistant tuberculosis, operational evidence on its feasibility and effectiveness is limited.
OBJECTIVE
To describe surgical outcomes and programmatic challenges of providing surgery for PTB in Mumbai, India.
DESIGN
A descriptive study of routinely collected data of surgical interventions for PTB from 2010 to 2014 in two Mumbai hospitals, one public, one private.
RESULTS
Of 85 patients, 5 (6%) died and 17 (20%) had complications, with wound infection being the most frequent. Repeat operation was required in 12 (14%) patients. Most procedures were performed on an emergency basis, and eligibility was established late in the course of treatment. Median time from admission to surgery was 51 days. Drug susceptibility test (DST) patterns and final treatment outcomes were not systematically collected.
CONCLUSION
In a high-burden setting such as Mumbai, important data on surgery for PTB were surprisingly limited in both the private and public sectors. Eligibility for surgery was established late, culture and DST were not systematically offered, the interval between admission and surgery was long and TB outcomes were not known. Systematic data collection would allow for proper evaluation of surgery as adjunctive therapy for all forms of TB under programmatic conditions.
Journal Article > ReviewSubscription Only
Curr Opin HIV AIDS. 2019 January 1; Volume 14 (Issue 1); 21-27.; DOI:10.1097/COH.0000000000000517
Fargher J, Reuter A, Furin J
Curr Opin HIV AIDS. 2019 January 1; Volume 14 (Issue 1); 21-27.; DOI:10.1097/COH.0000000000000517
PURPOSE OF REVIEW
More than two billion people are infected with Mycobacterium tuberculosis and few of them are ever offered therapy in spite of such treatment being associated with reduced rates of morbidity and mortality. This article reviews the current recommendations on the diagnosis and treatment of TB infection (or what is commonly referred to as 'prophylaxis' or 'preventive therapy' of latent TB) and discusses barriers to implementation that have led to low demand for this life-saving therapeutic intervention.
RECENT FINDINGS
Treatment of infection for both TB and drug-resistant TB is well tolerated and effective, and several new, shorter regimens - including rfiapenitine-based regimens of 1 month and 12 weeks duration - have been shown to be effective. Not all persons infected with TB go on to develop disease and the risk is the highest in the first 2 years after infection. Given this, additional work is needed to better identify those at the highest risk of developing active TB.
SUMMARY
Practitioners should offer newer, shorter regimens to persons who are infected with TB and at high risk of developing disease, including people living with HIV and household contacts of people living with TB who are age 5 years and under. This includes individuals who have been exposed to drug-resistant forms of disease. Socioeconomic risk factors may play a key role in the development of TB disease and should also be addressed.
More than two billion people are infected with Mycobacterium tuberculosis and few of them are ever offered therapy in spite of such treatment being associated with reduced rates of morbidity and mortality. This article reviews the current recommendations on the diagnosis and treatment of TB infection (or what is commonly referred to as 'prophylaxis' or 'preventive therapy' of latent TB) and discusses barriers to implementation that have led to low demand for this life-saving therapeutic intervention.
RECENT FINDINGS
Treatment of infection for both TB and drug-resistant TB is well tolerated and effective, and several new, shorter regimens - including rfiapenitine-based regimens of 1 month and 12 weeks duration - have been shown to be effective. Not all persons infected with TB go on to develop disease and the risk is the highest in the first 2 years after infection. Given this, additional work is needed to better identify those at the highest risk of developing active TB.
SUMMARY
Practitioners should offer newer, shorter regimens to persons who are infected with TB and at high risk of developing disease, including people living with HIV and household contacts of people living with TB who are age 5 years and under. This includes individuals who have been exposed to drug-resistant forms of disease. Socioeconomic risk factors may play a key role in the development of TB disease and should also be addressed.
Journal Article > ResearchFull Text
PLOS One. 2012 March 19; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0033704
Kosack CS, Page AL, Van Hulsteijn LT, Lentjes EG
PLOS One. 2012 March 19; Volume 7 (Issue 3); DOI:10.1371/journal.pone.0033704
Thyroid-stimulating hormone (TSH) promotes expression of thyroid hormones which are essential for metabolism, growth, and development. Second-line drugs to treat tuberculosis (TB) can cause hypothyroidism by suppressing thyroid hormone synthesis. Therefore, TSH levels are routinely measured in TB patients receiving second-line drugs, and thyroxin treatment is initiated where indicated. However, standard TSH tests are technically demanding for many low-resource settings where TB is prevalent; a simple and inexpensive test is urgently needed.
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 > ResearchFull Text
East Afr Med J. 2017 March 31; Volume 6 (Issue 2); 383.; DOI:10.4102/ajlm.v6i2.383
Orikiriza P, Nyehangane D, Atwine D, Kisakye JJ, Kassaza K, et al.
East Afr Med J. 2017 March 31; Volume 6 (Issue 2); 383.; DOI:10.4102/ajlm.v6i2.383
BACKGROUND
To confirm presence of Mycobacterium tuberculosis complex, some tuberculosis culture laboratories still rely on para-nitrobenzoic acid (PNB), a traditional technique that requires sub-culturing of clinical isolates and two to three weeks to give results. Rapid identification tests have improved turnaround times for mycobacterial culture results. Considering the challenges of the PNB method, we assessed the performance of the SD Bioline TB Ag MPT64 assay by using PNB as gold standard to detect M. tuberculosis complex from acid-fast bacilli (AFB) positive cultures.
OBJECTIVES
The aim of this study was to determine the sensitivity, specificity and turnaround time of the SD MPT64 assay for identification of M. tuberculosis complex, in a setting with high prevalence of tuberculosis and HIV.
METHODS
A convenience sample of 690 patients, with tuberculosis symptoms, was enrolled at Epicentre Mbarara Research Centre between April 2010 and June 2011. The samples were decontaminated using NALC-NaOH and re-suspended sediments inoculated in Mycobacterium Growth Indicator Tubes (MGIT) media, then incubated at 37 °C for a maximum of eight weeks. A random sample of 50 known negative cultures and 50 non-tuberculous mycobacteria isolates were tested for specificity, while sensitivity was based on AFB positivity. The time required from positive culture to reporting of results was also assessed with PNB used as the gold standard.
RESULTS
Of the 138 cultures that were AFB-positive, the sensitivity of the SD MPT64 assay was 100.0% [95% CI: 97.3 - 100] and specificity was 100.0% (95% CI, 96.4 - 100). The median time from a specimen receipt to confirmation of strain was 10 days [IQR: 8-12] with SD MPT64 and 24 days [IQR: 22-26] with PNB.
CONCLUSION
The SD MPT64 assay is comparable to PNB for identification of M. tuberculosis complex and reduces the time to detection.
To confirm presence of Mycobacterium tuberculosis complex, some tuberculosis culture laboratories still rely on para-nitrobenzoic acid (PNB), a traditional technique that requires sub-culturing of clinical isolates and two to three weeks to give results. Rapid identification tests have improved turnaround times for mycobacterial culture results. Considering the challenges of the PNB method, we assessed the performance of the SD Bioline TB Ag MPT64 assay by using PNB as gold standard to detect M. tuberculosis complex from acid-fast bacilli (AFB) positive cultures.
OBJECTIVES
The aim of this study was to determine the sensitivity, specificity and turnaround time of the SD MPT64 assay for identification of M. tuberculosis complex, in a setting with high prevalence of tuberculosis and HIV.
METHODS
A convenience sample of 690 patients, with tuberculosis symptoms, was enrolled at Epicentre Mbarara Research Centre between April 2010 and June 2011. The samples were decontaminated using NALC-NaOH and re-suspended sediments inoculated in Mycobacterium Growth Indicator Tubes (MGIT) media, then incubated at 37 °C for a maximum of eight weeks. A random sample of 50 known negative cultures and 50 non-tuberculous mycobacteria isolates were tested for specificity, while sensitivity was based on AFB positivity. The time required from positive culture to reporting of results was also assessed with PNB used as the gold standard.
RESULTS
Of the 138 cultures that were AFB-positive, the sensitivity of the SD MPT64 assay was 100.0% [95% CI: 97.3 - 100] and specificity was 100.0% (95% CI, 96.4 - 100). The median time from a specimen receipt to confirmation of strain was 10 days [IQR: 8-12] with SD MPT64 and 24 days [IQR: 22-26] with PNB.
CONCLUSION
The SD MPT64 assay is comparable to PNB for identification of M. tuberculosis complex and reduces the time to detection.
Journal Article > ResearchAbstract Only
Int J Tuberc Lung Dis. 2018 September 1; Volume 22 (Issue 9); 1023-1030.; DOI:10.5588/ijtld.17.0826
Snyman L, Venables E, Trivino Duran L, Mohr E, Azevedo VD, et al.
Int J Tuberc Lung Dis. 2018 September 1; Volume 22 (Issue 9); 1023-1030.; DOI:10.5588/ijtld.17.0826
SETTING
Early interventions for patients who interrupt their treatment for drug-resistant tuberculosis (DR-TB) are rarely reported and assessed. A novel, patient-centred intervention for patients at risk of loss to follow-up (LTFU) from DR-TB treatment was implemented in Khayelitsha, South Africa, in September 2013.
OBJECTIVE
To explore the experiences and perceptions of patients, key support persons, health care workers (HCWs) and programme managers of a patient-centred model.
DESIGN
This was a qualitative study consisting of 18 in-depth interviews with patients, key support persons, HCWs, key informants and one focus group discussion with HCWs, between July and September 2017. Data were coded and thematically analysed.
RESULTS
The model was well perceived and viewed positively by patients, care providers and programme managers. 'Normalisation' and tolerance of occasional treatment interruptions, tracing, tailored management plans and peer support were perceived to be beneficial for retaining patients in care. Although the model was resource-demanding, health workers were convinced that it 'needs to be sustained,' and proposed solutions for its standardisation.
CONCLUSION
An intervention based on early tracing of patients who interrupt treatment, peer-delivered counselling and individualised management plans by a multidisciplinary team was considered a beneficial and acceptable model to support patients at risk of LTFU from DR-TB treatment.
Early interventions for patients who interrupt their treatment for drug-resistant tuberculosis (DR-TB) are rarely reported and assessed. A novel, patient-centred intervention for patients at risk of loss to follow-up (LTFU) from DR-TB treatment was implemented in Khayelitsha, South Africa, in September 2013.
OBJECTIVE
To explore the experiences and perceptions of patients, key support persons, health care workers (HCWs) and programme managers of a patient-centred model.
DESIGN
This was a qualitative study consisting of 18 in-depth interviews with patients, key support persons, HCWs, key informants and one focus group discussion with HCWs, between July and September 2017. Data were coded and thematically analysed.
RESULTS
The model was well perceived and viewed positively by patients, care providers and programme managers. 'Normalisation' and tolerance of occasional treatment interruptions, tracing, tailored management plans and peer support were perceived to be beneficial for retaining patients in care. Although the model was resource-demanding, health workers were convinced that it 'needs to be sustained,' and proposed solutions for its standardisation.
CONCLUSION
An intervention based on early tracing of patients who interrupt treatment, peer-delivered counselling and individualised management plans by a multidisciplinary team was considered a beneficial and acceptable model to support patients at risk of LTFU from DR-TB treatment.