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Article ; Online: Impact of active case-finding for tuberculosis on case-notifications in Blantyre, Malawi: A community-based cluster-randomised trial (SCALE).

Feasey, Helena R A / Khundi, McEwen / Soko, Rebecca Nzawa / Bottomley, Christian / Chiume, Lingstone / Burchett, Helen E D / Nliwasa, Marriott / Twabi, Hussein H / Mpunga, James A / MacPherson, Peter / Corbett, Elizabeth L

PLOS global public health

2023 Volume 3, Issue 12, Page(s) e0002683

Abstract: Active case-finding (ACF) for tuberculosis can help find the "missing millions" with undiagnosed tuberculosis. In a cluster-randomised trial, we investigated impact of ACF on case-notifications in Blantyre, Malawi, where ACF has been intensively ... ...

Abstract	Active case-finding (ACF) for tuberculosis can help find the "missing millions" with undiagnosed tuberculosis. In a cluster-randomised trial, we investigated impact of ACF on case-notifications in Blantyre, Malawi, where ACF has been intensively implemented following 2014 estimates of ~1,000 per 100,000 adults with undiagnosed TB. Following a pre-intervention prevalence survey (May 2019 to March 2020), constrained randomisation allocated neighbourhoods to either door-to-door ACF (sputum microscopy for reported cough >2 weeks) or standard-of-care (SOC). Implementation was interrupted by COVID-19. Cluster-level bacteriologically-confirmed case-notification rate (CNR) ratio within 91 days of ACF was our redefined primary outcome; comparison between arms used Poisson regression with random effects. Secondary outcomes were 91-day CNR ratios comparing all tuberculosis registrations and all non-ACF registrations. Interrupted time series (ITS) analysis of CNRs in the SOC arm examined prevalence survey impact. (ISRCTN11400592). 72 clusters served by 10 study-supported tuberculosis registration centres were randomised to ACF (261,244 adults, 58,944 person-years follow-up) or SOC (256,713 adults, 52,805 person-years). Of 1,192 ACF participants, 13 (1.09%) were smear-positive. Within 91 days, 113 (42 bacteriologically-confirmed) and 108 (33 bacteriologically-confirmed) tuberculosis patients were identified as ACF or SOC cluster residents, respectively. There was no difference by arm, with adjusted 91-day CNR ratios 1.12 (95% CI: 0.61-2.07) for bacteriologically-confirmed tuberculosis; 0.93 (95% CI: 0.68-1.28) for all tuberculosis registrations; and 0.86 (95%CI: 0.63-1.16) for non-ACF (routinely) diagnosed. Of 7,905 ACF and 7,992 SOC pre-intervention survey participants, 12 (0.15%) and 17 (0.21%), respectively, had culture/Xpert-confirmed tuberculosis. ITS analysis showed no survey impact on SOC CNRs. Despite residual undiagnosed tuberculosis of 150 per 100,000 population, there was no increase in tuberculosis notifications from this previously successful approach targeting symptomatic disease, likely due to previous TB ACF and rapid declines in TB burden. In such settings, future ACF should focus on targeted outreach and demand creation, alongside optimised facility-based screening. Trial Registration: ISRCTN11400592.
Language	English
Publishing date	2023-12-05
Publishing country	United States
Document type	Journal Article
ISSN	2767-3375
ISSN (online)	2767-3375
DOI	10.1371/journal.pgph.0002683
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Article ; Online: Prevalence of bacteriologically-confirmed pulmonary tuberculosis in urban Blantyre, Malawi 2019-20: Substantial decline compared to 2013-14 national survey.

Feasey, Helena R A / Khundi, McEwen / Nzawa Soko, Rebecca / Nightingale, Emily / Burke, Rachael M / Henrion, Marc Y R / Phiri, Mphatso D / Burchett, Helen E / Chiume, Lingstone / Nliwasa, Marriott / Twabi, Hussein H / Mpunga, James A / MacPherson, Peter / Corbett, Elizabeth L

PLOS global public health

2023 Volume 3, Issue 10, Page(s) e0001911

Abstract: Recent evidence shows rapidly changing tuberculosis (TB) epidemiology in Southern and Eastern Africa, with need for subdistrict prevalence estimates to guide targeted interventions. We conducted a pulmonary TB prevalence survey to estimate current TB ... ...

Abstract	Recent evidence shows rapidly changing tuberculosis (TB) epidemiology in Southern and Eastern Africa, with need for subdistrict prevalence estimates to guide targeted interventions. We conducted a pulmonary TB prevalence survey to estimate current TB burden in Blantyre city, Malawi. From May 2019 to March 2020, 115 households in middle/high-density residential Blantyre, were randomly-selected from each of 72 clusters. Consenting eligible participants (household residents ≥ 18 years) were interviewed, including for cough (any duration), and offered HIV testing and chest X-ray; participants with cough and/or abnormal X-ray provided two sputum samples for microscopy, Xpert MTB/Rif and mycobacterial culture. TB disease prevalence and risk factors for prevalent TB were calculated using complete-case analysis, multiple imputation, and inverse probability weighting. Of 20,899 eligible adults, 15,897 (76%) were interviewed, 13,490/15,897 (85%) had X-ray, and 1,120/1,394 (80%) sputum-eligible participants produced at least one specimen, giving 15,318 complete cases (5,895, 38% men). 29/15,318 had bacteriologically-confirmed TB (189 per 100,000 complete-case (cc) / 150 per 100,000 with inverse weighting (iw)). Men had higher burden (cc: 305 [95% CI:144-645] per 100,000) than women (cc: 117 [95% CI:65-211] per 100,000): cc adjusted odds ratio (aOR) 2.70 (1.26-5.78). Other significant risk factors for prevalent TB on complete-case analysis were working age (25-49 years) and previous TB treatment, but not HIV status. Multivariable analysis of imputed data was limited by small numbers, but previous TB and age group 25-49 years remained significantly associated with higher TB prevalence. Pulmonary TB prevalence for Blantyre was considerably lower than the 1,014 per 100,000 for urban Malawi in the 2013-14 national survey, at 150-189 per 100,000 adults, but some groups, notably men, remain disproportionately affected. TB case-finding is still needed for TB elimination in Blantyre, and similar urban centres, but should focus on reaching the highest risk groups, such as older men.
Language	English
Publishing date	2023-10-20
Publishing country	United States
Document type	Journal Article
ISSN	2767-3375
ISSN (online)	2767-3375
DOI	10.1371/journal.pgph.0001911
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Article ; Online: Trial-of-antibiotics to assist tuberculosis diagnosis in symptomatic adults in Malawi (ACT-TB study): a randomised controlled trial.

Divala, Titus H / Corbett, Elizabeth L / Kandulu, Chikondi / Moyo, Brewster / MacPherson, Peter / Nliwasa, Marriott / French, Neil / Sloan, Derek J / Chiume, Lingstone / Ndaferankhande, Masiye John / Chilanga, Sanderson / Majiga, Sabina Tazirwa / Odland, Jon Øyvind / Fielding, Katherine L

The Lancet. Global health

2023 Volume 11, Issue 4, Page(s) e556–e565

Abstract: Background: Clinical practice and diagnostic algorithms often assume that tuberculosis can be ruled out in mycobacteriology-negative individuals whose symptoms improve with a trial-of-antibiotics. We aimed to investigate diagnostic performance, clinical ...

Abstract	Background: Clinical practice and diagnostic algorithms often assume that tuberculosis can be ruled out in mycobacteriology-negative individuals whose symptoms improve with a trial-of-antibiotics. We aimed to investigate diagnostic performance, clinical benefit, and antimicrobial resistance using a randomised controlled trial. Methods: In this three-arm, individually randomised, open-label, controlled trial, we enrolled Malawian adults (aged ≥18 years) attending primary care who reported being unwell for at least 14 days (including cough) with no immediate indication for hospitalisation at Limbe and Ndirande Health Centres in Blantyre. Participants were randomly allocated (1:1:1) to azithromycin (500 mg taken once per day for 3 days), amoxicillin (1 g taken three times per day for 5 days), or standard of care with no immediate antibiotics, stratified by study site. Sputum at enrolment and day 8 was tested for tuberculosis (microscopy, Xpert MTB/RIF, and culture). The primary efficacy outcome was day 8 specificity (percentage with symptom improvement among mycobacteriology-negative participants), and day 29 clinical outcome (death, hospitalisation, or missed tuberculosis diagnosis) among all randomised participants. This study is registered with ClinicalTrials.gov, NCT03545373. Findings: Between Feb 25, 2019, and March 14, 2020, 5825 adults were screened and 1583 (mean age 36 years; 236 [14·9%] HIV positive) were randomly assigned to standard of care (530 participants), azithromycin (527 participants), or amoxicillin (526 participants) groups. Overall, 6·3% (100 of 1583 participants) had positive baseline sputum mycobacteriology. 310 (79·1%) of 392 patients receiving standard of care reported symptom improvement at day 8, compared with 340 (88·7%) of 383 patients receiving azithromycin (adjusted difference 8·6%, 95% CI 3·9-13·3%; p<0·0004) and 346 (89·4%) of 387 receiving amoxicillin (adjusted difference 8·8%, 4·0-13·6%; p=0·0003). The proportion of participants with day 29 composite clinical outcomes was similar between groups (standard of care 1% [7 of 530 participants], azithromycin 1% [6 of 527 participants], amoxicillin 2% [12 of 526 participants]). Interpretation: Routine outpatient trial-of-antibiotics during tuberculosis investigations modestly improved diagnostic specificity for mycobacteriologically confirmed tuberculosis but had no appreciable effect on death, hospitalisation, and missed tuberculosis diagnosis. These results confirm the limited benefit of trial-of-antibiotics, presenting an opportunity for discontinuation of trial-of-antibiotics and improved antimicrobial stewardship during tuberculosis screening, without affecting clinical outcomes. Funding: Northern Norway Regional Health Authority (Helse Nord RHF), Commonwealth Scholarship Commission in the UK, Wellcome Trust, UK Medical Research Council, and the UK Department for International Development.
MeSH term(s)	Adult ; Humans ; Adolescent ; Anti-Bacterial Agents/therapeutic use ; Mycobacterium tuberculosis ; Malawi ; Azithromycin/therapeutic use ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; Amoxicillin/therapeutic use
Chemical Substances	Anti-Bacterial Agents ; Azithromycin (83905-01-5) ; Amoxicillin (804826J2HU)
Language	English
Publishing date	2023-03-15
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2723488-5
ISSN	2214-109X ; 2214-109X
ISSN (online)	2214-109X
ISSN	2214-109X
DOI	10.1016/S2214-109X(23)00052-9
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Article ; Online: Neighbourhood prevalence-to-notification ratios for adult bacteriologically-confirmed tuberculosis reveals hotspots of underdiagnosis in Blantyre, Malawi.

Khundi, McEwen / Carpenter, James R / Corbett, Elizabeth L / Feasey, Helena R A / Soko, Rebecca Nzawa / Nliwasa, Marriott / Twabi, Hussein / Chiume, Lingstone / Burke, Rachael M / Horton, Katherine C / Dodd, Peter J / Cohen, Ted / MacPherson, Peter

PloS one

2022 Volume 17, Issue 5, Page(s) e0268749

Abstract: Local information is needed to guide targeted interventions for respiratory infections such as tuberculosis (TB). Case notification rates (CNRs) are readily available, but systematically underestimate true disease burden in neighbourhoods with high ... ...

Abstract	Local information is needed to guide targeted interventions for respiratory infections such as tuberculosis (TB). Case notification rates (CNRs) are readily available, but systematically underestimate true disease burden in neighbourhoods with high diagnostic access barriers. We explored a novel approach, adjusting CNRs for under-notification (P:N ratio) using neighbourhood-level predictors of TB prevalence-to-notification ratios. We analysed data from 1) a citywide routine TB surveillance system including geolocation, confirmatory mycobacteriology, and clinical and demographic characteristics of all registering TB patients in Blantyre, Malawi during 2015-19, and 2) an adult TB prevalence survey done in 2019. In the prevalence survey, consenting adults from randomly selected households in 72 neighbourhoods had symptom-plus-chest X-ray screening, confirmed with sputum smear microscopy, Xpert MTB/Rif and culture. Bayesian multilevel models were used to estimate adjusted neighbourhood prevalence-to-notification ratios, based on summarised posterior draws from fitted adult bacteriologically-confirmed TB CNRs and prevalence. From 2015-19, adult bacteriologically-confirmed CNRs were 131 (479/371,834), 134 (539/415,226), 114 (519/463,707), 56 (283/517,860) and 46 (258/578,377) per 100,000 adults per annum, and 2019 bacteriologically-confirmed prevalence was 215 (29/13,490) per 100,000 adults. Lower educational achievement by household head and neighbourhood distance to TB clinic was negatively associated with CNRs. The mean neighbourhood P:N ratio was 4.49 (95% credible interval [CrI]: 0.98-11.91), consistent with underdiagnosis of TB, and was most pronounced in informal peri-urban neighbourhoods. Here we have demonstrated a method for the identification of neighbourhoods with high levels of under-diagnosis of TB without the requirement for a prevalence survey; this is important since prevalence surveys are expensive and logistically challenging. If confirmed, this approach may support more efficient and effective targeting of intensified TB and HIV case-finding interventions aiming to accelerate elimination of urban TB.
MeSH term(s)	Adult ; Bayes Theorem ; Humans ; Malawi/epidemiology ; Mass Screening/methods ; Mycobacterium tuberculosis ; Prevalence ; Sputum/microbiology ; Tuberculosis/complications ; Tuberculosis/diagnosis ; Tuberculosis/epidemiology
Language	English
Publishing date	2022-05-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2267670-3
ISSN	1932-6203 ; 1932-6203
ISSN (online)	1932-6203
ISSN	1932-6203
DOI	10.1371/journal.pone.0268749
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Article ; Online: Social mixing patterns relevant to infectious diseases spread by close contact in urban Blantyre, Malawi.

Thindwa, Deus / Jambo, Kondwani C / Ojal, John / MacPherson, Peter / Dennis Phiri, Mphatso / Pinsent, Amy / Khundi, McEwen / Chiume, Lingstone / Gallagher, Katherine E / Heyderman, Robert S / Corbett, Elizabeth L / French, Neil / Flasche, Stefan

Epidemics

2022 Volume 40, Page(s) 100590

Abstract: Introduction: Understanding human mixing patterns relevant to infectious diseases spread through close contact is vital for modelling transmission dynamics and optimisation of disease control strategies. Mixing patterns in low-income countries like ... ...

Abstract	Introduction: Understanding human mixing patterns relevant to infectious diseases spread through close contact is vital for modelling transmission dynamics and optimisation of disease control strategies. Mixing patterns in low-income countries like Malawi are not well known. Methodology: We conducted a social mixing survey in urban Blantyre, Malawi between April and July 2021 (between the 2nd and 3rd wave of COVID-19 infections). Participants living in densely-populated neighbourhoods were randomly sampled and, if they consented, reported their physical and non-physical contacts within and outside homes lasting at least 5 min during the previous day. Age-specific mixing rates were calculated, and a negative binomial mixed effects model was used to estimate determinants of contact behaviour. Results: Of 1201 individuals enroled, 702 (58.5%) were female, the median age was 15 years (interquartile range [IQR] 5-32) and 127 (10.6%) were HIV-positive. On average, participants reported 10.3 contacts per day (range: 1-25). Mixing patterns were highly age-assortative, particularly those within the community and with skin-to-skin contact. Adults aged 20-49 y reported the most contacts (median:11, IQR: 8-15) of all age groups; 38% (95%CI: 16-63) more than infants (median: 8, IQR: 5-10), who had the least contacts. Household contact frequency increased by 3% (95%CI: 2-5) per additional household member. Unemployed participants had 15% (95%CI: 9-21) fewer contacts than other adults. Among long range (>30 m away from home) contacts, secondary school children had the largest median contact distance from home (257 m, IQR 78-761). HIV-positive status in adults >=18 years-old was not associated with changed contact patterns (rate ratio: 1.01, 95%CI: (0.91-1.12)). During this period of relatively low COVID-19 incidence in Malawi, 301 (25.1%) individuals stated that they had limited their contact with others due to COVID-19 precautions; however, their reported contacts were 8% (95%CI: 1-13) higher. Conclusion: In urban Malawi, contact rates, are high and age-assortative, with little reported behavioural change due to either HIV-status or COVID-19 circulation. This highlights the limits of contact-restriction-based mitigation strategies in such settings and the need for pandemic preparedness to better understand how contact reductions can be enabled and motivated.
MeSH term(s)	Adolescent ; Adult ; COVID-19/epidemiology ; Child ; Communicable Diseases/epidemiology ; Female ; HIV Infections/epidemiology ; Humans ; Infant ; Malawi/epidemiology ; Male ; Schools
Language	English
Publishing date	2022-06-08
Publishing country	Netherlands
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2467993-8
ISSN	1878-0067 ; 1755-4365
ISSN (online)	1878-0067
ISSN	1755-4365
DOI	10.1016/j.epidem.2022.100590
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Article ; Online: Pattern of abnormalities amongst chest X-rays of adults undergoing computer-assisted digital chest X-ray screening for tuberculosis in Peri-Urban Blantyre, Malawi: A cross-sectional study.

Twabi, Hussein H / Semphere, Robina / Mukoka, Madalo / Chiume, Lingstone / Nzawa, Rebecca / Feasey, Helena R A / Lipenga, Trancizeo / MacPherson, Peter / Corbett, Elizabeth L / Nliwasa, Marriott

Tropical medicine & international health : TM & IH

2021 Volume 26, Issue 11, Page(s) 1427–1437

Abstract: Background: The prevalence of diseases other than tuberculosis (TB) detected during chest X-ray screening is poorly described in sub-Saharan Africa. Computer-assisted digital chest X-ray technology is available for TB screening and has the potential to ... ...

Abstract	Background: The prevalence of diseases other than tuberculosis (TB) detected during chest X-ray screening is poorly described in sub-Saharan Africa. Computer-assisted digital chest X-ray technology is available for TB screening and has the potential to be a screening tool for non-communicable diseases as well. Low- and middle-income countries are in a transition period where the burden of non-communicable diseases is increasing, but health systems are mainly focused on addressing infectious diseases. Methods: Participants were adults undergoing computer-assisted chest X-ray screening for tuberculosis in a community-wide tuberculosis prevalence survey in Blantyre, Malawi. Adults with abnormal radiographs by field radiographer interpretation were evaluated by a physician in a community-based clinic. X-ray classifications were compared to classifications of a random sample of normal chest X-rays by radiographer interpretation. Radiographic features were classified using WHO Integrated Management for Adult Illnesses (IMAI) guidelines. All radiographs taken at the screening tent were analysed by the Qure.ai qXR v2.0 software. Results: 5% (648/13,490) of adults who underwent chest radiography were identified to have an abnormal chest X-ray by the radiographer. 387 (59.7%) of the participants attended the X-ray clinic, and another 387 randomly sampled normal X-rays were available for comparison. Participants who were referred to the community clinic had a significantly higher HIV prevalence than those who had been identified to have a normal CXR by the field radiographer (90 [23.3%] vs. 43 [11.1%] p-value < 0.001). The commonest radiographic finding was cardiomegaly (20.7%, 95% CI 18.0-23.7). One in five (81/387) chest X-rays were misclassified by the radiographer. The overall mean Qure.ai qXR v2.0 score for all reviewed X-rays was 0.23 (SD 0.20). There was a high concordance of cardiomegaly classification between the physician and the computer-assisted software (109/118, 92.4%). Conclusion: There is a high burden of cardiomegaly on a chest X-ray at a community level, much of which is in patients with diabetes, heart disease and high blood pressure. Cardiomegaly on chest X-ray may be a potential tool for screening for cardiovascular NCDs at the primary care level as well as in the community.
MeSH term(s)	Adolescent ; Adult ; Aged ; Cardiomegaly/complications ; Cardiomegaly/diagnostic imaging ; Cardiomegaly/epidemiology ; Computers ; Cross-Sectional Studies ; Female ; Humans ; Malawi/epidemiology ; Male ; Middle Aged ; Prevalence ; Radiography, Thoracic ; Surveys and Questionnaires ; Tuberculosis, Pulmonary/complications ; Tuberculosis, Pulmonary/diagnostic imaging ; Young Adult
Language	English
Publishing date	2021-08-01
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1314080-2
ISSN	1365-3156 ; 1360-2276
ISSN (online)	1365-3156
ISSN	1360-2276
DOI	10.1111/tmi.13658
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Article ; Online: Accuracy and consequences of using

Divala, Titus Henry / Fielding, Katherine L / Sloan, Derek J / French, Neil / Nliwasa, Marriott / MacPherson, Peter / Kandulu, Chikondi Charity / Chiume, Lingstone / Chilanga, Sanderson / Ndaferankhande, Masiye John / Corbett, Elizabeth L

BMJ open

2020 Volume 10, Issue 3, Page(s) e033999

Abstract: Introduction: Over 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology- ... ...

Abstract	Introduction: Over 40% of global tuberculosis case notifications are diagnosed clinically without mycobacteriological confirmation. Standard diagnostic algorithms include 'trial-of-antibiotics'-empirical antibiotic treatment given to mycobacteriology-negative individuals to treat infectious causes of symptoms other than tuberculosis, as a 'rule-out' diagnostic test for tuberculosis. Potentially 26.5 million such antibiotic courses/year are prescribed globally for the 5.3 million/year mycobacteriology-negative patients, making trial-of-antibiotics the most common tuberculosis diagnostic, and a global-scale risk for antimicrobial resistance (AMR). Our systematic review found no randomised controlled trial (RCT) to support use of trial-of-antibiotic. The RCT aims to determine the diagnostic and clinical value and AMR consequences of trial-of-antibiotics. Methods and analysis: A three-arm, open-label, RCT randomising (1:1:1) Malawian adults (≥18 years) seeking primary care for cough into: (a) azithromycin 500 mg one time per day for 3 days or (b) amoxicillin 1 g three times per day for 5 days or (c) standard-of-care (no immediate antibiotic). We will perform mycobacteriology tests (microscopy, Xpert MTB/RIF ( Ethics and dissemination: The study has been reviewed and approved by Malawi College of Medicine Research and Ethics Committee, London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee and Regional Committee for Health and Research Ethics - Norway, and Malawi Pharmacy, Medicines and Poisons Board. We will present abstracts at relevant conferences, and prepare a manuscript for publication in a peer-reviewed journal. Trial registration number: The clinical trial is registered with ClinicalTrials.gov, NCT03545373.
MeSH term(s)	Humans ; Amoxicillin/administration & dosage ; Anti-Bacterial Agents/administration & dosage ; Anti-Bacterial Agents/therapeutic use ; Azithromycin/administration & dosage ; Drug Resistance, Bacterial ; Malawi ; Mycobacterium tuberculosis/isolation & purification ; Sensitivity and Specificity ; Streptococcus pneumoniae/drug effects ; Streptococcus pneumoniae/isolation & purification ; Tuberculosis/diagnosis ; Randomized Controlled Trials as Topic
Chemical Substances	Amoxicillin (804826J2HU) ; Anti-Bacterial Agents ; Azithromycin (83905-01-5)
Language	English
Publishing date	2020-03-25
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2019-033999
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Article ; Online: Tuberculosis in Hospitalized Patients With Human Immunodeficiency Virus: Clinical Characteristics, Mortality, and Implications From the Rapid Urine-based Screening for Tuberculosis to Reduce AIDS Related Mortality in Hospitalized Patients in Africa.

Gupta-Wright, Ankur / Fielding, Katherine / Wilson, Douglas / van Oosterhout, Joep J / Grint, Daniel / Mwandumba, Henry C / Alufandika-Moyo, Melanie / Peters, Jurgens A / Chiume, Lingstone / Lawn, Stephen D / Corbett, Elizabeth L

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

2019 Volume 71, Issue 10, Page(s) 2618–2626

Abstract: Background: Tuberculosis (TB) is the major killer of people living with human immunodeficiency virus (HIV) globally, with suboptimal diagnostics and management contributing to high case-fatality rates.: Methods: A prospective cohort of patients with ... ...

Abstract	Background: Tuberculosis (TB) is the major killer of people living with human immunodeficiency virus (HIV) globally, with suboptimal diagnostics and management contributing to high case-fatality rates. Methods: A prospective cohort of patients with confirmed TB (Xpert MTB/RIF and/or Determine TB-LAM Ag positive) identified through screening HIV-positive inpatients with sputum and urine diagnostics in Malawi and South Africa (Rapid urine-based Screening for Tuberculosis to reduce AIDS Related Mortality in hospitalized Patients in Africa [STAMP] trial). Urine was tested prospectively (intervention) or retrospectively (standard of care arm). We defined baseline clinical phenotypes using hierarchical cluster analysis, and also used Cox regression analysis to identify associations with early mortality (≤56 days). Results: Of 322 patients with TB confirmed between October 2015 and September 2018, 78.0% had ≥1 positive urine test. Antiretroviral therapy (ART) coverage was 80.2% among those not newly diagnosed, but with median CD4 count 75 cells/µL and high HIV viral loads. Early mortality was 30.7% (99/322), despite near-universal prompt TB treatment. Older age, male sex, ART before admission, poor nutritional status, lower hemoglobin, and positive urine tests (TB-LAM and/or Xpert MTB/RIF) were associated with increased mortality in multivariate analyses. Cluster analysis (on baseline variables) defined 4 patient subgroups with early mortality ranging from 9.8% to 52.5%. Although unadjusted mortality was 9.3% lower in South Africa than Malawi, in adjusted models mortality was similar in both countries (hazard ratio, 0.9; P = .729). Conclusions: Mortality following prompt inpatient diagnosis of HIV-associated TB remained unacceptably high, even in South Africa. Intensified management strategies are urgently needed, for which prognostic indicators could potentially guide both development and subsequent use.
MeSH term(s)	Acquired Immunodeficiency Syndrome ; Aged ; HIV ; HIV Infections/complications ; Humans ; Malawi/epidemiology ; Male ; Mycobacterium tuberculosis ; Prospective Studies ; Retrospective Studies ; Sensitivity and Specificity ; South Africa/epidemiology ; Sputum ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy
Language	English
Publishing date	2019-11-27
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1099781-7
ISSN	1537-6591 ; 1058-4838
ISSN (online)	1537-6591
ISSN	1058-4838
DOI	10.1093/cid/ciz1133
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Article ; Online: Social mixing patterns relevant to infectious diseases spread by close contact in urban Blantyre, Malawi.

Thindwa, Deus / Jambo, Kondwani C / Ojal, John / MacPherson, Peter / Phiri, Mphatso D / Khundi, McEwen / Chiume, Lingstone / Gallagher, Katherine / HEYDERMAN, Robert S / Corbett, Elizabeth L / French, Neil / Flasche, Stefan

medRxiv

Abstract	Introduction: Understanding human mixing patterns relevant to infectious diseases spread through close contact is vital for modelling transmission dynamics and optimisation of disease control strategies. Mixing patterns in low-income countries like Malawi are not well understood. Methodology: We conducted a social mixing survey in urban Blantyre, Malawi between April and July 2021 (between the 2nd and 3rd wave of COVID-19 infections). Participants living in densely-populated neighbourhoods were randomly sampled and, if they consented, reported their physical and non-physical contacts within and outside homes lasting at least 5 minutes during the previous day. Age-specific mixing rates were calculated, and a negative binomial mixed effects model was used to estimate determinants of contact behaviour. Results: Of 1,201 individuals enrolled, 702 (58.5%) were female, the median age was 15 years (interquartile range [IQR] 5-32) and 127 (10.6%) were HIV-positive. On average, participants reported 10.3 contacts per day (range: 1-25). Mixing patterns were highly age-assortative, particularly those within the community and with skin-to-skin contact. Adults aged 20-49y reported the most contacts (median:11, IQR: 8-15) of all age groups; 38% (95%CI: 16-63) more than infants (median: 8, IQR: 5-10), who had the least contacts. Household contact frequency increased by 3% (95%CI 2-5) per additional household member. Unemployed participants had 15% (95%CI: 9-21) fewer contacts than other adults. Among long range (>30 meters away from home) contacts, secondary school children had the largest median contact distance from home (257m, IQR 78-761). HIV-positive status in adults >18 years-old was not associated with increased contact patterns (1%, 95%CI -9-12). During this period of relatively low COVID-19 incidence in Malawi, 301 (25.1%) individuals stated that they had limited their contact with others due to COVID-19 precautions; however, their reported contacts were not fewer (8%, 95%CI 1-13). Conclusion: In urban Malawi, contact rates, are high and age-assortative, with little behavioural change due to either HIV-status or COVID-19 circulation. This highlights the limits of contact-restriction-based mitigation strategies in such settings and the need for pandemic preparedness to better understand how contact reductions can be enabled and motivated. Keywords: Social contacts, Transmission, Mixing data, Infectious disease, Malawi, Africa
Keywords	covid19
Language	English
Publishing date	2021-12-17
Publisher	Cold Spring Harbor Laboratory Press
Document type	Article ; Online
DOI	10.1101/2021.12.16.21267959
Database	COVID19

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Article ; Online: Rapid urine-based screening for tuberculosis in HIV-positive patients admitted to hospital in Africa (STAMP): a pragmatic, multicentre, parallel-group, double-blind, randomised controlled trial.

Gupta-Wright, Ankur / Corbett, Elizabeth L / van Oosterhout, Joep J / Wilson, Douglas / Grint, Daniel / Alufandika-Moyo, Melanie / Peters, Jurgens A / Chiume, Lingstone / Flach, Clare / Lawn, Stephen D / Fielding, Katherine

Lancet (London, England)

2018 Volume 392, Issue 10144, Page(s) 292–301

Abstract: Background: Current diagnostics for HIV-associated tuberculosis are suboptimal, with missed diagnoses contributing to high hospital mortality and approximately 374 000 annual HIV-positive deaths globally. Urine-based assays have a good diagnostic yield; ...

Abstract	Background: Current diagnostics for HIV-associated tuberculosis are suboptimal, with missed diagnoses contributing to high hospital mortality and approximately 374 000 annual HIV-positive deaths globally. Urine-based assays have a good diagnostic yield; therefore, we aimed to assess whether urine-based screening in HIV-positive inpatients for tuberculosis improved outcomes. Methods: We did a pragmatic, multicentre, double-blind, randomised controlled trial in two hospitals in Malawi and South Africa. We included HIV-positive medical inpatients aged 18 years or more who were not taking tuberculosis treatment. We randomly assigned patients (1:1), using a computer-generated list of random block size stratified by site, to either the standard-of-care or the intervention screening group, irrespective of symptoms or clinical presentation. Attending clinicians made decisions about care; and patients, clinicians, and the study team were masked to the group allocation. In both groups, sputum was tested using the Xpert MTB/RIF assay (Xpert; Cepheid, Sunnyvale, CA, USA). In the standard-of-care group, urine samples were not tested for tuberculosis. In the intervention group, urine was tested with the Alere Determine TB-LAM Ag (TB-LAM; Alere, Waltham, MA, USA), and Xpert assays. The primary outcome was all-cause 56-day mortality. Subgroup analyses for the primary outcome were prespecified based on baseline CD4 count, haemoglobin, clinical suspicion for tuberculosis; and by study site and calendar time. We used an intention-to-treat principle for our analyses. This trial is registered with the ISRCTN registry, number ISRCTN71603869. Findings: Between Oct 26, 2015, and Sept 19, 2017, we screened 4788 HIV-positive adults, of which 2600 (54%) were randomly assigned to the study groups (n=1300 for each group). 13 patients were excluded after randomisation from analysis in each group, leaving 2574 in the final intention-to-treat analysis (n=1287 in each group). At admission, 1861 patients were taking antiretroviral therapy and median CD4 count was 227 cells per μL (IQR 79-436). Mortality at 56 days was reported for 272 (21%) of 1287 patients in the standard-of-care group and 235 (18%) of 1287 in the intervention group (adjusted risk reduction [aRD] -2·8%, 95% CI -5·8 to 0·3; p=0·074). In three of the 12 prespecified, but underpowered subgroups, mortality was lower in the intervention group than in the standard-of-care group for CD4 counts less than 100 cells per μL (aRD -7·1%, 95% CI -13·7 to -0·4; p=0.036), severe anaemia (-9·0%, -16·6 to -1·3; p=0·021), and patients with clinically suspected tuberculosis (-5·7%, -10·9 to -0·5; p=0·033); with no difference by site or calendar period. Adverse events were similar in both groups. Interpretation: Urine-based tuberculosis screening did not reduce overall mortality in all HIV-positive inpatients, but might benefit some high-risk subgroups. Implementation could contribute towards global targets to reduce tuberculosis mortality. Funding: Joint Global Health Trials Scheme of the Medical Research Council, the UK Department for International Development, and the Wellcome Trust.
MeSH term(s)	AIDS-Related Opportunistic Infections/diagnosis ; AIDS-Related Opportunistic Infections/drug therapy ; AIDS-Related Opportunistic Infections/mortality ; AIDS-Related Opportunistic Infections/urine ; Adult ; Developing Countries ; Double-Blind Method ; Drug Resistance, Bacterial ; Female ; HIV Seropositivity/drug therapy ; HIV Seropositivity/mortality ; HIV Seropositivity/urine ; Humans ; Malawi ; Male ; Mass Screening ; Middle Aged ; Rifampin/therapeutic use ; South Africa ; Sputum/microbiology ; Tuberculosis/diagnosis ; Tuberculosis/drug therapy ; Tuberculosis/mortality ; Tuberculosis/urine ; Urinalysis
Chemical Substances	Rifampin (VJT6J7R4TR)
Language	English
Publishing date	2018-07-20
Publishing country	England
Document type	Journal Article ; Multicenter Study ; Pragmatic Clinical Trial ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	3306-6
ISSN	1474-547X ; 0023-7507 ; 0140-6736
ISSN (online)	1474-547X
ISSN	0023-7507 ; 0140-6736
DOI	10.1016/S0140-6736(18)31267-4
Database	MEDical Literature Analysis and Retrieval System OnLINE

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