Sociological variety and the transmission efficiency of Mycobacterium tuberculosis: a secondary analysis of qualitative and quantitative data from 15 communities in Zambia

ObjectivesSelected Zambian communities formed part of a cluster randomised trial: the Zambia and South Africa TB and AIDS Reduction study (ZAMSTAR). There was wide variability in the prevalence of Mycobacterium tuberculosis infection and tuberculosis (TB) disease across these communities. We sought to clarify whether specific communities could have been more/less vulnerable to M. tuberculosis transmission as a result of sociological variety relevant to transmission efficiency.DesignWe conducted a mixed methods secondary analysis using existing data sets. First, we analysed qualitative data to categorise and synthesise patterns of socio-spatial engagement across communities. Second, we compared emergent sociological variables with a measure of transmission efficiency: the ratio of the annual risk of infection to TB prevalence.SettingZAMSTAR communities in urban and peri-urban Zambia, spanning five provinces.ParticipantsFifteen communities, each served by a health facility offering TB treatment to a population of at least 25 000. TB notification rates were at least 400 per 100 000 per annum and HIV seroprevalence was estimated to be high.ResultsCrowding, movement, livelihoods and participation in recreational activity differed across communities. Based on 12 socio-spatial indicators, communities were qualitatively classified as more/less spatially crowded and as more/less socially ‘open’ to contact with others, with implications for the presumptive risk of M. tuberculosis transmission. For example, watching video shows in poorly ventilated structures posed a presumptive risk in more socially open communities, while outdoor farming and/or fishing were particularly widespread in communities with lower transmission measures.ConclusionsA dual dynamic of ‘social permeability’ and crowding appeared relevant to disparities in M. tuberculosis transmission efficiency. To reduce transmission, certain socio-spatial aspects could be adjusted (eg, increasing ventilation on transport), while more structural aspects are less malleable (eg, reliance on public transport). We recommend integrating community level typologies with genome sequencing techniques to further explore the significance of ‘social permeability’.Trial registration numberISRCTN36729271.

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Effectiveness of expanding annual mass azithromycin distribution treatment coverage for trachoma in Niger: a cluster randomised trial

British Journal of Ophthalmology ◽

10.1136/bjophthalmol-2017-310916 ◽

2017 ◽

Vol 102 (5) ◽

pp. 680-686 ◽

Cited By ~ 10

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Sun Y Cotter ◽

Nicole E Stoller ◽

...

Keyword(s):

Repeated Measures ◽

Randomised Trial ◽

Chlamydia Infection ◽

Cluster Randomised Trial ◽

Active Trachoma ◽

Treatment Coverage ◽

Significant Difference ◽

Registration Number ◽

Rate Of Decline ◽

Antibiotic Coverage

Background/aimsThe WHO recommends 3–5 years of annual mass azithromycin distribution with at least 80% treatment coverage to districts with active trachoma prevalence over 10% among children. Here, we assess the efficacy of expanding the coverage target to at least 90% for trachoma control in a mesoendemic region of Niger.MethodsTwenty-four communities were randomised to a single day of azithromycin distribution with a coverage target of 80% of the community or up to 4 days of treatment, aiming for greater than 90% coverage. Distributions were annual and individuals above 6 months of age were treated. Children under 5 years of age were monitored for ocular chlamydia infection and active trachoma.ResultsAt baseline, ocular chlamydia prevalence was 20.5% (95% CI 9.8% to 31.2%) in the standard coverage arm and 21.9% (95% CI 11.3% to 32.5%) in the enhanced coverage arm, which reduced to 4.6% (95% CI 0% to 9.5%, p=0.008) and 7.1% (95% CI 2.7% to 11.4%, p<0.001) at 36 months, respectively. There was no significant difference in 36-month ocular chlamydia prevalence between the two arms (p=0.21). There was no difference in the rate of decline in ocular chlamydia between the two arms in a repeated measures model (p=0.80).ConclusionsFor annual mass azithromycin distribution programme to an entire community, there may be no additional benefit of increasing antibiotic coverage above the WHO’s 80% target.Trial registration numberNCT00792922, post-results.

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Effect of the good school toolkit on school staff mental health, sense of job satisfaction and perceptions of school climate: Secondary analysis of a cluster randomised trial

Preventive Medicine ◽

10.1016/j.ypmed.2017.05.022 ◽

2017 ◽

Vol 101 ◽

pp. 84-90 ◽

Cited By ~ 4

Author(s):

Joshua Kayiwa ◽

Kelly Clarke ◽

Louise Knight ◽

Elizabeth Allen ◽

Eddy Walakira ◽

...

Keyword(s):

Mental Health ◽

Job Satisfaction ◽

School Climate ◽

Randomised Trial ◽

Secondary Analysis ◽

School Staff ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Good School ◽

Perceptions Of School

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Efficacy of pragmatic same-day ring prophylaxis for adult individuals exposed to SARS-CoV-2 in Switzerland (COPEP): protocol of an open-label cluster randomised trial

BMJ Open ◽

10.1136/bmjopen-2020-040110 ◽

2020 ◽

Vol 10 (11) ◽

pp. e040110

Author(s):

Mikaela Smit ◽

Annalisa Marinosci ◽

Giovanni Jacopo Nicoletti ◽

Thomas Perneger ◽

Silvio Ragozzino ◽

...

Keyword(s):

Randomised Trial ◽

Standard Of Care ◽

Cluster Randomised Trial ◽

Postexposure Prophylaxis ◽

Open Label ◽

Daily Monitoring ◽

Intention To Treat ◽

Cluster Randomised ◽

Registration Number ◽

Asymptomatic Individuals

IntroductionLopinavir/ritonavir (LPV/r) has been proposed as repurposed drugs for pre-exposure and postexposure prophylaxis as well as therapy of COVID-19. Coronavirus postexposure prophylaxis (COPEP) trial aims at assessing their efficacy as postexposure ring-prophylaxis among adults exposed to SARS-CoV-2.Methods and analysisCOPEP is a two-arm open-label cluster-randomised trial conducted in three cantons of Switzerland. Asymptomatic contacts (≥16 years) of individuals diagnosed with COVID-19 will be randomised (2:1) to either LPV/r (400 mg/100 mg two times per day) for 5 days, or a standard of care arm (no treatment). Asymptomatic individuals may be either SARS-CoV-2 positive or negative. Contacts living in the single household will form a cluster and will be randomised into the same arm. All participants will be followed-up for 21 days and undergo daily monitoring for COVID-19 symptoms. The primary endpoint is 21-day incidence of laboratory-confirmed COVID-19 with ≥1 compatible symptom, analysed in an intention-to-treat (ITT) analysis. The secondary endpoints include the 21-day incidence of COVID-19 as well as SARS-CoV-2 infection in a modified ITT analysis, excluding participants who had a positive SARS-CoV-2 RT-PCR from oropharyngeal swab and/or a positive SARS-CoV-2 IgG serology at baseline. Assuming a 21-day incidence for COVID-19 of 20% among contacts without postexposure chemoprophylaxis, to detect a relative risk reduction of 60% (ie, translating in an absolute reduction from 20% to 8%), with a power of 80%, an alpha of 5%. Accounting for design effect of cluster design of circa 1.1, we plan to enrol 200 participants to the LPV/r arm and 100 to the standard of care arm, 300 participants in total.Ethics and disseminationEthics approval has been granted by the Commission Cantonale d’Ethique de la Recherche, Ethikkommission Nordwest- und Zentralschweiz and Comitato Etico Cantonale (ref 2020-00864) and Swissmedic (2020DR3056). Results from this trial will be disseminated via journal articles and presentations at national and international conferences.Trial registration numberClinicaltrials.gov Registry (NCT04364022); Swiss National Clinical Trial Portal Registry (SNCTP 000003732).Registered report identifierCCER 2020-0864.

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Fidelity protocol for the Action Success Knowledge (ASK) trial: a psychosocial intervention administered by speech and language therapists to prevent depression in people with post-stroke aphasia

BMJ Open ◽

10.1136/bmjopen-2018-023560 ◽

2019 ◽

Vol 9 (5) ◽

pp. e023560

Author(s):

Marcella Carragher ◽

Brooke Ryan ◽

Linda Worrall ◽

Shirley Thomas ◽

Miranda Rose ◽

...

Keyword(s):

Health Behaviour ◽

Intervention Studies ◽

Language Disability ◽

Randomised Trial ◽

Experimental Treatment ◽

Cluster Randomised Trial ◽

Human Research ◽

Time Of Application ◽

Human Research Ethics ◽

Registration Number

IntroductionTreatment fidelity is a complex, multifaceted evaluative process which refers to whether a studied intervention was delivered as intended. Monitoring and enhancing fidelity is one recommendation of the TiDIER (Template for Intervention Description and Replication) checklist, as fidelity can inform interpretation and conclusions drawn about treatment effects. Despite the methodological and translational benefits, fidelity strategies have been used inconsistently within health behaviour intervention studies; in particular, within aphasia intervention studies, reporting of fidelity remains relatively rare. This paper describes the development of a fidelity protocol for the Action Success Knowledge (ASK) study, a current cluster randomised trial investigating an early mood intervention for people with aphasia (a language disability caused by stroke).Methods and analysisA novel fidelity protocol and tool was developed to monitor and enhance fidelity within the two arms (experimental treatment and attention control) of the ASK study. The ASK fidelity protocol was developed based on the National Institutes of Health Behaviour Change Consortium fidelity framework.Ethics and disseminationThe study protocol was approved by the Darling Downs Hospital and Health Service Human Research Ethics Committee in Queensland, Australia under the National Mutual Acceptance scheme of multicentre human research projects. Specific ethics approval was obtained for those participating sites who were not under the National Mutual Agreement at the time of application. The monitoring and ongoing conduct of the research project is in line with requirements under the National Mutual Acceptance. On completion of the trial, findings from the fidelity reviews will be disseminated via publications and conference presentations.Trial registration numberACTRN12614000979651.

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Physical Activity and Health-Related Quality of Life During Pregnancy: A Secondary Analysis of a Cluster-Randomised Trial

Maternal and Child Health Journal ◽

10.1007/s10995-014-1457-4 ◽

2014 ◽

Vol 18 (9) ◽

pp. 2098-2105 ◽

Cited By ~ 25

Author(s):

Päivi Kolu ◽

Jani Raitanen ◽

Riitta Luoto

Keyword(s):

Quality Of Life ◽

Physical Activity ◽

Randomised Trial ◽

Secondary Analysis ◽

Cluster Randomised Trial ◽

Health Related Quality ◽

Cluster Randomised ◽

Related Quality ◽

Health Related

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The association of urine markers of iodine intake with development and growth among children in rural Uganda: a secondary analysis of a randomised education trial

Public Health Nutrition ◽

10.1017/s1368980020001603 ◽

2020 ◽

pp. 1-10

Author(s):

Prudence Atukunda ◽

Grace KM Muhoozi ◽

Lien M Diep ◽

Jens P Berg ◽

Ane C Westerberg ◽

...

Keyword(s):

Child Development ◽

Randomised Trial ◽

Intervention Group ◽

Secondary Analysis ◽

Positive Association ◽

Study Groups ◽

Iodine Intake ◽

Cluster Randomised Trial ◽

Cognitive Score ◽

Ages And Stages Questionnaire

Abstract Objective: We examined associations of urine iodide excretion, proxy for iodine intake, with child development and growth. Design: This is a secondary analysis of a 1:1 cluster-randomised trial with a 6-month nutrition/stimulation/hygiene education intervention among mothers of children aged 6–8 months to improve child development and growth. Development was assessed using Bayley Scales of Infant and Toddler Development–III (BSID-III) and Ages and Stages Questionnaire (ASQ), whereas anthropometry was used to assess growth. Urine iodide concentration (UIC) and urine iodide/creatinine ratio (ICR) were measured. Setting: The current study was conducted in southern Uganda. Participants: We randomly selected 155 children from the 511 enrolled into the original trial and analysed data when they were aged 20–24 and 36 months. Results: Median UIC for both study groups at 20–24 and 36 months were similar (P > 0·05) and within the normal range of 100–199 µg/l (0·79–1·60 µmol/l), whereas the intervention group had significantly higher ICR at 20–24 months. The BSID-III cognitive score was positively associated (P = 0·028) with ICR at 20–24 months in the intervention group. The ASQ gross motor score was negatively associated (P = 0·020) with ICR at 20–24 months among the controls. ICR was not significantly associated with anthropometry in the two study groups at either time-point. Conclusions: Following the intervention, a positive association was noted between ICR and child’s cognitive score at 20–24 months, whereas no positive association with ICR and growth was detected. Iodine sufficiency may be important for child’s cognitive development in this setting.

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Effects of a worksite tobacco control intervention in India: the Mumbai worksite tobacco control study, a cluster-randomised trial

Tobacco Control ◽

10.1136/tobaccocontrol-2015-052671 ◽

2016 ◽

Vol 26 (2) ◽

pp. 210-216 ◽

Cited By ~ 6

Author(s):

Glorian Sorensen ◽

Mangesh Pednekar ◽

Laura Shulman Cordeira ◽

Pratibha Pawar ◽

Eve M Nagler ◽

...

Keyword(s):

Tobacco Control ◽

Manufacturing Sector ◽

Statistical Significance ◽

Randomised Trial ◽

Health Protection ◽

Cluster Randomised Trial ◽

Cluster Randomised ◽

Control Intervention ◽

Registration Number ◽

The Difference

ObjectivesWe assessed a worksite intervention designed to promote tobacco control among workers in the manufacturing sector in Greater Mumbai, India.MethodsWe used a cluster-randomised design to test an integrated health promotion/health protection intervention, the Healthy, Safe, and Tobacco-free Worksites programme. Between July 2012 and July 2013, we recruited 20 worksites on a rolling basis and randomly assigned them to intervention or delayed-intervention control conditions. The follow-up survey was conducted between December 2013 and November 2014.ResultsThe difference in 30-day quit rates between intervention and control conditions was statistically significant for production workers (OR=2.25, p=0.03), although not for the overall sample (OR=1.70; p=0.12). The intervention resulted in a doubling of the 6-month cessation rates among workers in the intervention worksites compared to those in the control, for production workers (OR=2.29; p=0.07) and for the overall sample (OR=1.81; p=0.13), but the difference did not reach statistical significance.ConclusionsThese findings demonstrate the potential impact of a tobacco control intervention that combined tobacco control and health protection programming within Indian manufacturing worksites.Trial registration numberNCT01841879.

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