cluster randomised trial
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Abstract Background Mother-to-baby transmission of group B Streptococcus (GBS) is the main cause of early-onset infection. We evaluated whether, in women with clinical risk factors for early neonatal infection, the use of point-of-care rapid intrapartum test to detect maternal GBS colonisation reduces maternal antibiotic exposure compared with usual care, where antibiotics are administered due to those risk factors. We assessed the accuracy of the rapid test in diagnosing maternal GBS colonisation, against the reference standard of selective enrichment culture. Methods We undertook a parallel-group cluster randomised trial, with nested test accuracy study and microbiological sub-study. UK maternity units were randomised to a strategy of rapid test (GeneXpert GBS system, Cepheid) or usual care. Within units assigned to rapid testing, vaginal-rectal swabs were taken from women with risk factors for vertical GBS transmission in established term labour. The trial primary outcome was the proportion of women receiving intrapartum antibiotics to prevent neonatal early-onset GBS infection. The accuracy of the rapid test was compared against the standard of selective enrichment culture in diagnosing maternal GBS colonisation. Antibiotic resistance profiles were determined in paired maternal and infant samples. Results Twenty-two maternity units were randomised and 20 were recruited. A total of 722 mothers (749 babies) participated in rapid test units; 906 mothers (951 babies) were in usual care units. There was no evidence of a difference in the rates of intrapartum antibiotic prophylaxis (relative risk 1.16, 95% CI 0.83 to 1.64) between the rapid test (41%, 297/716) and usual care (36%, 328/906) units. No serious adverse events were reported. The sensitivity and specificity measures of the rapid test were 86% (95% CI 81 to 91%) and 89% (95% CI 85 to 92%), respectively. Babies born to mothers who carried antibiotic-resistant Escherichia coli were more likely to be colonised with antibiotic-resistant strains than those born to mothers with antibiotic-susceptible E. coli. Conclusion The use of intrapartum rapid test to diagnose maternal GBS colonisation did not reduce the rates of antibiotics administered for preventing neonatal early-onset GBS infection than usual care, although with considerable uncertainty. The accuracy of the rapid test is within acceptable limits. Trial registration ISRCTN74746075. Prospectively registered on 16 April 2015

BACKGROUND Musculoskeletal and mental health complaints are the dominant diagnostic categories in long-term sick leave and disability pensions in Norway. Continuing to work despite health complaints is often beneficial, and a good work environment can improve work inclusion for people affected. In 2001, the Norwegian Labour and Welfare Administration (NAV) began to offer inclusive work measures (IWM) to improve the psychosocial work environment, as well as work inclusion of people with health complaints. In 2018, NAV and specialist health services started offering the new collaborative Health in work programme. Its workplace intervention (HIW) presents health- and welfare information that may improve employees´ coping ability regarding common health complaints. It encourages understanding of coworkers´ health complaints and appropriate work adjustments, in order to increase work participation. OBJECTIVE This protocol presents an ongoing, two-arm, pragmatic cluster-randomised trial. Its aim is to compare the effect of monodisciplinary IWM (treatment as usual) and interdisciplinary HIW in terms of changes in overall sickness absence, healthcare utilisation, health-related quality of life, and costs. Secondary objectives are to compare changes in individual sickness absence, psychosocial work environment, job and life satisfaction, health, and health anxiety, both at the individual and the group level. METHODS Data will be collected from national registers, trial-specific registrations and questionnaires. Effects will be explored by difference-in-difference analysis, and regression modelling. Multilevel analysis will visualise any cluster effects by intraclass correlation coefficients. RESULTS Inclusion is completed with 97 workplaces and 1383 individual consents. CONCLUSIONS Data collection will be finished with the last questionnaires to be sent out in July 2023. This trial will contribute to fill knowledge gaps about effectiveness and costs of workplace interventions, thereby benefitting health and welfare services, political decision-makers, and the public and business sectors. CLINICALTRIAL The trial is approved by the Norwegian Regional Committee for Medical and Health Research Ethics and registered in Clinicaltrials.gov (NCT04000035). Findings will be published in reports, peer-reviewed journals and at conferences.

Background Adolescents living with HIV have poor virological suppression and high prevalence of common mental disorders (CMDs). In Zimbabwe, the Zvandiri adolescent peer support programme is effective at improving virological suppression. We assessed the effect of training Zvandiri peer counsellors known as Community Adolescent Treatment Supporters (CATS) in problem-solving therapy (PST) on virological suppression and mental health outcomes. Methods and findings Sixty clinics were randomised 1:1 to either normal Zvandiri peer counselling or a peer counsellor trained in PST. In January to March 2019, 842 adolescents aged 10 to 19 years and living with HIV who screened positive for CMDs were enrolled (375 (44.5%) male and 418 (49.6%) orphaned of at least one parent). The primary outcome was virological nonsuppression (viral load ≥1,000 copies/mL). Secondary outcomes were symptoms of CMDs measured with the Shona Symptom Questionnaire (SSQ ≥8) and depression measured with the Patient Health Questionnaire (PHQ-9 ≥10) and health utility score using the EQ-5D. The adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were estimated using logistic regression adjusting for clinic-level clustering. Case reviews and focus group discussions were used to determine feasibility of intervention delivery. At baseline, 35.1% of participants had virological nonsuppression and 70.3% had SSQ≥8. After 48 weeks, follow-up was 89.5% for viral load data and 90.9% for other outcomes. Virological nonsuppression decreased in both arms, but there was no evidence of an intervention effect (prevalence of nonsuppression 14.7% in the Zvandiri-PST arm versus 11.9% in the Zvandiri arm; AOR = 1.29; 95% CI 0.68, 2.48; p = 0.44). There was strong evidence of an apparent effect on common mental health outcomes (SSQ ≥8: 2.4% versus 10.3% [AOR = 0.19; 95% CI 0.08, 0.46; p < 0.001]; PHQ-9 ≥10: 2.9% versus 8.8% [AOR = 0.32; 95% CI 0.14, 0.78; p = 0.01]). Prevalence of EQ-5D index score <1 was 27.6% versus 38.9% (AOR = 0.56; 95% CI 0.31, 1.03; p = 0.06). Qualitative analyses found that CATS-observed participants had limited autonomy or ability to solve problems. In response, the CATS adapted the intervention to focus on empathic problem discussion to fit adolescents’ age, capacity, and circumstances, which was beneficial. Limitations include that cost data were not available and that the mental health tools were validated in adult populations, not adolescents. Conclusions PST training for CATS did not add to the benefit of peer support in reducing virological nonsuppression but led to improved symptoms of CMD and depression compared to standard Zvandiri care among adolescents living with HIV in Zimbabwe. Active involvement of caregivers and strengthened referral structures could increase feasibility and effectiveness. Trial registration Pan African Clinical Trials Registry PACTR201810756862405.

ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant’s mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.

IntroductionThe WHO recommends oral amoxicillin for 2–59-month-old children with chest-indrawing pneumonia presenting at the health facility. Community-level health workers (CLHWs) are not allowed to treat these children when presented at the community level. This study aimed to evaluate whether CLHWs can safely and effectively treat children 2–59 months-old with chest indrawing with a 5-day course of oral amoxicillin in a few selected countries in Africa and Asia, especially when a referral is not feasible.MethodsWe conducted a prospective multicountry cluster-randomised, open-label, non-inferiority trial in rural areas of four countries (Bangladesh, Ethiopia, India and Malawi) from September 2016 to December 2018. Children aged 2–59 months having parents/caregivers reported cough and/or difficult breathing presenting to a CLHW were screened for enrolment. CLHWs in the intervention clusters assessed children for hypoxaemia and treated non-hypoxaemic chest-indrawing pneumonia with two times per day oral amoxicillin (50 mg/kg body weight per dose) for 5 days at the community level. CLHWs in the control clusters identified chest indrawing and referred them to a referral-level health facility for treatment. Study supervisors performed pulse oximetry in the control clusters except in Bangladesh. Children were assessed for the primary outcome (clinical treatment failure) up to day 14 after enrolment. The accuracy and impact of pulse oximetry by CLHWs in the intervention clusters were also assessed.ResultsIn 208 clusters, 1688 CLHWs assessed 62 363 children with cough and/or difficulty breathing. Of these, 4013 non-hypoxaemic 2–59-month-old children with chest-indrawing pneumonia were enrolled. We excluded 116 children from analysis, leaving 3897 for intention-to-treat analysis. In the intervention clusters, 4.3% (90/2081) failed treatment, including five deaths, while in the control clusters, 4.4% (79/1816) failed treatment, including five deaths. The adjusted risk difference was -0.01 (95% CI −1.5% to 1.5%), which satisfied the prespecified non-inferiority criterion. CLHWs correctly performed pulse oximetry in 91.1% (2001/2196) of cases in the intervention clusters.ConclusionsThe community treatment of non-hypoxaemic children with chest-indrawing pneumonia with 5-day oral amoxicillin by trained, equipped and supervised CLHWs is non-inferior to currently recommended facility-based treatment. These findings encourage a review of the existing strategy of community-based management of pneumonia.Trial registrationACTRN12617000857303; The Australian New Zealand Clinical Trials Registry.

Background Diarrheal disease remains a significant cause of morbidity and mortality among the under-fives in many low- and middle-income countries. Changes to food safety practices and feeding methods around the weaning period, alongside improved nutrition, may significantly reduce the risk of disease and improve development for infants. This article describes a protocol for a cluster randomized trial to evaluate the effectiveness of a multi-faceted community-based educational intervention that aims to improve food safety and hygiene behaviours and enhance child nutrition. Methods We will conduct a mixed-methods, parallel cluster randomised controlled trial with baseline measures. 120 clusters comprising small urban and rural communities will be recruited in equal numbers and randomly allocated in a 1:1 ratio to either treatment or control arms. Participants will be mother-child dyads (27 per cluster period) with children aged 6 to 24 months. Data collection will comprise a day of observation and interviews with each participating mother-child pair and will take place at baseline and four and 15 months post-intervention. The primary analysis will estimate the effectiveness of the intervention on changes to complementary food safety and preparation behaviours, food and water contamination, and diarrhoea. Secondary outcomes include maternal autonomy, enteric infection, nutritional content of meals, and child anthropometry. A secondary structural equation analysis will be conducted to examine the causal relationships between the different outcomes. Conclusions The trial will provide evidence on the effectiveness of community-based behavioural change and educational interventions designed to reduce the burden of diarrhoeal disease in the under fives, and how effectiveness varies across different contexts.