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Abstract Introduction In Uganda, although most women wish to delay or prevent future pregnancies, uptake of postpartum family planning (PPFP) is low. We explored behavioural factors influencing the utilisation of postpartum long-acting reversible contraceptives (LARCs) in Eastern Uganda. Methods We conducted a qualitative study in two districts of Eastern Uganda. We conducted 20 in-depth interviews and three focus group discussions with postpartum women, male partners, midwives, and village health team members. We analysed transcripts using framework analysis, based on the COM-B framework. Results The use of immediate postpartum LARC was affected by the capabilities of women in terms of their knowledge and misconceptions. Limited capabilities of health workers to provide counselling and insert IUDs, as well as shortages of implants, reduced the physical opportunites for women to access PPFP. Social opportunities for women were limited because men wanted to be involved in the decision but rarely had time to accompany their partners to health facilities, and health workers often appeared too stressed. Men also feared that PPFP would enable their partners to be unfaithful. Motivation to take up immediate postpartum LARC included the desire to space births, preference for contraceptive implants over intra uterine devices (IUD) at the 6-week postpartum period, resumption of sex and menses, partner support, and perceived effectiveness of postpartum contraception. Participants thought that uptake of immediate postpartum LARC could be improved by health education and outreach visits, male involvement and couples’ counselling in antenatal clinic appointments, and enabling switching between family planning methods (in case of side-effects) . Conclusion Low uptake of PPFP was caused by inadequate knowledge and misconceptions about LARC by women and their partners, insufficient numbers of midwives trained to provide PPFP, stock-outs of PPFP methods, and few social opportunities for couples to be counselled together. These factors could be addressed by scaling up effective, low cost and innovative ways to provide health education (such as films), involving men in decision-making, as well as training more midwives to provide PPFP services, and ensuring that they have sufficient time and supplies.

Abstract Introduction Non-pharmaceutical interventions (NPIs), such as handwashing, social distancing and face mask wearing, have been widely promoted to reduce the spread of COVID-19. This study aimed to explore the relationship between self-reported use of NPIs and COVID-19 infection. Methods We conducted an online questionnaire study recruiting members of the UK public from November 2020 to May 2021. The association between self-reported COVID-19 illness and reported use of NPIs was explored using logistic regression and controlling for participant characteristics, month of questionnaire completion, and vaccine status. Participants who had been exposed to COVID-19 in their household in the previous 2 weeks were excluded. Results Twenty-seven thousand seven hundred fifty-eight participants were included and 2,814 (10.1%) reported having a COVID-19 infection. The odds of COVID-19 infection were reduced with use of a face covering in unadjusted (OR 0.17 (95% CI: 0.15 to 0.20) and adjusted (aOR 0.19, 95% CI 0.16 to 0.23) analyses. Social distancing (OR 0.27, 95% CI: 0.22 to 0.31; aOR 0.35, 95% CI 0.28 to 0.43) and handwashing when arriving home (OR 0.57, 95% CI 0.46 to 0.73; aOR 0.63, 95% CI: 0.48 to 0.83) also reduced the odds of COVID-19. Being in crowded places of 10–100 people (OR 1.89, 95% CI: 1.70 to 2.11; aOR 1.62, 95% CI: 1.42 to 1.85) and > 100 people (OR 2.33, 95% CI: 2.11 to 2.58; aOR 1.73, 95% CI: 1.53 to 1.97) were both associated with increased odds of COVID-19 infection. Handwashing before eating, avoiding touching the face, and cleaning things with virus on were all associated with increased odds of COVID-19 infections. Conclusions This large observational study found evidence for strong protective effects for individuals from use of face coverings, social distancing (including avoiding crowded places) and handwashing on arriving home on developing COVID-19 infection. We also found evidence for an increased risk associated with other behaviours, possibly from recall bias.

Abstract Background Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are a major reason for consultations in primary care, hospital admissions, deterioration in function, and mortality. Despite the majority of exacerbations not being caused by bacteria, as many as 70% of patients who present in UK primary care with AECOPD are prescribed antibiotics as part of standard care. However, finding effective non-antibiotic treatments for COPD exacerbations is a priority to reduce antibiotic use. The Chinese herbal medicine Shufeng Jiedu® (SFJD) has the potential to reduce treatment failure and duration of hospital stay. This study aims to determine the feasibility of conducting a fully powered randomised, double blind, placebo-controlled clinical trial on SFJD for AECOPD in UK primary care. Methods This study is a phase III, two-arm individually double blind, randomised, placebo-controlled feasibility trial with nested qualitative study, coordinated by the Southampton Clinical Trial Unit (SCTU). Patients aged ≥ 40 years, with a current AECOPD, presenting with increased sputum purulence/volume, or breathlessness, and for whom the GP is considering use of antibiotics, will be eligible to participate. We aim to recruit seven eligible participants per month and randomise them to receive either the patent Chinese herbal medicine SFJD capsules or placebo for 14 consecutive days and to follow-up for 12 weeks. The primary outcomes include the feasibility of recruitment, study retention, and the percentage of diary completion. Discussion If this trial demonstrates the feasibility of recruitment, delivery, and follow-up, we will seek funding for a fully powered placebo-controlled trial of SFJD for the treatment of AECOPD in primary care. Trial registration This trial is registered via ISRCTN on 1 July 2021, identifier: ISRCTN26614726.

Plain Language summary Thousands of women and children in Uganda die every year due to problems related to pregnancy and childbirth. About 20% of these deaths are avoidable by better use of contraception. Many women are reluctant to begin contraception because of fears and myths about side-effects, and because they need the agreement of their husbands. The aim of this research was to study whether health education films could address these fears, and to compare a short documentary with a short drama film. We produced two health education films (a documentary and a drama) in two local languages with the involvement of local people. Films aimed to (1) dispel some myths on contraception, (2) encourage men to attend at least one antenatal clinic with their wives, and (3) discuss with a health worker whether they would like a method of family planning after the delivery. We showed these films to focus groups of local women, men and health workers in four contrasting areas of Uganda. The people taking part in the focus groups discussed their reactions to the films, whether they had learned anything from them, whether their attitudes towards family planning had changed as a result, and whether they intended to discuss this with their partner. Viewing a short documentary on the contraceptive implant improved knowledge, and short drama films improved attitudes and intentions to discuss the implant with their partner. The documentary and drama had different advantages, and most participants wanted to see both.

Abstract Background Although rarely indicated, antibiotics are commonly used for acute diarrhoea in China. We conducted a randomised, double blind exploratory clinical trial of loperamide, berberine and turmeric for treatment of acute diarrhoea. Methods Adults with acute uncomplicated diarrhoea aged 18 to 70 were randomised to 4 groups: (A) loperamide; (B) loperamide and berberine; (C) loperamide and turmeric; (D) loperamide, berberine and turmeric. All participants were given rescue ciprofloxacin for use after 48 h if symptoms worsened or were unimproved. Primary endpoints were feasibility and ciprofloxacin use during the 2-week follow-up period. Semi-structured interviews were conducted following recruitment and were analysed thematically. Recruiting doctors, delivery pharmacists and research assistants were blinded to treatment allocation. Results Only 21.5% (278/1295) of patients screened were deemed eligible, and 49% (136/278) of these consented and were entered into the final analysis. Most participants had mild symptoms, because most patients with moderate or severe symptoms wanted to be given antibiotics. Follow-up was good (94% at 2 weeks). Only three participants used rescue antibiotics compared to 67% of acute diarrhoea patients in the hospital during the recruitment period. The median symptom duration was 14 h in group B (interquartile range (IQR) 10-22), 16 h in group D (IQR 10-22), 18 h in group A (IQR 10-33) and 20 h in group C (IQR 16-54). Re-consultation rates were low. There were no serious treatment-related adverse events. Most interviewed participants said that although they had believed antibiotics to be effective for diarrhoea, they were surprised by their quick recovery without antibiotics in this trial. Conclusion Although recruitment was challenging because of widespread expectations for antibiotics, patients with mild diarrhoea accepted trying an alternative. The three nutraceuticals therapy require further evaluation in a fully powered, randomised controlled trial among a broader sample. Trial registration ChiCTR-IPR-17014107

Abstract Background Digital interventions have potential to efficiently support improved hygiene practices to reduce transmission of COVID-19. Objective To evaluate the evidence for digital interventions to improve hygiene practices within the community. Methods We reviewed articles published between 01 January 2000 and 26 May 2019 that presented a controlled trial of a digital intervention to improve hygiene behaviours in the community. We searched MEDLINE, Embase, PsycINFO, Cochrane Controlled Register of Trials (CENTRAL), China National Knowledge Infrastructure and grey literature. Trials in hospitals were excluded, as were trials aiming at prevention of sexually transmitted infections; only target diseases with transmission mechanisms similar to COVID-19 (e.g. respiratory and gastrointestinal infections) were included. Trials had to evaluate a uniquely digital component of an intervention. Study designs were limited to randomised controlled trials, controlled before-and-after trials, and interrupted time series analyses. Outcomes could be either incidence of infections or change in hygiene behaviours. The Risk of Bias 2 tool was used to assess study quality. Results We found seven studies that met the inclusion criteria. Six studies reported successfully improving self-reported hygiene behaviour or health outcomes, but only one of these six trials, Germ Defence, confirmed improvements using objective measures (reduced consultations and antibiotic prescriptions). Settings included kindergartens, workplaces, and service station restrooms. Modes of delivery were diverse: WeChat, website, text messages, audio messages to mobiles, electronic billboards, and electronic personal care records. Four interventions targeted parents of young children with educational materials. Two targeted the general population; these also used behaviour change techniques or theory to inform the intervention. Only one trial had low risk of bias, Germ Defence; the most common concerns were lack of information about the randomisation, possible bias in reporting of behavioural outcomes, and lack of an analysis plan and possible selective reporting of results. Conclusion There was only one trial that was judged to be at low risk of bias, Germ Defence, which reduced incidence and severity of illness, as confirmed by objective measures. Further evaluation is required to determine the effectiveness of the other interventions reviewed. Trial registration PROSPERO CRD42020189919 .

Abstract Background Pelargonium sidoides DC (Geraniaceae) root extract, EPs®7630 or “Kaloba®”, is a widely used herbal remedy for respiratory infections, with some evidence of effectiveness for acute bronchitis. However, it is not yet widely recommended by medical professionals in the UK. There is a need to undertake appropriately designed randomised trials to test its use as an alternative to antibiotics. The aim was to assess the feasibility of conducting a double-blind randomised controlled trial of Pelargonium sidoides root extract for treatment of acute bronchitis in UK primary care, investigating intervention compliance, patient preference for dosage form and acceptability of patient diaries. Study design Feasibility double-blind randomised placebo-controlled clinical trial. Methods We aimed to recruit 160 patients with cough (≤ 21 days) caused by acute bronchitis from UK general practices. Practices were cluster-randomised to liquid or tablet preparations and patients were individually randomised to Kaloba® or placebo. We followed participants up for 28 days through self-reported patient diaries with telephone support and reviewed medical records at one month. Outcomes included recruitment, withdrawal, safety, reconsultation and symptom diary completion rates. We also assessed treatment adherence, antibiotic prescribing and consumption, mean symptom severity (at days 2–4 after randomisation) and time to symptom resolution. We interviewed 29 patients and 11 health professionals to identify barriers and facilitators to running such a randomised trial. Results Of 543 patients screened, 261 were eligible, of whom 134 (51%) were recruited and 103 (77%) returned a completed diary. Overall, 41% (41/100) of patients took antibiotics (Kaloba® liquid group: 48% [15/31]; placebo liquid group: 23% [6/26]; Kaloba® tablet group: 48% [9/21]; placebo tablet group: 50% [11/22]). Most patients adhered to the study medication (median 19 out of 21 doses taken in week 1, IQR 18–21 - all arms combined). There were no serious adverse events relating to treatment. Most patients interviewed found study recruitment to be straightforward, but some found the diary too complex. Conclusions It was feasible and acceptable to recruit patients from UK primary care to a double-blind placebo-controlled trial of herbal medicine (Kaloba®) for the treatment of acute bronchitis, with good retention and low data attrition. Trial registration HATRIC was registered on the ISRCTN registry ( ISRCTN17672884 ) on 16 August 2018, retrospectively registered. The record can be found at http://www.isrctn.com/ISRCTN17672884 .

Abstract Background Chinese herbal medicine is widely used in combination with usual care for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) in China. Chinese patent medicine Shufeng Jiedu (SFJD) capsules is widely used for respiratory infectious diseases. This review aims to evaluate effectiveness and safety of SFJD for AECOPD. Methods A systematic review of randomised controlled trials (RCTs) in patients with AECOPD, who received SFJD as a single intervention or as add-on treatment to usual care. PubMed, the Cochrane Library, EMBASE, Scopus, Web of Science and four Chinese databases were searched from inception to April 2019. Two authors screened trials, extracted data, and assessed risk of bias, independently. Meta-analysis was performed using RevMan 5.3 software. We performed subgroup analyses and sensitivity analyses according to the predefined protocol. Quality of evidence was assessed using GRADE. Results Thirteen RCTs (1036 patients, with 936 inpatients) were included, all compared SFJD in combination with usual care (including antibiotics) to usual care alone. The mean age of participants ranged from 52 to 67 years, with approximately 60% male. Due to lack of blinding and other factors, all trials were of high risk of bias. SFJD was associated with a significant reduction in treatment failure, from 20.1 to 8.3% (11 trials; 815 patients; relative risk 0.43, 95% confidence interval [CI] 0.30 to 0.62), and duration of hospital stay (2 trials; 79 patients; mean difference − 4.32 days, 95% CI − 5.89 to − 2.75 days). No significant difference in adverse events was found between SFJD and control groups. Conclusion Low certainty evidence suggests SFJD may bring additional benefit in reducing treatment failure, shorten hospital stay, and improving symptoms. Further large, high quality RCTs are needed to confirm its benefit and safety. Trial registration PROSPERO CRD42019133682 .

Abstract Objectives To examine the effectiveness of randomising dissemination of the Germ Defence behaviour change website via GP practices across England UK. Trial design A two-arm (1:1 ratio) cluster randomised controlled trial implementing Germ Defence via GP practices compared with usual care. Participants Setting: All Primary care GP practices in England. Participants: All patients aged 16 years and over who were granted access by participating GP practices. Intervention and comparator Intervention: We will ask staff at GP practices randomised to the intervention arm to share the weblink to Germ Defence with all adult patients registered at their practice during the 4-month trial implementation period and care will otherwise follow current standard management. Germ Defence is an interactive website ( http://GermDefence.org/ ) employing behaviour change techniques and practical advice on how to reduce the spread of infection in the home. The coronavirus version of Germ Defence helps people understand what measures to take and when to take them to avoid infection. This includes hand washing, avoiding sharing rooms and surfaces, dealing with deliveries and ventilating rooms. Using behaviour change techniques, it helps users think through and adopt better home hygiene habits and find ways to solve any barriers, providing personalised goal setting and tailored advice that fits users’ personal circumstances and problem solving to overcome barriers. Comparator: Patients at GP practices randomised to the usual care arm will receive current standard management for the 4-month trial period after which we will ask staff to share the link to Germ Defence with all adult patients registered at their practice. Main outcomes The primary outcome is the effects of implementing Germ Defence on prevalence of all respiratory tract infection diagnoses during the 4-month trial implementation period. The secondary outcomes are: 1) incidence of COVID-19 diagnoses 2) incidence of COVID-19 symptom presentation 3) incidence of gastrointestinal infections 4) number of primary care consultations 5) antibiotic usage 6) hospital admissions 7) uptake of GP practices disseminating Germ Defence to their patients 8) usage of the Germ Defence website by individuals who were granted access by their GP practice Randomisation GP practices will be randomised on a 1:1 basis by the independent Bristol Randomised Trials Collaboration (BRTC). Clinical Commission Groups (CCGs) in England will be divided into blocks according to region, and equal numbers in each block will be randomly allocated to intervention or usual care. The randomisation schedule will be generated in Stata statistical software by a statistician not otherwise involved in the enrolment of general practices into the study. Blinding (masking) The principal investigators, the statistician and study collaborators will remain blinded from the identity of randomised practices until the end of the study. Numbers to be randomised (sample size) To detect planned effect size (based on PRIMIT trial, Little et al, 2015): 11.1 million respondents from 6822 active GP practices. Assuming 25% of these GP practices will engage, we will contact all GP practices in England spread across 135 Clinical Commissioning Groups. Trial status Protocol version 2.0, dated 13 January 2021. Implementation is ongoing. The implementation period started on 10 November 2020 and will end on 10 March 2021. Trial registration This trial was registered in the ISRCTN registry ( isrctn.com/ ISRCTN14602359 ) on 12 August 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Abstract Background Acute lower respiratory tract infection is a common acute infection managed in primary care. The current dominant management strategy in the UK is antibiotics, despite widespread publicity regarding antimicrobial resistance and evidence that the small benefits of antibiotics do not outweigh the harms. There is a need to address the rising problem of antibiotic resistance by providing credible alternative strategies, which reduce symptom burden. There is sufficient evidence to recommend the use of Pelargonium sidoides root extract in order to warrant undertaking an independent clinical trial. We propose a feasibility study to demonstrate our ability to recruit and retain patients and conduct a placebo-controlled trial of Pelargonium sidoides extract EPs®7630 in lower respiratory tract infection where pneumonia is not suspected. Both the tablet and liquid formulations will be included. Methods The HATRIC trial is a double-blind randomised placebo-controlled feasibility study aiming to determine the potential to conduct a fully powered trial of Pelargonium sidoides root extract as an alternative to the inappropriate use of antibiotics for acute bronchitis in UK primary care. Primary care sites will be equally randomised to one of two formulation groups (tablet or liquid preparation). Additionally, within each site, patients will be evenly randomised to active or placebo treatment. Antibiotic consumption will be monitored during the trial, but the use of a delayed prescription strategy is encouraged. The target sample size for this study is 160 patients overall or 40 per arm, recruited from approximately 20 primary care sites. The analysis will be descriptive focusing on estimation with no formal comparison of groups taking place. Discussion If this trial demonstrates the feasibility of recruitment and delivery, we will seek funding for a fully powered placebo-controlled trial of Pelargonium sidoides root extract for the treatment of lower respiratory tract infections in primary care. Trial registration HATRIC was registered on the ISRCTN registry (ISRCTN17672884) on 16 August 2018.

Abstract Background In Ethiopia, medicinal plants have been used to treat different diseases, including malaria, for many centuries. People living in rural areas are especially noted for their use of medicinal plants as a major component of their health care. This study aimed to study treatment-seeking and prioritize plants/plant recipes as anti-malarials, in Dembia district, one of the malarious districts in Northwest Ethiopia. Methods Parents of children aged under 5 years who had had a recent episode of fever were interviewed retrospectively about their child’s treatment and self-reported outcome. Treatments and subsequent clinical outcomes were analysed using Fisher’s exact test to elicit whether there were statistically significant correlations between them. Results and discussion Of 447 children with malaria-like symptoms, only 30% took the recommended first-line treatment (ACT) (all of whom were cured), and 47% took chloroquine (85% cured). Ninety-nine (22.2%) had used medicinal plants as their first-choice treatment. Allium sativum (Liliaceae), Justicia schimperiana (Acanthaceae), Buddleja polystachya (Scrophulariaceae) and Phytolacca dodecandra (Phytolaccaceae) were the most frequently used. Justicia schimperiana was the one associated with the best clinical outcomes (69% self-reported cure rate). However, the difference in clinical outcomes between the plants was not statistically significant. Conclusion In this study, only 30% of children took the recommended first-line treatment. 22% of children with presumed malaria were first treated with herbal medicines. The most commonly used herbal medicine was garlic, but J. schimperiana was associated with the highest reported cure rate of the plants. Further research is warranted to investigate its anti-malarial properties.

Abstract Background Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use. Methods/design Adult women with suspected urinary tract infection presenting to primary care will be randomised using a factorial trial design in which patients will be randomised to one of two interventions as below: Group 1 – Uva-ursi + advice to take ibuprofen Group 2 – Placebo + advice to take ibuprofen Group 3 – Uva-ursi + no advice to take ibuprofen Group 4 – Placebo + no advice to take ibuprofen Patients and physicians will be blinded to the randomised group for the herb. The main outcome is symptom severity at days 2–4 recorded in a validated, self-report diary used in previous studies. Secondary outcomes include antibiotic use and symptom duration. In total the trial will require 328 patients in order to achieve at least 90% power for the primary endpoint and 80% for the secondary endpoint. In accordance with CONSORT guidelines all comparative analyses will be conducted on an intention-to-treat basis using SPSS or similar package. Discussion The outcomes from this trial have the potential to modify the current approach to the management of acute urinary symptoms with less dependence on the use of antibiotics. Trial registration ISRCTN registry, ID: ISRCTN43397016 . Registered on 11 February 2015.