Community-based intervention trials

The randomized controlled trial has become the standard basis for the evaluation of new therapeutic agents and procedures (and for measuring the protective efficacy of new vaccines or for assessing the value of screening procedures). Patients, who have met the criteria for eligibility and have agreed to participate in the trial, are allocated on a random basis to the alternative therapies under consideration. In order to avoid possible bias in the handling or assessment of these groups, a double blind procedure is preferred; the therapy given is not known to those who administer it, to those who assess the course of the disease thereafter, nor to the patients themselves. There is an extensive literature on clinical trials covering their logic and history, modern developments and the many complex, often controversial, issues that such trials have provoked. Not all issues have been fully resolved but by and large the principle, the practice and the ethical concerns of clinical trials are worked out and firmly establishe

The integration of the treatment for common mental disorders in primary care: experiences of health care providers in the MANAS trial in Goa, India

BACKGROUND: The MANAS trial reported that a Lay Health Counsellor (LHC) led collaborative stepped care intervention (the "MANAS intervention") for Common Mental Disorders (CMD) was effective in public sector primary care clinics but private sector General Practitioners (GPs) did as well with or without the additional counsellor. This paper aims to describe the experiences of integrating the MANAS intervention in primary care. METHODS: Qualitative semi-structured interviews with key members (n = 119) of the primary health care teams upon completion of the trial and additional interviews with control arm GPs upon completion of the outcome analyses which revealed non-inferiority of this arm. RESULTS: Several components of the MANAS intervention were reported to have been critically important for facilitating integration, notably: screening and the categorization of the severity of CMD; provision of psychosocial treatments and adherence management; and the support of the visiting psychiatrist. Non-adherence was common, often because symptoms had been controlled or because of doubt that health care interventions could address one's 'life difficulties'. Interpersonal therapy was intended to be provided face to face by the LHC; however it could not be delivered for most eligible patients due to the cost implications related to travel to the clinic and the time lost from work. The LHCs had particular difficulty in working with patients with extreme social difficulties or alcohol related problems, and elderly patients, as the intervention seemed unable to address their specific needs. The control arm GPs adopted practices similar to the principles of the MANAS intervention; GPs routinely diagnosed CMD and provided psychoeducation, advice on life style changes and problem solving, prescribed antidepressants, and referred to specialists as appropriate. CONCLUSION: The key factors which enhance the acceptability and integration of a LHC in primary care are training, systematic steps to build trust, the passage of time, the observable impacts on patient outcomes, and supervision by a visiting psychiatrist. Several practices by the control arm GPs approximated those of the LHC which may partly explain our findings that they were as effective as the MANAS intervention arm GPs in enabling recovery

Lay health worker led intervention for depressive and anxiety disorders in India: impact on clinical and disability outcomes over 12 months.

BACKGROUND: Depressive and anxiety disorders (common mental disorders) are the most common psychiatric condition encountered in primary healthcare. AIMS: To test the effectiveness of an intervention led by lay health counsellors in primary care settings (the MANAS intervention) to improve the outcomes of people with common mental disorders. METHOD: Twenty-four primary care facilities (12 public, 12 private) in Goa (India) were randomised to provide either collaborative stepped care or enhanced usual care to adults who screened positive for common mental disorders. Participants were assessed at 2, 6 and 12 months for presence of ICD-10 common mental disorders, the severity of symptoms of depression and anxiety, suicidal behaviour and disability levels. All analyses were intention to treat and carried out separately for private and public facilities and adjusted for the design. The trial has been registered with clinical trials.gov (NCT00446407). RESULTS: A total of 2796 participants were recruited. In public facilities, the intervention was consistently associated with strong beneficial effects over the 12 months on all outcomes. There was a 30% decrease in the prevalence of common mental disorders among those with baseline ICD-10 diagnoses (risk ratio (RR) = 0.70, 95% CI 0.53-0.92); and a similar effect among the subgroup of participants with depression (RR = 0.76, 95% CI 0.59-0.98). Suicide attempts/plans showed a 36% reduction over 12 months (RR=0.64, 95% CI0.42–0.98) among baseline ICD-10 cases. Strong effects were observed on days out of work and psychological morbidity, and modest effects on overall disability [corrected]. In contrast, there was little evidence of impact of the intervention on any outcome among participants attending private facilities. CONCLUSIONS: Trained lay counsellors working within a collaborative-care model can reduce prevalence of common mental disorders, suicidal behaviour, psychological morbidity and disability days among those attending public primary care facilities

Effect of the Newhints home-visits intervention on neonatal mortality rate and care practices in Ghana: a cluster randomised controlled trial.

BACKGROUND: In 2009, on the basis of promising evidence from trials in south Asia, WHO and UNICEF issued a joint statement about home visits as a strategy to improve newborn survival. In the Newhints trial, we aimed to test this home-visits strategy in sub-Saharan Africa by assessing the effect on all-cause neonatal mortality rate (NMR) and essential newborn-care practices. METHODS: The Newhints cluster randomised trial was undertaken in 98 zones in seven districts in the Brong Ahafo Region, Ghana. 49 zones were randomly assigned to the Newhints intervention and 49 to the control intervention by use of restricted randomisation with stratification to ensure comparability between interventions. Community-based surveillance volunteers (CBSVs) in Newhints zones were trained to identify pregnant women in their community and to make two home visits during pregnancy and three in the first week of life to promote essential newborn-care practices, weigh and assess babies for danger signs, and refer as necessary. Primary outcomes were NMR and coverage of key essential newborn-care practices. Analyses were by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00623337. FINDINGS: 16,168 (99%) of 16,329 deliveries between November, 2008, and December, 2009, were livebirths; the status at 1 month was known for 15,619 (97%) livebirths. 482 neonatal deaths were recorded. Coverage data were available from 6029 women in Newhints zones; of these 4358 (72%) reported having CBSV visits during pregnancy and 3815 (63%) reported having postnatal visits. This coverage increased substantially from June, 2009, after the introduction of new implementation strategies and reached almost 90% for pregnancy visits by the end of the trial and 75% for postnatal visits. The Newhints intervention significantly increased coverage of key essential newborn-care behaviours, except for four or more antenatal-care visits (5975 [76%] of 7859 vs 5988 [74%] of 8121, respectively; relative risk 1·02, 95% CI 0·96-1·09; p=0·52) and baby delivered in a facility (5373 [68%] vs 5539 [68%], respectively; 0·97, 0·81-1·14; p=0·69). The largest increase was for care-seeking, with 102 (77%) of 132 sick babies in Newhints zones taken to a hospital or clinic compared with 77 (55%) of 139 in control zones (1·43, 1·17-1·76; p=0·001). Increases were also noted in bednet use during pregnancy (5398 [69%] of 7859 vs 5135 [63%] of 8121, respectively; 1·12, 1·03-1·21; p=0·005), money saved for delivery or emergency (5730 [86%] of 6681 vs 5525 [80%] of 6941, respectively; 1·09, 1·05-1·12; p<0·0001), transport arranged in advance for facility (2496 [37%] vs 2061 [30%], respectively; 1·30, 1·12-1·49; p=0·0004), birth assistant for home delivery washed hands with soap (1853 [93%] of 1992 vs 1817 [87%] of 2091, respectively; 1·05, 1·02-1·09; p=0·001), initiation of breastfeeding in less than 1 h of birth (3743 [49%] of 7673 vs 3280 [41%] of 7921, respectively; 1·22, 1·07-1·40; p=0·004), skin to skin contact (3355 [44%] vs 1931 [24%], respectively; 2·30, 1·85-2·87; p=0·0002), first bath delayed for longer than 6 h (3131 [41%] vs 2269 [29%], respectively; 1·65, 1·27-2·13; p<0·0001), exclusive breastfeeding for 26-32 days (1217 [86%] of 1414 vs 1091 [80%] of 1371; 1·10, 1·04-1·16; p=0·001), and baby sleeping under bednet for 8-56 days (4548 [79%] of 5756 vs 4291 [73%] of 5846; 1·09, 1·03-1·15; p=0·002). There were 230 neonatal deaths in the Newhints zones compared with 252 in the control zones. The overall NMRs per 1000 livebirths were 29·8 and 31·9, respectively (0·92, 0·75-1·12; p=0·405). INTERPRETATION: The reduction in NMR with Newhints is consistent with the reductions achieved in three trials undertaken in programme settings in south Asia. Because there is no suggestion of any heterogeneity (p=0·850) between these trials and Newhints, the meta-analysis summary estimate of a reduction of 12% (95% CI 5-18) provides the best evidence for the likely effect of the home-visits strategy delivered within programmes in sub-Saharan Africa and in south Asia. Improvements in the quality of delivery and neonatal care in health facilities and development of innovative, effective strategies to increase coverage of home visits on the day of birth could lead to the achievement of more substantial reductions. FUNDING: WHO, Bill & Melinda Gates Foundation, and UK Department for International Development

Neonatal mortality within 24 hours of birth in six low- and lower-middle-income countries

OBJECTIVE: To assess the rates, timing and causes of neonatal deaths and the burden of stillbirths in rural Uttar Pradesh, India. We discuss the implications of our findings for neonatal interventions. METHODS: We used verbal autopsy interviews to investigate 1048 neonatal deaths and stillbirths. FINDINGS: There were 430 stillbirths reported, comprising 41% of all deaths in the sample. Of the 618 live births, 32% deaths were on the day of birth, 50% occurred during the first 3 days of life and 71% were during the first week. The primary causes of death on the first day of life (i.e. day 0) were birth asphyxia or injury (31%) and preterm birth (26%). During days 1–6, the most frequent causes of death were preterm birth (30%) and sepsis or pneumonia (25%). Half of all deaths caused by sepsis or pneumonia occurred during the first week of life. The proportion of deaths attributed to sepsis or pneumonia increased to 45% and 36% during days 7–13 and 14–27, respectively. CONCLUSION: Stillbirths and deaths on the day of birth represent a large proportion of perinatal and neonatal deaths, highlighting an urgent need to improve coverage with skilled birth attendants and to ensure access to emergency obstetric care. Health interventions to improve essential neonatal care and care-seeking behavior are also needed, particularly for preterm neonates in the early postnatal period

Neonatal vaccination of low birthweight infants in Ghana.

OBJECTIVES: Global vaccination policy advocates for identifying and targeting groups who are underserved by vaccination to increase equity and uptake. We investigated whether birth weight and other factors are determinants of neonatal BCG vaccination in order to identify infants underserved by vaccination. METHODS: We used logistic regression to calculate adjusted ORs (AORs) for the association between birth weight (categorised as non-low birth weight (NLBW) (≥2.50 kg) and low birth weight (LBW) (2-2.49 kg, 1.50-1.99 kg and 0.19). Facility-born infants were vaccinated at a mean of 6 days, suggesting that they were not vaccinated in the facility at birth but were referred for vaccination. CONCLUSIONS: LBW is a risk factor for neonatal under-vaccination, even for facility-born infants. Ensuring vaccination at facility births would substantively improve timing and equitable BCG vaccination

Supervising community health workers in low-income countries--a review of impact and implementation issues.

BACKGROUND: Community health workers (CHWs) are an increasingly important component of health systems and programs. Despite the recognized role of supervision in ensuring CHWs are effective, supervision is often weak and under-supported. Little is known about what constitutes adequate supervision and how different supervision strategies influence performance, motivation, and retention. OBJECTIVE: To determine the impact of supervision strategies used in low- and middle-income countries and discuss implementation and feasibility issues with a focus on CHWs. DESIGN: A search of peer-reviewed, English language articles evaluating health provider supervision strategies was conducted through November 2013. Included articles evaluated the impact of supervision in low- or middle-income countries using a controlled, pre-/post- or observational design. Implementation and feasibility literature included both peer-reviewed and gray literature. RESULTS: A total of 22 impact papers were identified. Papers were from a range of low- and middle-income countries addressing the supervision of a variety of health care providers. We classified interventions as testing supervision frequency, the supportive/facilitative supervision package, supervision mode (peer, group, and community), tools (self-assessment and checklists), focus (quality assurance/problem solving), and training. Outcomes included coverage, performance, and perception of quality but were not uniform across studies. Evidence suggests that improving supervision quality has a greater impact than increasing frequency of supervision alone. Supportive supervision packages, community monitoring, and quality improvement/problem-solving approaches show the most promise; however, evaluation of all strategies was weak. CONCLUSION: Few supervision strategies have been rigorously tested and data on CHW supervision is particularly sparse. This review highlights the diversity of supervision approaches that policy makers have to choose from and, while choices should be context specific, our findings suggest that high-quality supervision that focuses on supportive approaches, community monitoring, and/or quality assurance/problem solving may be most effective

Parental experiences of the impacts of Covid-19 on the care of young children; qualitative interview findings from the Nairobi Early Childcare in Slums (NECS) project

Introduction: The Covid-19 pandemic, and societal attempts to control it, have touched almost every aspect of people’s lives around the world, albeit in unequal ways. In particular, there is considerable concern about the way that stringent ‘lockdowns’, as implemented in Kenya and many other countries, affected young children, especially those living in informal settlements. However, to date, there has been little research attempting to unpack and understand how the pandemic has impacted on the care of young children. // Methods: In-depth telephone interviews were conducted with 21 parents/carers of children aged under five years living in three Nairobi slums between May and September 2021 exploring the ways in which Covid-19, and policies to control the pandemic, impacted on their household and the care of their child/children. // Results: The impacts of Covid-19 control measures on the care of children have been widely felt, deep and multiple. The impact of economic hardship has been significant, reportedly undermining food security and access to services including healthcare and childcare. Respondents reported an associated increase in domestic and community violence. Many people relied on help from others; this was most commonly reported to be in the form of variable levels of flexibility from landlords and help from other community members. No direct harms from Covid-19 disease were reported by respondents. // Conclusion: The impacts of Covid-19 control measures on the care of young children in informal settlements have been indirect but dramatic. Given the breadth and depth of these reported impacts, and the particular vulnerability of young children, deeper consideration ought to inform decisions about approaches to implementation of stringent disease control measures in future. In addition, these findings imply a need for both short- and long-term policy responses to ameliorate the impacts described

Mothers explanatory models of infant stress & adversity in rural Haryana, India: qualitative findings from the Early Life Stress sub-study of the SPRING cluster-randomised controlled trial (SPRING-ELS).

Background   Exposure to a range of biological and psychosocial adversities in early childhood is of negative consequence through the lifecourse. This is particularly important for children in low- and middle-income countries where at least 250 million children are at high-risk of not meeting their developmental potential. Minimal evidence describes mothers' views of this. We therefore elicited an explanatory model exploring mothers' perceptions of infant stress and adversity in rural Haryana, India. Methods We did eight focus-group discussions to explore the perspectives of mothers in the general population of this rural area of India using a discussion guide based on Kleinman's explanatory model. Data were coded by two analysts and arranged in themes for presentation. Illustrative quotations were used for presentation of findings. Results All mothers identified several causes of adversity and stress for children, including poverty, neglect and violence. They described the consequences of this for emotions, behaviour and school readiness of children, and that some of the consequences were reversible with appropriate management. Mothers described younger children as being unable to be affected by adversity, because they were "too young to understand". Conclusions Mothers agreed with much of the current biomedical model for early childhood development, however the predominant view was that young infants were "too young to understand" is an important deviation. These findings are of importance in designing behaviour change strategies for this crucial period of early childhood which is rising up the global policy agenda with the aim of giving every child the opportunity to thrive

Parental experiences of childcare in an informal urban settlement: qualitative interview findings from the Nairobi Early Childcare in Slums (NECS) project

OBJECTIVES: To gain an in-depth understanding of parent/carers' perspectives on, and decision-making about, early childhood care in general, and paid childcare specifically, in informal settlements in Nairobi. DESIGN: In-depth telephone interviews, conducted using a topic guide, were analysed through a combination of deductive and inductive thematic analysis and regular reflexivity meetings. We explored parents' childcare needs and experiences over time, and their perspectives on the provision of paid childcare in the slums. SETTING: Three informal settlements or slums in Nairobi: Kibera; Kawangware; and Mukuru-Viwandani. PARTICIPANTS: A purposively selected sample of 21 parental and non-parental carers of children aged under 5 years who were currently living in three Nairobi slums, including men and women, and users and non-users of paid childcare. RESULTS: Childcare is complex, with a plurality of approaches being used. Common strategies include family member provided care (often but not exclusively by mothers, at home or at a place of work), paid childcare and informal or ad hoc arrangements with neighbours. Childcare decision-making in these settings is constrained by economics and the broader context of living in the slum. Paid childcare is frequently used, but is widely understood to be lacking in quality, especially for the poorest. Quality of childcare is understood to comprise a combination of structural factors, such as the physical space, play and learning resources and processes such as interactions between the care provider and children or parents. CONCLUSIONS: These findings suggest a need, and opportunity, to improve early childhood care in slums. Understanding parental perspectives on both the deficiencies and valued features of childcare is likely to be vital to informing efforts to improve childcare in these settings