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Effect of a multicomponent, person-centred care intervention on client experience and HIV treatment outcomes in Zambia: a stepped-wedge, cluster-randomised trial.
Get PDFBACKGROUND: Recipients of health services value not only convenience but also respectful, kind, and helpful providers. To date, research to improve person-centred HIV treatment has focused on making services easier to access (eg, differentiated service delivery) rather than the interpersonal experience of care. We developed and evaluated a person-centred care (PCC) intervention targeting practices of health-care workers. METHODS: Using a stepped-wedge, cluster-randomised design, we randomly allocated 24 HIV clinics stratified by size in Zambia into four groups and introduced a PCC intervention that targeted caring aspects of the behaviour of health-care workers in one group every 6 months. The intervention entailed training and coaching for health-care workers on PCC practices (to capacitate), client experience assessment with feedback to facilities (to create opportunities), and small performance-based incentives (to motivate). In a probability sample of clients who were pre-trained on a client experience exit survey and masked to facility intervention status, we evaluated effects on client experience by use of mean score change and also proportion with poor encounters (ie, score of ≤8 on a 12-point survey instrument). We examined effects on missed visits (ie, >30 days late for next scheduled encounter) in all groups and retention in care at 15 months in group 1 and group 4 by use of electronic health records. We assessed effects on treatment success at 15 months (ie, HIV RNA concentration <400 copies per mL or adjudicated care status) in a prospectively enrolled subset of clients from group 1 and group 4. We estimated treatment effects with mixed-effects logistic regression, adjusting for sex, age, and baseline care status. This trial is registered at the Pan-African Clinical Trials Registry (202101847907585), and is completed. FINDINGS: Between Aug 12, 2019, and Nov 30, 2021, 177 543 unique clients living with HIV made at least one visit to one of the 24 study clinics. The PCC intervention reduced the proportion of poor visits based on exit surveys from 147 (23·3%) of 632 during control periods to 33 (13·3%) of 249 during the first 6 months of intervention, and then to eight (3·5%) of 230 at 6 months or later (adjusted risk difference [aRD] for control vs ≥6 months intervention -16·9 percentage points, 95% CI -24·8 to -8·9). Among all adult scheduled appointments, the PCC intervention reduced the proportion of missed visits from 90 593 (25·3%) of 358 741 during control periods to 40 380 (22·6%) of 178 523 in the first 6 months, and then 52 288 (21·5%) of 243 350 at 6 months or later (aRD for control vs the intervention -4·2 percentage points, 95% CI -4·8 to -3·7). 15-month retention improved from 33 668 (80·2%) of 41 998 in control to 35 959 (83·6%) of 43 005 during intervention (aRD 5·9 percentage points, 95% CI 0·6 to 11·2), with larger effects in clients newly starting treatment (aRD 12·7 percentage points, 1·4 to 23·9). We found no effect on treatment success (based on viral load) in a nested subcohort (379 [83·7%] of 453 in the control phase vs 402 [83·8%] of 480 in the intervention phase; aRD 0·9 percentage points, -5·4 to 7·2). INTERPRETATION: Improving the caring aspects of health-care worker behaviour is feasible in public health settings, enhances client experience, reduces missed appointments, and increases retention. FUNDING: The Bill & Melinda Gates Foundation
Parents' experiences of accessing childhood vaccination services in England: A qualitative longitudinal cohort study.
Get PDFBACKGROUND: In England, declining childhood vaccine uptake and related inequalities are causes for concern. Existing evidence suggests challenges accessing services contribute to this decline. This is particularly true for parents facing socioeconomic disadvantage. This study aimed to explore parents' experiences of the vaccination process to generate recommendations for improving the accessibility of childhood vaccination services. METHODS: A longitudinal cohort study was established in May 2023. Sequential interviews were conducted with 22 parents from the birth of their child as they progressed through the vaccination pathway. Data collection comprised life journey interviews and diary keeping. Data were analysed using temporal thematic analysis. RESULTS: Four vaccination trajectories were observed collectively referred to as the 4S Vaccination Trajectory Framework: supported (n = 9), struggled (n = 10), stalled (n = 2), and shunned (n = 1). Three main temporal themes were identified which accounted for the diverging vaccination trajectories: booking systems, the unexpected (e.g., how General Practices managed parents who were late or missed their appointment), and vaccine information provision. For example, many within the 'struggled' trajectory, initiated contact with their General Practice and had considerable difficulty securing appointments due to inflexible booking systems. CONCLUSIONS: To address declining vaccination coverage within England it is vital that vaccine accessibility is improved and that services meet parents' needs. This study deepens our understanding of accessibility issues with the vaccination service and discusses implications for policy and practice
A cluster-randomised trial of a continuous quality improvement intervention to support the triple elimination of antenatal syphilis, HIV and Hepatitis B in Indonesia: protocol for the MENJAGA (“Protection”) study
Get PDFIntroduction:
Prevention of mother-to-child-transmission (PMTCT) of human immunodeficiency virus HIV, syphilis and hepatitis B (HBV) is a key priority for the Indonesian government. Despite national guidelines and strong antenatal care (ANC) attendance, screening for these diseases among pregnant women remains relatively low in Indonesia. Continuous Quality Improvement (CQI) – an approach involving an iterative development and testing process of data-driven intervention to achieve improvement, has been effectively used to strengthen ANC in a number of Sub-Saharan African countries. This protocol describes a study that aims to evaluate the effectiveness, cost-effectiveness and implementation process of a CQI intervention designed to promote antenatal screening for HIV, syphilis, and HBV in primary health care (PHCs) in Indonesia.
Methods and analysis:
The study will be conducted as a two-arm, parallel cluster randomised control trial in 40 PHCs in two districts in West Java province (Bandung and Bogor). PHCs randomized to the intervention arm (n=10 per district) will receive targeted and enhanced support in line with the CQI approach. PHCs randomized to the control arm (n=10 per district) will continue to provide HIV, syphilis, and hepatitis B testing as per the existing standard of care for the PMTCT. The primary outcome (proportion of pregnant women tested for HIV, syphilis, and Hepatitis B at the first trimester) will be evaluated at pre-baseline, baseline, and endline. Secondary clinical outcomes include the proportion of women tested for HIV/syphilis/HBV during their first ANC visit and during pregnancy, also, proportion of pregnant women that tested positive and commenced treatment. The process evaluation will examine intervention implementation, acceptability, reach and possible causal pathways. The economic evaluation will calculate programme costs and incremental cost-effectiveness ratios (ICERs).
Ethics and dissemination
Ethical approval has been granted by the Observational/Interventions Research Ethics Committee London School of Hygiene and Tropical Medicine Ethics (approval number: 28328), and from Medical and Health Research Ethics Committee Universitas Gadjah Mada (approval number: KE/FK/0485/EC/2023). Written informed consent is obtained from the heads of all participating clinics, CQI advocates and coaches, staff, and women participating in interviews for the evaluation. There is no individual consent process for the outcome evaluation due to the reliance on anonymous routine data. Results will be published in international journals.
Trial registration: NCT06058286; ISRCTN 1125187
Associations between night/shift working and late-life brain health.
Get PDFSleep and circadian disturbances are associated with increased dementia risk. The mechanism remains poorly understood. We aimed to examine the relationship between night/shift working at age 31 and biomarkers of late-life brain health and to estimate the extent to which these relationships are mediated by unhealthy lifestyle behaviours. A prospective longitudinal cohort study, Insight 46, recruited participants from the Medical Research Council National Survey of Health and Development (NSHD) 1946 British Birth cohort. All born in the same week in 1946, participants were assessed at age 70 with multi-modal structural and molecular brain imaging and fluid biomarkers, from which whole-brain and hippocampal volumes, white matter hyper-intensity volume (WMHV), 18F-florbetapir amyloid-β PET Centiloids and plasma phosphorylated tau (p-tau)217 were derived. Prospective data collection included night/shift working at age 31, alongside smoking, alcohol intake, body mass index, exercise, blood pressure, Framingham risk score (FRS) at multiple timepoints from age 20 to 70 and dementia diagnosis or death by age 78. Analyses were adjusted for sex, age, education, socioeconomic position and, where appropriate, total intracranial volume or apolipoprotein E (APOE) genotype. Night/shift working data were available for 431 Insight 46 participants {50% female, mean age 70.7 years [standard deviation (SD) 0.6]}. Night/shift workers had lower whole-brain volume [-19.9 mL, 95% confidence interval (CI) -31.9, -7.9, P = 0.001], lower amyloid PET Centiloids (-9.45, 95% CI -14.7, -4.1, P = 0.0008) and lower plasma p-tau217 concentration (-0.05 pg/mL, 95% CI -0.10, -0.001, P = 0.04), without significant difference in hippocampal volume or WMHV. p-tau217 concentrations were also lower in night/shift workers from a wider sample from the NSHD cohort [n = 1067, mean age 69.9 (SD 0.7), -0.05 pg/mL, 95% CI -0.08, -0.02, P = 0.004]. By age 78, night/shift workers in the NSHD cohort (n = 3040) had lower rates of all-cause (excluding vascular) dementia (hazard ratio 0.33, 95% CI 0.12, 0.92, P = 0.03). Night/shift workers had 0.6% higher FRS (P = 0.01) at age 36, smoked 5.9 more pack-years by age 53 (P = 0.005), consumed 10.7 g/day more alcohol by age 63 (P = 0.006) and had higher rates of APOE ɛ4 allele carriage. Lifestyle behaviours mediated 28% of the lower brain volume in night/shift workers. Despite less healthy lifestyles, higher rates of APOE ɛ4 allele carriage and smaller brains, night/shift workers had lower levels of Alzheimer's disease pathology as measured by amyloid PET and plasma p-tau217 and approximately one-third of the risk of dementia by age 78 compared with non-night/shift workers. Lower brain volume in night/shift workers was partially mediated by unhealthy behaviours. Reduced dementia risk in night/shift workers is unexpected and will require further study
Coverage, timeliness of measles immunisation and its predictors in Pakistan: an analysis of 6.2 million children enrolled in the Provincial Electronic Immunisation Registry.
Get PDFBACKGROUND: Measles-related morbidity and mortality persists due to suboptimal and delayed vaccination, predominantly in low- and middle-income countries where more than 95% of global measles deaths occur. We evaluated the coverage, timeliness of measles vaccination and its predictors for children aged 12-23 months in Sindh, Pakistan. METHODS: We analysed immunisation data from Sindh Province's Electronic Immunisation Registry for 6.2 million children aged 12-23 months. We assessed vaccination coverage at specific ages, calculated timeliness using Expanded Programme on Immunisation-Sindh criteria and examined predictors for timely vaccination using Cox proportional hazard regression. Spatial mapping was used to identify zero-dose measles hotspots. RESULTS: Among 6 227 450 children aged 12-23 months, 80.6% received the first measles vaccine dose and only 58.1% of those vaccinated children aged 15-23 months received the second dose. Only 36.6% and 31.4% of children received measles-1 and 2 at the recommended age range (measles-1: 270-301 days; measles-2: 453-484 days). Subnational analysis identified 26.5% of Union Councils with ≥25% measles unvaccinated children. Children of educated mothers (≥11 years) compared with uneducated mothers had a higher timely measles vaccination likelihood (measles-1: HR=1.24; 95% CI: 1.23 to 1.26; p=0.010 and measles-2: HR=1.19; 95% CI: 1.18 to 1.21; p<0.001), while children who received the last vaccination at an outreach compared with a fixed site had a lower timely measles vaccination likelihood (measles-1: HR=0.91; 95% CI: 0.90 to 0.91; p<0.001 and measles-2: HR=0.93; 95% CI: 0.93 to 0.94; p<0.001). CONCLUSION: Suboptimal and delayed measles vaccination coverage casts serious doubts on attaining measles elimination by 2030, as stated in the Immunisation Agenda. Continued high-level national commitment and implementation of targeted strategies are imperative to achieving global measles immunisation goals
Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER): study protocol for a randomised controlled trial.
Get PDFBACKGROUND: Longitudinal observational studies have found an association between vision impairment and accelerated decline in cognition. However, no randomised trials have assessed the possible benefit of vision correction on cognitive change. We present the protocol for a three-year randomised controlled trial designed to assess the impact of spectacles for distance and/or near vision correction on cognitive change among community-dwelling elderly participants in India. METHODS: Cognitive Level Enhancement through Vision Exams and Refraction (CLEVER) is a single-centre, open-label, parallel-group, individually-randomised trial. Participants (760 total, 380 in each arm) aged ≥ 60 years with correctable vision impairment at distance and/or near (presenting visual acuity = 6/18 with spectacles and/or presenting near vision worse than N6 at 40 cm and improving to N6 with spectacles), normal hearing (able to repeat at least three out of six words whispered from a 50 cm distance in the better ear) and normal cognition (Hindi Mini-mental Status Examination score > 18/31) will be enrolled. After a comprehensive eye examination, intervention group participants will receive distance, near, or bifocal spectacles, while controls will receive a prescription and spectacles at the end of the trial. The primary outcome will be the three-year change in Longitudinal Aging Study in India-Diagnostic Assessment of Dementia (LASI DAD) global cognitive factor score, with and without adjustment for baseline score, age, gender, education and other potential confounders. CONCLUSION: CLEVER is designed to assess the effectiveness of spectacles as a low-cost intervention to prevent or delay cognitive decline. TRIAL REGISTRATION: This trial is registered with ClinicalTrials.gov, number NCT05458323, February 15, 2023
Clinical evaluation of computer-aided digital x-ray detection of pulmonary tuberculosis during community-based screening or active case-finding: a case-control study.
Get PDFBACKGROUND: Computer-aided detection (CAD) has been recommended as a tuberculosis screening tool. However, there are limited data about its utility, specifically in a community-based setting where the targeted population and the highest burden of undetected individuals resides. The aim of this study was to evaluate the diagnostic accuracy and clinical utility of CAD during community-based active case-finding (ACF) for tuberculosis.
METHODS: In this case-control study, we used individual patient data from adults aged 15 years or older who resided in tuberculosis-endemic or HIV-endemic communities, pooled from five community-based ACF studies in South Africa from November, 2016 to August, 2023. Cases were defined as participants who were tuberculosis positive (diagnosed with pulmonary tuberculosis by sputum Xpert Ultra or culture positivity, or both) and controls were tuberculosis negative. Controls were randomly sampled from each study at an approximate 1:2 ratio (case to control). We assessed CAD-interpreted chest radiography (CAD4TB version 7) against a microbiological reference standard. Diagnostic accuracy of CAD was determined by sensitivity, specificity, and area under the receiver operating curve (AUC). CAD performance was additionally assessed in various subgroups. We evaluated the clinical utility of CAD and performed a preliminary cost analysis comparing the cost per tuberculosis case detected and initiated on treatment (per 10 000 individuals screened) for two community-based diagnostic strategies: Xpert Ultra in everyone screened versus Xpert Ultra only in CAD-positive individuals.
FINDINGS: Of the 20 770 individuals enrolled across all studies, 530 (2·6%) had microbiologically proven tuberculosis. Data were available for 501 (94·5%) of the individuals with tuberculosis (cases) and 938 tuberculosis-negative individuals (controls). CAD achieved an AUC of 0·83 (95% CI 0·80-0·85). At a fixed sensitivity of 90% (threshold: 5) specificity was 44·9% (95% CI 42·5-47·3) and at a fixed sensitivity of 85% (threshold: 10) specificity was 54·1% (51·7-56·5). In the subgroup analysis, CAD performed worse in people living with HIV compared with HIV-negative people (AUC of 0·76 [0·71-0·81] vs 0·85 [0·82-0·87]; p=0·0037) and in asymptomatic people compared with symptomatic people (0·79 [0·76-0·82] vs 0·85 [0·82-0·88]; p=0·0079. Nevertheless, a CAD-directed Xpert Ultra strategy reduced costs by 20-53% compared with a universal Xpert Ultra only strategy (US3745 vs $4698 per tuberculosis case detected and initiated on treatment per 10 000 people screened), at the detriment of lower diagnostic yield (40-59% vs 65% per 10 000 individuals screened).
INTERPRETATION: In the setting of community-based ACF, CAD did not meet the WHO screening test target product profile (>90% sensitivity and >70% specificity) and performed more poorly in some subgroups. However, a context-specific CAD-directed strategy could still be cost saving. These data inform community-based ACF strategies aiming to disrupt the tuberculosis transmission cycle.
FUNDING: South African Medical Research Council
Barriers to Skin Cancer Diagnosis and Treatment in Low- and Middle-Income Countries and Solutions: A Literature Review.
Get PDFSkin cancer mortality disproportionately affects low- and lower-middle-income regions despite the prevalence being lower than in high-income countries. Considering the need to diagnose it early for the best outcomes, this review addresses the barriers preventing it from being diagnosed and treated promptly and proposes possible solutions. Some of the barriers we found include the low number of dermatologists and pathologists, inadequate facilities, lack of education, the cost of healthcare, the denial of needing professional help, the fear and stigmatization of a skin cancer diagnosis, and the reliance on non-medical therapies. Meanwhile, solutions we identified are training programs for healthcare professionals and the public, technological advancements (including nanotechnology-based treatments, telemedicine, and social media use, the development and implementation of artificial intelligence programs), international collaborations, research, and increasing the number of cancer registries and national cancer control plans. Despite these solutions not being foolproof, they will lead to earlier cancer diagnosis, more individuals seeking skin check-ups, better knowledge of skin cancer, improving the quality of life of vulnerable populations, and decrease in mortality
Effectiveness of interventions for improving educational outcomes for people with disabilities in low- and middle-income countries: A systematic review.
Get PDFBACKGROUND: People with disabilities are consistently falling behind in educational outcomes compared to their peers without disabilities, whether measured in terms of school enrolment, school completion, mean years of schooling, or literacy levels. These inequalities in education contribute to people with disabilities being less likely to achieve employment, or earn as much if they are employed, as people without disabilities. Evidence suggests that the gap in educational attainment for people with and without disabilities is greatest in low- and middle-income countries (LMICs). Exclusion of people with disabilities from mainstream education, and low rates of participation in education of any kind, are important issues for global equity. Interventions which might have a positive impact include those that improve educational outcomes for people with disabilities, whether delivered in specialist or inclusive education settings. Such interventions involve a wide range of initiatives, from those focused on the individual level - such as teaching assistance to make mainstream classes more accessible to children with specific learning needs - to those which address policy or advocacy.
OBJECTIVES: The objectives of this review were to answer the following research questions:
(1) What is the nature of the interventions used to support education for people with disabilities in LMICs?
(2) What is the size and quality of the evidence base of the effectiveness of interventions to improve educational outcomes for people with disabilities in LMICs?
(3) What works to improve educational outcomes for people with disabilities in LMICs?
(4) Which interventions appear to be most effective for different types of disability?
(5) What are the barriers and facilitators to the improvement of educational outcomes for people with disabilities?
(6) Is there evidence of cumulative effects of interventions?
SEARCH METHODS: The search for studies followed two steps. Firstly, we conducted an electronic search of databases and sector-specific websites. Then, after initial screening, we examined the reference lists of all identified reviews and screened the cited studies for inclusion. We also conducted a forward search and an ancestral search. No restrictions in terms of date or format were placed on the search, but only English-language publications were eligible for inclusion.
SELECTION CRITERIA: In our review, we included studies on the basis that they were able to detect intervention impact. Descriptive studies of various designs and methodologies were not included. We also excluded any study with a sample size of fewer than five participants. We included studies which examined the impact of interventions for people with disabilities living in LMICs. There were no restrictions on comparators/comparison groups in included studies. However, to be eligible for inclusion, a study needed to have both an eligible intervention and an eligible outcome. Any duration of follow-up was eligible for inclusion.
DATA COLLECTION AND ANALYSIS: We used EppiReviewer for bibliographic management, screening, coding, and data synthesis. Eligibility was assessed using a predesigned form based on the inclusion criteria developed by the authors. We piloted all coding sheets with at least five studies before use. The form allowed for coding of multiple intervention domains and multiple outcomes domains. The entire screening process was reported using a PRISMA flow chart. We screened all unique references from our search title and abstract, with two independent reviewers determining relevance, and repeated this process for full texts. Data was extracted from studies according to a coding sheet.
Coding included:
(1) extraction of basic study characteristics,
(2) a narrative summary of procedures and findings (including recording of iatrogenic effects),
(3) a summary of findings/results table,
(4) an assessment of confidence in study findings, and
(5) creation of a forest plot of effect sizes.
A third data collector, a research associate, checked the results of this process. Confidence in study findings was assessed using a standardised tool. All coding categories were not mutually exclusive and so multiple coding was done where an intervention covered more than one category of intervention.
MAIN RESULTS: Twenty-eight studies were included in this review. Most studies (n = 25) targeted children with disabilities. Only two studies directly targeted family members, and the remaining three focused on service providers. Individuals with intellectual or learning and developmental impairments were most frequently targeted by interventions (n = 17). The category of interventions most represented across studies was 'Educational attainment support', for instance, a reading comprehension intervention that combined strategy instruction (graphic organisers, visual displays, mnemonic illustrations, computer exercises, predicting, inference, text structure awareness, main idea identification, summarisation, and questioning) for children with dyslexia. The second most common category of intervention was 'Accessible learning environments', for instance, programmes which aimed to improve social skills or to reduce rates of victimisation of children with disabilities in schools. Regarding intervention effects, included studies concerned with 'Conditions for inclusion of people with disabilities in education' showed a moderately significant effect, and one study concerned with teacher knowledge showed a significant effect size. Among the 18 studies included in the analysis of intervention effects on 'Skills for learning', 12 interventions had a significant effect. When considering the effect of interventions on different outcomes, we see that the effect on literacy, cognitive skills, handwriting, and numeracy are significant. All these effects are large but are based on a low number of studies. The studies concerned with speech and school behaviour show no significant effect of intervention. Across studies, heterogeneity is high, and risk of publication bias varies but was frequently high. All but one study received an overall rating of low confidence in study findings. However, this lack of confidence across studies was largely due to the use of low-rigour study designs and was not always reflective of multiple points of weakness within a given study.
AUTHORS' CONCLUSIONS: Children with disabilities fall behind in educational outcomes as the current school systems are not set up to teach children with different impairment types. There is no one 'magic bullet' intervention which can equalise health outcomes for this group. A twin-track approach is needed, which both addresses the specific needs of children with disabilities but also ensures that they are included in mainstream activities (e.g., through improving the skills of teachers and accessibility of the classroom). However, currently most interventions included in this systematic review targeted individual children with disabilities in an attempt to improve their functioning, skills, and competencies, but did not focus on mainstreaming these children into the school by system-level or school-level changes. Consequently, a focus on evaluation of interventions which target not just the individual with a disability but also their broader environment, are needed
Early-life serological profiles and the development of natural protective humoral immunity to Streptococcus pyogenes in a high-burden setting.
Get PDFStreptococcus pyogenes leads to 500,000 deaths annually, many due to rheumatic heart disease in low-income settings. Limited understanding of natural protective immunity to S. pyogenes hinders vaccine development. Here we describe the evolution of serological profiles to conserved vaccine antigens and serotype-specific M proteins from birth and throughout the life course in The Gambia. As placentally transferred IgG waned after birth, serological evidence of new exposure was seen in 23% of infants during the first year of life. After culture-confirmed S. pyogenes events, the highest IgG increases occurred in children younger than 2 years of age after both pharyngeal and skin disease and asymptomatic carriage at both sites. Higher IgG levels against conserved vaccine antigens correlated with functional activity and were associated with protection from culture-confirmed events after adjustment for age and anti-M protein IgG levels. To our knowledge, our data provide the first evidence of protection associated with humoral immunity to conserved vaccine candidate antigens in humans