scholarly journals Assessing the impact of the National Department of Health’s National Adherence Guidelines for Chronic Diseases in South Africa using routinely collected data: a cluster-randomised evaluation

BMJ Open ◽  
2018 ◽  
Vol 8 (1) ◽  
pp. e019680 ◽  
Author(s):  
Matthew P Fox ◽  
Sophie J Pascoe ◽  
Amy N Huber ◽  
Joshua Murphy ◽  
Mokgadi Phokojoe ◽  
...  
Keyword(s):  
South Africa ◽  
Chronic Diseases ◽  
Standard Of Care ◽  
Local Health ◽  
Human Research Ethics ◽  
Cluster Randomised ◽  
Institutional Review ◽  
Track Initiation ◽  
Adherence Counselling ◽  
The Impact

IntroductionIn 2016, South Africa’s National Department of Health (NDOH) launched the National Adherence Guidelines for Chronic Diseases for phased implementation throughout South Africa. Early implementation of a ‘minimum package’ of eight interventions in the Adherence Guidelines for patients with HIV is being undertaken at 12 primary health clinics and community health centres in four provinces. NDOH and its partners are evaluating the impact of five of the interventions in four provinces in South Africa.Methods and analysisThe minimum package is being delivered at the 12 health facilities under NDOH guidance and through local health authorities. The five evaluation interventions are: (1) fast track initiation counselling for patients eligible for antiretroviral therapy (ART); (2) adherence clubs for stable ART patients; (3) decentralised medication delivery for stable ART patients; (4) enhanced adherence counselling for unstable ART patients; and (5) early tracing of patients who miss an appointment by ≥5 days. For evaluation, NDOH matched the 12 intervention clinics with 12 comparison clinics and randomly allocated one member of each pair to intervention or comparison (standard of care) status within pairs, allowing evaluation of the interventions using a matched cluster-randomised design. The evaluation uses data routinely collected by the clinics, with no study interaction with subjects to prevent influencing the primary outcomes. Enrolment began on 20 June 2016 and was completed on 16 December 2016. A total of 3456 patients were enrolled and will now be followed for 14 months to estimate effects on short-term and final outcomes. Primary outcomes include viral suppression, retention and medication pickups, evaluated at two time points during follow-up.Ethics and disseminationThe study received approval from the University of Witwatersrand Human Research Ethics Committee and Boston University Institutional Review Board. Results will be presented to key stakeholders and at international conferences and published in peer-reviewed journals.Trial registration numberNCT02536768; Pre-results.

scholarly journals Effects of parenting classes and economic strengthening for caregivers on the cognition of HIV-exposed infants: a pragmatic cluster randomised controlled trial in rural Zimbabwe

2019 ◽  
Vol 4 (5) ◽  
pp. e001651 ◽  
Author(s):  
Helen Mebrahtu ◽  
Victoria Simms ◽  
Zivai Mupambireyi ◽  
Andrea M Rehman ◽  
Rudo Chingono ◽  
...  
Keyword(s):  
Child Development ◽  
Standard Of Care ◽  
Hiv Care ◽  
Parental Distress ◽  
Multicomponent Intervention ◽  
Cluster Randomised ◽  
Retention In Hiv Care ◽  
Hiv Exposed ◽  
The Impact ◽  
Economic Strengthening

IntroductionHIV-exposed children show signs of developmental delay. We assessed the impact of a pragmatic multicomponent intervention for caregivers of HIV-exposed children aged 0–2 years in Zimbabwe.MethodsWe conducted a cluster-randomised trial from 2016 to 2018. Clusters were catchments surrounding clinics, allocated (1:1) to either National HIV guidelines standard of care or standard care plus an 18-session group intervention comprising i) early childhood stimulation (ECS) and parenting training with home visits to reinforce skills and retention in HIV care; ii) economic strengthening. Primary outcomes measured 12 months after baseline (4.5 months postintervention completion) included: i) global child development measured using the Mullen early learning composite score; ii) retention in HIV care. Analysis used mixed effects regression to account for clustering and adjusted minimally for baseline prognostic factors and was by intention to treat.ResultsThirty clusters, 15 in each arm, were randomised. 574 dyads were recruited with 89.5% retained at follow-up. Ninety one of 281 (32.4%) were recorded as having received the complete intervention package, with 161/281 (57.3%) attending ≥14 ECS sessions. There was no evidence of an intervention effect on global child development (intervention mean 88.1 vs standard of care mean 87.6; adjusted mean difference=0.06; 95% CI −2.68 to 2.80; p=0.97) or infant retention in care (proportion of children who had missed their most recent HIV test: intervention 21.8% vs standard of care 16.9%, p=0.18). There was weak evidence that the proportion of caregivers with parental stress was reduced in the intervention arm (adjusted OR (aOR)=0.69; 95% CI 0.45 to 1.05; p=0.08) and stronger evidence that parental distress specifically was reduced (intervention arm 17.4% vs standard of care 29.1% scoring above the cut-off; aOR=0.56; 95% CI 0.35 to 0.89; p=0.01).ConclusionThis multicomponent intervention had no impact on child development outcomes within 4.5 months of completion, but had an impact on parental distress. Maternal mental health remains a high priority.Trial registration numberPACTR201701001387209.

scholarly journals Study protocol forSmartphoneMonitoring forAtrial fibrillation inReal-Time in India (SMART-India): a community-based screening and referral programme

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017668 ◽  
Author(s):  
Apurv Soni ◽  
Sunil Karna ◽  
Harshil Patel ◽  
Nisha Fahey ◽  
Shyamsundar Raithatha ◽  
...  
Keyword(s):  
Health Workers ◽  
Survey Design ◽  
Mobile Technologies ◽  
Local Health ◽  
Community Based ◽  
Novel Technologies ◽  
Regression Methods ◽  
Human Research Ethics ◽  
Institutional Review ◽  
University Of Massachusetts

IntroductionAtrial fibrillation (AF), the world’s most common arrhythmia, often goes undetected and untreated in low-resource communities, including India, where AF epidemiology is undefined. AF is an important risk factor for stroke, which plagues an estimated 1.6 million Indians annually. As such, early detection of AF and management of high-risk patients is critically important to decrease stroke burden in individuals with AF. This study aims to describe the epidemiology of AF in Anand District, Gujarat, India, characterise the clinical profile of individuals who are diagnosed with AF and determine the performance of two mobile technologies for community-based AF screening.MethodsThis observational study builds on findings from a previous feasibility study and leverages two novel technologies as well as an existing community health programme to perform door-to-door AF screening for 2000 people from 60 villages of Anand District, Gujarat, India using local health workers. A single-lead ECG and a pulse-based application is used to screen each individual for AF three times over a period of 5 days. Participants with suspected arrhythmias are followed up by study cardiologist who makes final diagnoses. Participants diagnosed with AF are initiated on treatment based on current anticoagulation guidelines and clinical reasoning.Analytical planAge-stratified and sex-stratified prevalence of AF in the Anand District will be calculated for sample and estimated for Anand distribution using survey design weights. Sociodemographic and clinical factors associated with AF will be evaluated using multivariable regression methods. Performance of each mobile technology in detecting AF will be evaluated using a 12-lead ECG interpretation as the gold standard.Ethics and disseminationThis protocol was approved separately by the Institutional Review Board of University of Massachusetts Medical School and the Human Research Ethics Committee at Charutar Arogya Mandal. The findings of this study will be disseminated through peer-reviewed journals and scientific conferences.

scholarly journals Capturing patient-reported and quality of life outcomes with use of shorter regimens for drug-resistant tuberculosis: mixed-methods substudy protocol, TB PRACTECAL-PRO

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e043954
Author(s):  
Beverley Stringer ◽  
Karen Lowton ◽  
Nicola James ◽  
Bern-Thomas Nyang'wa
Keyword(s):  
Quality Of Life ◽  
South Africa ◽  
Mixed Methods ◽  
Data Collection ◽  
Short Form ◽  
Standard Of Care ◽  
Local Health ◽  
Resistant Tuberculosis ◽  
Patient Reported

IntroductionPeople living with multidrug-resistant tuberculosis currently have few options for effective treatment and cure. Regimens that are available are toxic, may involve injections and take up to 2 years to complete treatment, with success rates as low as 50%. The TB-PRACTECAL trial is evaluating shorter, more tolerable regimens of oral drugs; we detail the substudy within this trial, PRACTECAL-PRO, which aims to evaluate patient experiences and perspectives on treatment, to understand outcomes more fully.Methods and analysisWe are conducting a mixed-methods evaluation within both investigational and standard of care arms within the TB-PRACTECAL trial, using sequential quality of life (QoL) surveys and in-depth interviews. Data collection involves the Short Form 12 (SF-12) and St George’s Respiratory Questionnaire (SGRQ), collected at up to four fixed timepoints, from baseline, to up to 12 months later. Healthy volunteers will be surveyed to establish locally relevant controls. We will also purposively sample participants for qualitative data collection and analysis, to provide rich explanation of QoL scores. The study will be implemented in all six TB-PRACTECAL study sites in Uzbekistan, South Africa and Belarus. QoL surveys will be scored and analysed according to SF-12 and SGRQ developers’ manuals. Differences between scores at baseline and later timepoints will be evaluated as well as graphical exploration of group score trajectories of investigational and standard of care arms.Ethics and disseminationEthics approval was obtained from the Médecins Sans Frontières Ethics Review Board. Local ethics approval has been obtained in Uzbekistan, Belarus and South Africa. Results of the substudy will be shared with local health authorities, the WHO and submitted for publication in a peer-reviewed journal.Trial registration numberNCT03942354; Pre-results.

scholarly journals Accounting for health literacy and intervention preferences when reducing unhealthy snacking: protocol for an online randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028544 ◽  
Author(s):  
Julie Ayre ◽  
Erin Cvejic ◽  
Carissa Bonner ◽  
Robin M Turner ◽  
Stephen D Walter ◽  
...  
Keyword(s):  
Health Literacy ◽  
Action Plan ◽  
Controlled Trial ◽  
Local Health ◽  
Random Allocation ◽  
Literacy Interventions ◽  
Human Research Ethics ◽  
Volitional Strategies ◽  
Randomised Controlled ◽  
The Impact

IntroductionHealth literacy describes the cognitive and social skills that individuals use to access, understand and act on health information. Health literacy interventions typically take the ‘universal precautions approach’ where all consumers are presented with simplified materials. Although this approach can improve knowledge and comprehension, its impact on complex behaviours is less clear. Systematic reviews also suggest that health literacy interventions underuse volitional strategies (such as planning) that play an important role in behaviour change. A recent study found volitional strategies may need to be tailored to the participant’s health literacy. The current study aims to replicate these findings in a sample of people who have diabetes and/or are overweight or obese as measured by body mass index, and to investigate the most effective method of allocating an action plan to a participant to reduce unhealthy snacking.Methods and analysisWe plan to recruit approximately 2400 participants at baseline. Participants will receive one of two alternative online action plans intended to reduce unhealthy snacking (‘standard’ action plan or ‘literacy-sensitive’ action plan). Participants will be randomised to a method of allocation to an action plan: (1) random allocation; (2) allocation by health literacy screening tool or (3) allocation by participant selection. Primary outcome is self-reported serves of unhealthy snacks during the previous month. Multiple linear regression will evaluate the impact of health literacy on intervention effectiveness. The analysis will also identify independent contributions of each action plan, method of allocation, health literacy and participant selections on unhealthy snacking at 4-week follow-up.Ethics and disseminationThis study was approved by the University of Sydney Human Research Ethics Committee (2017/793). Findings will be disseminated through peer-reviewed international journals, conferences and updates with collaborating public health bodies (Diabetes New South Wales (NSW) & Australian Capital Territory (ACT), and Western Sydney Local Health District).Trial registration numberACTRN12618001409268; Pre-results.

scholarly journals Community engagement with HIV drug adherence in rural South Africa: a transdisciplinary approach

2018 ◽  
Vol 44 (4) ◽  
pp. 239-246 ◽  
Author(s):  
Astrid Treffry-Goatley ◽  
Richard John Lessells ◽  
Relebohile Moletsane ◽  
Tulio de Oliveira ◽  
Bernhard Gaede
Keyword(s):  
South Africa ◽  
Community Engagement ◽  
Personal Narratives ◽  
Video Production ◽  
People Living With Hiv ◽  
Local Health ◽  
Art Adherence ◽  
Digital Stories ◽  
The Impact ◽  
Engagement Intervention

Digital storytelling (DST) is an emerging participatory visual method which combines storytelling traditions with computer and video production technology. In this project, at the heart of the HIV epidemic in KwaZulu-Natal, South Africa, we used DST to create a culturally grounded community engagement intervention. Our aim was to use narratives of people living with HIV on antiretroviral therapy (ART) to stimulate dialogue among the wider community and to encourage reflection on the contextual factors that influence ART adherence in this setting. We also wanted to explore whether exposure to the personal narratives might influence health literacy around HIV and ART. We ran two DST workshops, where 20 community participants were supported to create short digital stories about personal experiences of adherence. We then hosted 151 screenings of the digital stories at seven local health facilities and evaluated the impact of the intervention using a three-tiered mixed methods approach. We conducted two independent quantitative surveys of healthcare users (852 respondents during the preintervention round and 860 people during the postintervention round), five focus group discussions and observation of practice. Exposure to the digital stories did stimulate rich dialogue among community members, which broadened from the focus on ART adherence to other aspects around the impact of HIV and its treatment on individuals and the community. In the independently conducted surveys, we found no clear difference in knowledge or understanding of HIV and ART between the people exposed to the digital stories and those who were not exposed. Our findings provide support for the use of DST as an engagement intervention, but highlight some of the challenges in delivering this type of intervention and in evaluating the impact of this approach.

scholarly journals Investigating the impact of enhanced community case management and monthly screening and treatment on the transmissibility of malaria infections in Burkina Faso: study protocol for a cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030598 ◽  
Author(s):  
Katharine A Collins ◽  
Alphonse Ouedraogo ◽  
Wamdaogo Moussa Guelbeogo ◽  
Shehu S Awandu ◽  
Will Stone ◽  
...  
Keyword(s):  
Case Management ◽  
Burkina Faso ◽  
Malaria Transmission ◽  
Randomised Trial ◽  
Standard Of Care ◽  
Recruitment Strategy ◽  
Cluster Randomised Trial ◽  
Community Case Management ◽  
Cluster Randomised ◽  
The Impact

IntroductionA large proportion of malaria-infected individuals in endemic areas do not experience symptoms that prompt treatment-seeking. These asymptomatically infected individuals may retain their infections for many months during which sexual-stage parasites (gametocytes) are produced that may be transmissible to mosquitoes. Reductions in malaria transmission could be achieved by detecting and treating these infections early. This study assesses the impact of enhanced community case management (CCM) and monthly screening and treatment (MSAT) on the prevalence and transmissibility of malaria infections.Methods and analysisThis cluster-randomised trial will take place in Sapone, an area of intense, highly seasonal malaria in Burkina Faso. In total, 180 compounds will be randomised to one of three interventions: arm 1 - current standard of care with passively monitored malaria infections; arm 2 - standard of care plus enhanced CCM, comprising active weekly screening for fever, and detection and treatment of infections in fever positive individuals using conventional rapid diagnostic tests (RDTs); or arm 3 - standard of care and enhanced CCM, plus MSAT using RDTs. The study will be conducted over approximately 18 months covering two high-transmission seasons and the intervening dry season. The recruitment strategy aims to ensure that overall transmission and force of infection is not affected so we are able to continuously evaluate the impact of interventions in the context of ongoing intense malaria transmission. The main objectives of the study are to determine the impact of enhanced CCM and MSAT on the prevalence and density of parasitaemia and gametocytaemia and the transmissibility of infections. This will be achieved by molecular detection of infections in all study participants during start and end season cross-sectional surveys and routine sampling of malaria-positive individuals to assess their infectiousness to mosquitoes.Ethics and disseminationThe study has been reviewed and approved by the London School of Hygiene and Tropical Medicine (LSHTM) (Review number: 14724) and The Centre National de Recherche et de Formation sur le Paludisme institutional review board (IRB) (Deliberation N° 2018/000002/MS/SG/CNRFP/CIB) and Burkina Faso national medical ethics committees (Deliberation N° 2018-01-010).Findings of the study will be shared with the community via local opinion leaders and community meetings. Results may also be shared through conferences, seminars, reports, theses and peer-reviewed publications; disease occurrence data and study outcomes will be shared with the Ministry of Health. Data will be published in an online digital repository.Trial registration numberNCT03705624.

scholarly journals Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa

BMJ Open ◽  
2019 ◽  
Vol 9 (7) ◽  
pp. e027227 ◽  
Author(s):  
Lynn T Matthews ◽  
Manjeetha Jaggernath ◽  
Yolandie Kriel ◽  
Patricia M Smith ◽  
Kasey O’Neil ◽  
...  
Keyword(s):  
South Africa ◽  
Longitudinal Study ◽  
Qualitative Interviews ◽  
Primary Objective ◽  
Local Health ◽  
Safer Conception ◽  
Stable Relationship ◽  
Human Research Ethics ◽  
Hiv Acquisition ◽  
Living With Hiv

IntroductionWomen who choose to conceive a baby with a partner living with HIV or a partner whose HIV serostatus is unknown in HIV-endemic settings need prevention strategies to mitigate HIV acquisition during conception and pregnancy.Methods and analysisWe are conducting a single-arm longitudinal study offering oral tenofovirdisoproxil fumarate/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) for periconception use to 350 HIV-uninfected women in KwaZulu-Natal, South Africa. PrEP is offered as part of woman-centred safer conception programme that promotes couples-based HIV counselling and testing, antiretroviral therapy for partners who are HIV-infected, treatment for sexually transmitted infections and safer conception strategies, such as limiting condomless sex to peak fertility. We enrol HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a partner living with HIV or of unknown serostatus, and personal or partner plans for pregnancy in the next 12 months. We follow enrolled women for 12 months. Women who become pregnant are followed through pregnancy outcome, independent of their decisions regarding PrEP use. The primary objective of the study is to evaluate the uptake of and adherence to PrEP during the periconception period and pregnancy. Secondary outcomes include the uptake of other safer conception strategies. We also measure clinical outcomes including HIV seroconversion rates and pregnancy and infant outcomes. Finally, we will explore conduct and evaluate qualitative interviews in 25 participants to further inform our conceptual framework for periconception PrEP uptake and adherence among HIV-exposed women in South Africa.Ethics and disseminationThe protocol has been approved by the Human Research Ethics Committee at the University of the Witwatersrand (Johannesburg, South Africa) and the Institutional Review Board of Partners Healthcare (Boston, Massachusetts, USA). Study findings will be made available to interested participants. Results will be presented to local health officials and stakeholders at meetings. Investigators will share the results at meetings and in manuscripts. De-identified quantitative data will be made available.Trial registration numberThe protocol is registered with the South African Health Products Regulatory Agency (SAHPRA, formerly known as the Medicine Controls Council, MCC#20170131) and ClinicalTrials.gov (NCT03194308); Pre-results.

scholarly journals Intensified household contact tracing, prevention and treatment support versus enhanced standard of care for contacts of tuberculosis cases in South Africa: study protocol for a household cluster-randomised trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Peter MacPherson ◽  
Emily L. Webb ◽  
Ebrahim Variava ◽  
Sanjay G. Lala ◽  
Minja Milovanovic ◽  
...  
Keyword(s):  
South Africa ◽  
Standard Of Care ◽  
Household Contact ◽  
Sub Saharan Africa ◽  
Contact Tracing ◽  
Free Survival ◽  
Hiv Intervention ◽  
Household Contacts ◽  
Cluster Randomised ◽  
Household Cluster

Abstract Background Household contact tracing of index TB cases has been advocated as a key part of TB control for many years, but has not been widely implemented in many low-resource setting because of the current dearth of high quality evidence for effectiveness. Innovative strategies for earlier, more effective treatment are particularly important in contexts with hyper-endemic levels of HIV, where levels of TB infection remain extremely high. Methods We present the design of a household cluster-randomised controlled trial of interventions aimed at improving TB-free survival and reducing childhood prevalence of Mycobacterium tuberculosis infection among household contacts of index TB cases diagnosed in two provinces of South Africa. Households of index TB cases will be randomly allocated in a 1:1 ratio to receive either an intensified home screening and linkage for TB and HIV intervention, or enhanced standard of care. The primary outcome will compare between groups the TB-free survival of household contacts over 15 months. All participants, or their next-of-kin, will provide written informed consent to participate. Discussion Evidence from randomised trials is required to identify cost-effective approaches to TB case-finding that can be applied at scale in sub-Saharan Africa. Trial registration ISRCTN16006202 (01/02/2017: retrospectively registered) and NHREC4399 (11/04/2016: prospectively registered). Protocol version: 4.0 (date: 18th January 2018).

scholarly journals Heterogeneous Recommendations for School Attendance in Children With Chronic Kidney Diseases During the COVID-19 Pandemic in Europe

2021 ◽  
Vol 9 ◽  
Author(s):  
Raphael Schild ◽  
Luke Hopf ◽  
Sebastian Loos ◽  
Jun Oh ◽  
Elena Levtchenko
Keyword(s):  
Chronic Diseases ◽  
School Attendance ◽  
Kidney Diseases ◽  
Pediatric Nephrology ◽  
Local Health ◽  
Health Providers ◽  
National Guidelines ◽  
Health Authorities ◽  
Long Time ◽  
The Impact

Introduction: After worldwide closures due to the COVID-19 pandemic, schools have reopened in most European countries in late 2020. Consequently, for children with chronic diseases the risks of COVID-19 have to be weighed against the long-time risks of missing school.Methods: To evaluate the impact of chronic diseases on school attendance for children in Europe during the COVID-19 pandemic we conducted a survey among members of the European Society for Pediatric Nephrology (ESPN) between September and November 2020. We asked for current forms of schooling, the existence of national guidelines, parental concerns, and the pediatric nephrologists recommendations for school attendance for specific virtual patients with chronic kidney disease (CKD).Results: Recommendations varied widely among pediatric nephrologists. A minority stated that specific recommendations for COVID-19 risk in children with kidney diseases existed in their country from local health authorities (9 of 29 countries; 31%) and/or national pediatric nephrology societies (9 of 29 countries; 31%). Over 90% of physicians have experienced parents keeping their children out of school against medical advice of their health providers and about 50% have experienced their patients being refused by school authorities. Consequently, 25% of all pediatric nephrologists estimated that more than 10% of their patients will not attend school regularly.Conclusion: COVID-19 causes educational deficits in the already vulnerable population of children with CKD. As the evidence for the course of COVID-19 in children with chronic diseases grows, rapidly adapted recommendations from pediatric societies could help reduce uncertainty among doctors, patients, and parents.

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