Dataset Information

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

ABSTRACT:

Background

South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension.

Methods/design

The Nkateko trial will test the effectiveness of clinic-based lay health workers (LHWs) in supporting hypertension management. It is a pragmatic, cluster randomised controlled trial based in the Agincourt subdistrict of northeast South Africa, and it is underpinned by long-term health and demographic surveillance. Eight primary care facilities, with their catchment communities, are randomised to usual care or the addition of LHWs focused on chronic care. All clinics (intervention and control) will be provided with a clerk to collect information on clinic attendees and will match them to preexisting surveillance records. Intervention clinics will have LHWs working alongside nursing staff and focusing on health care for people with chronic conditions, particularly hypertension. The LHWs will be supported by an implementation manager, who will work with clinic staff to develop the most effective role for the LHWs. Control clinics will continue to provide usual care. The primary outcome will be the change between two population surveys conducted before and after the intervention in the proportion of the population with uncontrolled hypertension and a risk profile indicating at least moderate risk of cardiovascular disease. A process evaluation will be based on a realist approach using patient exit interviews, clinic observations and interviews with health professionals, LHWs and patients to document the intervention and its implementation.

Discussion

There are challenges in the design of this trial. Assessing change through population surveys may reduce measurable effects; however, we feel this is appropriate because we aim to attract those who currently do not use clinics, and we hope to improve care for clinic users. Clinics were randomised at an open meeting because we were concerned that a remote process of randomisation would not be trusted by the community. We are constantly working to achieve an effective balance between the intervention and process evaluations.

Trial registration

ISRCTN12128227 (registered 5 March 2014).

SUBMITTER: Thorogood M

PROVIDER: S-EPMC4289183 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

Thorogood Margaret M Goudge Jane J Bertram Melanie M Chirwa Tobias T Eldridge Sandra S Gómez-Olivé Francesc Xavier FX Limbani Felix F Musenge Eustasius E Myakayaka Nokuzola N Tollman Stephen S Twine Rhian R

Trials 20141107

<h4>Background</h4>South Africa has a high and rising prevalence of hypertension. Many affected individuals are not using medication, and few have controlled blood pressure. Until recently, primary care clinics focused on maternal and child health and management of acute conditions, but new government initiatives have shifted the focus to chronic diseases, including HIV/AIDS and hypertension.<h4>Methods/design</h4>The Nkateko trial will test the effectiveness of clinic-based lay health workers ( ...[more]

PMID: 25380994

Similar Datasets

Project description:BackgroundThere is poor viral load monitoring (VLM) and inadequate management of virological failure in HIV-positive individuals on antiretroviral therapy in rural KwaZulu-Natal, South Africa. This could be contributing to increasing HIV drug resistance in the setting. This study aims to investigate the clinical and process impediments in VLM within the health system and to evaluate a quality improvement package (QIP) to address the identified gaps. The QIP comprises (i) a designated viral load champion responsible for administrative management and triaging of viral load results (ii) technological enhancement of the routine clinic-based Three Interlinked Electronic Register (TIER.Net) to facilitate daily automatic import of viral load results from the National Health Service Laboratory to TIER.Net (iii) development of a dashboard system to support VLM.Methods/designThe study will evaluate the effectiveness of the QIP compared to current care for improving VLM and virological suppression using an effectiveness implementation hybrid type 3 design. This will use a cluster-randomised design with the primary healthcare clinics as the unit of randomisation with ten clinics randomised in a 1:1 ratio to either the intervention or control arm. We will enrol 150 HIV-positive individuals who had been on ART for ≥ 12 months from each of the ten clinics (750 in 5 intervention clinics vs. 750 in 5 control clinics) and follow them up for a period of 12 months. The primary outcome is the proportion of all patients who have a viral load (VL) measurement and are virally suppressed (composite outcome) after 12 months of follow up. Secondary outcomes during follow up include proportion of all patients with at least one documented VL in TIER.Net, proportion with VL ≥ 50 copies/mL, proportion with VL ≥ 1000 copies/mL (virological failure) and subsequent switch to second-line ART.DiscussionWe aim to provide evidence that a staff-centred quality improvement package, designated viral load monitoring champion, and augmentation of TIER.Net with a dashboard system will improve viral load monitoring and lead to improved virological suppression.Trial registrationThis trial is registered on ClinicalTrials.gov on 8 Oct 2021. Identifier: NCT05071573; https://clinicaltrials.gov/ct2/show/NCT05071573?term=NCT05071573&draw=2&rank=1.

Project description:BackgroundThe high co-morbidity of mental disorders, particularly depression, with non-communicable diseases (NCDs) such as cardiovascular disease (CVD), is concerning given the rising burden of NCDs globally, and the role depression plays in confounding prevention and treatment of NCDs. The objective of this randomised control trial (RCT) is to determine the real-world effectiveness of strengthened depression identification and management on depression outcomes in hypertensive patients attending primary health care (PHC) facilities in South Africa (SA).Methods/designThe study design is a pragmatic, two-arm, parallel-cluster RCT, the unit of randomisation being the clinics, with outcomes being measured for individual participants. The 20 largest eligible clinics from one district in the North West Province are enrolled in the trial. Equal numbers of hypertensive patients (n = 50) identified as having depression using the Patient Health Questionnaire (PHQ-9) are enrolled from each clinic, making up a total of 1000 participants with 500 in each arm. The nurse clinicians in the control facilities receive the standard training in Primary Care 101 (PC101), a clinical decision support tool for integrated chronic care that includes guidelines for hypertension and depression care. Referral pathways available include referrals to PHC physicians, clinical or counselling psychologists and outpatient psychiatric and psychological services. In the intervention clinics, this training is supplemented with strengthened training in the depression components of PC101 as well as training in clinical communication skills for nurse-led chronic care. Referral pathways are strengthened through the introduction of a facility-based behavioural health counsellor, trained to provide structured manualised counselling for depression and adherence counselling for all chronic conditions. The primary outcome is defined as at least 50% reduction in PHQ-9 score measured at 6 months.DiscussionThis trial should provide evidence of the real world effectiveness of strengtheneddepression identification and collaborative management on health outcomes of hypertensive patients withcomorbid depression attending PHC facilities in South Africa.Trial registrationSouth African National Clinical Trial Register: SANCTR ( http://www.sanctr.gov.za/SAClinicalTrials ) (DOH-27-0916-5051). Registered on 9 April 2015. ClinicalTrials.gov : ID: NCT02425124 . Registered on 22 April 2015.

Project description:ObjectiveTo determine if an intervention consisting of telemonitoring and supervision by usual primary care clinicians of home self measured blood pressure and optional patient decision support leads to clinically important reductions in daytime systolic and diastolic ambulatory blood pressure in patients with uncontrolled blood pressure.DesignMulticentre randomised controlled trial.Setting20 primary care practices in south east Scotland.Participants401 people aged 29-95 years with uncontrolled blood pressure (mean daytime ambulatory measurement ≥ 135/85 mm Hg but ≤ 210/135 mm Hg).InterventionSelf measurement and transmission of blood pressure readings to a secure website for review by the attending nurse or doctor and participant, with optional automated patient decision support by text or email for six months.Main outcome measuresBlinded assessment of mean daytime systolic ambulatory blood pressure six months after randomisation.Results200 participants were randomised to the intervention and 201 to usual care; primary outcome data were available for 90% of participants (182 and 177, respectively). The mean difference in daytime systolic ambulatory blood pressure adjusted for baseline and minimisation factors between intervention and usual care was 4.3 mm Hg (95% confidence interval 2.0 to 6.5; P=0.0002) and for daytime diastolic ambulatory blood pressure was 2.3 mm Hg (0.9 to 3.6; P=0.001), with higher values in the usual care group. The intervention was associated with a mean increase of one general practitioner (95% confidence interval 0.5 to 1.6; P=0.0002) and 0.6 (0.1 to 1.0; P=0.01) practice nurse consultations during the course of the study.ConclusionsSupported self monitoring by telemonitoring is an effective method for achieving clinically important reductions in blood pressure in patients with uncontrolled hypertension in primary care settings. However, it was associated with increase in use of National Health Service resources. Further research is required to determine if the reduction in blood pressure is maintained in the longer term and if the intervention is cost effective.Trial registrationCurrent Controlled Trials ISRCTN72614272.

Project description:INTRODUCTION:India has high prevalence of hypertension but low awareness, treatment and control rate. A cluster randomised trial entitled 'm-Power Heart Project' is being implemented to test the effectiveness of a nurse care coordinator (NCC) led complex intervention to address uncontrolled hypertension in the community health centres (CHCs). The trial's process evaluation will assess the fidelity and quality of implementation, clarify the causal mechanisms and identify the contextual factors associated with variation in the outcomes. The trial will use a theory-based mixed-methods process evaluation, guided by the Consolidated Framework for Implementation Research. METHODS AND ANALYSIS:The process evaluation will be conducted in the CHCs of Visakhapatnam (southern India). The key stakeholders involved in the intervention development and implementation will be included as participants. In-depth interviews will be conducted with intervention developers, doctors, NCCs and health department officials and focus groups with patients and their caregivers. NCC training will be evaluated using Kirkpatrick's model for training evaluation. Key process evaluation indicators (number of patients recruited and retained; concordance between the treatment plans generated by the electronic decision support system and treatment prescribed by the doctor and so on) will be assessed. Fidelity will be assessed using Borrelli et al's framework. Qualitative data will be analysed using the template analysis technique. Quantitative data will be summarised as medians (IQR), means (SD) and proportions as appropriate. Mixed-methods analysis will be conducted to assess if the variation in the mean reduction of systolic blood pressure between the intervention CHCs is influenced by patient satisfaction, training outcome, attitude of doctors, patients and NCCs about the intervention, process indicators etc. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the ethics committees at Public Health Foundation of India and Deakin University. Findings will be disseminated via peer-reviewed publications, national and international conference presentations. TRIAL REGISTRATION NUMBER:NCT03164317; Pre-results.

Project description:BackgroundWith 7.7 million South Africans currently infected with human immunodeficiency virus (HIV) and 4.8 million currently receiving antiretroviral treatment (ART), the epidemic represents a considerable burden for the country's resource-limited health system. In response to the health and human resource shortages, task shifting to community health workers (CHWs) and empowering people living with HIV (PLWH) are integral parts of a sustainable ART strategy. Despite the success of the ART programme, South Africa still faces both prevention and treatment challenges. To tackle these challenges, future endeavours need to focus on the role played by the households of PLWH in mediating between the community and PLWH themselves. Building health-enabling "HIV competent" households with the capacity to actively stimulate lifestyles that foster health, offers a potential strategy to tackle South Africa's HIV-related challenges. The aim of the "Sinako: Households and HIV" study is to investigate to what extent and how an intervention can increase HIV competence in PLWH and their households, and subsequently optimise the impact of CHW support on individual ART outcomes.MethodsThe "Sinako" study is a cluster-randomised controlled trial with two arms. In the control arm, CHWs offer a standard package of support to PLWH during home visits, focused on the individual. The intervention arm includes both a focus on the individual and the household to enable the patient to self-manage their treatment within an HIV competent household. A longitudinal mixed methods design is adopted to analyse the data. For the quantitative data analysis, methods including latent cross-lagged modelling, multilevel modelling and logistic regression will be used. To assess the acceptability and feasibility of the intervention and to construct a comprehensive picture of the mechanisms underlying the impact on the household and the PLWH, qualitative data (in-depth interviews and focus group discussions) will be collected and analysed.DiscussionStimulating HIV competence in households could be a feasible and sustainable strategy to optimise the outcomes of CHW interventions and thus be important for HIV treatment interventions in resource-limited settings.Trial registrationPan African Clinical Trial Registry, PACTR201906476052236. Registered on 24 June 2019.

Project description:IntroductionParticipation in antiretroviral therapy (ART) programmes has been associated with greater utilization of care for hypertension and diabetes in rural South Africa. The objective of this study was to assess whether people living with HIV on ART with comorbid hypertension or diabetes also have improved chronic disease management indicators.MethodsThe Health and Aging in Africa: a longitudinal study of an INDEPTH Community in South Africa (HAALSI) is a cohort of 5059 adults >40 years old. Enrollment took place between November 2014 and November 2015. The study collected population-based data on demographics, healthcare utilization, height, weight, blood pressure (BP) and blood glucose as well as HIV infection, HIV-1 RNA viral load (VL) and ART exposure. We used regression models to determine whether HIV care cascade stage (HIV-negative, HIV+ /No ART, ART/Detected HIV VL, and ART/Undetectable VL) was associated with diagnosis or treatment of hypertension or diabetes, and systolic blood pressure and glucose among those with diagnosed hypertension or diabetes. ART use was measured from drug level testing on dried blood spots.Results and discussionCompared to people without HIV, ART/Undetectable VL was associated with greater awareness of hypertension diagnosis (adjusted risk ratio (aRR) 1.18, 95% CI: 1.09 to 1.28) and treatment of hypertension (aRR 1.24, 95% CI: 1.10 to 1.41) among those who met hypertension diagnostic criteria. HIV care cascade stage was not significantly associated with awareness of diagnosis or treatment of diabetes. Among those with diagnosed hypertension or diabetes, ART/Undetectable VL was associated with lower mean systolic blood pressure (5.98 mm Hg, 95% CI: 9.65 to 2.32) and lower mean glucose (3.77 mmol/L, 95% CI: 6.85 to 0.69), compared to being HIV-negative.ConclusionsParticipants on ART with an undetectable VL had lower systolic blood pressure and blood glucose than the HIV-negative participants. HIV treatment programmes may provide a platform for health systems strengthening for cardiometabolic disease.

Project description:In countries with a high burden of HIV, such as South Africa, where the epidemic remains the world's largest, improving early uptake of and consistent adherence to antiretroviral therapy could bring substantial HIV prevention gains. However, patients are not linked to or retained in care at rates needed to curtail the epidemic. Two strategies that have demonstrated a potential to stem losses along the HIV care cascade in the sub-Saharan African context are use of text messaging or short message service (SMS) and peer-navigation services.We designed a cluster randomized trial to assess the efficacy of an SMS intervention and a peer-navigation intervention to improve retention in care and treatment, timely linkage to care and treatment, medication adherence, and prevention behaviors in South Africa. Eighteen primary and community healthcare clinics in Rustenburg and Moses Kotane Sub-districts in the North West Province were randomized to one of three conditions: SMS intervention (n = 7), peer navigation intervention (n = 7), or standard of care (n = 4). Approximately 42 participants are being recruited at each clinic, which will result in a target of 750 participants. Eligible participants include patients accessing HIV testing or care in a study clinic, recently diagnosed with HIV, aged 18 years or older, and with access to a cellular telephone where they are willing to receive automated SMS with HIV-related messaging. Data collection includes extraction of visit information from clinical files and participant surveys at baseline, 6 months, and 12 months. Intent-to-treat (ITT) analysis will explore differences between randomization arms and the primary outcome of patient retention in care at 12 months following enrollment. We will also explore secondary outcomes including participants' a) timely linkage to care (within 3 months of HIV diagnosis), b) adherence to treatment based on self-report and clinic's medication dispensation dates, and c) condom-use behaviors.The findings will allow us to compare the efficacy of two complementary interventions, one that requires fewer resources to implement (SMS) and one (peer navigation) that offers more flexibility in terms of the patient barriers to care that it can address.NCT02417233, registered 12 December 2014.

Dataset Information

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

Background

Methods/design

Discussion

Trial registration

Publications

The Nkateko health service trial to improve hypertension management in rural South Africa: study protocol for a randomised controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets