Dataset Information

Integration of a task strengthening strategy for hypertension management into HIV care in Nigeria: a cluster randomized controlled trial study protocol

ABSTRACT:

Background

In regions with weak healthcare systems, critical shortages of the healthcare workforce, and increasing prevalence of dual disease burdens, there is an urgent need for the implementation of proven effective interventions and strategies to address these challenges. Our mixed-methods hybrid type II effectiveness-implementation study is designed to fill this evidence-to-practice gap. This study protocol describes a cluster randomized controlled trial which evaluates the effectiveness of an implementation strategy, practice facilitation (PF), on the integration, adoption, and sustainability of a task-strengthening strategy for hypertension control (TASSH) intervention within primary healthcare centers (PHCs) in Lagos State, Nigeria.

Design

Guided by the Consolidated Framework for Implementation Research (CFIR) and the Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM), this study tests the impact of a proven effective implementation strategy to integrate hypertension management into the HIV care cascade, across 30 PHCs. The study will be conducted in three phases: (1) a pre-implementation phase that will use CFIR to develop a tailored PF intervention for integrating TASSH into HIV clinics; (2) an implementation phase that will use RE-AIM to compare the clinical effectiveness of PF vs. a self-directed condition (receipt of information on TASSH without PF) on BP reduction; and (3) a post-implementation phase that will use RE-AIM to evaluate the effect of PF vs. self-directed condition on adoption and sustainability of TASSH. The PF intervention components comprise (a) an advisory board to provide leadership support for implementing TASSH in PHCs; (b) training of the HIV nurses on TASSH protocol; and (c) training of practice facilitators, who will serve as coaches, provide support, and performance feedback to the HIV nurses.

Discussion

This study is one of few, if any trials, to evaluate the impact of an implementation strategy for integrating hypertension management into HIV care, on clinical and implementation outcomes. Findings from this study will advance implementation science research on the effectiveness of tailoring an implementation strategy for the integration of an evidence-based, system-level hypertension control intervention into HIV care and treatment.

Trial registration

ClinicalTrials.gov (NCT04704336). Registered on 11 January 2021.

SUBMITTER: Aifah A

PROVIDER: S-EPMC8597211 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPhysician shortage is a major barrier to hypertension (HTN) control in Ghana, with only one physician to 10,000 patients in 2015, thus limiting its capacity for HTN control at the primary care level such as the Community Health Planning and Services (CHPS) compounds, where most Ghanaians receive care. A Task-Shifting Strategy for HTN control (TASSH) based on the WHO Cardiovascular (CV) Risk Package is an evidence-based strategy for mitigating provider- and systems-level barriers to optimal HTN control. Despite its effectiveness, TASSH remains untested in CHPS zones. Additionally, primary care practices in low- and middle-income countries (LMICs) lack resources and expertise needed to coordinate multilevel system changes without assistance. The proposed study will evaluate the effectiveness of practice facilitation (PF) as a quality improvement strategy for implementing TASSH within CHPS zones in Ghana.MethodsGuided by the Consolidated Framework for Implementation Research and the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we will evaluate, in a hybrid clinical effectiveness-implementation design, the effect of PF on the uptake of an evidence-based TASSH, among 700 adults who present to 70 CHPS zones with uncontrolled HTN. Components of the PF strategy include (a) an advisory board that provides leadership support for implementing the intervention within the CHPS zones and (b) trained task-strengthening facilitators (TSFs) who serve as practice coaches to provide training, and performance feedback to community health officers (CHOs) who will deliver TASSH at the CHPS zones. For this purpose, the TSFs are trained to identify, counsel, and refer adults with uncontrolled HTN to community health centers in Bono East Region of Ghana.DiscussionUptake of community-based evidence-supported interventions for hypertension control in Ghana is urgently needed to address the CVD epidemic and its associated morbidity, mortality, and societal costs. Findings from this study will provide policymakers and other stakeholders the "how to do it" empirical literature on the uptake of evidence-based task-strengthening interventions for HTN control in Ghana and will serve as a model for similar action in other low, middle-income countries.Trial registrationClinicalTrials.gov, NCT03490695 . Registered on 6 April 2018.Protocol version and dateVersion 1, date: 21 August, 2019.

Project description:IntroductionIn sub-Saharan Africa, the burden of non-communicable diseases (NCDs), particularly diabetes mellitus (DM) and hypertension, has increased rapidly in recent years, although HIV infection remains a leading cause of death among young-middle-aged adults. Health service coverage for NCDs remains very low in contrast to HIV, despite the increasing prevalence of comorbidity of NCDs with HIV. There is an urgent need to expand healthcare capacity to provide integrated services to address these chronic conditions.Methods and analysisThis protocol describes procedures for a qualitative process evaluation of INTE-AFRICA, a cluster randomised trial comparing integrated health service provision for HIV infection, DM and hypertension, to the current stand-alone vertical care. Interviews, focus group discussions and observations of consultations and other care processes in two clinics (in Tanzania, Uganda) will be used to explore the experiences of stakeholders. These stakeholders will include health service users, policy-makers, healthcare providers, community leaders and members, researchers, non-governmental and international organisations. The exploration will be carried out during the implementation of the project, alongside an understanding of the impact of broader structural and contextual factors.Ethics and disseminationEthical approval was granted by the Liverpool School of Tropical Medicine (UK), the National Institute of Medical Research (Tanzania) and TASO Research Ethics Committee (Uganda) in 2020. The evaluation will provide the opportunity to document the implementation of integration over several timepoints (6, 12 and 18 months) and refine integrated service provision prior to scale up. This synergistic approach to evaluate, understand and respond will support service integration and inform monitoring, policy and practice development efforts to involve and educate communities in Tanzania and Uganda. It will create a model of care and a platform of good practices and lessons learnt for other countries implementing integrated and decentralised community health services.Trial registration numberISRCTN43896688; Pre-results.

Project description:BackgroundAs people living with HIV (PLWH) experience earlier and more pronounced onset of noncommunicable diseases (NCDs), advancing integrated care networks and models in low-resource-high-need settings is critical. Leveraging current health system initiatives and addressing gaps in treatment for PLWH, we report our approach using a late-stage (T4) implementation research study to test the adoption and sustainability of a proven-effective implementation strategy which has been minimally applied in low-resource settings for the integration of hypertension control into HIV treatment. We detail our protocol for the Managing Hypertension Among People Living with HIV: an Integrated Model (MAP-IT) trial, which uses a stepped wedge cluster randomized trial (SW-CRT) design to evaluate the effectiveness of practice facilitation on the adoption of a hypertension treatment program for PLWH receiving care at primary healthcare centers (PHCs) in Akwa Ibom State, Nigeria.DesignIn partnership with the Nigerian Federal Ministry of Health (FMOH) and community organizations, the MAP-IT trial takes place in 30 PHCs. The i-PARiHS framework guided pre-implementation needs assessment. The RE-AIM framework will guide post-implementation activities to evaluate the effect of practice facilitation on the adoption, implementation fidelity, and sustainability of a hypertension program, as well as blood pressure (BP) control. Using a SW-CRT design, PHCs sequentially crossover from the hypertension program only (usual care) to hypertension plus practice facilitation (experimental condition). PHCs will recruit and enroll an average of 28-32 patients to reach a maximum of 960 PLWH participants with uncontrolled hypertension who will be followed longitudinally for BP outcomes.DiscussionGiven the need for integrated NCD-HIV care platforms in low-resource settings, MAP-IT will underscore the challenges and opportunities for integrating hypertension treatment into HIV care, particularly concerning adoption and sustainability. The evaluation of our integration approach will also highlight the potential impact of a health systems strengthening approach on BP control among PLWH.Trial registrationClinicaltrials.gov ( NCT05031819 ). Registered on 2nd September 2021.

Project description:BACKGROUND:Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral networks between different levels of the health system is one factor that threatens the ability to achieve adequate blood pressure control and prevent CVD-related morbidity. Health information technology and peer support are two strategies that have improved care coordination and clinical outcomes for other disease entities in other settings; however, their effectiveness and cost-effectiveness in strengthening referral networks to improve blood pressure control and reduce CVD risk in low-resource settings are unknown. METHODS/DESIGN:We will use the PRECEDE-PROCEED framework to conduct transdisciplinary implementation research, focused on strengthening referral networks for hypertension in western Kenya. We will conduct a baseline needs and contextual assessment using a mixed-methods approach, in order to inform a participatory, community-based design process to fully develop a contextually and culturally appropriate intervention model that combines health information technology and peer support. Subsequently, we will conduct a two-arm cluster randomized trial comparing 1) usual care for referrals vs 2) referral networks strengthened with our intervention. The primary outcome will be one-year change in systolic blood pressure. The key secondary clinical outcome will be CVD risk reduction, and the key secondary implementation outcomes will include referral process metrics such as referral appropriateness and completion rates. We will conduct a mediation analysis to evaluate the influence of changes in referral network characteristics on intervention outcomes, a moderation analysis to evaluate the influence of baseline referral network characteristics on the effectiveness of the intervention, as well as a process evaluation using the Saunders framework. Finally, we will analyze the incremental cost-effectiveness of the intervention relative to usual care, in terms of costs per unit decrease in systolic blood pressure, per percentage change in CVD risk score, and per disability-adjusted life year saved. DISCUSSION:This study will provide evidence for the implementation of innovative strategies for strengthening referral networks to improve hypertension control in LMICs. If effective, it has the potential to be a scalable model for health systems strengthening in other low-resource settings worldwide. TRIAL REGISTRATION:Clinicaltrials.gov, NCT03543787 . Registered on 29 June 2018.

Project description:BackgroundChild mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, is low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality.MethodsThis is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 to September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n = 33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted 'whole systems strengthening' package of three evidence-based methods: community men's and women's groups, Partnership Defined Quality Scorecard and healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: (a) baseline mortality of 100 per 1000 livebirths, (b) 4480 compounds with 3 eligible children per compound, (c) 80% power, (d) 5% significance, (e) intra-cluster correlation of 0.007 and (f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering.DiscussionThis study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data and the uncertain impacts of the COVID-19 pandemic.Trial registrationISRCTN 39213655 . Registered on 11 December 2019.

Project description:BackgroundGiven the growing burden of cardiovascular diseases in sub-Saharan Africa, global donors and governments are exploring strategies for integrating evidence-based cardiovascular diseases prevention into HIV clinics. We assessed the capabilities, motivations and opportunities that exist for HIV clinics to apply evidence-based strategies for hypertension control among people living with HIV (PLHIV) in Nigeria.MethodsWe used a concurrent Quan-Qual- study approach (a quantitative first step using structured questionnaires followed by a qualitative approach using stakeholder meetings).We invited key stakeholders and representatives of HIV and non-communicable disease organizations in Lagos, Nigeria to 1) assess the capacity of HIV clinics (n = 29) to, and; 2) explore their attitudes and perceptions towards implementing evidence-based strategies for hypertension management in Lagos, Nigeria (n = 19)The quantitative data were analyzed using SPSS whereas responses from the stakeholders meeting were coded and analyzed using thematic approach and an implementation science framework, the COM-B (Capabilities, Opportunities, Motivations and Behavior) model, guided the mapping and interpretation of the data.ResultsOut of the 29 HIV clinics that participated in the study, 28 clinics were public, government-owned facilities with 394 HIV patients per month with varying capabilities, opportunities and motivations for integrating evidence-based hypertension interventions within their services for PLHIV. Majority of the clinics (n = 26) rated medium-to-low on the psychological capability domains, while most of the clinics (n = 25) rated low on the physical capabilities of integrating evidence-based hypertension interventions within HIV clinics. There was high variability in the ratings for the opportunity domains, with physical opportunities rated high in only eight HIV clinics, two clinics with a medium rating and nineteen clinics with a low rating. Social opportunity domain tended to be rated low in majority of the HIV clinics (n = 21). Lastly, almost all the HIV clinics (n = 23) rated high on the reflective motivation domain although automatic motivations tended to be rated low across the HIV clinics.ConclusionIn this study, we found that with the exception of motivations, the relative capabilities whether physical or psychological and the relative opportunities for integrating evidence-based hypertension intervention within HIV clinics in Nigeria were minimal. Thus, there is need to strengthen the HIV clinics in Lagos for the implementation of evidence-based hypertension interventions within HIV clinics to improve patient outcomes and service delivery in Southwest Nigeria.

Project description:Background: Poor access to care and physician shortage are major barriers to hypertension control in sub-Saharan Africa. Implementation of evidence-based systems-level strategies targeted at these barriers are lacking. We conducted a study to evaluate the comparative effectiveness of provision of health insurance coverage (HIC) alone versus a nurse-led task shifting strategy for hypertension control (TASSH) plus HIC on systolic blood pressure (SBP) reduction among patients with uncontrolled hypertension in Ghana.Methods and findings: Using a pragmatic cluster randomized trial, 32 community health centers within Ghana's public healthcare system were randomly assigned to either HIC alone or TASSH + HIC. A total of 757 patients with uncontrolled hypertension were recruited between November 28, 2012, and June 11, 2014, and followed up to October 7, 2016. Both intervention groups received health insurance coverage plus scheduled nurse visits, while TASSH + HIC comprised cardiovascular risk assessment, lifestyle counseling, and initiation/titration of antihypertensive medications for 12 months, delivered by trained nurses within the healthcare system. The primary outcome was change in SBP from baseline to 12 months. Secondary outcomes included lifestyle behaviors and blood pressure control at 12 months and sustainability of SBP reduction at 24 months. Of the 757 patients (389 in the HIC group and 368 in the TASSH + HIC group), 85% had 12-month data available (60% women, mean BP 155.9/89.6 mm Hg). In intention-to-treat analyses adjusted for clustering, the TASSH + HIC group had a greater SBP reduction (-20.4 mm Hg; 95% CI -25.2 to -15.6) than the HIC group (-16.8 mm Hg; 95% CI -19.2 to -15.6), with a statistically significant between-group difference of -3.6 mm Hg (95% CI -6.1 to -0.5; p = 0.021). Blood pressure control improved significantly in both groups (55.2%, 95% CI 50.0% to 60.3%, for the TASSH + HIC group versus 49.9%, 95% CI 44.9% to 54.9%, for the HIC group), with a non-significant between-group difference of 5.2% (95% CI -1.8% to 12.4%; p = 0.29). Lifestyle behaviors did not change appreciably in either group. Twenty-one adverse events were reported (9 and 12 in the TASSH + HIC and HIC groups, respectively). The main study limitation is the lack of cost-effectiveness analysis to determine the additional costs and benefits, if any, of the TASSH + HIC group.Conclusions: Provision of health insurance coverage plus a nurse-led task shifting strategy was associated with a greater reduction in SBP than provision of health insurance coverage alone, among patients with uncontrolled hypertension in Ghana. Future scale-up of these systems-level strategies for hypertension control in sub-Saharan Africa requires a cost-benefit analysis.Trial registration: ClinicalTrials.gov NCT01802372.

Project description:BackgroundNigeria has one of the largest Human Immunodeficiency Virus (HIV) epidemics in the world. Addressing the epidemic of HIV in such a high-burden country has necessitated responses of a multidimensional nature. Historically, community-based organizations (CBOs) have played an essential role in targeting key populations (eg. men who have sex with men, sex workers) that are particularly burdened by HIV. CBOs are an essential part of the provision of health services in sub-Saharan Africa, but very little is known about the management practices of CBOs that provide HIV prevention interventions.MethodsWe interviewed 31 CBO staff members and other key stakeholders in January 2017 about management practices in CBOs. Management was conceptualized under the classical management process perspective; these four management phases-planning, organizing, leading, and evaluating-guided the interview process and code development. Data analysis was conducted thematically using Atlas.ti software. The protocol was approved by the ethics committees of the National Institute of Public Health of Mexico (INSP), the National Agency for the Control of AIDS in Nigeria (NACA), and the Nigerian Institute for Medical Research (NIMR).ResultsWe found that CBOs implement variable management practices that can either hinder or facilitate the efficient provision of HIV prevention services. Long-standing CBOs had relatively strong organizational infrastructure and capacity that positively influenced service planning. In contrast, fledgling CBOs were deficient of organizational infrastructure and lacked program planning capacity. The delivery of HIV services can become more efficient if management practices are taken into account.ConclusionsThe delivery of HIV services by CBOs in Nigeria was largely influenced by inherent issues related to skills, organizational structure, talent retention, and sanction application. These, in turn, affected management practices such as planning, organizing, leading, and evaluating. This study shows that KP-led CBOs are evolving and have strong potentials and capacity for growth, and can become more efficient and effective if attention is paid to issues such as hierarchy, staff recruitment, and talent retention.

Project description:Although China has a large number of older people living with diabetes and hypertension, the primary care system is underdeveloped and so management of these conditions in community care settings is suboptimal. Studies have shown that the collaborative care model across care settings that address both pharmacology and nonpharmacology interventions can achieve hypertension control for older people with diabetes. Barriers to implementing and evaluating this model of care are widely recognized in low and middle-income countries including China. This study will therefore test the hypothesis that a hypertension management program built on collaboration between hospitals and community health service centers in China can improve blood pressure control in people aged 60 years and older with diabetes as compared to usual care.A cluster randomized controlled trial will randomly allocate 10 wards from four hospitals in Nanchang to either an intervention group (N?=?5) or a usual care group (N?=?5). At least 27 participants will be recruited from each ward and the estimated sample size will be 135 patients in each group. The intervention includes individualized self-care education prior to discharge and 6-month follow-up in community health service centers. Health professionals from both hospitals and community health service centers will be resourced to collaborate on the implementation of the postdischarge interventions that reinforce self-care. The primary outcome is systolic blood pressure at 6-month follow-up adjusted for baseline value. Secondary outcomes are self-care knowledge, treatment adherence, HbA1c and lipid levels, quality of life, the incidence of adverse events and the incidence of unplanned hospital readmission at 6-month follow-up adjusted for baseline value. A multilevel mixed-effect linear regression model will be used to compare the changes in health outcomes between the intervention and usual care groups.This study will determine whether collaborative care among health professionals between hospitals and community health service centers will improve hypertension management for older people with diabetes in the study sites. The program, if effective, will have an immediate application to hypertension management in the healthcare system in China.Australia New Zealand Clinical Trials Registry, ACTRN12617001352392 . Retrospectively registered on 26 September 2017.

Project description:BackgroundDespite tremendous investment worldwide, hypertension treatment and control rates remain low. The complexity and long-term dynamics of influencing factors make personalized management inevitable and challenging. This protocol describes Personalized Hypertension Management in Anhui, China (PHMA), a project that uses a package of innovative approaches in tailoring interventions to individual patient's dynamic complications and contexts.Methods/designPHMA strives to reduce hypertension harms by eight "objective behaviors" (e.g., self-monitoring and reporting, healthy diet, physical exercise/activities). These objective behaviors are promoted through five intervention measures: support for self- monitoring, supervised machine communications, daily education or reminder messages, weekly blood pressure notification, and quarterly signed feedback. PHMA uses ten categories and over 300 variables in selecting and refining intervention procedures and content for individual patients. Efficacy of the intervention package is evaluated using a cluster randomized controlled trial design involving a total of 60 site communities and 3352 hypertension patients. Primary measure for the evaluation is systolic and diastolic blood pressure; while secondary evaluation measures include quality of life (EQ5D-5L), occurrence of hypertension-related complications (such as cerebral hemorrhage, coronary heart disease, myocardial or cerebral infarction), healthcare utilization and scores of objective behaviors.DiscussionPHMA uses novel, low cost and sustainable approaches to tailor interventions to the dynamic conditions and contexts of individual patients. Unlike contemporary approaches to hypertension management which are mainly population based, each participant patient in PHMA applies a unique intervention package and all messages, feedbacks and other materials sent out to individual patients are different from each other. PHMA is the first project that adopts comprehensive tailoring and if proved effective, it should have important implications for future research, practice and policy-making. Trial registration ISRCTN10999269. July 17, 2020; https://doi.org/10.1186/ISRCTN10999269 .