Scaling Out and Scaling Up the Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Screening EFFECTIVENESS Year 4 - Proportion initiating HTN medication
研究概览
简要总结
Undiagnosed and untreated hypertension is a main driver of cardiovascular disease, affecting disproportionately low and middle-income countries, where guidelines to screen and manage hypertension are poorly used. More than 13% of Mozambique adults are infected with HIV, and over 900,000 are on anti-retroviral therapy. HIV clinics are the only services within primary care providing continued care, and can be used to standardize and scale the hypertension care cascade. Hypertension affects 40% of Mozambican adults, and thus HIV and HTN often coexist in the same person.
The investigators propose to use low-cost tools that improve service performance, promote routine hypertension diagnosis and management, and ameliorate flow through the hypertension cascade, thus improving patients outcomes. Building on a current project some districts of two provinces of central Mozambique, the investigators will establish scientific evidence on the effectiveness of a tool that uses cycles of evaluation and improvement of health system, to address the hypertension care cascade in HIV-infected people. The investigators will strengthen the framework currently in use (based on nurses) setting a novel modality delivered by district health supervisors, and will expand the geographic study area by adding 6 districts of one additional province in southern Mozambique (Maputo Province), to create a foundation for national scale-up.
The Project planning phase (two years) will develop a multi-sectoral partnership of key stakeholders, establish national technical working groups with the participation of the provinces, and identify key facilitators and barriers that could affect uptake of the results, integration of high blood pressure and HIV services, scale-up to the entire country, and sustainability of the tested framework. Additionally, the investigators will i) conduct a six-months pilot study to assess feasibility and acceptability of the district supervisor-led intervention in one primary care facility; and, ii) redesign tools and standard operating procedures, as necessary. During the implementation phase (last three years) the investigators will deploy the district-based dissemination and implementation randomized trial in 18 health facilities - using an intervention that involves assessment, effectiveness evaluation, promotion of local uptake, implementation and maintenance - and determine the costs of the hypertension care cascade optimization, by estimating the total incremental costs.
详细描述
In Mozambique HIV prevalence is over 13% and hypertension (HTN) affects 40% of adults. HIV and HTN comorbidity is increasing with the aging of HIV-infected population and expansion of antiretroviral therapy (ART), but guideline application for HTN screening and management remains low and uneven. Around 14% of adults are aware of their HTN status and only 3% of those with HTN have their condition controlled. The HIV treatment platform is the only broadly implemented chronic care service and provides an opportunity to standardize and scale HTN screening and management.
Systems-level implementation strategies may reduce drop-offs along the HTN cascade, improve service quality, and maximize availability of efficacious HTN medicines. Systems engineering tools can identify drivers of inefficiency, support locally informed provider decision-making to prioritize solutions, and improve integration of services to reduce inefficiencies in complex, multi-step health services using simple, low cost, iterative adaptations in service delivery design. The participation of frontline staff and senior management champions in this process improves patient outcomes.
The investigators aim to describe HTN care cascade at the health facility level and use it as the entry point for systems optimization of HIV services, using cascade analysis and associated systems engineering tools. In central Mozambique a Systems Analysis and Improvement Approach (SAIA) identified HTN cascade steps for PLHIV, developed a HTN Cascade Analysis Tool (HCAT), mapped data sources, and developed a registry to populate the HCAT and capture study outcomes from outpatient registries and patient charts (SAIA-HTN). Building on this, our project will 'scale out' through the novel modality of delivery by district health supervisors, and 'scale up' by expanding to six districts in one additional province (SCALE SAIA-HTN). It also aims at developing a dissemination and implementation model to serve as a foundation for national scaling.
Projects Aims:
- To develop a multi-sectoral partnership of key stakeholders and establish HTN technical working groups at the national level and participating provinces;
- To identify key facilitators and barriers that could affect the adoption, integration, scale-up and sustainment of the SAIA-HTN implementation strategy;
- To conduct a pilot study to assess feasibility and acceptability of the district MOH supervisor-led SAIA-HTN intervention over six months in one primary care facility (to redesign tools and standard operating procedures as necessary);
- Develop a district-based dissemination and implementation of SAIA-HTN (SCALE SAIA-HTN) using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model to evaluate the program: a. Determine the proportion of health facilities and population in the six districts reached, and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached); b.Assess the intervention effect on HTN process measures (BP screening, HTN diagnosis, HTN medication initiation, maintenance on HTN treatment), and HTN treatment effectiveness (HTN control, HIV viral load suppression); c.Determine the proportion of districts and facilities adopting the intervention (target: 95%), and explore the determinants of adoption identified using the Organizational Readiness for Implementing Change (ORIC); d.Determine core elements of the scaled SAIA-HTN implementation process and describe drivers of success/failure using the Consolidated Framework for Implementation Research (CFIR); e.Calculate the proportion of districts sustaining the intervention 9, 18, 27 months post-introduction (target: >90% at 9 months, >80% at 18 months, and >65% at 27 months).
- Determine the costs of SCALE SAIA-HTN for care cascade optimization, including total incremental and unit costs of integrating HTN diagnosis and management into HIV care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary care facility with ongoing cohort of ART patients (minimum 800 patients)
排除标准
- •Health facility unaccessible during part of the year
结局指标
主要结局
Screening EFFECTIVENESS Year 4 - Proportion initiating HTN medication
时间窗: Year 4
Proportion initiating HTN medication
Screening EFFECTIVENESS Year 5 - Prevalence of HTN among those screened
时间窗: Year 5
Prevalence of HTN among those screened
REACH Year 3 - health facilities
时间窗: Year 3
Proportion of health facilities in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
REACH Year 4 - health facilities
时间窗: Year 4
Proportion of health facilities in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
REACH Year 5 - health facilities
时间窗: Year 5
Proportion of health facilities in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
Screening EFFECTIVENESS Year 3 - Proportion maintained on treatment
时间窗: Year 3
Proportion maintained on treatment
Screening EFFECTIVENESS Year 3 - Prevalence
时间窗: Year 3
Prevalence of HTN among those screened
Screening EFFECTIVENESS Year 4 - Prevalence of HTN among those screened
时间窗: Year 4
Prevalence of HTN among those screened
Treatment EFFECTIVENESS Year 4 - HIV viral load suppression
时间窗: Year 4
proportion of HIV patients with viral load suppression
ADOPTION Year 4 - Organizational Readiness for Implementing Change (ORIC)
时间窗: Year 4
Assess the extent to which organizational members are psychologically and behaviorally prepared to implement change (change commitment and change efficacy) using the Likert scale from 1("disagree") to 5 ("strongly agree")
MAINTENANCE Year 5
时间窗: Year 5
Proportion of districts sustaining the intervention as designed 9, 18 and 27 months post introduction for third, second and first wave of health facilities, respectively
COST ESTIMATION Year 5
时间窗: Year 5
Estimate incremental costs of SCALE SAIA HTN compared to the status quo
ESTIMATING AFFORDABILITY AND BUDGET IMPACT Year 5
时间窗: Year5
Estimate the cost per person screened and treated for HTN
REACH Year 3 - population
时间窗: Year 3
Proportion of population in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
REACH Year 4 - population
时间窗: Year 4
Proportion of population in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
REACH Year 5 - population
时间窗: Year 5
Proportion of population in Maputo Province reached and identification of sub-groups not reached (target: 33% of facilities and 80% HIV+ adults reached).
Screening EFFECTIVENESS Year 3 - BP screening coverage
时间窗: Year 3
Proportion of adult patients screened
Screening EFFECTIVENESS Year 4 - Proportion maintained on treatment
时间窗: Year 4
Proportion maintained on treatment
Screening EFFECTIVENESS Year 5 - Proportion maintained on treatment
时间窗: Year 5
Proportion maintained on treatment
Treatment EFFECTIVENESS Year 3 - HTN control
时间窗: Year 3
proportion of patients with HTN controlled
Treatment EFFECTIVENESS Year 3 - HIV viral load suppression
时间窗: Year 3
proportion of HIV patients with viral load suppression
IMPLEMENTATION Year 3 - Determine core elements of the scaled SAIA-HTN implementation process
时间窗: Year 3
Use the Consolidated Framework for Implementation Research to guide examination of implementation process through semi-structured in-depth interviews and focus group discussions
IMPLEMENTATION Year 3 - drivers of success/failure
时间窗: Year 3
Use the Consolidated Framework for Implementation Research (CFIR) to describe determinants of success and failure found across implementing districts and facilities through semi-structured in-depth interviews and focus group discussions
Screening EFFECTIVENESS Year 3 - Proportion initiating HTN medication
时间窗: Year 3
Proportion initiating HTN medication
Screening EFFECTIVENESS Year 4 - BP screening coverage
时间窗: Year 4
Proportion of adult patients screened
Screening EFFECTIVENESS Year 5 - BP screening coverage
时间窗: Year 5
Proportion of adult patients screened
Screening EFFECTIVENESS Year 5 - Proportion initiating HTN medication
时间窗: Year 5
Proportion initiating HTN medication
ADOPTION Year 5 - Organizational Readiness for Implementing Change (ORIC)
时间窗: Year 5
Assess the extent to which organizational members are psychologically and behaviorally prepared to implement change (change commitment and change efficacy) using the Likert scale from 1("disagree") to 5 ("strongly agree")
IMPLEMENTATION Year 5 - Determine core elements of the scaled SAIA-HTN implementation process
时间窗: Year 5
Use the Consolidated Framework for Implementation Research to guide examination of implementation process through semi-structured in-depth interviews and focus group discussions
IMPLEMENTATION Year 5 - drivers of success/failure
时间窗: Year 5
Use the Consolidated Framework for Implementation Research (CFIR) to describe determinants of success and failure found across implementing districts and facilities through semi-structured in-depth interviews and focus group discussions
MAINTENANCE Year 4
时间窗: Year 4
Proportion of districts sustaining the intervention as designed 18 and 27 months post introduction for second and first wave of health facilities, respectively
Treatment EFFECTIVENESS Year 4 - HTN control
时间窗: Year 4
proportion of patients with HTN controlled
Treatment EFFECTIVENESS Year 5 - HIV viral load suppression
时间窗: Year 5
proportion of HIV patients with viral load suppression
IMPLEMENTATION Year 4 - Determine core elements of the scaled SAIA-HTN implementation process
时间窗: Year 4
Use the Consolidated Framework for Implementation Research to guide examination of implementation process through semi-structured in-depth interviews and focus group discussions
Treatment EFFECTIVENESS Year 5 - HTN control
时间窗: Year 5
proportion of patients with HTN controlled
ADOPTION Year 4 - districts and facilities
时间窗: Year 4
Proportion of districts and facilities adopting the intervention (target: 95%)
ADOPTION Year 5 - districts and facilities
时间窗: Year 5
Proportion of districts and facilities adopting the intervention (target: 95%)
ESTIMATING AFFORDABILITY AND BUDGET IMPACT Year 4
时间窗: Year 4
Estimate the cost per person screened and treated for HTN
IMPLEMENTATION Year 4 - drivers of success/failure
时间窗: Year 4
Use the Consolidated Framework for Implementation Research (CFIR) to describe determinants of success and failure found across implementing districts and facilities through semi-structured in-depth interviews and focus group discussions
MAINTENANCE Year 3
时间窗: Year 3
Proportion of districts sustaining the intervention as designed 9 months post introduction (first wave of health facilities)
COST ESTIMATION Year 4
时间窗: Year 4
estimate its incremental costs of SCALE SAIA HTN compared to the status quo
ECONOMIC EVALUATION Year 4
时间窗: Year 4
Comparing the total costs of HTN diagnosis and care as a proportion of the HIV care budget and estimate QALYs
ECONOMIC EVALUATION Year 5
时间窗: Year 5
Comparing the total costs of HTN diagnosis and care as a proportion of the HIV care budget and estimate QALYs
次要结局
未报告次要终点