Clinical trial NCT05002322: Expanding Health Systems Research to Optimize Hypertension Care Cascade in HIV-Infected Individuals in Mozambique
Official title: Scaling Out and Scaling Up the Systems Analysis and Improvement Approach to Optimize the Hypertension Diagnosis and Care Cascade for HIV-infected Individuals
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Keywords: Systems analysis and improvement approach (SAIA),
Hypertension
CFIR
ORIC
Process mapping
Cascade analysis
Continuous quality improvement
Implementation science
Systems engineering
HIV
Lead sponsor: Eduardo Mondlane University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: Instituto Nacional de Saúde, Mozambique
name: Mozambique Institute for Health Education and Research
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2021-08-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: phased-in (stepped wedge) design with random assignment of two districts to each of the three nine-month intervention waves, to reach six districts in Maputo Province by the end of the trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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:

1. To develop a multi-sectoral partnership of key stakeholders and establish HTN technical working groups at the national level and participating provinces;
2. To identify key facilitators and barriers that could affect the adoption, integration, scale-up and sustainment of the SAIA-HTN implementation strategy;
3. 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);
4. 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).
5. 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.

Methods: The investigators will use the SAIA strategy to visualize and quantify interconnected service delivery steps, informed by previous SAIA research, epidemiologic research on HTN, and ongoing SAIA-HTN research to optimize HTN screening, care and treatment for PLHIV in central Mozambique (to evaluate SAIA-HTN's effectiveness on systems' and patient-level health outcomes for PLHIV).

Study Plan: The investigators will use multiple novel implementation science methods to understand and explain what influences implementation outcomes, including i) the CFIR to identify barriers and facilitators (determinants) to implementation, ii) the ORIC scale to assesses readiness for change as an organizational-level determinant of adoption, and iii) the RE-AIM evaluative Framework, which measures the active ingredients for public health impact (Reach, Effectiveness, Adoption, Implementation and Maintenance).

Planning phase: The investigators will mobilize a multi-sectoral stakeholder partnership, conduct a needs assessment (to evaluate facilitators and barriers that could affect adoption, integration, scale-up and sustainment of SCALE SAIA-HTN in the two provinces), and pilot the intervention's feasibility and acceptability over six months in one clinics (to refine implementation procedures for follow-on scaling out and scaling up).Implementation phase: 'scale out' SAIA-HTN to test a novel delivery modality (using district supervisors), 'scale up' to cover six districts in Maputo province, and evaluate its impact on cascade performance and patient outcomes. The investigators will randomly allocate health facilities from the six districts in Maputo Province into three implementation waves, staggered by nine months (27 months total).

The SAIA-HTN implementation strategy uses an iterative, five-step process applied at the facility level to give clinic staff and managers a systems view of cascade performance, identify priority areas for improvement, discern modifiable solutions, and test workflow modifications.

SCALE SAIA-HTN will test integration and scale up of SAIA-HTN through routine management systems relying on district Ministry of Health (MOH) supervisors as the disseminating agents (rather than research nurses), in three facilities per district during a nine-month intensive phase (mentored by study assistants), and subsequent sustainment phase (led independently by district MOH supervisors). Based on trial results, the investigators will model out the costs and potential benefits on HTN management for PLHIV given different scale-up scenarios nationwide. The trial will culminate in the development and dissemination of the SCALE SAIA-HTN package, summarizing trial results and providing implementation and cost guidance to inform policy development and support national scale-up through routine management structures.

Study design: phased-in (stepped wedge) with random assignment of two districts to each of the three nine-month intervention waves, to reach six districts in Maputo Province by the end of the trial.

Study Setting: Maputo Province (population of \>1.5 million inhabitants; \>98% of formal health services offered through public sector clinics). Health facilities with highest numbers of active HIV+ patients on ART will be enrolled.

Study Team: This project brings together a diverse and uniquely qualified team of cardiovascular, HIV, community surveys, health systems, and implementation scientists.

Procedures Stakeholders meetings: to create a multi-sectoral partnership of key stakeholders and establish HTN technical working groups (TWG) at the national level and with participating provinces.

Stakeholder field visits to SAIA-HTN trial in central Mozambique: for key personnel and district MOH supervisors from the pilot facility.

Orientation meetings/workshops: for introducing SCALE SAIA-HTN, the implementation approach, and evaluation design to study investigators, provincial MOH managers, and district MOH supervisors in each province, who will review and agree on study procedures, and clinical and organizational skills-building approaches. Throughout the two phases of the project the TWG will inform on mediators and mechanisms of action, scale-up and sustainment efforts, and ensure responsiveness to local needs; at end of the planning phase, the TWG will review findings, discuss necessary adaptations and refine SCALE SAIA-HTN for the implementation phase.

Standardized readiness assessments: in the six first wave health facilities to assess structural and organizational readiness to deliver HTN services (ORIC measures, staffing levels, attributes and training, availability of essential commodities, equipment and supplies, and infrastructure) and repeated for subsequent waves prior to launching intensive implementation phases.

Pilot study: Outpatient staff managing HIV/CVD care and district MOH supervisors will participate in orientation training for the feasibility and acceptability of the SCALE SAIA-HTN intervention, which will be carried out over six months in one primary care facility. Tools and standard operating procedures will be redesigned as necessary for the implementation phase. Facility-based HTN screening will be carried out by nurses at entry into the pilot facility; all hypertensive (new and existing) patients will be recruited, with the support of district supervisors and study teams. Feasibility and acceptability will include i) measurement of intervention fidelity, reach and exposure, and adoption; ii) knowledge and competency questionnaire to health personnel. Follow-up visits to both monitor and support implementation will be carried out twice in the first month, and monthly thereafter. Additional data will be collected by: focus group discussion (FGD) with key staff to assess acceptability of content and delivery of the intervention; questionnaire to participating staff pre and post-intervention; key informant interviews with the district supervisors, facility managers and frontline staff.

Evaluate programs' Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) Reach: determine the number, proportion/representativeness of individuals reached by interventions; use study reports to estimate the proportion of facilities in the six districts reached by SCALE SAIA-HTN (target: 30%); determine the number and proportion of HIV-infected adults with HTN reached (target: 80%).

Effectiveness: HTN treatment effectiveness (primary effectiveness outcome: HTN control, Secondary outcomes: HIV viral load suppression, proportion of HIV- infected patients screened for HTN in outpatient services, HTN diagnosis, HTN prescription of eligible patients, \>90% patient adherence to HTN treatment).

Adoption: ORIC assessment scale (target of 95%) used to six frontline staff working across the HIV-HTN cascade and facility leadership in each clinic (n=108), and two supervisors (NCD and HIV) from each district (n=12) to describe determinants of adoption.

Implementation: Tools at CFIR website will be adapted to gather data via interviews and FGDs with facility and district staff (qualitative), intervention meeting minutes (qualitative), and annual quantitative questionnaires to quantify facility structural determinants of implementation of HTN management guidelines.

Maintenance. Proportion of districts sustaining the intervention as designed 9, 18 and 27 months post-introduction (target: \>90% at 9 months, \>80% at 18 months, and \>65% at 27 months). In-depth interviews and FGDs to probe district/facility perspectives on determinants of sustainment

Determination of the costs of SCALE SAIA-HTN for care cascade optimization: total incremental and unit costs of integrating HTN diagnosis and management into HIV care. For cost estimation activity-based cost menus will identify start up and recurrent activities, and measure resource use and costs from design through implementation. Cost metrics will include the total incremental costs and average unit costs.

Eligibility criteria: Inclusion Criteria:

* Primary care facility with ongoing cohort of ART patients (minimum 800 patients)

Exclusion Criteria:

* Health facility unaccessible during part of the year

Primary outcomes:
measure: REACH Year 3 - health facilities
timeFrame: Year 3
measure: REACH Year 3 - population
timeFrame: Year 3
measure: REACH Year 4 - health facilities
timeFrame: Year 4
measure: REACH Year 4 - population
timeFrame: Year 4
measure: REACH Year 5 - health facilities
timeFrame: Year 5
measure: REACH Year 5 - population
timeFrame: Year 5
measure: Screening EFFECTIVENESS Year 3 - BP screening coverage
timeFrame: Year 3
measure: Screening EFFECTIVENESS Year 3 - Prevalence
timeFrame: Year 3
measure: Screening EFFECTIVENESS Year 3 - Proportion initiating HTN medication
timeFrame: Year 3
measure: Screening EFFECTIVENESS Year 3 - Proportion maintained on treatment
timeFrame: Year 3
measure: Screening EFFECTIVENESS Year 4 - BP screening coverage
timeFrame: Year 4
measure: Screening EFFECTIVENESS Year 4 - Prevalence of HTN among those screened
timeFrame: Year 4
measure: Screening EFFECTIVENESS Year 4 - Proportion initiating HTN medication
timeFrame: Year 4
measure: Screening EFFECTIVENESS Year 4 - Proportion maintained on treatment
timeFrame: Year 4
measure: Screening EFFECTIVENESS Year 5 - BP screening coverage
timeFrame: Year 5
measure: Screening EFFECTIVENESS Year 5 - Prevalence of HTN among those screened
timeFrame: Year 5
measure: Screening EFFECTIVENESS Year 5 - Proportion initiating HTN medication
timeFrame: Year 5
measure: Screening EFFECTIVENESS Year 5 - Proportion maintained on treatment
timeFrame: Year 5
measure: Treatment EFFECTIVENESS Year 3 - HTN control
timeFrame: Year 3
measure: Treatment EFFECTIVENESS Year 3 - HIV viral load suppression
timeFrame: Year 3
measure: Treatment EFFECTIVENESS Year 4 - HTN control
timeFrame: Year 4
measure: Treatment EFFECTIVENESS Year 4 - HIV viral load suppression
timeFrame: Year 4
measure: Treatment EFFECTIVENESS Year 5 - HTN control
timeFrame: Year 5
measure: Treatment EFFECTIVENESS Year 5 - HIV viral load suppression
timeFrame: Year 5
measure: ADOPTION Year 4 - districts and facilities
timeFrame: Year 4
measure: ADOPTION Year 4 - Organizational Readiness for Implementing Change (ORIC)
timeFrame: Year 4
measure: ADOPTION Year 5 - districts and facilities
timeFrame: Year 5
measure: ADOPTION Year 5 - Organizational Readiness for Implementing Change (ORIC)
timeFrame: Year 5
measure: IMPLEMENTATION Year 3 - Determine core elements of the scaled SAIA-HTN implementation process
timeFrame: Year 3
measure: IMPLEMENTATION Year 3 - drivers of success/failure
timeFrame: Year 3
measure: IMPLEMENTATION Year 4 - Determine core elements of the scaled SAIA-HTN implementation process
timeFrame: Year 4
measure: IMPLEMENTATION Year 4 - drivers of success/failure
timeFrame: Year 4
measure: IMPLEMENTATION Year 5 - Determine core elements of the scaled SAIA-HTN implementation process
timeFrame: Year 5
measure: IMPLEMENTATION Year 5 - drivers of success/failure
timeFrame: Year 5
measure: MAINTENANCE Year 3
timeFrame: Year 3
measure: MAINTENANCE Year 4
timeFrame: Year 4
measure: MAINTENANCE Year 5
timeFrame: Year 5
measure: COST ESTIMATION Year 4
timeFrame: Year 4
measure: COST ESTIMATION Year 5
timeFrame: Year 5
measure: ESTIMATING AFFORDABILITY AND BUDGET IMPACT Year 4
timeFrame: Year 4
measure: ESTIMATING AFFORDABILITY AND BUDGET IMPACT Year 5
timeFrame: Year5
measure: ECONOMIC EVALUATION Year 4
timeFrame: Year 4
measure: ECONOMIC EVALUATION Year 5
timeFrame: Year 5
Secondary outcomes:
Other outcomes:
Locations:
city: Bela Vista
country: Mozambique
facility: Centro de Saude da Ponta do Ouro
state: Maputo
city: Bela Vista
country: Mozambique
facility: Centro de Saude de Matutuine
state: Maputo
city: Bela Vista
country: Mozambique
facility: Centro de Saude de Salamanga
state: Maputo
city: Magude
country: Mozambique
facility: Centro de Saúde de Magude
state: Maputo
city: Magude
country: Mozambique
facility: Centro de Saúde de Motaze
state: Maputo
city: Magude
country: Mozambique
facility: Centro de Saúde de Chichuco
Study officials:
affiliation: Eduardo Mondlane University
name: Ana OH Mocumbi, MD PhD
role: PRINCIPAL_INVESTIGATOR
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