Hypertension Treatment in Nigeria (HTN) Program Rationale and Design for a Type 2 Hybrid, Effectiveness, and Implementation Interrupted Time Series Trial

Abstract

Background Hypertension is the most common cardiovascular disease in Nigeria and contributes to a large non-communicable disease burden. Our aim was to implement and evaluate a large-scale hypertension treatment and control program, adapted from the Kaiser Permanent Northern California and World Health Organization HEARTS models, within public primary healthcare centers in the Federal Capital Territory, Nigeria. Methods A type 2 hybrid, interrupted time series design was used to generate novel information on large-scale implementation and effectiveness of a multi-level hypertension control program within 60 primary healthcare centers in the Federal Capital Territory, Nigeria. During the formative phase, baseline qualitative assessments were held with patients, health workers, and administrators to inform implementation package adaptation. The package includes a hypertension patient registry with empanelment, performance and quality reporting, simplified treatment guideline emphasizing fixed-dose combination therapy, reliable access to quality essential medicines and technology, team-based care, and health coaching and home blood pressure monitoring . Strategies to implement and adapt the package were identified based on barriers and facilitators mapped in the formative phase, previous implementation experience, mid-term qualitative evaluation, and ongoing stakeholder and site feedback. The control phase included 11 months of sequential registration of hypertensive patients at participating primary healthcare centers, followed by implementation of the remainder of the package components and evaluation over 37 subsequent, consecutive months of the intervention phase. The formative phase was completed between April 2019 to August 2019, followed by initiation of the control phase in January 2020. The control phase included 11 months (January 2020 to November 2020) of sequential registration and empanelment of hypertensive patients at participating primary healthcare centers. After completion of the control phase in November 2020, the intervention phase commenced in December 2020 and will be completed in December 2023. Discussion This trial will provide robust evidence for implementation and effectiveness of a multi-level implementation package more broadly throughout the Federal Capital Territory, which may inform hypertension systems of care throughout Nigeria and in other low- and middle-income countries. Implementation outcome results will be important to understand what system-, site-, personnel-, and patient-level factors are necessary for successful implementation of this intervention. Trial RegistrationThe trial was prospectively registered at www.clinicaltrials.gov under NCT04158154 on November 8, 2019; https://clinicaltrials.gov/ct2/show/NCT04158154.

Fixed‐dose combination therapy‐based protocol compared with free pill combination protocol: Results of a cluster randomized trial

“…PHCs with at least two full-time staff within the Federal Capital Territory, Nigeria, that were accessible to the study team by road and in all seasons, were functional (i.e., defined as open at least between the hours of 8 am to 4 pm and providing the minimum service package for primary healthcare centers), and were willing to participate were randomly selected through a multi-stage sampling frame. 18 To capitalize upon the availability of quality BP-lowering medicines and single pill combinations that are aligned with Nigeria's National Hypertension Treatment protocol, the study team embedded a pragmatic cluster-randomized trial to evaluate the effectiveness and safety of FDC therapy (Protocol 2) on hypertension control compared with the free pill combination (Protocol 1) over a 6-month follow-up period (Table S1). All 60 PHCs in the HTN Program were invited, and all agreed to participate as a cluster in this trial.…”

“…This trial was embedded within the Hypertension Treatment in Nigeria (HTN) Program, a prospective, longitudinal type 2 hybrid study design to evaluate implementation and effectiveness of a multi‐level, evidence‐based implementation package in 60 public PHCs using an interrupted time series design 17,18 . The HTN Program was initiated in January 2020.…”

“…This trial was embedded within the Hypertension Treatment in Nigeria (HTN) Program, a prospective, longitudinal type 2 hybrid study design to evaluate implementation and effectiveness of a multi-level, evidence-based implementation package in 60 public PHCs using an interrupted time series design. 17,18 The HTN Program was initiated in January 2020. PHCs with at least two full-time staff within the Federal Capital Territory, Nigeria, that were accessible to the study team by road and in all seasons, were functional (i.e., defined as open at least between the hours of 8 am to 4 pm and providing the minimum service package for primary healthcare centers), and were willing to participate were randomly selected through a multi-stage sampling frame.…”

“…Women who were pregnant were registered and were then referred for specialist care in accordance with Nigeria's National Hypertension Treatment protocol. Further details about the study population have been reported 17,18 …”

Integrating Community-Based Health Information System with a Patient-Centered Medical Home to Improve Care of Patients with Hypertension: A Longitudinal Observational Study Protocol

“…We will use the RE-AIM framework to evaluate the effectiveness of this integrated model on HTN management at the patient and community levels. RE-AIM's five domains (Reach, Effectiveness, Adoption, Implementation, and Maintenance) have been used in various settings to evaluate the impact of both clinical and community-based interventions, including the management of disease-focused interventions (31)(32)(33). Both quantitative and qualitative data will be collected to help with the monitoring and evaluation of the program.…”