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Table 1 Hypertension Treatment in Nigeria Program implementation package

From: Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial

Component

Start date

Number of sites

Level of intervention

Description as used in the HTN Program

Evaluation

Hypertension Patient Registry and Empanelment

January 2020

60

Health System

Paper-based registration and case report forms facilitate site-based tracking and follow-up of patients, aligns with existing practices for health record management, and are easy to implement.

The electronic database facilitates rapid roll up of information in a structured database with built-in quality assurance checks.

Supportive supervision visits include comparison of the site visit logs and the hypertension registry to evaluate completeness of the registry.

Bi-weekly data and safety quality reports are generated to review electronic data.

Central and on-site training and reinforcement are provided, including the latter during site supervision visits to register all adult hypertensive patients.

Performance and Quality Reporting

December 2020

60

Health Clinic

Monthly performance and quality reports are issued to each participating site to summarize key metrics, aggregated over a rolling 3-month period.

Metrics include treatment, control, and retention rates, along with lists of patients for targeted follow-up.

Comparisons are made with other sites in the HTN Program.

Data quality audits are conducted during supportive supervision visits to compare data between the paper and electronic case report forms, and correct errant data points.

Study team members communicate with sites on a quarterly basis to follow up on performance reports and ascertain if the site has reviewed and understood the report. In interim and final qualitative evaluations, sites will be asked for their feedback on the performance reports.

Simplified Treatment Guideline

December 2020

60

National Policy

A four-step simplified treatment guideline was enacted in the 2019 Nigeria Hypertension Protocol.

Medications data collected in the registry are used to calculate adherence to the four-step protocol by site, and across the program.

In interim and final qualitative evaluations, sites will be asked for their feedback on the treatment guideline (appropriateness, feasibility, and adaptation).

Fixed-dose combination

December 2020

60

Health System

Fixed-dose combinations are encouraged in the hypertension treatment guideline when available.

Medications data collected in the registry are used to evaluate administration of fixed-dose or single pill prescriptions by site, and across the program.

In interim and final qualitative evaluations, site will be asked for their feedback on fixed-dose combinations (appropriateness, feasibility, and adaptation).

Access to Essential Medicines and Technology

December 2020

60

Health System

Initial hypertension drug supplies were provided to all participating sites to prime the Drug Revolving Fund. During the first year of the intervention phase, work was completed to enact agreements for provision of hypertension medications at reasonable cost. The study team developed protocols, strategies, and training for adding hypertension medications to the Drug Revolving Fund.

Implementation of the Drug Revolving Fund will be evaluated in a separate protocol through RE-AIM outcomes.

Early access to medicines in the study is evaluated through treatment rates, as well as stockout and replenishment rates at the participating sites.

Team-Based Care and Community Health Extension Worker Provided Hypertension Management

December 2020

60

Health Worker

Frontline workers (CHEWs, CHOs, pharmacists) have been trained during the control and intervention phase on components of the intervention package. A multidisciplinary team is involved in providing hypertension services in the participating health clinics.

Implementation of team-based care is evaluated through site supervision visits and provider reported experience.

Health Coaching and Home BP Monitoring

September 2022

10

Patient

CHEWs will lead a home-based blood pressure monitoring and health coaching (using motivational interviewing approach) intervention.

Implementation and effectiveness of the home blood pressure monitoring arm will be evaluated through a separate protocol including evaluation of blood pressures and pre- and post-intervention questionnaires.

  1. Abbreviations: CHEW Community health extension worker, CHO Community health officer, HTN Hypertension Treatment in Nigeria