Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini

Strengthening Primary Healthcare Delivery for Diabetes and Hypertension in Eswatini: A Cluster-randomized Trial

The WHO-PEN@Scale project is a three-arm cluster-randomized trial that is investigating the population-level effects of a healthcare reform in Eswatini, which aims to strengthen primary care for diabetes and hypertension. Prior to the reform, healthcare for diabetes and hypertension was mostly provided through physician-led teams in hospital outpatient departments. The healthcare reform aims to strengthen the provision of nurse-led care for diabetes and hypertension in primary healthcare facilities and community health worker-led care for these conditions in the facilities' catchment areas. The reform will broadly be guided by the World Health Organization's "Package of Essential Noncommunicable Disease Interventions for Primary Health Care in Low-Resource Settings" (WHO-PEN). The trial will take place at 84 clusters (a primary healthcare facility and its catchment area) across the country.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes Mellitus
• Intervention / Treatment: Other: DSD; Other: CDP

• Study Type: Interventional
• Enrollment (Actual): 3500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Swaziland
  • Mbabane, Swaziland
    • Clinton Health Access Initiative

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion criteria for the outcome assessment (household survey):

• Residing in one of the selected households
• Age ≥40 years

Exclusion criteria for the outcome assessment (household survey):

• Pregnant
• Inability to provide written informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Health services for diabetes and hypertension are provided as was the standard of care prior to the healthcare reform after the emergency decentralization motivated by the COVID-19 outbreak. Healthcare for diabetes and hypertension for complicated cases is provided through physician-led teams at hospitals and health centers. Healthcare for diabetes and hypertension for uncomplicated cases is provided at primary care clinics through nurses.
Experimental: DSD; Clients are invited to participate in one of three Differentiated Service Delivery models tailored to their needs.	Other: DSD; This intervention consist of three Differentiated Service Delivery Models in which stable clients can be enrolled. The fast-track model gives preferential treatment to enrolled clients. Clients arrive at clinics, usually early in the morning, and can see the nurse as well as collect their medication without queuing. This model mainly targets the working population. The facility-based treatment clubs consist of bimonthly meetings where clients meet in groups of approximately 20 members. They receive health counselling, risk factor screening and medication prescription. This model mainly targets clients living close to the facility. The community advisory groups consist of groups of up to six clients. Groups are equipped with a point of care blood pressure and blood glucose measurement devices. They take turns in collecting the medication for the entire group and meet on a monthly basis. This model targets clients in hard-to-reach areas.
Experimental: CDP; Health services for diabetes and hypertension are provided in the scope of outreach activities set up on a monthly basis in communities.	Other: CDP; Community Distribution Points are set up on a monthly basis in communities linked to the clinic. Healthcare staff sets up a temporary point of contact where clients can obtain screening for diabetes and hypertension, health counselling, referral to primary or tertiary facilities, and medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control (continuous) among adults with diabetes	Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes	12 months
Systolic blood pressure among adults with hypertension	Mean systolic blood pressure among adults aged 40 years and older with hypertension	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c among adults with diabetes or prediabetes	Mean glycated haemoglobin (HbA1c) among adults aged 40 years and older with diabetes or prediabetes	12 months
Glycemic control (binary) among adults with diabetes	The proportion of adults aged 40 years and older with diabetes who have an HbA1c less than 7.0%	12 months
Glycemic control (binary) among adults with diabetes or prediabetes	The proportion of adults aged 40 years and older with diabetes or prediabetes who have an HbA1c less than 7.0%	12 months
Awareness of one's diabetes diagnosis	The proportion of adults aged 40 years and older with diabetes who report to have been diagnosed with diabetes prior to the household survey	12 months
Awareness of one's diabetes or prediabetes diagnosis	The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have been diagnosed with diabetes or prediabetes prior to the household survey	12 months
Probability of being treated for diabetes among adults with diabetes	The proportion of adults aged 40 years and older with diabetes who report to be taking medication for their diabetes	12 months
Probability of having been tested for diabetes among adults with diabetes	The proportion of adults aged 40 years and older with diabetes who report to have ever been tested for diabetes	12 months
Probability of having been tested for diabetes among adults with diabetes or prediabetes	The proportion of adults aged 40 years and older with diabetes or prediabetes who report to have ever been tested for diabetes	12 months
Probability of smoking among adults with diabetes, prediabetes, or hypertension	The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to be a current smoker	12 months
Time spent doing moderate- or vigorous-intensity exercise among adults with diabetes, prediabetes, or hypertension	The mean number of minutes in a typical week spent doing moderate- or vigorous-intensity exercise among adults aged 40 years and older with diabetes	12 months
Systolic blood pressure among adults with diabetes	Mean systolic blood pressure among adults aged 40 years and older with diabetes	12 months
Systolic blood pressure among adults with diabetes or prediabetes	Mean systolic blood pressure among adults aged 40 years and older with diabetes or prediabetes	12 months
Diastolic blood pressure among adults with diabetes	Mean diastolic blood pressure among adults aged 40 years and older with diabetes	12 months
Diastolic blood pressure among adults with diabetes or prediabetes	Mean diastolic blood pressure among adults aged 40 years and older with diabetes or prediabetes	12 months
Hypertension control (binary) among adults with hypertension	The proportion of adults aged 40 years and older with hypertension who have a systolic blood pressure <140 mm Hg and a diastolic blood pressure <90 mm Hg	12 months
Diastolic blood pressure among adults with hypertension	Mean diastolic blood pressure among adults aged 40 years and older with hypertension	12 months
Awareness of one's hypertension diagnosis	The proportion of adults aged 40 years and older with hypertension who report to have been diagnosed with hypertension prior to the household survey	12 months
Probability of being treated for hypertension among adults with hypertension	The proportion of adults aged 40 years and older with hypertension who report to be taking blood-pressure-lowering medication	12 months
Probability of having been tested for hypertension among adults with hypertension	The proportion of adults aged 40 years and older with hypertension who report to have ever had their blood pressure measured	12 months
Frequency of drinking alcohol in the past 12 months among adults with diabetes, prediabetes, or hypertension	The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who report to having drunk daily, 5-6 days per week, 3-4 days per week, 1-2 days per week, 1-3 days per month, less than once a month, or never over the past 12 months.	12 months
21. Knowledge on diabetes and hypertension among adults with diabetes, prediabetes, or hypertension	The proportion of adults aged 40 years and older with diabetes, prediabetes, or hypertension who correctly responded to each individual question on diabetes and hypertension related knowledge.	12 months

Collaborators and Investigators

• Sponsor: University Hospital Heidelberg
• Collaborators: Amsterdam Institute for Global Health and Development; Swiss Tropical & Public Health Institute; University of Göttingen; Clinton Health Access Initiative, Eswatini; University of Eswatini; SWABCHA, Eswatini; Diabetes Swaziland
• Investigators: Principal Investigator: Pascal Geldsetzer, MD ScD MPH, Stanford University; Principal Investigator: Jan-Walter De Neve, MD ScD MPH, Heidelberg Institute of Global Health, Heidelberg University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 5, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 27, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Hypertension; Diabetes Mellitus; Cost-effectiveness; Comorbidity; Mixed methods; Community Health Worker; Implementation research; Swaziland; WHO-PEN; Health service decentralization; Eswatini; Scale-up; Non-Communicable Disease; Cardiovascular disease risk factors
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Hypertension; Diabetes Mellitus
• Other Study ID Numbers: WHO-PEN@Scale

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: No detailed IPD sharing plan has been developed yet.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No