Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania

February 12, 2025 updated by: Dr. Karen Yeates, Kingston Health Sciences Centre

STOP NCDs: Scaling Up Evidence-based Health System Interventions Through the Use of Sustainable Healthcare Financing and Digital TechnOlogy Platforms to Improve Non- Communicable Disease Prevention and Control in Tanzania

The aim of our proposed program is to develop and implement a multilevel, multicomponent and health-financing intervention that will facilitate the scale up of evidence-based strategies to improve non-communicable diseases prevention, detection and control in Tanzania. The investigators will accomplish this by: 1) adapting two intervention components that are candidates for inclusion in a highly effective optimized strategy (called STOP-NCDs) and; (b) Assess their individual and combined effectiveness and 2) conducting a robust, mixed-methods evaluation of the implementation process and assess factors that may influence implementation and sustainability for delivering and scaling the optimized STOP-NCDs strategy. The investigators will select and/or adapt intervention components making up the optimized STOP-NCDs strategy. Using a hybrid clinical-effectiveness implementation design, the investigators will conduct a study in 2 sequential phases: 1) A clinical-effectiveness phase in which the investigators evaluate the effect of our combined strategies (task-sharing and WelTel) versus Usual Care, on rates of systolic BP reduction at 12 months; as well as other secondary outcomes including diagnosis and treatment of diabetes and, patient knowledge of CVD risks and prevention, and, other features of health provider NCD prevention activities. 2) A post-implementation phase in which the investigators use the RE-AIM framework to evaluate changes in the adoption and maintenance of our combined strategies in participating iCHF health facilities across Kilimanjaro region. The investigators will use the WelTel communication and Patient Management platform for to deliver culturally and contextually appropriate evidence-based text messaging to patients. It allows for quality improvement and is a unique tool for our program to scaling low-cost interventions that provide capabilities for tracking of health system service uptake, quality-metrics at health facilities, drug stock-out management, and patient-centered behavioral health interventions. Deployment of WelTel will allow for integration of NCD prevention targeted health services to all adult iCHF members across differing life stages and NCD risk and have a significant impact on increasing quality of care and sustainability of health financing and performance-based incentives through improved prescribing, patient engagement, medication adherence and healthy behaviour change.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1320

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.

Exclusion Criteria:

  • Adults with controlled HTN or those without a diagnosis of HTN
  • Unable or unwilling to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Enhanced Usual Care (EUC)
Enhanced usual care provided by facility MD or equivalent (control group)
Active Comparator: EUC + community support
Enhanced usual care AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring
Other: Community-based peer-support model
Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring
Active Comparator: EUC + nurse-delivered check ins
Enhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS
Other: Nurse-delivered care using WelTel check-ins and BCC SMS
Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS
Active Comparator: EUC + community support + nurse-delivered check ins
Enhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring
Other: Community-based peer-support model
Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring
Other: Nurse-delivered care using WelTel check-ins and BCC SMS
Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic blood pressure
Time Frame: 12 months
Change in systolic blood pressure from baseline to last follow-up visit
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure control
Time Frame: 12 months
Proportion of participants with controlled blood pressure (<140 mm Hg for systolic and <90 mm Hg for diastolic) at the last follow-up visit
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kingston Health Sciences Centre

Collaborators

Muhimbili University of Health and Allied Sciences
Kilimanjaro Clinical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

April 18, 2024

First Submitted That Met QC Criteria

April 18, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 12, 2025

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STOPNCD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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