HypertensionNCT06379750
Using Healthcare Financing and Digital Technology to Improve Hypertension Prevention and Control in Tanzania
A study testing Nurse-delivered care using WelTel check-ins and BCC SMS and Community-based peer-support model in people with Hypertension and Diabetes, run by Dr. Karen Yeates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Hypertension, Diabetes
- What is being tested?
- Nurse-delivered care using WelTel check-ins and BCC SMS and Community-based peer-support model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,320 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.
Who cannot join
- Adults with controlled HTN or those without a diagnosis of HTN
- Unable or unwilling to provide informed consent
About this study
Official title: 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.
- Conditions
- Hypertension, Diabetes
- Being tested
- Nurse-delivered care using WelTel check-ins and BCC SMS, Community-based peer-support model
- Keywords
- hypertension, diabetes, NCD management, NCD prevention, mHealth, healthcare financing
- Medical subject headings
- Hypertension, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-delivered care using WelTel check-ins and BCC SMSOther
Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS
Community-based peer-support modelOther
Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | No intervention | Enhanced usual care provided by facility MD or equivalent (control group) |
| EUC + community support | Active comparator | Enhanced usual care AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring Receives: Other: Community-based peer-support model |
| EUC + nurse-delivered check ins | Active comparator | Enhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS Receives: Other: Nurse-delivered care using WelTel check-ins and BCC SMS |
| EUC + community support + nurse-delivered check ins | Active comparator | 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 Receives: Other: Nurse-delivered care using WelTel check-ins and BCC SMS; Other: Community-based peer-support model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Change in systolic blood pressure from baseline to last follow-up visit
Measured: 12 months
Secondary outcomes (1)
Blood pressure control
Proportion of participants with controlled blood pressure (<140 mm Hg for systolic and <90 mm Hg for diastolic) at the last follow-up visit
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Oct 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 1,320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Karen Yeates
- Sponsor type
- University, hospital or other
- Collaborators
- Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor-investigator, Dr. Karen Yeates, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379750
- Sponsor's protocol ID
- STOPNCD
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06379750
- Acronym / sponsor ID
- STOPNCD
- Conditions
- Hypertension, Diabetes
- Keywords
- hypertension, diabetes, NCD management, NCD prevention, mHealth, healthcare financing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,320 participants (estimated)
- Lead sponsor
- Dr. Karen YeatesUniversity, hospital or other
- Collaborators
- Kilimanjaro Clinical Research Institute, Muhimbili University of Health and Allied Sciences
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | No intervention | –Enhanced usual care provided by facility MD or equivalent (control group) |
| EUC + community support | Active comparator | Other: Community-based peer-support modelEnhanced usual care AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring |
| EUC + nurse-delivered check ins | Active comparator | Other: Nurse-delivered care using WelTel check-ins and BCC SMSEnhanced usual care AND nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management using WelTel check-ins and BCC SMS |
| EUC + community support + nurse-delivered check ins | Active comparator | Other: Nurse-delivered care using WelTel check-ins and BCC SMS, Other: Community-based peer-support modelEnhanced 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 |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adults with uncontrolled HTN who receive care through iCHF membership and are able to provide informed consent.
Key exclusion criteria (2 listed)
- Adults with controlled HTN or those without a diagnosis of HTN
- Unable or unwilling to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-delivered care using WelTel check-ins and BCC SMSNurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS | Other | EUC + community support + nurse-delivered check ins, EUC + nurse-delivered check ins |
| Community-based peer-support modelCommunity-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring | Other | EUC + community support, EUC + community support + nurse-delivered check ins |
Primary outcome
Systolic blood pressure
Time frame: 12 months
Change in systolic blood pressure from baseline to last follow-up visit
1 secondary outcome
Blood pressure control
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-delivered care using WelTel check-ins and BCC SMS and Community-based peer-support model in people with Hypertension and Diabetes, run by Dr. Karen Yeates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.