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

NCT ID: NCT06379750

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2028-03-01

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Enhanced Usual Care (EUC)

Enhanced usual care provided by facility MD or equivalent (control group)

Group Type: NO_INTERVENTION

No interventions assigned to this group

EUC + community support

Enhanced usual care AND community-based peer-support model using WelTel check-ins and BCC SMS and facilitated group self monitoring

Group Type: ACTIVE_COMPARATOR

Community-based peer-support model

Intervention Type: OTHER

Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring

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

Group Type: ACTIVE_COMPARATOR

Nurse-delivered care using WelTel check-ins and BCC SMS

Intervention Type: OTHER

Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS

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

Group Type: ACTIVE_COMPARATOR

Nurse-delivered care using WelTel check-ins and BCC SMS

Intervention Type: OTHER

Nurse-delivered HTN, DM and CVD risk assessment, diagnosis and Management (through NIMONCD) using WelTel check-ins and BCC SMS

Community-based peer-support model

Intervention Type: OTHER

Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring

Interventions

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

Intervention Type: OTHER

Community-based peer-support model

Community-based peer- support model using Weltel check-ins and BCC SMS and facilitated group self monitoring

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kilimanjaro Clinical Research Institute

OTHER

Sponsor Role: collaborator

Muhimbili University of Health and Allied Sciences

OTHER

Sponsor Role: collaborator

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Karen Yeates

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

STOPNCD

Identifier Type: -

Identifier Source: org_study_id