NCT06379750

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,320

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
23mo left

Started Apr 2025

Typical duration for not_applicable hypertension

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Apr 2025Mar 2028

First Submitted

Initial submission to the registry

April 18, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

February 14, 2025

Status Verified

May 1, 2024

Enrollment Period

1.9 years

First QC Date

April 18, 2024

Last Update Submit

February 12, 2025

Conditions

Keywords

hypertensiondiabetesNCD managementNCD preventionmHealthhealthcare financing

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure

    Change in systolic blood pressure from baseline to last follow-up visit

    12 months

Secondary Outcomes (1)

  • Blood pressure control

    12 months

Study Arms (4)

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

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

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

Other: Nurse-delivered care using WelTel check-ins and BCC SMSOther: Community-based peer-support model

Interventions

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 insEUC + nurse-delivered check ins

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

EUC + community supportEUC + community support + nurse-delivered check ins

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

HypertensionDiabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 18, 2024

First Posted

April 23, 2024

Study Start

April 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

February 14, 2025

Record last verified: 2024-05