Ignite Creation Date:
2025-12-24 @ 1:00 PM
Ignite Modification Date:
2025-12-27 @ 10:02 PM
Study NCT ID:
NCT04624061
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2020-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Leveraging the HIV Platform for Hypertension Control in Uganda (INTEGRATED HIV/HTN) STUDY
Sponsor:
Infectious Diseases Research Collaboration, Uganda
Organization:
Study Overview
Official Title:
Leveraging the HIV Platform for Hypertension Control in Uganda
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The INTEGRATED HIV/HTN is a hybrid type-1 effectiveness/implementation cluster randomised trial evaluating the introduction of a multi-component integrated HIV/HTN care model intervention, randomised to 13 districts in the intervention arm compared to 13 districts in the control. Selected health facilities within the 13 intervention districts will receive the intervention while those in the 13 control districts will continue implementing the standard of care as per the Ministry of Health (MoH) guidelines. All the participating facilities will receive blood pressure (BP) machines, and Non- communicable diseases (NCDs) registers as a standard of care.
Detailed Description:
The investigators propose to evaluate a multi-component integrated HIV/HTN care intervention through a cluster randomised controlled trial. A cluster has been defined at the level of the district which is the randomisation unit. A total of 26 districts will be randomised. Selected health facilities within the 13 intervention districts will receive the multi-component intervention of combined HIV and (hypertension) HTN care which includes; 1) Training and capacity building on the INTEGRATED HIV/HTN model and NCD care; 2) the Integrated HIV/HTN care delivery model by promoting HTN screening and care in HIV clinics; 3) Health management information system (HMIS) enhancements through mentorship and coaching on the use of NCD registers and NCD patient cards and HTN data capture in the EMR system; and 4) Short messaging system (SMS) and/or WhatsApp for data coordination and communication among providers, DHOs and the study team (who acts as mentors). The 13 control districts will continue implementing the current standard of care as per MoH guidelines.
The investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.
Specific Objectives are as follows;
1. To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
2. To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
3. To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.
The investigators will test the hypothesis that a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities.
Specific Objectives are as follows;
1. To determine the effectiveness of an integrated HIV/HTN care model on HTN and dual HIV/HTN control among adult patients in HIV clinics.
2. To assess the barriers and facilitators of the integrated HIV/HTN care model for HIV patients at different levels.
3. To determine the cost, cost-effectiveness and incremental gain costs of the integrated HIV/Hypertension care model approach.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 22196 | OTHER | London School of Hygiene and Tropical Medicine | View |