Ignite Creation Date:
2024-05-06 @ 3:25 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04624061
Status:
UNKNOWN
Last Update Posted:
2022-11-04
First Post:
2020-10-27
Brief Title:
Leveraging the HIV Platform for Hypertension Control in Uganda INTEGRATED HIVHTN STUDY
Sponsor:
Infectious Diseases Research Collaboration Uganda
Organization:
Infectious Diseases Research Collaboration Uganda
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 HIVHTN is a hybrid type-1 effectivenessimplementation cluster randomised trial evaluating the introduction of a multi-component integrated HIVHTN 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 HIVHTN 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 HIVHTN model and NCD care 2 the Integrated HIVHTN 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 andor 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 HIVHTN 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 HIVHTN care model on HTN and dual HIVHTN control among adult patients in HIV clinics
2 To assess the barriers and facilitators of the integrated HIVHTN care model for HIV patients at different levels
3 To determine the cost cost-effectiveness and incremental gain costs of the integrated HIVHypertension 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 HIVHTN 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 HIVHTN care model on HTN and dual HIVHTN control among adult patients in HIV clinics
2 To assess the barriers and facilitators of the integrated HIVHTN care model for HIV patients at different levels
3 To determine the cost cost-effectiveness and incremental gain costs of the integrated HIVHypertension care model approach
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22196 | OTHER | London School of Hygiene and Tropical Medicine | None |