Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996081
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-16
First Post:
2023-07-21
Brief Title:
Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia
Sponsor:
University of Groningen
Organization:
University of Groningen
Study Overview
Official Title:
A Practical Adherence Toolkit for Managing Nonadherence to HIV Medications in Indonesia Protocol for a Usability Study and Cluster Randomised Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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 goal of this usability study and a cluster randomised controlled trial is to investigate the effectiveness of an adherence toolkit as a decision support tool to improve adherence to antiretroviral therapy The main questions it aims to answer are 1 is the adherence toolkit useable and acceptable among HIV care providers in Indonesian clinical practice and 2 is the adherence toolkit superior than the usual care in improving adherence to antiretroviral therapy among people living with HIV in Indonesia HIV clinics in Surabaya Indonesia will be recruited to participate in the study HIV care providers will be included in the usability study whereas people living with HIV will be enrolled in the cluster randomised controlled trial People living with HIV will be randomly assigned in a 11 ratio to the control group receiving usual HIV care and the intervention group receiving an intervention using the adherence toolkit in addition to usual HIV care
Detailed Description:
Consistent adherence to antiretroviral therapy ART is important to maintain viral suppression and good quality of life among people living with HIV However maintaining a high level of ART adherence is challenging because adherence is a complex behaviour and many factors contribute to nonadherence Therefore a decision support tool is proposed to help HIV care providers in addressing the barriers and providing the adherence-promoting interventions tailored to the individual needs The present study comprises a usability assessment followed by a cluster randomised controlled trial to investigate the effectiveness of the adherence toolkit as a decision support tool on improving adherence to ART Twelve HIV clinics in Surabaya Indonesia will be randomised 11 to the control usual care and intervention adherence toolkit and usual care group The intervention period will last for 12 months with outcome measures will be collected at initiation 3- 6- and 12-month post-initiation The primary outcome is adherence to ART measured using a self-reported adherence questionnaire and pharmacy refill records The secondary outcomes include clinical outcomes viral load CD4 HIV treatment knowledge medication beliefs and health-related quality of life The findings will enable HIV care providers people living with HIV and policy makers to make informed decision about the value of the adherence toolkit for being used in daily clinical practice
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