Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608069
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Pharmacist-Led Intervention to Improve TB Treatment and Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis and Human Immunodeficiency Virus Co-Infected Patients A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RA-15041995
Brief Summary:
The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group
The main questionsit aims to answer are
How will pharmacist-led interventions improve the medication adherence level of TB and HIV con-infected patients
Has there been an increase in the adherence level of co-infected patients following pharmacist-led interventions
Participants will be interviewed to measure the level of adherence
If there is a comparison group
Enrolled patient will be counselled and educated by pharmacist on the therapy and benefits of adherence Control group
Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence Patients will be reminded to take the medication through SMS every day by the pharmacist Experimental group
The main questionsit aims to answer are
How will pharmacist-led interventions improve the medication adherence level of TB and HIV con-infected patients
Has there been an increase in the adherence level of co-infected patients following pharmacist-led interventions
Participants will be interviewed to measure the level of adherence
If there is a comparison group
Enrolled patient will be counselled and educated by pharmacist on the therapy and benefits of adherence Control group
Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence Patients will be reminded to take the medication through SMS every day by the pharmacist Experimental group
Detailed Description:
In 2019 tuberculosis TB remained the leading cause of death due to a single infectious pathogen An estimated 10 million people had TB worldwide with 12 million TB fatalities among Human immune deficiency virus HIV-negative people and 208 000 deaths among HIV-positive people Literature indicated that treatment adherence for coinfections diseases is difficult due to the complexity low tolerability and extended duration of current treatment regimens especially for both drug-susceptible and drug-resistant TB There is a need for continuing the quest for low-cost reliable and acceptable measures of adherence for the treatment of TB and HIV co-infection A qualitative approach and pharmacist-led intervention are needed to improve the adherence level of medication for TB patients The study is aimed to investigate the degree of adherence and evaluate its impacts on clinical outcomes in TB and HIV co-infected patients To determine the uptake and usage of the intervention the study will include nested qualitative and economic evaluation sub-studies as well as a process evaluation A longitudinal study design will adopt to carry out the present study involving TB and HIV co-infected patients in either the pharmacist-led intervention adherence and medication reminder follow-up reminders and counselling or control arm To determine the uptake and usage of the intervention the study will include theoretical and conceptual models and theories The study will conclude with targeted efforts of Pharmacist led intervention to improve and sustain excellent adherence in the real-world clinical setting which is critical for maximizing the effectiveness of each medication and treatment These innovative technologies can thereby be harnessed to improve adherence to TB and HIV regimens in Malaysia and worldwide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None