Clinical trial NCT06608069: Pharmacist-Led Intervention to Improve TB Treatment and Outcomes
Official title: Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tuberculosis, Pulmonary
HIV Coinfection
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2024-09-23
Enrollment: 383
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group

The main question\[s\]it 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).
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group

The main question\[s\]it aims to answer are:

1. To evaluate the impact of pharmacist-led educational intervention on treatment adherence among patients with PTB using the health belief model theory and MARS-5.
2. To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
3. To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.

Participants will be interviewed to measure the level of adherence.

If there is a comparison group:

The enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (Control group).

Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (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 1.2 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.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 years or more.
* Newly bacteriologically confirmed TB case.

Exclusion Criteria:

* Pregnancy and any medical condition unrelated to TB

Primary outcomes:
measure: Level of adherence among PTB patients.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: George Town
country: Malaysia
facility: Universiti Sains Malaysia
Study officials:
affiliation: Universiti Sains Malaysia
name: Aner H Khan
role: PRINCIPAL_INVESTIGATOR
References: