Pharmacist-Led Intervention to Improve TB Treatment Adherence (RA-15041995)

Universiti Sains Malaysia

Status: Completed

Conditions: HIV Coinfection; Tuberculosis, Pulmonary

Treatments: Behavioral: Educational counselling

Study type: Interventional

Funder types: Other

Identifiers

NCT06608069

NMRR ID-22-01964-WWH

Details and patient eligibility

About

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).

Full 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.

Enrollment: 383 patients

Sex: All

Ages: 19 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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383 participants in 2 patient groups

Educational councelling and Reminder.

Experimental group

Description:

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

Treatment:

Behavioral: Educational counselling

DOTS therapy

No Intervention group

Description:

Enrolled patient will be given the DOT therapy for TB.