Tuberculosis, PulmonaryRA-15041995NCT06608069
Pharmacist-Led Intervention to Improve TB Treatment Adherence
A study testing Educational counselling in people with Tuberculosis, Pulmonary and HIV Coinfection, run by Universiti Sains Malaysia at 2 sites in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis, Pulmonary, HIV Coinfection
- What is being tested?
- Educational counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 383 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Sep 2023to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years or more.
- Newly bacteriologically confirmed TB case.
Who cannot join
- Pregnancy and any medical condition unrelated to TB
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Hospital Pulau Pinang
George Town, 11800
Universiti Sains Malaysia
George Town, 11800
About this study
Official title: Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial
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:
Read more
- 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.
- To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
- 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).
Read the 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.
- Conditions
- Tuberculosis, Pulmonary, HIV Coinfection
- Being tested
- Educational counselling
- Medical subject headings
- Tuberculosis, Pulmonary, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational counsellingBehavioural
Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence.
| Study group | Role | What they receive |
|---|---|---|
| Educational councelling and Reminder. | Experimental | Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. Receives: Behavioral: Educational counselling |
| DOTS therapy | No intervention | Enrolled patient will be given the DOT therapy for TB. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of adherence among PTB patients.
The patient's level of adherence will be checked using the Health Belief Model Questionnaire and the MARS-5 adherence scale, as well as the patient's interview. The MARS-5 scores will indicate if a patient is adherent or not. Scores are calculated as, Score individual items (5 = never to 1 = always) i.e. high scores = high adherence.
Add the individual scores to form a scale score (range = 5 to 25).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- None (open label)
- Enrolment
- 383 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMER HAYAT KHAN, Universiti Sains Malaysia
- Investigators
- Aner H Khan, Principal investigator, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608069
- Sponsor's protocol ID
- NMRR ID-22-01964-WWH
- Acronym
- RA-15041995
- Status last verified
- Oct 2024
- First submitted
- 3 Sep 2024
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06608069
- Acronym / sponsor ID
- RA-15041995 / NMRR ID-22-01964-WWH
- Conditions
- Tuberculosis, Pulmonary, HIV Coinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 383 participants (actual)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Educational councelling and Reminder. | Experimental | Behavioral: Educational counsellingEnrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. |
| DOTS therapy | No intervention | –Enrolled patient will be given the DOT therapy for TB. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women aged 18 years or more.
- Newly bacteriologically confirmed TB case.
Key exclusion criteria (1 listed)
- Pregnancy and any medical condition unrelated to TB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational counsellingEnrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. | Behavioural | Educational councelling and Reminder. |
Primary outcome
Level of adherence among PTB patients.
Time frame: 6 months
The patient's level of adherence will be checked using the Health Belief Model Questionnaire and the MARS-5 adherence scale, as well as the patient's interview. The MARS-5 scores will indicate if a patient is adherent or not. Scores are calculated as, Score individual items (5 = never to 1 = always) i.e. high scores = high adherence. Add the individual scores to form a scale score (range = 5 to 25).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aner H Khan principal investigator
Universiti Sains Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational counselling in people with Tuberculosis, Pulmonary and HIV Coinfection, run by Universiti Sains Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of adherence among PTB patients. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2025.