Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-05 @ 5:41 PM
Study NCT ID:
NCT06608069
Status:
COMPLETED
Last Update Posted:
2025-08-07
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacist-Led Intervention to Improve TB Treatment Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014397', 'term': 'Tuberculosis, Pulmonary'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': "To ensure the security of the patients' information, a double-blind randomization technique will be adopted. The computer gives each patient a code number, and the code numbers will then be allocated randomly to the treatment groups. All data will be kept in a database, and backup file with password protectors."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group\n\nThe main question\\[s\\]it aims to answer are:\n\n* How will pharmacist-led interventions improve the medication adherence level of TB and HIV con-infected patients?\n* Has there been an increase in the adherence level of co-infected patients following pharmacist-led interventions?\n\nParticipants will be interviewed to measure the level of adherence.\n\nIf there is a comparison group:\n\nEnrolled patient will be counselled and educated by pharmacist on the therapy and benefits of adherence (Control group).\n\nEnrolled 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).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-02', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of adherence among PTB patients.', 'timeFrame': '6 months', 'description': "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.\n\nAdd the individual scores to form a scale score (range = 5 to 25)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tuberculosis, Pulmonary', 'HIV Coinfection']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare the adherence of co-morbid patients in control and experimental group\n\nThe main question\\[s\\]it aims to answer are:\n\n1. 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.\n2. To evaluate the impact of pharmacist-led educational intervention on treatment outcomes among patients with PTB.\n3. To evaluate the impact of pharmacist-led educational intervention on HRQoL among patients with PTB.\n\nParticipants will be interviewed to measure the level of adherence.\n\nIf there is a comparison group:\n\nThe enrolled patient will be counselled and educated by the pharmacist on the therapy and the benefits of adherence (Control group).\n\nEnrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence. (Experimental group).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 years or more.\n* Newly bacteriologically confirmed TB case.\n\nExclusion Criteria:\n\n* Pregnancy and any medical condition unrelated to TB'}, 'identificationModule': {'nctId': 'NCT06608069', 'acronym': 'RA-15041995', 'briefTitle': 'Pharmacist-Led Intervention to Improve TB Treatment Adherence', 'organization': {'class': 'OTHER', 'fullName': 'Universiti Sains Malaysia'}, 'officialTitle': 'Relationship Between the Variation in Medication Adherence Level and Clinical Outcomes Among Tuberculosis: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NMRR ID-22-01964-WWH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational councelling and Reminder.', 'description': 'Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence.', 'interventionNames': ['Behavioral: Educational counselling']}, {'type': 'NO_INTERVENTION', 'label': 'DOTS therapy', 'description': 'Enrolled patient will be given the DOT therapy for TB.'}], 'interventions': [{'name': 'Educational counselling', 'type': 'BEHAVIORAL', 'description': 'Enrolled participants will be counselled and educated by pharmacist on the therapy and benefits of adherence.', 'armGroupLabels': ['Educational councelling and Reminder.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11800', 'city': 'George Town', 'country': 'Malaysia', 'facility': 'Hospital Pulau Pinang', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}, {'zip': '11800', 'city': 'George Town', 'country': 'Malaysia', 'facility': 'Universiti Sains Malaysia', 'geoPoint': {'lat': 5.41123, 'lon': 100.33543}}], 'overallOfficials': [{'name': 'Aner H Khan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Sains Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiti Sains Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'AMER HAYAT KHAN', 'investigatorAffiliation': 'Universiti Sains Malaysia'}}}}