Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001882213
Ethics application status
Approved
Date submitted
6/11/2018
Date registered
20/11/2018
Date last updated
13/11/2019
Date data sharing statement initially provided
20/11/2018
Date results information initially provided
13/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacist-led counseling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled study.
Scientific title
A randomized controlled study to evaluate the effect of pharmacist led educational intervention on antiretroviral therapy adherence among human immuno deficiency virus infected patients.
Secondary ID [1] 296429 0
Nil known
Universal Trial Number (UTN)
U1111-1223-0852
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human immunodeficiency virus 310270 0
Condition category
Condition code
Infection 308938 308938 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Antiretroviral therapy adherence intervention.
intervention is delivered by the pharmacist.
the mode of delivery will be face to face education.
WHO basic counseling guidelines for antiretroviral therapy programs will be used.
no specific physical material will be provided to participants but the information will be given verbally on the advantages of taking antiretroviral therapy and what will be the adverse effects of leaving therapy.
the intervention will be given two times at the first meeting and then at followup.
the intervention includes 30 minutes session, once/month for 2 months.
intervention will be given in clinic settings.
The self-report strategy will be used to assess fidelity. It involves information collected directly from the practitioner or intervention participant. Data will be gathered using a checklist or a verbal report.
Intervention code [1] 312810 0
Treatment: Other
Comparator / control treatment
Active control group will be on standard care receiving antiretroviral therapy as the intervention group.
the standard care includes
1 fumarate de Tenofovir Disoproxil/Lamivudine/Efavirenz Comprimes 300mg/300mg/600mg once a day.
2 lamivudine and Zidovudine Tablets USP 150mg/300mg twice a day
3 Efavirenz Tablets 600mg once a day.
and standard care also includes general disease and medication counselling by the clinic counselors.
Control group
Active

Outcomes
Primary outcome [1] 307969 0
mean adherence level assessed using AACTG Adherence Questionnaire (Adults AIDS Clinical Trials Groups).
Timepoint [1] 307969 0
baseline and after 8 weeks
Primary outcome [2] 307970 0
Cd4 cell count, it provides the measure of disease progression and immune status. it was taken from the medical records of patients, both on the day of enrollment and after the end of the study that is 8 weeks.
Timepoint [2] 307970 0
Baseline, and at 4 weeks after intervention commencement.
Secondary outcome [1] 353528 0
Reasons for nonadherence,
The AACTG baseline questionnaire was used to access the reasons for nonadherence.
Timepoint [1] 353528 0
at baseline and after 8 weeks.
Secondary outcome [2] 376829 0
adherence self-efficacy and medication beliefs. this is a composite secondary outcome. The AACTG baseline questionnaire was used to access adherence self-efficacy and medication beliefs.
Timepoint [2] 376829 0
at baseline and then after 8 weeks

Eligibility
Key inclusion criteria
Having the HIV diagnosis formally registered in their chart.
Able to provide informed consent, and intending to obtain care at the clinic for the next year.
Age range from 18 years to 65.
Patients come under Islamabad region.
Patients newly initiating an ART regimen or less than 3 months.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with cognitive impairment.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealed
Envelopes containing the treatment allocation will be opened by the participant on enrolment. To be robust, the envelopes will be truly opaque, sequentially numbered, and opened in the correct order. The envelopes will not be opened in advance and recruiter will ensure that the envelope seal has not been broken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
the data were analyzed using R (The R Foundation for Statistical Computing, Vienna, Austria) version 3.5.1.
The CD4 count was analyzed by using a linear regression model and the other outcomes were by using ordinal logistic regression

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2018
Actual
20/11/2018
Date of last participant enrolment
Anticipated
31/12/2018
Actual
31/12/2018
Date of last data collection
Anticipated
31/03/2019
Actual
28/02/2019
Sample size
Target
66
Accrual to date
Final
66
Recruitment outside Australia
Country [1] 20986 0
Pakistan
State/province [1] 20986 0
Federal

Funding & Sponsors
Funding source category [1] 301031 0
University
Name [1] 301031 0
Quaid-I-Azam University, Islamabad, Pakistan
Country [1] 301031 0
Pakistan
Primary sponsor type
Individual
Name
Zeenat Fatima Chatha
Address
zeenat fatima chatha, Mphil pharmacy practice, Department of Pharmacy , Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country
Pakistan
Secondary sponsor category [1] 300621 0
Individual
Name [1] 300621 0
Prof.Dr Gul Majid Khan
Address [1] 300621 0
Chairman Department of Pharmacy , Quaid-i-Azam University Islamabad, 45320, Pakistan.
Country [1] 300621 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301785 0
Faculty Of Biological Sciences Bioethics Committee, Quaid-I-Azam University
Ethics committee address [1] 301785 0
Faculty Of Biological Sciences Bioethics Committee, Quaid-I-Azam University, Islamabad, 45320, Pakistan
Ethics committee country [1] 301785 0
Pakistan
Date submitted for ethics approval [1] 301785 0
04/09/2018
Approval date [1] 301785 0
14/09/2018
Ethics approval number [1] 301785 0
#BEC-FBS-QAU2018-107

Summary
Brief summary
Pakistan has less prevalence of HIV infection but on high risk country. Coverage of antiretroviral therapy is only 8% and less adherence rate. So, the study will help to demonstrate the value of implementing a pharmacist-led educational intervention. The purpose is to find how much patients adhere to their medicines after counselling by pharmacist. It may improve the knowledge of patients about their disease and medication, which then leads to better adherence of therapy and improved quality of life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88094 0
Miss Zeenat Fatima Chatha
Address 88094 0
Zeenat Fatima Chatha, Mphil Pharmacy Practice, Department Of Pharmacy, Quaid-i-azam University, 45320, Islamabad, Pakistan.
Country 88094 0
Pakistan
Phone 88094 0
+923316287017
Fax 88094 0
Email 88094 0
[email protected]
Contact person for public queries
Name 88095 0
Miss Zeenat Fatima Chatha
Address 88095 0
Zeenat Fatima Chatha, Mphil Pharmacy Practice, Department Of Pharmacy, Quaid-i-azam University, 45320, Islamabad, Pakistan.
Country 88095 0
Pakistan
Phone 88095 0
+923316287017
Fax 88095 0
Email 88095 0
[email protected]
Contact person for scientific queries
Name 88096 0
Miss Zeenat Fatima Chatha
Address 88096 0
Zeenat Fatima Chatha, Mphil Pharmacy Practice, Department Of Pharmacy, Quaid-i-azam University, 45320, Islamabad, Pakistan.
Country 88096 0
Pakistan
Phone 88096 0
+923316287017
Fax 88096 0
Email 88096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To protect the identities and rights of patients who participate in trial.


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 376259-(Uploaded-27-10-2019-23-34-22)-Basic results summary.docx
Plain language summaryNo The study enrolled 100 participants from whom only... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePharmacist-led counselling intervention to improve antiretroviral drug adherence in Pakistan: a randomized controlled trial.2020https://dx.doi.org/10.1186/s12879-020-05571-w
N.B. These documents automatically identified may not have been verified by the study sponsor.