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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Date results information initially provided
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)
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)

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
Other design features
Not Applicable
Type of endpoint(s)
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 status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 20986 0
State/province [1] 20986 0

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

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 301785 0
Approval date [1] 301785 0
Ethics approval number [1] 301785 0

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

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
Phone 88094 0
Fax 88094 0
Email 88094 0
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
Phone 88095 0
Fax 88095 0
Email 88095 0
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
Phone 88096 0
Fax 88096 0
Email 88096 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
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?
Study protocol
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 151 0
Informed consent form
Citation [1] 151 0
Link [1] 151 0
Email [1] 151 0
Other [1] 151 0
Type [2] 154 0
Study protocol
Citation [2] 154 0
Link [2] 154 0
Email [2] 154 0
Other [2] 154 0
Type [3] 155 0
Ethical approval
Citation [3] 155 0
Link [3] 155 0
Email [3] 155 0
Other [3] 155 0
University ethical approval
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – plain English summary
The study enrolled 100 participants from whom only 66 completed the study; 33 in the intervention group and 33 in the control group. At the end of the eight-week study period, the intervention group showed a statistically significant increase in CD4 cell counts compared to the usual care group. In addition, Antiretroviral therapy adherence had improved in the intervention group. When asked about 14 different reasons that might cause them to miss their medication (such as being away from home, being busy, forgetting), participants in the intervention group were 7.74 times more likely to report that they less frequently missed their ART for these reasons, which fits with the improved adherence in this group. In addition, at the end of the study, over 75% of the intervention group were ‘extremely sure’ that they would be able to take their medication as directed, that the medication would have a positive effect on their health, and that not taking their medicine would lead to ART resistance, compared to <10% of the control group.