- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07284914
Community Interventions for Tackling Antimicrobial Resistance in Ghana (CITAR-Ghana)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Interventions that discourage community pharmacies from providing antibiotics without proper diagnosis and a physician's prescription are critically needed in low- and middle-income countries in order to address the rising threat of antimicrobial resistance. In this study, we will test the effect of two interventions targeted to community pharmacies in the Greater Accra region of Ghana. We will conduct a baseline survey, followed by visits by standardized patients (SPs). We will then implement the interventions (described below) and assess the outcomes again using SPs.
The study has 4 key objectives:
Objective 1. Assess the effect of two behavioral interventions targeted to community pharmacies on antibiotics dispensing rates. We randomly assign 285 pharmacies in Greater Accra 1:1:1 into one of three arms: 1) Control, 2) Individualized Feedback, and 3) Legal Reminder. In the Individualized Feedback arm, we use information from the first visits to provide customized feedback to the pharmacies. In the Legal Reminder arm, we provide a letter from the Ghana authorities emphasizing that providing antibiotics without a physician prescription is against the law.
Objective 2. Assess the extent of know-do gap in antibiotics dispensing behavior among community pharmacies. We compare self-reported data from a baseline survey and the one obtained from SP visits to assess the gap between what the pharmacies know and what they do in practice.
Objective 3. Examine the effect of reduced pressure from patients for antibiotics on pharmacies' dispensing behavior. The two demand variations we will test are the following: 1) Patient asks for a medicine (normal demand pressure), 2) Patient explicitly says that they would prefer not to take antibiotics and mention that they do not have a physician prescription and that their condition appears to be viral (reduced demand pressure).
Objective 4. Assess differential effects of the two interventions and reduced demand pressure across patient's age.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yubraj Acharya, Ph.D.
- Phone Number: 814-865-6898
- Email: yua36@psu.edu
Study Locations
-
-
-
Legon, Ghana
- University of Ghana, Regional Institute for Population Studies
-
Contact:
- Adriana Biney, Ph.D.
- Phone Number: 0302 906 800
- Email: abiney@ug.edu.gh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for community pharmacies:
- Operating within the Greater Accra region of Ghana
- Registered with Ghana Pharmacy Council
- "Stand-alone", i.e., not affiliated or next to a hospital
Exclusion Criteria:
- Operating only outside the Greater Accra region of Ghana
- Not registered with Ghana Pharmacy Council
- Hospital pharmacy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Experimental: Individualized Feedback
Pharmacies receive customized feedback on their antibiotics dispensing behavior.
|
We use information from the baseline visits (e.g., on whether they give antibiotics without a prescription and the time they spend with patients) to provide customized feedback to the pharmacies.
|
|
Experimental: Legal Reminder
Pharmacies receive letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law.
|
We provide a letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-prescription antibiotics dispensing rate
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Whether the pharmacy dispenses antibiotics without prescription in scenarios not requiring them
|
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Watch or reserve antibiotics
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Whether the dispensed antibiotics fall into the Watch or Reserve category in the WHO AWaRE classification.
|
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
|
Out-of-pocket costs to patients
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Amount patients spend out-of-pocket on medications including antibiotics.
|
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
|
Referral to a physician
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Whether the pharmacist recommends the patient to see a doctor before antibiotics can be dispensed.
|
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
|
History taking
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Number of questions asked by the pharmacist based on a pre-specified checklist of appropriate history taking behavior
|
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
|
Interaction time
Time Frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Amount of time the pharmacist spends on the patient before giving medicine.
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From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00026602
- 102725 (Other Grant/Funding Number: Merck and Company, Inc.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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