Community Interventions for Tackling Antimicrobial Resistance in Ghana (CITAR-Ghana)

July 9, 2026 updated by: Yubraj Acharya, Ph.D., Penn State University
This research project aims to test the effect of two interventions targeted to community pharmacies in the Greater Accra region, Ghana, on antibiotics dispensing rates. The general goal is to inform the design of future policies to address the rising threat of antimicrobial resistance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
285

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Yubraj Acharya, Ph.D.
  • Phone Number: 814-865-6898
  • Email: yua36@psu.edu

Study Locations

  • Ghana
      • Legon, Ghana
        • University of Ghana, Regional Institute for Population Studies

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
No intervention
Experimental: Individualized Feedback
Pharmacies receive customized feedback on their antibiotics dispensing behavior.
Behavioral: Individualized Feedback
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.
Behavioral: Legal Reminder
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ghana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00026602
  • 102725 (Other Grant/Funding Number: Merck and Company, Inc.)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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