Upper Resp Tract InfectionCITAR-GhanaNCT07284914
Community Interventions for Tackling Antimicrobial Resistance in Ghana
A study testing Individualized Feedback and Legal Reminder in people with Upper Resp Tract Infection, run by Penn State University at 1 site in Ghana.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Resp Tract Infection
- What is being tested?
- Individualized Feedback and Legal Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteGhana
- Study dates
- 1 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Operating within the Greater Accra region of Ghana
- Registered with Ghana Pharmacy Council
- "Stand-alone", i.e., not affiliated or next to a hospital
Who cannot join
- Operating only outside the Greater Accra region of Ghana
- Not registered with Ghana Pharmacy Council
- Hospital pharmacy
Trial locations and contacts
1 site in 1 country.
Ghana1 site
University of Ghana, Regional Institute for Population Studies
Legon
About this study
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.
Read the 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.
- Conditions
- Upper Resp Tract Infection
- Being tested
- Individualized Feedback, Legal Reminder
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized FeedbackBehavioural
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.
Legal ReminderBehavioural
We provide a letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No intervention |
| Individualized Feedback | Experimental | Pharmacies receive customized feedback on their antibiotics dispensing behavior. Receives: Behavioral: Individualized Feedback |
| Legal Reminder | Experimental | Pharmacies receive letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law. Receives: Behavioral: Legal Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-prescription antibiotics dispensing rate
Whether the pharmacy dispenses antibiotics without prescription in scenarios not requiring them
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Secondary outcomes (5)
Watch or reserve antibiotics
Whether the dispensed antibiotics fall into the Watch or Reserve category in the WHO AWaRE classification.
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Out-of-pocket costs to patients
Amount patients spend out-of-pocket on medications including antibiotics.
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Referral to a physician
Whether the pharmacist recommends the patient to see a doctor before antibiotics can be dispensed.
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
History taking
Number of questions asked by the pharmacist based on a pre-specified checklist of appropriate history taking behavior
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Interaction time
Amount of time the pharmacist spends on the patient before giving medicine.
Measured: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Resp Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Community pharmacies will be randomized into 3 arms (control, Individualized Feedback, and Legal Reminder). Pharmacies in each arm will be visited by standardized patients under 4 scenarios (low demand-young patient; low demand-old patient, normal demand-young patient, normal demand-old patient).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ghana
- Responsible party
- Principal investigator, Yubraj Acharya, Ph.D., Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284914
- Sponsor's protocol ID
- STUDY00026602
- Other IDs
- 102725
- Acronym
- CITAR-Ghana
- Status last verified
- Jul 2026
- First submitted
- 3 Dec 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventions for Tackling Antimicrobial Resistance in Ghana
- ClinicalTrials.gov ID
- NCT07284914
- Acronym / sponsor ID
- CITAR-Ghana / STUDY00026602
- Conditions
- Upper Resp Tract Infection
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Collaborators
- University of Ghana
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Community pharmacies will be randomized into 3 arms (control, Individualized Feedback, and Legal Reminder). Pharmacies in each arm will be visited by standardized patients under 4 scenarios (low demand-young patient; low demand-old patient, normal demand-young patient, normal demand-old patient).
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No intervention |
| Individualized Feedback | Experimental | Behavioral: Individualized FeedbackPharmacies receive customized feedback on their antibiotics dispensing behavior. |
| Legal Reminder | Experimental | Behavioral: Legal ReminderPharmacies receive letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Operating within the Greater Accra region of Ghana
- Registered with Ghana Pharmacy Council
- "Stand-alone", i.e., not affiliated or next to a hospital
Key exclusion criteria (3 listed)
- Operating only outside the Greater Accra region of Ghana
- Not registered with Ghana Pharmacy Council
- Hospital pharmacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized FeedbackWe 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. | Behavioural | Individualized Feedback |
| Legal ReminderWe provide a letter from the authorities in Ghana emphasizing that providing antibiotics without a physician prescription is against the law. | Behavioural | Legal Reminder |
Primary outcome
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
5 secondary outcomes
Watch or reserve antibiotics
Time frame: 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.
Referral to a physician
Time frame: 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.
Interaction time
Time frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Feedback and Legal Reminder in people with Upper Resp Tract Infection, run by Penn State University at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-prescription antibiotics dispensing rate (time frame: From baseline (1st SP visit) to the final SP visit (visit 5), lasting approximately 5 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.