COVID-19NCT06191211
Can Doctors Reduce COVID-19 Misinformation and Increase Vaccine Uptake in Ghana? A Cluster-randomised Controlled Trial
A study testing Motivational Interviewing, AIMS and Facility engagement in people with COVID-19, run by London School of Economics and Political Science at 1 site in Ghana.
Trial summary
Whilst Ghana was one of the first countries to start vaccinating its population against COVID-19, less than 30% of the population was fully vaccinated at the end of 2022. To improve COVID-19 vaccine uptake, the government has so far relied on two strategies: sensitization in communities and specific national… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Motivational Interviewing, AIMS and Facility engagement
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,000 participants
- Where
- 1 siteGhana
- Study dates
- 7 Feb 2024to 15 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Mentally sound adults who are aged 16 years and above
- Presenting at the health centre on the day of surveys
Who cannot join
- Received a COVID-19 vaccination dose within last 6 months, or received 2 or more doses
- Have fever, chills, or are experiencing severe pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Routine Consultations be Used to Reduce COVID-19 Misinformation and Increase Vaccine Uptake? An Experimental Study in Ghana
Whilst Ghana was one of the first countries to start vaccinating its population against COVID-19, less than 30% of the population was fully vaccinated at the end of 2022. To improve COVID-19 vaccine uptake, the government has so far relied on two strategies: sensitization in communities and specific national vaccination days. Against the backdrop of strict budget constraints and the return to normalcy in health-seeking behaviours, the investigators aim to test the effectiveness of leveraging interactions of patients with the healthcare system to reduce misinformation and increase vaccination. The investigators collaborate with the Ghana Health Service to offer vaccination as a default option during routine consultations. To dispel information and encourage vaccination uptake effectively, the investigators test two interventions designed to encourage and equip front-line providers with skills to discuss COVID-19 vaccination with patients. The study evaluates the effect of the two interventions in a cluster-randomised trial where the investigators allocate 120 facilities to one of three groups: a control group where providers are not asked to offer COVID-19 vaccines; a light engagement group, where providers receive information about COVID-19 and vaccines and a light-touch vaccine monitoring device is deployed in their facility, and a communication skills building group, where providers receive all the elements of the light intervention, plus training in motivational engagement techniques to encourage vaccination. The primary outcome will be vaccination uptake and intentions. The study will also evaluate the impact of the intervention on patients' knowledge, beliefs and satisfaction. The investigators will track the effectiveness of the training on providers as well as the extent to which they apply their training to actual practice. Results will contribute to a nascent evidence base on potential ways to encourage adult vaccination during routine consultations.
- Conditions
- COVID-19
- Being tested
- Motivational Interviewing, AIMS, Facility engagement
- Keywords
- Vaccination Hesitancy, Communication
- Medical subject headings
- COVID-19, Vaccination Hesitancy, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing, AIMSBehavioural
Motivational interviewing (MI). MI is an approach to patient engagement which promotes a collaborative conversation style for strengthening a person's own motivation and commitment to change. With MI, the doctor facilitates patient exploration of potential reasons for behaviour change in the context of what is important to the patient, rather than the physician directly telling the patient what to do. MI has been found more effective than other approaches to patient engagement and health behaviour change and can be effectively taught to primary care providers.
Facility engagementBehavioural
A letter to the facility from the local health officials; a meeting with the facility manager and health staff to formally announce that we would like providers to encourage COVID-19 vaccinations; deploying a tracking sheet for vaccinations.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard of care - no engagement or communication skills training for first-line providers. |
| Doctors Light Communication | Active comparator | In facilities randomised to this group, all front-line health workers receiving patients in outpatient consultations over the trial duration will be asked to encourage eligible patients to get vaccinated or receive a booster of the Covid-19 vaccine.
At the start of the intervention period, all facilities will receive a visit from the District office of the Ghana Health Service. The visit will (1) remind them of the importance of covid19 vaccination to all consulting staff; (2) ask all consulting staff to have discussions with patients about Covid19 vaccination during routine consultations and (3) provide a simple tracking sheet to be used by consulting staff to record these consultations. Receives: Behavioral: Facility engagement |
| Doctors Enhanced Communication | Experimental | In addition to facility engagement described in the "Doctor light communication" group, five front-line health workers from each of the facilities in the treatment group will be invited to take part in a training providing information and developing specific communication skills to encourage patients to get vaccinated. The communication skills are based on principles rooted in Motivational Interviewing (MI) and have been used in Ghana to address vaccine hesitancy. Receives: Behavioral: Motivational Interviewing, AIMS; Behavioral: Facility engagement |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccination uptake rates in the health centre
Measured: 8 weeks
Proportion of patients who intend to get vaccinated
Measured: Immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start7 Feb 2024
- Primary completion15 May 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Economics and Political Science
- Sponsor type
- University, hospital or other
- Collaborators
- Innovations for Poverty Action, Ghana Health Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06191211
- Sponsor's protocol ID
- 214743
- Status last verified
- Aug 2024
- First submitted
- 29 Dec 2023
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will share a complete dataset at the individual-level containing all primary and secondary study outcomes, any other variables used in the analysis, and treatment assignments. Data will be anonymised to ensure no participants can be personally identified (directly or indirectly)
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Routine Consultations be Used to Reduce COVID-19 Misinformation and Increase Vaccine Uptake? An Experimental Study in Ghana
- ClinicalTrials.gov ID
- NCT06191211
- Acronym / sponsor ID
- 214743
- Conditions
- COVID-19
- Keywords
- Vaccination Hesitancy, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- London School of Economics and Political ScienceUniversity, hospital or other
- Collaborators
- Innovations for Poverty Action, Ghana Health Services
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 5 Jan 2024 (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.
Whilst Ghana was one of the first countries to start vaccinating its population against COVID-19, less than 30% of the population was fully vaccinated at the end of 2022. To improve COVID-19 vaccine uptake, the government has so far relied on two strategies: sensitization in communities and specific national vaccination days. Against the backdrop of strict budget constraints and the return to normalcy in health-seeking behaviours, the investigators aim to test the effectiveness of leveraging interactions of patients with the healthcare system to reduce misinformation and increase vaccination. The investigators collaborate with the Ghana Health Service to offer vaccination as a default option during routine consultations. To dispel information and encourage vaccination uptake effectively, the investigators test two interventions designed to encourage and equip front-line providers with skills to discuss COVID-19 vaccination with patients. The study evaluates the effect of the two interventions in a cluster-randomised trial where the investigators allocate 120 facilities to one of three groups: a control group where providers are not asked to offer COVID-19 vaccines; a light engagement group, where providers receive information about COVID-19 and vaccines and a light-touch vaccine monitoring device is deployed in their facility, and a communication skills building group, where providers receive all the elements of the light intervention, plus training in motivational engagement techniques to encourage vaccination. The primary outcome will be vaccination uptake and intentions. The study will also evaluate the impact of the intervention on patients' knowledge, beliefs and satisfaction. The investigators will track the effectiveness of the training on providers as well as the extent to which they apply their training to actual practice. Results will contribute to a nascent evidence base on potential ways to encourage adult vaccination during routine consultations.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard of care - no engagement or communication skills training for first-line providers. |
| Doctors Light Communication | Active comparator | Behavioral: Facility engagementIn facilities randomised to this group, all front-line health workers receiving patients in outpatient consultations over the trial duration will be asked to encourage eligible patients to get vaccinated or receive a booster of the Covid-19 vaccine. At the start of the intervention period, all facilities will receive a visit from the District office of the Ghana Health Service. The visit will (1) remind them of the importance of covid19 vaccination to all consulting staff; (2) ask all consulting staff to have discussions with patients about Covid19 vaccination during routine consultations and (3) provide a simple tracking sheet to be used by consulting staff to record these consultations. |
| Doctors Enhanced Communication | Experimental | Behavioral: Motivational Interviewing, AIMS, Behavioral: Facility engagementIn addition to facility engagement described in the "Doctor light communication" group, five front-line health workers from each of the facilities in the treatment group will be invited to take part in a training providing information and developing specific communication skills to encourage patients to get vaccinated. The communication skills are based on principles rooted in Motivational Interviewing (MI) and have been used in Ghana to address vaccine hesitancy. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mentally sound adults who are aged 16 years and above
- Presenting at the health centre on the day of surveys
Key exclusion criteria (2 listed)
- Received a COVID-19 vaccination dose within last 6 months, or received 2 or more doses
- Have fever, chills, or are experiencing severe pain
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 |
|---|---|---|
| Motivational Interviewing, AIMSMotivational interviewing (MI). MI is an approach to patient engagement which promotes a collaborative conversation style for strengthening a person's own motivation and commitment to change. With MI, the doctor facilitates patient exploration of potential reasons for behaviour change in the context of what is important to the patient, rather than the physician directly telling the patient what to do. MI has been found more effective than other approaches to patient engagement and health behaviour change and can be effectively taught to primary care providers. | Behavioural | Doctors Enhanced Communication |
| Facility engagementA letter to the facility from the local health officials; a meeting with the facility manager and health staff to formally announce that we would like providers to encourage COVID-19 vaccinations; deploying a tracking sheet for vaccinations. | Behavioural | Doctors Enhanced Communication, Doctors Light Communication |
Primary outcome
COVID-19 vaccination uptake rates in the health centre
Time frame: 8 weeks
Proportion of patients who intend to get vaccinated
Time frame: Immediately after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2024.
- Individual participant dataSharing planned: Yes. The investigators will share a complete dataset at the individual-level containing all primary and secondary study outcomes, any other variables used in the analysis, and treatment assignments. Data will be anonymised to ensure no participants can be personally identified (directly or indirectly)
Related trials for COVID-19
RecruitingPhase 3
A Study of Secutrelvir in Participants With Coronavirus Disease 2019 (COVID-19) Who Are at High Risk for Progression to Severe Disease
SARS-CoV-2
RecruitingObservational study
Viral Infections in Healthy and Immunocompromised Hosts
Anogenital Herpes, COVID-19
Active, not recruiting
Motivational Interviewing Intervention for Families With Overweight and Obesity
Obesity & Overweight
Active, not recruiting
Lupus Education Alliance Program
Systemic Lupus Erythematosus, COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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 Motivational Interviewing, AIMS and Facility engagement in people with COVID-19, run by London School of Economics and Political Science 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
COVID-19 vaccination uptake rates in the health centre (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 Aug 2024.