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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06191211
Other study ID # 214743
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 7, 2024
Est. completion date December 31, 2024

Study information

Verified date June 2024
Source London School of Economics and Political Science
Contact Mylene Lagarde, PhD
Phone +44 7595 911011
Email m.lagarde@lse.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15000
Est. completion date December 31, 2024
Est. primary completion date May 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - Mentally sound adults who are aged 16 years and above - Presenting at the health centre on the day of surveys Exclusion Criteria: - Received a COVID-19 vaccination dose within last 6 months, or received 2 or more doses - Have fever, chills, or are experiencing severe pain

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Motivational Interviewing, AIMS
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 engagement
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.

Locations

Country Name City State
Ghana Ghana Health Service Accra Greater Accra

Sponsors (3)

Lead Sponsor Collaborator
London School of Economics and Political Science Ghana Health Services, Innovations for Poverty Action

Country where clinical trial is conducted

Ghana, 

Outcome

Type Measure Description Time frame Safety issue
Primary COVID-19 vaccination uptake rates in the health centre 8 weeks
Primary Proportion of patients who intend to get vaccinated Immediately after treatment
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