Evaluation StudyNCT05118373
Generic Behavioural Change Campaign for COVID-19 Prevention
A study testing BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA in people with Evaluation Study, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
Trial summary
Since the start of the COVID-19 pandemic in Zambia, multiple information, education and communication (IEC) materials and strategies have been disseminated by national risk communication and community engagement (RCCE) committees to create awareness on the facts of the novel coronavirus, prevention measures and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Evaluation Study
- What is being tested?
- BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,004 participants
- Where
- 1 siteZambia
- Study dates
- 18 Aug 2021to 23 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18years and above
- Must reside in Lusaka, Copperbelt, Southern or Eastern Province
- Volunteer to take part in the study
Who cannot join
- Participants not from Lusaka, Copperbelt, Southern or Eastern Province
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Generic Behavioural Change Campaign for COVID-19 Prevention in Zambia
Since the start of the COVID-19 pandemic in Zambia, multiple information, education and communication (IEC) materials and strategies have been disseminated by national risk communication and community engagement (RCCE) committees to create awareness on the facts of the novel coronavirus, prevention measures and care-seeking options. To complement these efforts in Zambia, CIDRZ in collaboration with the London School of Hygiene and Tropical Medicine (LSHTM) are implementing an internationally produced communication campaign that promotes the uptake of four key behaviours to reduce the transmission of COVID-19, namely, hand washing with soap, mask wearing, social distancing and surface cleaning. The campaign presents these behaviours as a 'password' that should be enacted to get lives back to normal and was created by the Hygiene Behaviour Change Coalition (HBCC). The idea of a password has been used to symbolize access into a world where protective habits are practiced in order to get back a world that is corona free. The password in this case is Hands-Face-Space-Surface. This campaign is a mass media campaign that will be delivered through TV, radio and billboards.
This study aims to evaluate the process and effect of the HBCC campaign on the uptake of COVID-19 preventative behaviours among people living in Lusaka and Copperbelt Provinces of Zambia.
Read the detailed description
Currently, there is not enough evidence on the impact of specific behavioural interventions on the uptake of COVID-19 prevention behaviours, including in Zambia.
The password campaign is rooted in behaviour change principles and was carefully created by the HBCC as a unifying intervention promoting memorability and behaviour uptake. It is being implemented in countries in Asia and Africa to increase the uptake of hand washing with soap, mask wearing, social distancing and surface cleaning. This study will be the first to provide evidence on the impact of this intervention on the uptake of behaviours within low-resourced settings.
Research questions:
- To what extent have adults aged 18years and above been exposed to the password campaign?
- What effect has the HBCC campaign had on practice of COVID-19 prevention behaviours in the community?
Main Aim: This study aims to evaluate the process and effect of the HBCC campaign on the uptake of COVID-19 preventative behaviours among people living in Lusaka and Copperbelt Provinces of Zambia.
Specific objectives:
- To assess the contribution of process indicators on the performance of the HBCC campaign with respect to dose delivered and reach.
- To evaluate the effect of the HBCC campaign on COVID-19 preventative behaviours.
Methodology (design, sampling, data collection methods and tools): In order to assess the intervention effect of the HBCC mass media campaign on the uptake of COVID-19 prevention behaviours among the general population, we will use a post-test quasi-experimental design where we will compare the uptake of three COVID-19 prevention behaviours among the general population in four provinces (Lusaka, Copperbelt, Southern and Eastern), where the intervention is variably ongoing. We will compare responses between exposed to unexposed individuals after intervention (i.e., a per protocol analysis). We define exposure as a positive response about exposure to, and memory of, the Password campaign (in particular it's specific slogan). We will stratify on biological sex and age.
Interactive Voice Response (IVR), an automated telephone system technology that interacts with the callers and routes the calls to the appropriate recipient will be used to collect data. This method had been chosen due to restriction on face to face data collection as a result of the COVID-19 pandemic. A random sample will be drawn from the phone number pool of persons >18 years old registered to participate in surveys.
Data management issues (data management plan, analysis and storage):
Viamo (https://viamo.io/) will provide descriptive analysis for all variables including all respondents. They will further extract fully completed questionnaires and export it to Microsoft excel for cleaning and coding. They will send this de-identified data to CIDRZ, who will export the cleaned data to Stata 16 MP4 (Stata Corp, College Station, TX. USA) for further analyses. De- identification will protect confidentiality. When all the data has been extracted, it will be stored in a database using PostgreSQL object-relational database management for security purposes. PostgreSQL is a highly secure and easy to use.
- Conditions
- Evaluation Study
- Being tested
- BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA
- Keywords
- Behavioural change, Evaluation, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIABehavioural
The intervention is a mass media campaign using TV, radio, billboard and posters to disseminate the message. The content are well-produced videos and pictures emphasising the need to wash hands, wear a mask, maintain social distance and clean surfaces. The English version of the video can be viewed at this link: https://youtu.be/tcjaLAxy4Ms.
| Study group | Role | What they receive |
|---|---|---|
| Exposure | Other | The campaign targets 3 TV stations, 8 radio stations, 2 billboard companies and social media platforms including YouTube, Twitter, Facebook, Instagram and LinkedIn with an anticipated reach of 1,433,201 people in Lusaka and Copperbelt provinces. Of the targeted TV and radio media houses, two each are national stations and will reach beyond these two intervention provinces including to Central and Southern province with an estimated 8% and 11% mass-media penetration compared to 21% and 38% for Copperbelt and Lusaka respectively. Receives: Behavioral: BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behaviour Change
Difference in proportion reporting one of three behaviors (masking, distancing and hand washing among those exposed and not exposed to the mass media campaign
Measured: Two months of intervention
Secondary outcomes (2)
Effective Reach
The proportion of people exposed to the intervention who can recall the password
Measured: Two months
Reach
The total number of different people exposed to the intervention, at least once, to any one medium during the two months.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start18 Aug 2021
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Evaluation StudyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Nation-wide mass media behaviour change campaign.
- Masking
- None (open label)
- Enrolment
- 2,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Infectious Disease Research in Zambia
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Unilever R&D
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118373
- Sponsor's protocol ID
- 25741
- Status last verified
- Nov 2021
- First submitted
- 18 Aug 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anwar A, Malik M, Raees V, Anwar A. Role of Mass Media and Public Health Communications in the COVID-19 Pandemic. Cureus. 2020 Sep 14;12(9):e10453. doi: 10.7759/cureus.10453.
PubMed 33072461Adewuyi, E. O., 2016. Behavior Change Communication Using Social Media: A Review. THE INTERNATIONAL JOURNAL OF COMMUNICATION AND HEALTH, January.pp. 109-116.
Abdullahi L, Onyango JJ, Mukiira C, Wamicwe J, Githiomi R, Kariuki D, Mugambi C, Wanjohi P, Githuka G, Nzioka C, Orwa J, Oronje R, Kariuki J, Mayieka L. Community interventions in Low-And Middle-Income Countries to inform COVID-19 control implementation decisions in Kenya: A rapid systematic review. PLoS One. 2020 Dec 8;15(12):e0242403. doi: 10.1371/journal.pone.0242403. eCollection 2020.
PubMed 33290402CDC, 2012. Efforts to Prevent and Reduce Tobacco Use Among Young People., Atlanta GA: s.n.
Curtis V, Dreibelbis R, Sidibe M, Cardosi J, Sara J, Bonell C, Mwambuli K, Ghosh Moulik S, White S, Aunger R. How to set up government-led national hygiene communication campaigns to combat COVID-19: a strategic blueprint. BMJ Glob Health. 2020 Aug;5(8):e002780. doi: 10.1136/bmjgh-2020-002780.
PubMed 32764128Graffigna G, Bosio C, Savarese M, Barello M, Barello S. "#I-Am-Engaged": Conceptualization and First Implementation of a Multi-Actor Participatory, Co-designed Social Media Campaign to Raise Italians Citizens' Engagement in Preventing the Spread of COVID-19 Virus. Front Psychol. 2020 Nov 5;11:567101. doi: 10.3389/fpsyg.2020.567101. eCollection 2020.
PubMed 33250811Lin Y, Hu Z, Alias H, Wong LP. Influence of Mass and Social Media on Psychobehavioral Responses Among Medical Students During the Downward Trend of COVID-19 in Fujian, China: Cross-Sectional Study. J Med Internet Res. 2020 Jul 20;22(7):e19982. doi: 10.2196/19982.
PubMed 32584779Li X, Liu Q. Social Media Use, eHealth Literacy, Disease Knowledge, and Preventive Behaviors in the COVID-19 Pandemic: Cross-Sectional Study on Chinese Netizens. J Med Internet Res. 2020 Oct 9;22(10):e19684. doi: 10.2196/19684.
PubMed 33006940Wakefield MA, Loken B, Hornik RC. Use of mass media campaigns to change health behaviour. Lancet. 2010 Oct 9;376(9748):1261-71. doi: 10.1016/S0140-6736(10)60809-4.
PubMed 20933263
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Generic Behavioural Change Campaign for COVID-19 Prevention in Zambia
- ClinicalTrials.gov ID
- NCT05118373
- Acronym / sponsor ID
- 25741
- Conditions
- Evaluation Study
- Keywords
- Behavioural change, Evaluation, COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,004 participants (actual)
- Lead sponsor
- Centre for Infectious Disease Research in ZambiaUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Unilever R&D
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 12 Nov 2021 (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.
Since the start of the COVID-19 pandemic in Zambia, multiple information, education and communication (IEC) materials and strategies have been disseminated by national risk communication and community engagement (RCCE) committees to create awareness on the facts of the novel coronavirus, prevention measures and care-seeking options. To complement these efforts in Zambia, CIDRZ in collaboration with the London School of Hygiene and Tropical Medicine (LSHTM) are implementing an internationally produced communication campaign that promotes the uptake of four key behaviours to reduce the transmission of COVID-19, namely, hand washing with soap, mask wearing, social distancing and surface cleaning. The campaign presents these behaviours as a 'password' that should be enacted to get lives back to normal and was created by the Hygiene Behaviour Change Coalition (HBCC). The idea of a password has been used to symbolize access into a world where protective habits are practiced in order to get back a world that is corona free. The password in this case is Hands-Face-Space-Surface. This campaign is a mass media campaign that will be delivered through TV, radio and billboards.
This study aims to evaluate the process and effect of the HBCC campaign on the uptake of COVID-19 preventative behaviours among people living in Lusaka and Copperbelt Provinces of Zambia.
Detailed description
Currently, there is not enough evidence on the impact of specific behavioural interventions on the uptake of COVID-19 prevention behaviours, including in Zambia.
The password campaign is rooted in behaviour change principles and was carefully created by the HBCC as a unifying intervention promoting memorability and behaviour uptake. It is being implemented in countries in Asia and Africa to increase the uptake of hand washing with soap, mask wearing, social distancing and surface cleaning. This study will be the first to provide evidence on the impact of this intervention on the uptake of behaviours within low-resourced settings.
Research questions:
- To what extent have adults aged 18years and above been exposed to the password campaign?
- What effect has the HBCC campaign had on practice of COVID-19 prevention behaviours in the community?
Main Aim: This study aims to evaluate the process and effect of the HBCC campaign on the uptake of COVID-19 preventative behaviours among people living in Lusaka and Copperbelt Provinces of Zambia.
Specific objectives:
- To assess the contribution of process indicators on the performance of the HBCC campaign with respect to dose delivered and reach.
- To evaluate the effect of the HBCC campaign on COVID-19 preventative behaviours.
Methodology (design, sampling, data collection methods and tools): In order to assess the intervention effect of the HBCC mass media campaign on the uptake of COVID-19 prevention behaviours among the general population, we will use a post-test quasi-experimental design where we will compare the uptake of three COVID-19 prevention behaviours among the general population in four provinces (Lusaka, Copperbelt, Southern and Eastern), where the intervention is variably ongoing. We will compare responses between exposed to unexposed individuals after intervention (i.e., a per protocol analysis). We define exposure as a positive response about exposure to, and memory of, the Password campaign (in particular it's specific slogan). We will stratify on biological sex and age.
Interactive Voice Response (IVR), an automated telephone system technology that interacts with the callers and routes the calls to the appropriate recipient will be used to collect data. This method had been chosen due to restriction on face to face data collection as a result of the COVID-19 pandemic. A random sample will be drawn from the phone number pool of persons >18 years old registered to participate in surveys.
Data management issues (data management plan, analysis and storage):
Viamo (https://viamo.io/) will provide descriptive analysis for all variables including all respondents. They will further extract fully completed questionnaires and export it to Microsoft excel for cleaning and coding. They will send this de-identified data to CIDRZ, who will export the cleaned data to Stata 16 MP4 (Stata Corp, College Station, TX. USA) for further analyses. De- identification will protect confidentiality. When all the data has been extracted, it will be stored in a database using PostgreSQL object-relational database management for security purposes. PostgreSQL is a highly secure and easy to use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Nation-wide mass media behaviour change campaign.
| Arm | Type | Receives |
|---|---|---|
| Exposure | Other | Behavioral: BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIAThe campaign targets 3 TV stations, 8 radio stations, 2 billboard companies and social media platforms including YouTube, Twitter, Facebook, Instagram and LinkedIn with an anticipated reach of 1,433,201 people in Lusaka and Copperbelt provinces. Of the targeted TV and radio media houses, two each are national stations and will reach beyond these two intervention provinces including to Central and Southern province with an estimated 8% and 11% mass-media penetration compared to 21% and 38% for Copperbelt and Lusaka respectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 18years and above
- Must reside in Lusaka, Copperbelt, Southern or Eastern Province
- Volunteer to take part in the study
Key exclusion criteria (1 listed)
- Participants not from Lusaka, Copperbelt, Southern or Eastern Province
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 |
|---|---|---|
| BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIAThe intervention is a mass media campaign using TV, radio, billboard and posters to disseminate the message. The content are well-produced videos and pictures emphasising the need to wash hands, wear a mask, maintain social distance and clean surfaces. The English version of the video can be viewed at this link: https://youtu.be/tcjaLAxy4Ms. | Behavioural | Exposure |
Primary outcome
Behaviour Change
Time frame: Two months of intervention
Difference in proportion reporting one of three behaviors (masking, distancing and hand washing among those exposed and not exposed to the mass media campaign
2 secondary outcomes
Effective Reach
Time frame: Two months
Reach
Time frame: Two months
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 12 Nov 2021.
- Background: PubMed 33072461Anwar A, Malik M, Raees V, Anwar A. Role of Mass Media and Public Health Communications in the COVID-19 Pandemic. Cureus. 2020 Sep 14;12(9):e10453. doi: 10.7759/cureus.10453.
- BackgroundAdewuyi, E. O., 2016. Behavior Change Communication Using Social Media: A Review. THE INTERNATIONAL JOURNAL OF COMMUNICATION AND HEALTH, January.pp. 109-116.
- Background: PubMed 33290402Abdullahi L, Onyango JJ, Mukiira C, Wamicwe J, Githiomi R, Kariuki D, Mugambi C, Wanjohi P, Githuka G, Nzioka C, Orwa J, Oronje R, Kariuki J, Mayieka L. Community interventions in Low-And Middle-Income Countries to inform COVID-19 control implementation decisions in Kenya: A rapid systematic review. PLoS One. 2020 Dec 8;15(12):e0242403. doi: 10.1371/journal.pone.0242403. eCollection 2020.
- BackgroundCDC, 2012. Efforts to Prevent and Reduce Tobacco Use Among Young People., Atlanta GA: s.n.
- Background: PubMed 32764128Curtis V, Dreibelbis R, Sidibe M, Cardosi J, Sara J, Bonell C, Mwambuli K, Ghosh Moulik S, White S, Aunger R. How to set up government-led national hygiene communication campaigns to combat COVID-19: a strategic blueprint. BMJ Glob Health. 2020 Aug;5(8):e002780. doi: 10.1136/bmjgh-2020-002780.
- Background: PubMed 33250811Graffigna G, Bosio C, Savarese M, Barello M, Barello S. "#I-Am-Engaged": Conceptualization and First Implementation of a Multi-Actor Participatory, Co-designed Social Media Campaign to Raise Italians Citizens' Engagement in Preventing the Spread of COVID-19 Virus. Front Psychol. 2020 Nov 5;11:567101. doi: 10.3389/fpsyg.2020.567101. eCollection 2020.
- Background: PubMed 32584779Lin Y, Hu Z, Alias H, Wong LP. Influence of Mass and Social Media on Psychobehavioral Responses Among Medical Students During the Downward Trend of COVID-19 in Fujian, China: Cross-Sectional Study. J Med Internet Res. 2020 Jul 20;22(7):e19982. doi: 10.2196/19982.
- Background: PubMed 33006940Li X, Liu Q. Social Media Use, eHealth Literacy, Disease Knowledge, and Preventive Behaviors in the COVID-19 Pandemic: Cross-Sectional Study on Chinese Netizens. J Med Internet Res. 2020 Oct 9;22(10):e19684. doi: 10.2196/19684.
- Background: PubMed 20933263Wakefield MA, Loken B, Hornik RC. Use of mass media campaigns to change health behaviour. Lancet. 2010 Oct 9;376(9748):1261-71. doi: 10.1016/S0140-6736(10)60809-4.
- Guidance for wearing MasksLink provided by the sponsor.
- Handwashing Clean Hands SavesLink provided by the sponsor.
- Zambia Risk Communication and Community EngagementLink provided by the sponsor.
- WHO Social DistancingLink provided by the sponsor.
- 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 BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA in people with Evaluation Study, run by Centre for Infectious Disease Research in Zambia at 1 site in Zambia.
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 1 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 12 Nov 2021. 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 Zambia. 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?
Behaviour Change (time frame: Two months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118373, which also lists 9 linked publications.
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 12 Nov 2021.