MalariaNCT06590597
Improving Knowledge, Attitudes and Practices for Malaria Prevention in the Embera Katio Population
A study testing EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION in people with Malaria, run by Universidad de Antioquia at 1 site in Colombia.
Trial summary
Objective: To evaluate the effectiveness of an educational intervention compared to regular education in improving knowledge, attitudes and practices (KAP) for the prevention of malaria among indigenous people of the Embera Katío ethnic group in the department of Córdoba (Colombia). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteColombia
- Study dates
- 5 Mar 2024to 30 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Living in the Alto Sinú region Belonging to the Embera Katio community
Who cannot join
- Failure to attend one of the sessions scheduled to receive the intervention Incomplete response to at least 20% of the questionnaire Voluntary withdrawal from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Educational Intervention to Improve Knowledge, Attitudes and Practices for the Prevention of Malaria in the Embera Katio Population of the Department of Cordoba
Objective: To evaluate the effectiveness of an educational intervention compared to regular education in improving knowledge, attitudes and practices (KAP) for the prevention of malaria among indigenous people of the Embera Katío ethnic group in the department of Córdoba (Colombia). Methods: Intervention study with a quasi-experimental design with a control group carried out in three phases: (I) design of the educational intervention, (II) validation of the content of the educational intervention by expert judgement, and (III) implementation of a quasi-experimental study with two groups: intervention (n=60) and control (n=58). The intervention consisted of 4 modules delivered in an equal number of face-to-face sessions using educational strategies such as lectures, guided discussions, workshops, and a primer designed for the study. The control group received the usual education provided by the Ministry of Health. The Pan American Health Organization\'s instrument \"Survey on knowledge, attitudes and practices in addressing malaria in indigenous communities\" was used to measure for pre-intervention and post-intervention knowledge, attitudes, practices, and total scores. Results: In the content validation phase by expert jurors, it was found that the four modules obtained adequate content validity indexes ranging between 0.83 and 0.90. The general linear repeated measures models showed a positive effect of the educational intervention on the KAP scores (p\<0.001), indicating an effect size of 91% in knowledge, 49% in attitudes, 85% in practices and 93% of the total score. Conclusion: The educational intervention was effective in improving knowledge, attitudes and practices for malaria prevention in the indigenous population of the Embera Katío community in the Department of Córdoba.
Read the detailed description
From the review of articles about educational interventions to improve KAPs regarding malaria prevention in indigenous communities, an educational intervention was designed that was initially presented to the leaders of the community object of study, who provided their input and knowledge and which were incorporated to the final intervention. This educational intervention was structured into four modules to be administered in an equal number of face-to-face sessions, once per week and lasting three hours per session. The contents addressed per session were: (i) Definition of the disease, its signs and symptoms, (ii) Forms of the infection, (iii) Breeding sites of the vector, and (iv) Preventive actions to reduce the risk of infection. Each module was designed employing educational strategies, such as master classes, guided discussions, workshops, drawings, and use of a printed booklet, designed bearing in mind the observations made by indigenous authorities from the Emberá Katío community, who were consulted to know their perceptions and suggestions about the intervention. Each educational session began with a welcome greeting and assessment of prior knowledge, then the planned theme was developed and, finally, an activity was assigned to be developed at home and socialized during the following session.
- Conditions
- Malaria
- Being tested
- EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EDUCATIONAL INTERVENTION FOR MALARIA PREVENTIONBehavioural
The intervention consisted of 4 modules administered in the same number of face-to-face sessions in which educational strategies such as classes, guided discussions, workshops and a booklet designed for the study were used.
| Study group | Role | What they receive |
|---|---|---|
| GRUPO EXPERIMENTAL | Experimental | GROUP RECEIVING EDUCATIONAL INTERVENTION Receives: Behavioral: EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION |
| GRUPO CONTROL | No intervention | GROUP RECEIVING USUAL CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
IMPROVING KNOWLEDGE, ATTITUDES AND PRACTICES FOR MALARIA PREVENTION
SCORES ON KNOWLEDGE, ATTITUDES AND PRACTICES
Measured: 6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 Mar 2024
- Primary completion20 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Antioquia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARIA DE LOS ANGELES RODRIGUEZ GAZQUEZ, Universidad de Antioquia
- Investigators
- MARIA Rodríguez Gázquez, Study director, Universidad de Antioquia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590597
- Sponsor's protocol ID
- CEI-FE 2021-37
- Status last verified
- Sep 2024
- First submitted
- 31 May 2024
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Educational Intervention to Improve Knowledge, Attitudes and Practices for the Prevention of Malaria in the Embera Katio Population of the Department of Cordoba
- ClinicalTrials.gov ID
- NCT06590597
- Acronym / sponsor ID
- CEI-FE 2021-37
- Conditions
- Malaria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Universidad de AntioquiaUniversity, hospital or other
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 19 Sep 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.
Objective: To evaluate the effectiveness of an educational intervention compared to regular education in improving knowledge, attitudes and practices (KAP) for the prevention of malaria among indigenous people of the Embera Katío ethnic group in the department of Córdoba (Colombia). Methods: Intervention study with a quasi-experimental design with a control group carried out in three phases: (I) design of the educational intervention, (II) validation of the content of the educational intervention by expert judgement, and (III) implementation of a quasi-experimental study with two groups: intervention (n=60) and control (n=58). The intervention consisted of 4 modules delivered in an equal number of face-to-face sessions using educational strategies such as lectures, guided discussions, workshops, and a primer designed for the study. The control group received the usual education provided by the Ministry of Health. The Pan American Health Organization\'s instrument \"Survey on knowledge, attitudes and practices in addressing malaria in indigenous communities\" was used to measure for pre-intervention and post-intervention knowledge, attitudes, practices, and total scores. Results: In the content validation phase by expert jurors, it was found that the four modules obtained adequate content validity indexes ranging between 0.83 and 0.90. The general linear repeated measures models showed a positive effect of the educational intervention on the KAP scores (p\<0.001), indicating an effect size of 91% in knowledge, 49% in attitudes, 85% in practices and 93% of the total score. Conclusion: The educational intervention was effective in improving knowledge, attitudes and practices for malaria prevention in the indigenous population of the Embera Katío community in the Department of Córdoba.
Detailed description
From the review of articles about educational interventions to improve KAPs regarding malaria prevention in indigenous communities, an educational intervention was designed that was initially presented to the leaders of the community object of study, who provided their input and knowledge and which were incorporated to the final intervention. This educational intervention was structured into four modules to be administered in an equal number of face-to-face sessions, once per week and lasting three hours per session. The contents addressed per session were: (i) Definition of the disease, its signs and symptoms, (ii) Forms of the infection, (iii) Breeding sites of the vector, and (iv) Preventive actions to reduce the risk of infection. Each module was designed employing educational strategies, such as master classes, guided discussions, workshops, drawings, and use of a printed booklet, designed bearing in mind the observations made by indigenous authorities from the Emberá Katío community, who were consulted to know their perceptions and suggestions about the intervention. Each educational session began with a welcome greeting and assessment of prior knowledge, then the planned theme was developed and, finally, an activity was assigned to be developed at home and socialized during the following session.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GRUPO EXPERIMENTAL | Experimental | Behavioral: EDUCATIONAL INTERVENTION FOR MALARIA PREVENTIONGROUP RECEIVING EDUCATIONAL INTERVENTION |
| GRUPO CONTROL | No intervention | –GROUP RECEIVING USUAL CARE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Living in the Alto Sinú region Belonging to the Embera Katio community
Key exclusion criteria (1 listed)
- Failure to attend one of the sessions scheduled to receive the intervention Incomplete response to at least 20% of the questionnaire Voluntary withdrawal from the study.
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 |
|---|---|---|
| EDUCATIONAL INTERVENTION FOR MALARIA PREVENTIONThe intervention consisted of 4 modules administered in the same number of face-to-face sessions in which educational strategies such as classes, guided discussions, workshops and a booklet designed for the study were used. | Behavioural | GRUPO EXPERIMENTAL |
Primary outcome
IMPROVING KNOWLEDGE, ATTITUDES AND PRACTICES FOR MALARIA PREVENTION
Time frame: 6 MONTHS
SCORES ON KNOWLEDGE, ATTITUDES AND PRACTICES
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 19 Sep 2024.
- 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.
MARIA Rodríguez Gázquez study director
Universidad de Antioquia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION in people with Malaria, run by Universidad de Antioquia at 1 site in Colombia.
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 1 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 19 Sep 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 Colombia. 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?
IMPROVING KNOWLEDGE, ATTITUDES AND PRACTICES FOR MALARIA PREVENTION (time frame: 6 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 19 Sep 2024.