NCT06590597

Brief 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). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 31, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

May 31, 2024

Last Update Submit

September 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • IMPROVING KNOWLEDGE, ATTITUDES AND PRACTICES FOR MALARIA PREVENTION

    SCORES ON KNOWLEDGE, ATTITUDES AND PRACTICES

    6 MONTHS

Study Arms (2)

GRUPO EXPERIMENTAL

EXPERIMENTAL

GROUP RECEIVING EDUCATIONAL INTERVENTION

Behavioral: EDUCATIONAL INTERVENTION FOR MALARIA PREVENTION

GRUPO CONTROL

NO INTERVENTION

GROUP RECEIVING USUAL CARE

Interventions

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.

GRUPO EXPERIMENTAL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Living in the Alto Sinú region Belonging to the Embera Katio community

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CORDOBA

Montería, Departamento de Córdoba, Colombia

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • MARIA Rodríguez Gázquez

    Universidad de Antioquia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D in Public Health

Study Record Dates

First Submitted

May 31, 2024

First Posted

September 19, 2024

Study Start

March 5, 2024

Primary Completion

May 20, 2024

Study Completion

May 30, 2024

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations