MalariaPhase 3NCT00269178
Cluster Randomized Trial of Peer Health Education in Malaria in The Gambia
A Phase 3 study testing Peer Health Education Programme in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
Trial summary
Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Peer Health Education Programme
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 960 participants
- Where
- 1 siteThe Gambia
- Study dates
- Aug 2003to Oct 2004
- Phase
- Phase 3
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Woman caring for a child under 5 years of age, living in the compound of one of the peer health educators
- Student attending school
Who cannot join
- Not caring for a child under 5 years (for women)
- Not living in a compound of a peer health educator (for women)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cluster Randomized Trial of the Impact of a Peer-health Education Programme on Malaria Knowledge Attitudes and Practice in Students and Their Families
Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. We incorporated a malaria component to an established peer health education programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and practice (KAP) of school students and their families using a cluster randomized design. Since malaria is a particular problem among children under 5 and pregnant women, students were encouraged to explain what they learned to their families, and we sought to evaluate whether the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in students, and KAP in women living in the school students' home compound.
Read the detailed description
12 communities in The Gambia, each including an upper basic and/or a senior secondary school, were pair-matched on urban/rural location and school type, and one community in each pair randomly selected to receive the peer-health education programme immediately or after a delay, to permit evaluation. The intervention programme comprised training of peer health educators, teacher coordinators, and members of drama troupes, in key malaria messages and principles of health education. The peer educators then conducted a rolling programme of presentations to children and youth in their own schools using drama, puppetry, small group and in-class presentations about malaria, as well as community outreach programs targeting out-of-school youth and the general public. In each school a systematic sample of 75 students were interviewed 10 weeks and 6 months after the start of the programme, and in each school catchment area a sample of 80 women were interviewed at the same time, and bednet use by children under 5 yrs in their care was recorded. From the interviews scores were derived for knowledge about malaria treatment and prevention and knowledge scores and net coverage in children compared between intervention and control schools.
- Conditions
- Malaria
- Being tested
- Peer Health Education Programme
- Keywords
- malaria, knowledge attitudes and practice (KAP), bednets, peer health education
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Health Education ProgrammeBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Bednet use among children under 5yrs of age living in the household of peer health educators 10 wweks and 6 months after the start of the intervention
2. Malaria knowledge attitudes and practice among women in the family of peer health educators 10 week and 6 months after the start of the intervention
3. Malaria knowledge attitudes and practice among school students 10 weeks and 6 months after the start of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startAug 2003
- Study completionOct 2004
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 960 participants
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Nova Scotia Gambia Association, The Gambia, Centre for Innovation Against Malaria, The Gambia
- Investigators
- Paul JM Milligan, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269178
- Sponsor's protocol ID
- SCC L2002.69
- Other IDs
- SSC L2002.69
- Status last verified
- Mar 2003
- First submitted
- 22 Dec 2005
- Last updated
- 26 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of the Impact of a Peer-health Education Programme on Malaria Knowledge Attitudes and Practice in Students and Their Families
- ClinicalTrials.gov ID
- NCT00269178
- Acronym / sponsor ID
- SCC L2002.69
- Conditions
- Malaria
- Keywords
- malaria, knowledge attitudes and practice (KAP), bednets, peer health education
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 960 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Medical Research Council Unit, The Gambia, Nova Scotia Gambia Association, The Gambia, Centre for Innovation Against Malaria, The Gambia
- Study start
- Aug 2003
- Study completion
- Oct 2004 (actual)
- First posted
- 23 Dec 2005 (estimated)
- 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.
Health promotion in schools aims to improve the health and well being of students by empowering them with the knowledge, skills and confidence to take responsibility for their own health. We incorporated a malaria component to an established peer health education programme in schools in The Gambia, and evaluated its impact on knowledge attitudes and practice (KAP) of school students and their families using a cluster randomized design. Since malaria is a particular problem among children under 5 and pregnant women, students were encouraged to explain what they learned to their families, and we sought to evaluate whether the malaria messages were taken up by the students' families. Evaluation endpoints are KAP in students, and KAP in women living in the school students' home compound.
Detailed description
12 communities in The Gambia, each including an upper basic and/or a senior secondary school, were pair-matched on urban/rural location and school type, and one community in each pair randomly selected to receive the peer-health education programme immediately or after a delay, to permit evaluation. The intervention programme comprised training of peer health educators, teacher coordinators, and members of drama troupes, in key malaria messages and principles of health education. The peer educators then conducted a rolling programme of presentations to children and youth in their own schools using drama, puppetry, small group and in-class presentations about malaria, as well as community outreach programs targeting out-of-school youth and the general public. In each school a systematic sample of 75 students were interviewed 10 weeks and 6 months after the start of the programme, and in each school catchment area a sample of 80 women were interviewed at the same time, and bednet use by children under 5 yrs in their care was recorded. From the interviews scores were derived for knowledge about malaria treatment and prevention and knowledge scores and net coverage in children compared between intervention and control schools.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Woman caring for a child under 5 years of age, living in the compound of one of the peer health educators
- Student attending school
Key exclusion criteria (2 listed)
- Not caring for a child under 5 years (for women)
- Not living in a compound of a peer health educator (for women)
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 |
|---|---|---|
| Peer Health Education Programme | Behavioural | – |
Primary outcome
1. Bednet use among children under 5yrs of age living in the household of peer health educators 10 wweks and 6 months after the start of the intervention
2. Malaria knowledge attitudes and practice among women in the family of peer health educators 10 week and 6 months after the start of the intervention
3. Malaria knowledge attitudes and practice among school students 10 weeks and 6 months after the start of the intervention
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 26 Nov 2024.
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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.
Paul JM Milligan, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Peer Health Education Programme in people with Malaria, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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 26 Nov 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 The Gambia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1. Bednet use among children under 5yrs of age living in the household of peer health educators 10 wweks and 6 months after the start of the intervention. The study lists 3 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 26 Nov 2024.