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Cluster Randomized Trial of Peer Health Education in Malaria in The Gambia

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ClinicalTrials.gov Identifier: NCT00269178
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : March 8, 2017
Sponsor:
Collaborators:
Medical Research Council Unit, The Gambia
Nova Scotia Gambia Association, The Gambia
Centre for Innovation Against Malaria, The Gambia
Information provided by:
London School of Hygiene and Tropical Medicine

Tracking Information
First Submitted Date  ICMJE December 22, 2005
First Posted Date  ICMJE December 23, 2005
Last Update Posted Date March 8, 2017
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00269178 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cluster Randomized Trial of Peer Health Education in Malaria in The Gambia
Official Title  ICMJE Cluster Randomized Trial of the Impact of a Peer-health Education Programme on Malaria Knowledge Attitudes and Practice in Students and Their Families
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Malaria
Intervention  ICMJE Behavioral: Peer Health Education Programme
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: December 22, 2005)
960
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Woman caring for a child under 5 years of age, living in the compound of one of the peer health educators
  • Student attending school

Exclusion Criteria:

  • Not caring for a child under 5 years (for women)
  • Not living in a compound of a peer health educator (for women)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Gambia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00269178
Other Study ID Numbers  ICMJE SCC L2002.69
SSC L2002.69
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE London School of Hygiene and Tropical Medicine
Collaborators  ICMJE
  • Medical Research Council Unit, The Gambia
  • Nova Scotia Gambia Association, The Gambia
  • Centre for Innovation Against Malaria, The Gambia
Investigators  ICMJE
Principal Investigator: Paul JM Milligan, PhD London School of Hygiene and Tropical Medicine
PRS Account London School of Hygiene and Tropical Medicine
Verification Date March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP