- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
4 août 2015 mis à jour par: IDinsight
Measuring Attendance of Community Point Distribution of Insecticide-treated Bed Nets and the Impact of Community Health Worker Hang-up in Rural Zambia: A Randomized Controlled Trial and Cost Analysis
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs).
Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province.
Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals.
Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit.
Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit.
All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.
Type d'étude
Interventionnel
Inscription (Réel)
560
Phase
- N'est pas applicable
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
- Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia
Exclusion Criteria:
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Group 1 - 1-3 days
Community health worker hang-up visit 1-3 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Expérimental: Group 2 - 5-7 days
Community health worker hang-up visit 5-7 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Expérimental: Group 3 - 10-12 days
Community health worker hang-up visit 10-12 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Expérimental: Group 4 - 15-17 days
Community health worker hang-up visit 15-17 days after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
|
|
Comparateur placebo: Group 5 - No hang-up visit
Did not receive any hang-up visit after the community point distribution
|
Households were invited to a central location in their community (i.e.
school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities).
Households were provided with malaria prevention messaging at the distribution.
They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Community point distribution attendance
Délai: At time 0
|
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
|
At time 0
|
|
Self-installation of ITNs
Délai: Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
|
Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
|
|
Household ITN retention
Délai: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household ITN retention
Délai: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
|
Household percentage of ITNs hung
Délai: An average of 9 weeks after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household percentage of ITNs hung
Délai: An average of 5.5 months after community point distribution
|
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
|
Household percentage of sleeping spaces covered
Délai: An average of 9 weeks after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 7-11 week follow-up.
|
An average of 9 weeks after community point distribution
|
|
Household percentage of sleeping spaces covered
Délai: An average of 5.5 months after community point distribution
|
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 5-6 month follow-up.
|
An average of 5.5 months after community point distribution
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2013
Achèvement primaire (Réel)
1 mai 2014
Achèvement de l'étude (Réel)
1 mai 2014
Dates d'inscription aux études
Première soumission
27 juillet 2015
Première soumission répondant aux critères de contrôle qualité
4 août 2015
Première publication (Estimation)
7 août 2015
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
7 août 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
4 août 2015
Dernière vérification
1 août 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 003 (033)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .