Intervention Study to Improve Maternal Handwashing
22 septembre 2022 mis à jour par: State University of New York at Buffalo
Effects of Promoting Handwashing With Soap to Improve Maternal Handwashing Behavior During the Neonatal Period
The purpose of the handwashing intervention trial is to determine whether an interactive, storytelling approach to promoting handwashing with soap by health care workers can improve mothers' handwashing behavior during the first month of her child's life.
Aperçu de l'étude
Statut
Retiré
Intervention / Traitement
Description détaillée
Infectious diseases, such as umbilical cord infection, pneumonia, and sepsis, are responsible for about a quarter of neonatal deaths.
Contaminated hands likely play a role in transmitting pathogens to a neonate, therefore handwashing with soap has the potential to interrupt transmission and improve neonatal health.
The primary objective of this study is to develop and evaluate a scalable, cost-effective handwashing promotion program to improve handwashing behavior among mothers and caregivers of neonates.
The investigators will first conduct a qualitative study to assess the feasibility and acceptability of a set of interventions.
The investigators propose to evaluate the impact of the intervention components, designed as three progressively intense interventions, using a randomized controlled trial with elements of a stepped wedge design.
The study will be conducted in Meru County, Kenya, enrolling a total of 800 pregnant women who seek non-emergency antenatal care at a government health facility during a 1 year period.
Clinic based health care workers and community health volunteers will disseminate the intervention using an interactive storytelling approach.
The focus of the interactions between the health care workers and volunteers and the participant will be on addressing barriers to handwashing through interactive question and answer sessions, rather than a didactic, educational session.
The investigators will assess the impact of interventions on observed maternal and caregiver handwashing behavior and estimate the cost effectiveness for each intervention.
Type d'étude
Interventionnel
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Meru County
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Igembe North And Igembe South Subcounties, Meru County, Kenya
- Government funded antenatal care clinics
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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
Femelle
La description
Inclusion Criteria:
- Pregnant women
- Seeking routine (non-emergency) care at a participating antenatal care clinic during the study period
- Between 30 and 36 weeks pregnant (calculated based on last known menstrual period) when they seek antenatal care
- Live within 30 minutes or 1-2 km one-way travel from the clinic
- Plan to remain in the study area for at least one month post-partum
- Willing to allow the field worker to visit her home following the antenatal care visit on the day of enrollment to conduct baseline assessments at the household
- Sought antenatal care from a qualified medical provider for the first time at or after 28 weeks gestation
Exclusion Criteria:
- Excluded if another member of their household or compound/homestead enrolled in this study
- Excluded if enrolled in the formative research for this study
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: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Control
Women will receive standard antenatal care but will not receive any additional handwashing promotion, soap, or handwashing device during their enrollment.
At the end of data collection, handwashing with soap will be recommended to participants in the control arm and their families.
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Expérimental: Clinic
Handwashing promotion from healthcare workers at antenatal care clinic.
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Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic.
To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session.
The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home.
A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home.
A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
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Expérimental: Clinic + home
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits.
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Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer.
All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
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Expérimental: Clinic + home + handwashing device
Handwashing promotion from healthcare workers at antenatal care clinic and from community health volunteers at home visits with provision of one handwashing device.
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Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e.
tap and basin to use as a handwashing station) during the first home visit by the community health volunteer.
The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Délai: 1 week post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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1 week post-natal
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Frequency of washing hands with soap at potential pathogen transmission events by mothers of neonate
Délai: 2 weeks post-natal
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Direct observation of handwashing behavior of mothers at times when pathogens may be transmitted from the mother to the neonate
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2 weeks post-natal
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Délai: 1 week post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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1 week post-natal
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Number of participants with soap and water present at a handwashing station
Délai: 1 week post-natal
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Observed presence of soap and/or water at a handwashing station
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1 week post-natal
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Cost-effectiveness
Délai: 1 month post-partum
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Approximate cost of the intervention per participant
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1 month post-partum
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Frequency of washing hands with soap at potential pathogen transmission events by caregivers of neonate (other than mother)
Délai: 2 weeks post-natal
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Direct observation of handwashing behavior of caregivers (other than mother) at times when pathogens may be transmitted from the caregiver to the neonate
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2 weeks post-natal
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Number of participants with soap and water present at a handwashing station
Délai: 2 weeks post-natal
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Observed presence of soap and/or water at a handwashing station
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2 weeks post-natal
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Pavani K. Ram, M.D., State University of New York at Buffalo
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 (Anticipé)
1 février 2016
Achèvement primaire (Anticipé)
1 décembre 2016
Achèvement de l'étude (Anticipé)
1 août 2018
Dates d'inscription aux études
Première soumission
13 janvier 2016
Première soumission répondant aux critères de contrôle qualité
3 mai 2016
Première publication (Estimation)
6 mai 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
23 septembre 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 septembre 2022
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 748140-1
- ESRC P176/2015 (Autre identifiant: Amref)
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
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