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Cholerová nemocniční intervence na 7 dní (CHOBI7) Cílená intervence v oblasti vody, hygieny a hygieny (WASH)

4. listopadu 2026 aktualizováno: Johns Hopkins Bloomberg School of Public Health

Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

Background: Worldwide there are estimated to be 2.9 million cholera cases annually. Effective targeted water, sanitation, and hygiene (WASH) interventions are urgently needed to reduce cholera globally. The investigators study in Bangladesh found that individuals living within 50 meters of a cholera patient were at 30 times higher risk of developing cholera than the general population during the first week after the index patient sought care at a health facility. However, there has been little work done to develop and evaluate interventions for this high risk population.

Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted WASH intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

Previous studies: The investigators research group developed the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), a WASH intervention delivered to cholera patients and the participants household members in a health facility. the investigators randomized controlled trial (RCT) in Bangladesh of CHoBI7 demonstrated this intervention was effective in significantly reducing cholera, and led to sustained increases in handwashing with soap and improved drinking water quality 12 months post-intervention in cholera patient households. This intervention, however, solely focused on cholera patients households. There are no studies to date that have evaluated the impact on reducing cholera of delivering a ring WASH intervention to households living near cholera patients.

Design and Setting: The Director of Disease Control at the Bangladesh Ministry of Health and Family Welfare would like to take CHoBI7 to scale across Bangladesh, and has requested the investigators build evidence on scalable approaches for delivering CHoBI7 as a CATI in a ring around cholera patient households. This study will have 3 phases. During the formative research and planning phase the investigators will develop a scalable, theory and evidence based ring WASH intervention through in-depth interviews, focus group discussions, workshops, and a pilot. During the intervention implementation and evaluation phase the investigators will conduct a RCT to prospectively follow 3120 participants from 1040 households living in 40 rings around cholera cases to evaluate the effectiveness of the intervention in: (1) reducing cholera infections during the first week after the index patient in the ring seeks care at a health facility; and (2) increasing handwashing with soap and stored water quality over a 12 month period. The first arm will receive the standard recommendation given in Bangladesh during diarrhea outbreaks on oral rehydration solution use and a leaflet on WASH practices during a single visit. The second arm will receive this message and the ring WASH intervention which includes group sessions and home visits and mobile health messages. Whole genome sequencing will be performed on water and clinical Vibrio cholerae strains collected to investigate spatiotemporal transmission dynamics of V. cholerae in hotspots. During the dissemination and policy planning phase, the investigators will partner with the Director of Disease Control to disseminate study findings and inform cholera control policies.

Significance: This will be the first RCT of a CATI WASH program to evaluate whether this intervention approach can reduce cholera.

Typ studie

Intervenční

Zápis (Odhadovaný)

3140

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Christine Marie George, PhD
  • Telefonní číslo: (202) 657-5798
  • E-mail: cmgeorge@jhu.edu

Studijní místa

      • Dhaka, Bangladéš
        • Nábor
        • International Centre for Diarrhoeal Disease Research, Bangladesh
        • Kontakt:
          • ASG Faruque, MBBS MPH
        • Kontakt:
      • Dhaka, Bangladéš
        • Nábor
        • Research Training and Management International
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Tahmina Parvin

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dítě
  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Index cholera patient have no running water inside of their home

Exclusion Criteria:

  • No one will be excluded because of age, sex, religion, or sexual preference

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI

The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.

The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.

Aktivní komparátor: Standard Message Arm

Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution

Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
Časové okno: 1 month

cholera infection assessed by bacterial culture and/or vibriocidal antibody titer

1 month

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Diarrhea among individuals residing in a ring around cholera patients
Časové okno: 12 months

Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period)

12 months
Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
Časové okno: 12 Months

Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)

12 Months
Rate of Handwashing with soap at stool and food related events
Časové okno: 12 Months

Rate of patient household members handwashing with soap at stool and food related events

12 Months
Free chlorine concentration (mg/L) in stored drinking water
Časové okno: 12 months

Free chlorine concentration (mg/L) in stored drinking water

12 months
Presence of Vibrio cholerae and E. coli in stored drinking water
Časové okno: 12 months

E.coli and Vibrio cholerae measured by bacterial culture

12 months
Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
Časové okno: 12 months

Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks

12 months
Height-for-age measurements among children under 2 years of age
Časové okno: 12 months

Height and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards

12 months
Height-for-age measurements among children under 5 years of age
Časové okno: 12 months

Height and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards

12 months
Weight-for-age measurements among children under 2 years of age
Časové okno: 12 months

Weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards

12 months
Weight-for-age measurements among children under 5 years of age
Časové okno: 12 months

Weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards

12 months
Weight-for-height measurements among children under 2 years of age
Časové okno: 12 months

Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards

12 months
Weight-for-height measurements among children under 5 years of age
Časové okno: 12 months

Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards

12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Christine Marie George, PhD, Johns Hopkins Bloomberg School of Public Health

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

18. října 2023

Primární dokončení (Odhadovaný)

30. listopadu 2027

Dokončení studie (Odhadovaný)

30. listopadu 2027

Termíny zápisu do studia

První předloženo

16. srpna 2023

První předloženo, které splnilo kritéria kontroly kvality

16. srpna 2023

První zveřejněno (Aktuální)

22. srpna 2023

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

4. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • IRB00009931
  • 1R01AI148332-01 (Grant/smlouva NIH USA)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

All data will be de-identified and available to our collaborators

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .