NCT03186768

Brief Summary

The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive cue (the soap on a rope hall pass) can influence hand washing behavior for students in Namwala District, Zambia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

4 months

First QC Date

May 18, 2017

Last Update Submit

May 14, 2018

Conditions

Hand Disinfection

Outcome Measures

Primary Outcomes (1)

  • Change in hand washing behavior

    Students exiting the latrine will be monitored to determine if they wash their hands using soap and water.

    Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.

Study Arms (2)

Intervention arm

EXPERIMENTAL

Intervention arm receives a training of trainers on the soap on a rope hall pass intervention.

Behavioral: Soap on a rope hall pass intervention

Control arm

NO INTERVENTION

Control arm delays the training of trainers on the soap on a rope hall pass intervention until endline hand washing data has been collected.

Interventions

Soap on a rope hall pass interventionBEHAVIORAL

School health and nutrition coordinators will be trained on how to make and utilize the soap on a rope hall pass to improve hand washing behavior in schools.

Intervention arm

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Students in study schools who use the latrine on the day of observation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namwala District

Namwala, Zambia

Location

Study Officials

  • David A Larsen, PhD, MPH

    Syracuse University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
School group (intervention or control) will be blinded for data analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: School-randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2017

First Posted

June 14, 2017

Study Start

June 12, 2017

Primary Completion

September 30, 2017

Study Completion

December 31, 2017

Last Updated

May 17, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

De-identified data will be shared upon reasonable request. Email Dr. David Larsen at dalarsen@syr.edu.

Locations

ZA(1)