Hand DisinfectionNCT03186768
Soap on a Rope Trial
A study testing Soap on a rope hall pass intervention in people with Hand Disinfection, run by Syracuse University at 1 site in Zambia.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hand Disinfection
- What is being tested?
- Soap on a rope hall pass intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteZambia
- Study dates
- 12 Jun 2017to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Students in study schools who use the latrine on the day of observation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Soap on a Rope Hall Pass Behavior Intervention: a School-randomized Controlled Trial
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.
- Conditions
- Hand Disinfection
- Being tested
- Soap on a rope hall pass intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soap on a rope hall pass interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | Intervention arm receives a training of trainers on the soap on a rope hall pass intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hand washing behavior
Students exiting the latrine will be monitored to determine if they wash their hands using soap and water.
Measured: Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study start12 Jun 2017
- Primary completion30 Sep 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand DisinfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- School-randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Larsen, Syracuse University
- Investigators
- David A Larsen, PhD, MPH, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186768
- Sponsor's protocol ID
- SoapRopetrial
- Status last verified
- May 2018
- First submitted
- 18 May 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared upon reasonable request. Email Dr. David Larsen at dalarsen@syr.edu.
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Soap on a Rope Hall Pass Behavior Intervention: a School-randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03186768
- Acronym / sponsor ID
- SoapRopetrial
- Conditions
- Hand Disinfection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- School-randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Soap on a rope hall pass interventionIntervention arm receives a training of trainers on the 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Students in study schools who use the latrine on the day of observation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soap on a rope hall pass interventionSchool 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. | Behavioural | Intervention arm |
Primary outcome
Change in hand washing behavior
Time frame: Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.
Students exiting the latrine will be monitored to determine if they wash their hands using soap and water.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2018.
- Individual participant dataSharing planned: Yes. De-identified data will be shared upon reasonable request. Email Dr. David Larsen at dalarsen@syr.edu.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Larsen, PhD, MPH principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soap on a rope hall pass intervention in people with Hand Disinfection, run by Syracuse University at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hand washing behavior (time frame: Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2018.