Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02037243 |
| Other study ID # |
PR-11024 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1
|
| First received |
November 1, 2011 |
| Last updated |
June 11, 2015 |
| Start date |
August 2011 |
| Est. completion date |
June 2014 |
Study information
| Verified date |
January 2014 |
| Source |
International Centre for Diarrhoeal Disease Research, Bangladesh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Bangladesh: Ethical Review Committee |
| Study type |
Interventional
|
Clinical Trial Summary
An estimated 2.2 million children under the age of 5 years die from diarrheal disease each
year. Most of the burden of diarrheal disease is thought to be preventable with improvements
in sanitation, water quality, and hygiene. Large scale interventions promoting these
behaviours have either not been rigorously tested or have not produced sufficient change to
warrant being rolled out at scale.
Research into the determinants of hand washing behaviour has identified disgust and shame as
key motivators. Evidence supports the theory that disgust is a natural behavioural reaction
to objects carrying disease risk, thus it may act as a key motivator for other health
related behaviours such as water treatment. Whether this knowledge can be harnessed to
increase the efficacy of hand washing and safe water campaigns in Bangladesh or elsewhere
has yet to be rigorously tested.
The investigators will develop an intervention that utilizes disgust and shame eliciting
messages to promote hand washing with soap and point of use water treatment in low income
housing compounds of urban Dhaka. The investigators will test the efficacy of this
intervention against a more traditional public health intervention based on increasing
knowledge of health risks and germ transmission using a randomized controlled trial. The
study sample will be broken into the following four arms.
1. Standard Public Health Intervention with Water Treatment
2. Standard Public Health Intervention with Water Treatment & Hand Washing
3. Disgust and Shame Based Intervention with Water Treatment
4. Disgust and Shame Based Intervention with Water Treatment & Hand
This design will allow us to compare outcomes for hand washing and water treatment between
both standard public health interventions and disgust and shame based interventions as well
as test the overall efficacy of the program comparing with the control. Data will be
collected from all compounds at baseline, three month midline and at the six month endline
giving us the practical and analytical benefits of a longitudinal dataset.
Compounds will participate in interactive, educational safe water and/or hygiene promotion
meetings. For the Disgust and Shame group, these meetings will emphasize disgust and shame
related to unsafe water and/or hygiene practices, whereas the Standard group's meetings will
resemble a more typical public health intervention explaining the risks and methods of
contamination.
At the first meeting, compounds will receive a one month free trial of the latest compound
based chlorine dispenser model to treat their drinking water. A randomly selected half will
also receive a one month free trial of the latest compound based handwashing station. At the
end of the month, there will be a sales meeting in which the investigators will measure
compound members' willingness to pay for the trialled products by giving them the
opportunity purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction.
In assessing the impact of the interventions, the investigators are primarily interested in
whether the prevalences of safe water and hygiene behaviours differ by treatment arm and
over time. The best measurements for approximating behaviour prevalence are physical
observations (presence of residual chlorine, hand cleanliness inspections), structured
observation of behaviour, rapid physical observations (physical state of hardware/drinking
water), self-report of water treatment and hand washing behaviour and willingness to pay for
necessary products. The investigators will also attempt to measure and track changes in
personal determinants of behaviour such as feelings of disgust and shame related to hand
washing and water treatment behaviours.
Description:
Study Design To rigorously test the main study hypotheses the investigators are using a
stratified, cluster randomized trial. Sample compounds will be divided into four strata
based on compound size and presence of gas and will then be randomly assigned to one of four
study arms . Thus the proportion of compounds in each arm will be the same within each
stratum.
Strata
1. Gas & Fewer than 8 households per compound
2. Gas & 8 households per compound or more
3. No Gas & Fewer than 8 households per compound
4. No Gas & 8 households per compound or more
Study Arms
1. Standard Public Health Intervention with Water Treatment
2. Standard Public Health Intervention with Water Treatment & Hand Washing
3. Disgust and Shame Based Intervention with Water Treatment
4. Disgust and Shame Based Intervention with Water Treatment & Hand Washing
Via randomization, half of compounds will be assigned to standard treatment groups one
and two and half to disgust and shame groups three and four. Within these halves, one
third will receive water treatment only and two thirds will receive water treatment and
hand washing.
Randomization will allow us to infer causality when analyzing the differences in
outcomes and stratification will increase the statistical power of our inference.
Field Staff The investigators will have three field staff designations, Field Research
Assistants (FRAs), Field Intervention Specialists (FISs) and Field Assistants (FAs).
FRAs will be responsible for baseline, midline and endline data collection as well as
structured observation. FAs will be responsible for fee collection visits. FISs will be
responsible for all remaining visits.
Site Selection Based on the literature review and hypotheses to be tested, the
investigators determined that our study would be most feasible and would provide the
most benefit in poor housing compounds of Dhaka city. To identify specific sites where
the intervention would take place, the investigators created a list of feasibility
criteria (see appendix 2) and received recommendations from ICDDR,B Research
Investigators with experience in urban Dhaka. The investigators then sent two FRAs to
evaluate the recommended sites using the list. With their evaluation the investigators
selected six communities: Mohammedpur, Mirpur, Badda, Korail, Khilgaon and Bashabo.
Piloting Phase The first five of our specific aims, all involving development of new
techniques, are the subject of our piloting phase.
Aims One and Two To develop our disgust and shame intervention for water treatment and
for water treatment and hand washing the investigators will refine a long list of
potential intervention script contents. Our Qualitative Research Investigator and
members of his/her team will field test and review all items from this list,
systematically changing, removing and adding items until the list has become a feasible
intervention script that is culturally appropriate and appears to be effective. The
Qualitative team will use focus group discussions and in depth interviews as primary
tools to assess field tests.
Aim Three To develop a group version of the Becker-DeGroot-Marsckek (BDM) auction our
staff Economist along with the Qualitative Research Investigator and a team of FRAs
will field test and review different variations of the auction to determine which is
most feasible and which appears to produce the most accurate measurement of true
willingness to pay in our communities. The Qualitative team will use focus group
discussions and in depth interviews as primary tools to assess field tests.
Aim Four To develop a survey instrument which allows us to measure behavioural
determinants of hand washing and water treatment, the investigators will perform
multiple pilots and revisions of our questionnaire on small sample groups similar to
our sample. Revisions will be made based on qualitative review of subjects' impressions
and a quantitative review of gathered data. In the quantitative review the
investigators will perform principal components analysis and factor analysis of data to
refine scales for behavioural determinants already defined and/or to investigate
whether there are other determinants worth measuring.
Aim Five The investigators have a short list of new measurement ideas that the
investigators will field test and review prior to implementation. For more details on
this list, see the "Data Collection" section below.
Implementation
Visit 1: Sample Enrollment, Baseline Data Collection and Set-up of Promotion Meeting
Within the chosen field sites, FRAs will search for compounds which, match all the
essential criteria (see below), match at least 2 of the preferred criteria (see below)
and which are located at least 75 footsteps apart from each other. Our field team will
make several visits during the six months of the study to each of the enrolled
compounds. During each of these visits the investigators will conduct different
activities including a household survey, structured observation, and physical
observations. The investigators will ask for consent from all the compound members
verbally during a courtyard meeting, and ask the members to come to a consensus of who
can sign as the compound head or manager. In the written consent form all the study
activities have been described briefly to make it simple and easy to administer and
understand. For each specific activity the investigators will again ask for an
individual's verbal consent, which will serve as a reminder that individuals are still
willing to take part in the activity. Taking written consent for each activity during
each visit could make the visit even longer. Signing paper documents several times
could make the participants confused and concerned because most of them cannot t read
or write. For any household members who miss the first courtyard meeting, the
investigators will repeat all the information and process.
If they do not agree, then FRAs will move to the next suitable compound. If they agree
and sign the form, then FRAs will record stratification data and perform baseline data
collection which consists of two household questionnaires and six household physical
observation forms (see "Data Collection" below for more details on questionnaire and
physical observation). Later, FROs will use stratification data to determine the
stratum and randomly assign the treatment arm for each compound.
Household representatives who will participate in baseline data collection will be
randomly selected from the pool of compound members present at visit 1. To ensure
random selection, the FRA will first arbitrarily assign numbers to the households with
members present. He/she will then write the numbers on small plastic balls and drop the
balls into a cup. He/she will then shake the cup and pour out one ball. The number on
the ball corresponds to the first household to approach for data collection. The FRA
will ask the present members of the household who is responsible for collecting water.
This person will be asked to participate, if he/she declines, the FRA will pour another
ball out of the cup and repeat the procedure. These steps will be repeated until six
consenting compounds have been selected. The first two will be given the questionnaire
and physical observation form and the last four, only the physical observation.
Essential compound criteria
- Between 3 and 15 House`holds
- Shared water source
- Physical space exists to hold a compound meeting here or nearby
- No other interventions going on at this time
- Population is all Bangali
Preferred criteria
- Use of water source is visible to others
- Shared kitchen
- Shared toilets visible from common area Visit 2: First Meeting- Promotion and Free
Trial FISs will conduct a three hour integrated behaviour change/product promotion
program taking place in the compound or at a convenient meeting place nearby. The
content of the program, which will vary by treatment arm, will be developed during
piloting and is briefly described below under "Meeting Content and Hardware".
At the end of the program, compounds will be offered a one month free trial of the
hardware specific to their study arm (see "Meeting Content and Hardware").
Visit 3: Reminder Visit Roughly two weeks after the first meeting compounds will
receive a check-up and reminder visit. FISs will meet with available individuals in two
smaller groups. The FIS will reiterate messages from the first meeting and discuss
understanding and agreement with these messages in order to further understanding and
reduce perceived barriers to the new behaviours.
Visit 4: Setup of Second Meeting and BDM Auction Coaching Roughly three weeks after the
first meeting, FISs will visit compounds to set up a time and date for the second
compound meeting and to prepare the compound members for the auction. FISs will meet
with groups of two to four prospective bidders for an hour each and will explain in
detail the process and hold multiple mock auctions.
Visit 5: Second Meeting- Promotion and Sales Roughly one month after the first meeting,
as the free trial is ending, FISs will return to treatment compounds to conduct the
promotion and sales meetings.
The promotion segment will be a one and a half hour behaviour change/product promotion
program similar to the first meeting but containing fresh material.
In the second one and a half hour segment of the meeting, FISs will measure compound
members' willingness to pay for the trialled products by giving them the opportunity
purchase and keep the hardware in a Becker-DeGroot-Marschek (BDM) style auction.
Compounds not willing to pay the offered price will be offered other options to keep
the hardware assuring that at least 75% of compounds keep the products until endline
(more details on this in Auction section below).
Fee Collection Visits Every month for a year after the sales meeting, compounds will be
visited by an FA who will collect fees and take rapid observation data (detailed under
"Data Collection" below).
Visit 6: Midline Data Collection Three months after baseline data collection, FRAs will
return to compounds to collect midline data which consists of two household
questionnaires and six household physical observation forms (see "Data Collection"
below for more details on questionnaire and physical observation). FRAs will attempt to
use the same households as before, but if they are not present after returning to the
compound for a second attempt, then FRAs will use the randomization strategy from the
first visit to select new households.
Visit 7: Structured Observation Half way between midline and endline data collection a
separate team of FRAs will perform 5 hour structured observations of hand washing and
water treatment behaviour in a representative subgroup of our sample. More on this
under "Data Collection" below.
Visit 8: Endline Data Collection Six months after baseline data collection, FRAs will
return to compounds to collect endline data which consists of two household
questionnaires and six household physical observation forms (see "Data Collection"
below for more details on questionnaire and physical observation). FRAs will attempt to
use the same households as before, but if they are not present after returning to the
compound for a second attempt, then FRAs will use the randomization strategy from the
first visit to select new households.
Meeting Content and Hardware:
Hardware Water Treatment One wall mounted liquid chlorine dispenser One 40 liter
reservoir with tap Hand Washing One reused 1.5 liter water bottle to be filled with
soapy water (laundry detergent mixed with water)
Meeting Content
All compounds:
All will receive water treatment promotion interventions, whether standard or disgust
and shame based. Two thirds will be randomly selected to receive hand washing promotion
along with water treatment.
Standard Public Health Intervention:
The standard public health intervention meetings will be modeled after typical
pre-existing high quality water treatment and/or hand washing interventions. The
content will include explaining/demonstrating how germs can enter into our body via
untreated water and/or unwashed hands, how they can make us sick and lead to death, and
how these risks can be reduced by practicing safe water and/or hand hygiene behaviour.
Disgust and Shame Based Intervention:
The disgust and shame meetings will contain similar explanations/demonstrations of
contamination mechanisms and risk, but will place most emphasis on the presence of
fecal matter in or on contaminated objects. FIS' will use more vivid or harsh local
terms equivalent to "crap" or "shit" to try to elicit a stronger reaction from
participants. They will try to communicate the information that we sometimes
unknowingly serve feces to our family by not washing hands with soap or by not treating
our drinking water. They will emphasize how fecal matter can spread between people,
especially neighbours, to try to encourage people to care about others behaviours and
what others think of their behaviours. Pending piloting, the meetings will also contain
promotion of positive identities—being a good mother, a strong father or a good
Muslim—to stand in contrast with shameful and disgusting activities. The content and
terms used will be determined by qualitative investigation with community members.
Data Collection Questionnaire All compounds will be surveyed at baseline, a three month
midline and a six month endline. The questionnaire for each of these instances will be
largely the same excepting corrections made during implementation and small changes for
administering at different times. The questionnaire will measure self-reported usage,
reports of neighbours' usage, knowledge and practice pertaining to hand washing and
safe water, perceptions of risk and severity of diarrhoea, norms/ beliefs/ feelings/
reactions relating disgust and shame, social networking, and demographic information.
These measurements will allow us to study the differences in behaviour and of
behavioral determinants over time and between groups.
Physical Observation One of each of the following is taken in 6 households per compound
each time the questionnaire is administered and also during the structured observation.
Chlorine residual testing of stored drinking water (not taken at baseline) Hand
cleanliness inspections of child (see scoring sheet in appendix 4) Hand washing
demonstration by mother The investigators will ask her to demonstrate how she washes
her hands after defecation. The investigators will evaluate her performance as outlined
in appendix 4.
Others the investigators may include pending piloting:
Hand rinse water testing via H2S testing (see appendix 13 for previous principle and
interpretation) Other finger cleanliness checks Wiping fingers on a white material and
evaluating darkness Wiping fingers on oil blotter paper Drinking water quality testing
via H2S testing
Rapid Physical Observation Rapid observations will take place in all compound visits
and consist of identifying the location and usability/usage status of hand washing and
water treatment hardware.
Structured observation There will be one structured observation visit halfway between
the midline and endline data collection visit. FRAs will conduct 5 hour structured
observations of hand washing and water treatment behaviours in a sub-group of compounds
which is representative of our sample. Hand hygiene and water treatment behaviours will
be assessed using the score sheet in appendix 6.
Auction/Willingness to Pay After the courtyard meeting, the investigators will conduct
an experimental auction to elicit individual households willingness to pay (WTP)for a
monthly rent-to-own subscription to the chlorine dispenser and the reservoir. The
investigators will use Becker-DeGroot-Marschek (BDM) procedure to elicit WTP, whereby
participants bid against a predetermined randomly assigned price confidentially kept in
an envelope. The investigators will collect individual bids and list them to find the
lowest of these bids, which will then be compared with the price in the envelope. In
this auction, if the lowest of participants bid exceeds the preassigned price,
participants as a group win the auction but each pay the price in the envelope. The
investigators assume the mechanism is incentive compatible for participants to bid
truthfully as their bid does not affect the transaction price. The investigators aim to
keep the actual sales price very low so that most compounds have the opportunity to
keep the dispenser.
Payment data After the sales meeting the investigators will measure continued
enrollment and maintenance of the safe water (or safe water and hand-washing) station
on a monthly basis.
Qualitative Data Collection:
During implementation our qualitative team will regularly visit a representative
sub-group of our sample to gather data on how the intervention is going, how it is
perceived and to give us an idea of what needs to be changed in our meetings or our
survey. The standards the investigators are using to determine the frequency of
qualitative work are as follows: Roughly one in every five compounds will participate
in in-depth interviews and one in every 18 compounds will take place in focused group
discussions. These numbers may vary depending on data redundancy.
