Household Water TreatmentHNWTNCT01907945
Healthy Networks Water Treatment Study
A study testing Microclinic Water Program and Household education in people with Household Water Treatment and Waterborne Illness, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
This study is a non-randomized double cohort study evaluating the impact of social network-based water treatment education on sustained household water treatment behaviors over 12 months of follow up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Household Water Treatment, Waterborne Illness
- What is being tested?
- Microclinic Water Program and Household education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteKenya
- Study dates
- Oct 2012to Apr 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in the Mfangano Island Healthy Networks Impact Study
- Resident of Mfangano Island in the East or North sub-locations
- 18 years of age or older
- Conversant in DhoLuo or English
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
This study is a non-randomized double cohort study evaluating the impact of social network-based water treatment education on sustained household water treatment behaviors over 12 months of follow up. A three-session curriculum was developed on the spread of water borne illness, water treatment methods, and the role of social support in water treatment. Participants in the intervention arm will receive this curriculum in a group setting, where group members are self-selected members of the study participants' social networks. Participants in the comparison arm will receive the same curriculum taught at the individual household level. All participants will receive CeraMaji ceramic filters for use in household water treatment after participating in the three sessions. Research staff will conduct surveys and water quality testing over a period of 12 months to determine whether participants continue to use the ceramic filters. Investigators hypothesize that social network-based training on household water treatment will result in a higher proportion of households using ceramic filters at 6- and 12-months as compared to households receiving individual training.
- Conditions
- Household Water Treatment, Waterborne Illness
- Being tested
- Microclinic Water Program, Household education
- Keywords
- Household water treatment, Waterborne illness, ceramic filters, social network
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microclinic Water ProgramBehavioural
Three session educational program is delivered to study participants and their self-selected social networks in a group setting. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member.
Household educationBehavioural
Three session educational program is delivered to study participants at an individual household level. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participant households in this arm are eligible for participation in the social network-based water treatment education program (referred to as the Microclinic Water Program). Participant households who do not enroll in the Microclinic Water Program receive household-based education identical to that of the 'comparison' arm. Receives: Behavioral: Microclinic Water Program |
| Comparison | Active comparator | Participant households in this arm receive household drinking water treatment education at the household level. Receives: Behavioral: Household education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ceramic filter use
'use' defined as 1) self-reported use in the three days prior to the survey, 2) presence of filter in household and 3) presence of water/moisture in the filter indicating recent use
Measured: 6 months post-intervention
Ceramic filter use
'use' defined as 1) self-reported use in the three days prior to the survey, 2) presence of filter in household and 3) presence of water/moisture in the filter indicating recent use
Measured: 12 months post-intervention
Secondary outcomes (2)
Fecal coliforms
fecal coliforms will be measured in drinking water stored in participant households using the IDEXX QuantiTray 2000 system.
Measured: 6 months post-intervention
Fecal coliforms
fecal coliforms will be measured in drinking water stored in participant households using the IDEXX QuantiTray 2000 system.
Measured: 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startOct 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Household Water TreatmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Organic Health Response, Microclinic International, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Craig R Cohen, MD, MPH, Principal investigator, University of California, San FranciscoElizabeth Bukusi, MBChB, M.Med, Principal investigator, Kenya Medical Research InstituteMatthew D Hickey, MD Candidate, Principal investigator, University of California, San FranciscoCharles R Salmen, MSc, MD candidate, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907945
- Sponsor's protocol ID
- HNWT
- Acronym
- HNWT
- Status last verified
- Jul 2014
- First submitted
- 22 Jul 2013
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Networks Water Treatment Study
- ClinicalTrials.gov ID
- NCT01907945
- Acronym / sponsor ID
- HNWT / HNWT
- Conditions
- Household Water Treatment, Waterborne Illness
- Keywords
- Household water treatment, Waterborne illness, ceramic filters, social network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Organic Health Response, Microclinic International, Kenya Medical Research Institute
- Study start
- Oct 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 25 Jul 2013 (estimated)
- 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.
This study is a non-randomized double cohort study evaluating the impact of social network-based water treatment education on sustained household water treatment behaviors over 12 months of follow up. A three-session curriculum was developed on the spread of water borne illness, water treatment methods, and the role of social support in water treatment. Participants in the intervention arm will receive this curriculum in a group setting, where group members are self-selected members of the study participants' social networks. Participants in the comparison arm will receive the same curriculum taught at the individual household level. All participants will receive CeraMaji ceramic filters for use in household water treatment after participating in the three sessions. Research staff will conduct surveys and water quality testing over a period of 12 months to determine whether participants continue to use the ceramic filters. Investigators hypothesize that social network-based training on household water treatment will result in a higher proportion of households using ceramic filters at 6- and 12-months as compared to households receiving individual training.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Microclinic Water ProgramParticipant households in this arm are eligible for participation in the social network-based water treatment education program (referred to as the Microclinic Water Program). Participant households who do not enroll in the Microclinic Water Program receive household-based education identical to that of the 'comparison' arm. |
| Comparison | Active comparator | Behavioral: Household educationParticipant households in this arm receive household drinking water treatment education at the household level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in the Mfangano Island Healthy Networks Impact Study
- Resident of Mfangano Island in the East or North sub-locations
- 18 years of age or older
- Conversant in DhoLuo or English
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Microclinic Water ProgramThree session educational program is delivered to study participants and their self-selected social networks in a group setting. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member. | Behavioural | Intervention |
| Household educationThree session educational program is delivered to study participants at an individual household level. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member. | Behavioural | Comparison |
Primary outcome
Ceramic filter use
Time frame: 6 months post-intervention
'use' defined as 1) self-reported use in the three days prior to the survey, 2) presence of filter in household and 3) presence of water/moisture in the filter indicating recent use
Ceramic filter use
Time frame: 12 months post-intervention
'use' defined as 1) self-reported use in the three days prior to the survey, 2) presence of filter in household and 3) presence of water/moisture in the filter indicating recent use
2 secondary outcomes
Fecal coliforms
Time frame: 6 months post-intervention
Fecal coliforms
Time frame: 12 months post-intervention
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 31 Jul 2014.
- Organic Health Response HNWT pageLink provided by the sponsor.
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.
Craig R Cohen, MD, MPH principal investigator
University of California, San Francisco
Elizabeth Bukusi, MBChB, M.Med principal investigator
Kenya Medical Research Institute
Matthew D Hickey, MD Candidate principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microclinic Water Program and Household education in people with Household Water Treatment and Waterborne Illness, run by University of California, San Francisco at 1 site in Kenya.
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 4 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 31 Jul 2014. 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 Kenya. 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?
Ceramic filter use (time frame: 6 months post-intervention). The study lists 2 primary outcomes in all. 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 31 Jul 2014.