DiarrheaSWIMNCT01116908
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study
A study testing LifeStraw Family in people with Diarrhea and HIV Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial summary
The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diarrhea, HIV Infection
- What is being tested?
- LifeStraw Family
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteZambia
- Study dates
- Apr 2010to Aug 2011
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Known HIV-status based on clinical testing
- Have a child between 6-12 months at the initiation of the study
- Within the catchment area of Kasisi or Ngwerere health clinics, Chongwe district, Lusaka
Who cannot join
- Lived in the catchment area less than one year or planning to move
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Ngwerere Health Clinic and Kasisi Health Clinic
Lusaka, Chongwe District, Lusaka Province
About this study
Official title: Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention
The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.
Read the detailed description
Contaminated drinking water is a leading cause of morbidity and mortality in low-income settings. Safe drinking water is of particular concern for HIV-positive mothers since many HIV-infected Zambian women choose replacement feeding and early cessation of breastfeeding of infants to minimize the risk of transmission of the virus. This study builds upon preliminary baseline research which determined that HIV-positive mothers would potentially benefit from an intervention that encourages HIV-positive mothers to treat their water at the household level.
- Conditions
- Diarrhea, HIV Infection
- Being tested
- LifeStraw Family
- Keywords
- Diarrhea, Water, Household Water Treatment, HIV, Infant Health
- Medical subject headings
- Diarrhea, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LifeStraw FamilyDevice
LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| LifeStraw Family | Active comparator | Not described Receives: Device: LifeStraw Family |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of LifeStraw Family for children under 2 and all household members
Use, acceptability, and longevity of LifeStraw Family will be assessed for replacement and complementary feeds for children under 2 and for drinking water for all members of the household
Measured: One year
Secondary outcomes (2)
Microbiological performance of LifeStraw Family
Microbiological performance of LifeStraw Family, measured in terms of thermotolerant coliforms (TTC), a well-established WHO indicator organism for faecal contamination
Measured: One year
Impact of LifeStraw Family on longitudinal prevalence of diarrhea
Impact of the intervention on longitudinal prevalence of diarrhoea among infants under 2 years and all household members, measured both as reported by the primary caretaker of the child and by their weight-for-age z-score (WAZ) as a proxy for diarrhoea
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, University of Zambia, Vestergaard Frandsen
- Investigators
- Thomas Clasen, JD, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01116908
- Sponsor's protocol ID
- QA270
- Acronym
- SWIM
- Status last verified
- Aug 2011
- First submitted
- 4 May 2010
- Last updated
- 15 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Peletz R, Simunyama M, Sarenje K, Baisley K, Filteau S, Kelly P, Clasen T. Assessing water filtration and safe storage in households with young children of HIV-positive mothers: a randomized, controlled trial in Zambia. PLoS One. 2012;7(10):e46548. doi: 10.1371/journal.pone.0046548. Epub 2012 Oct 17.
PubMed 23082124
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention
- ClinicalTrials.gov ID
- NCT01116908
- Acronym / sponsor ID
- SWIM / QA270
- Conditions
- Diarrhea, HIV Infection
- Keywords
- Diarrhea, Water, Household Water Treatment, HIV, Infant Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University Teaching Hospital, Lusaka, Zambia, University of Zambia, Vestergaard Frandsen
- Study start
- Apr 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 5 May 2010 (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.
The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.
Detailed description
Contaminated drinking water is a leading cause of morbidity and mortality in low-income settings. Safe drinking water is of particular concern for HIV-positive mothers since many HIV-infected Zambian women choose replacement feeding and early cessation of breastfeeding of infants to minimize the risk of transmission of the virus. This study builds upon preliminary baseline research which determined that HIV-positive mothers would potentially benefit from an intervention that encourages HIV-positive mothers to treat their water at the household level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| LifeStraw Family | Active comparator | Device: LifeStraw Family |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Known HIV-status based on clinical testing
- Have a child between 6-12 months at the initiation of the study
- Within the catchment area of Kasisi or Ngwerere health clinics, Chongwe district, Lusaka
Key exclusion criteria (1 listed)
- Lived in the catchment area less than one year or planning to move
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 |
|---|---|---|
| LifeStraw FamilyLifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality | Device | LifeStraw Family |
Primary outcome
Use of LifeStraw Family for children under 2 and all household members
Time frame: One year
Use, acceptability, and longevity of LifeStraw Family will be assessed for replacement and complementary feeds for children under 2 and for drinking water for all members of the household
2 secondary outcomes
Microbiological performance of LifeStraw Family
Time frame: One year
Impact of LifeStraw Family on longitudinal prevalence of diarrhea
Time frame: One year
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 15 Aug 2011.
- Derived from this study: PubMed 23082124Peletz R, Simunyama M, Sarenje K, Baisley K, Filteau S, Kelly P, Clasen T. Assessing water filtration and safe storage in households with young children of HIV-positive mothers: a randomized, controlled trial in Zambia. PLoS One. 2012;7(10):e46548. doi: 10.1371/journal.pone.0046548. Epub 2012 Oct 17.
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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.
Thomas Clasen, JD, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LifeStraw Family in people with Diarrhea and HIV Infection, run by London School of Hygiene and Tropical Medicine 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 3 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 15 Aug 2011. 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?
Use of LifeStraw Family for children under 2 and all household members (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01116908, which also lists 1 linked publication.
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 15 Aug 2011.