MalariaNCT02517879
Community Point Distribution of Insecticide Treated Bed Nets
A study testing Community point distribution and Community health worker hang-up visit in people with Malaria, run by IDinsight.
Trial summary
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs). Households were then randomized to different intervals for a community health worker (CHW) hang-up visit. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Community point distribution and Community health worker hang-up visit
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 560 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to May 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
- Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia
Who cannot join
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
About this study
Official title: Measuring Attendance of Community Point Distribution of Insecticide-treated Bed Nets and the Impact of Community Health Worker Hang-up in Rural Zambia: A Randomized Controlled Trial and Cost Analysis
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs). Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.
Read the detailed description
Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province. Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals. Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit. Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit. All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.
- Conditions
- Malaria
- Being tested
- Community point distribution, Community health worker hang-up visit
- Keywords
- ITNs, malaria prevention
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community point distributionOther
Households were invited to a central location in their community (i.e. school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities). Households were provided with malaria prevention messaging at the distribution. They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
Community health worker hang-up visitOther
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - 1-3 days | Experimental | Community health worker hang-up visit 1-3 days after the community point distribution Receives: Other: Community point distribution; Other: Community health worker hang-up visit |
| Group 2 - 5-7 days | Experimental | Community health worker hang-up visit 5-7 days after the community point distribution Receives: Other: Community point distribution; Other: Community health worker hang-up visit |
| Group 3 - 10-12 days | Experimental | Community health worker hang-up visit 10-12 days after the community point distribution Receives: Other: Community point distribution; Other: Community health worker hang-up visit |
| Group 4 - 15-17 days | Experimental | Community health worker hang-up visit 15-17 days after the community point distribution Receives: Other: Community point distribution; Other: Community health worker hang-up visit |
| Group 5 - No hang-up visit | Placebo comparator | Did not receive any hang-up visit after the community point distribution Receives: Other: Community point distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community point distribution attendance
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
Measured: At time 0
Self-installation of ITNs
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
Measured: Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
Household ITN retention
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
Measured: An average of 9 weeks after community point distribution
Household ITN retention
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
Measured: An average of 5.5 months after community point distribution
Household percentage of ITNs hung
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
Measured: An average of 9 weeks after community point distribution
Household percentage of ITNs hung
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
Measured: An average of 5.5 months after community point distribution
Household percentage of sleeping spaces covered
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 7-11 week follow-up.
Measured: An average of 9 weeks after community point distribution
Household percentage of sleeping spaces covered
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 5-6 month follow-up.
Measured: An average of 5.5 months after community point distribution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startNov 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- IDinsight
- Sponsor type
- University, hospital or other
- Collaborators
- National Malaria Control Program, Ministry of Health, Zambia, Clinton Health Access Initiative Inc.
- Responsible party
- Sponsor
- Investigators
- Paul Wang, MPAID/MBA, Principal investigator, IDinsight
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517879
- Sponsor's protocol ID
- 003
- Status last verified
- Aug 2015
- First submitted
- 27 Jul 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Attendance of Community Point Distribution of Insecticide-treated Bed Nets and the Impact of Community Health Worker Hang-up in Rural Zambia: A Randomized Controlled Trial and Cost Analysis
- ClinicalTrials.gov ID
- NCT02517879
- Acronym / sponsor ID
- 003
- Conditions
- Malaria
- Keywords
- ITNs, malaria prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- IDinsightUniversity, hospital or other
- Collaborators
- National Malaria Control Program, Ministry of Health, Zambia, Clinton Health Access Initiative Inc.
- Study start
- Nov 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Aug 2015 (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.
All households in three zones in Zambia's Eastern Province were invited to attend a community point distribution of insecticide treated bed nets (ITNs). Households were then randomized to different intervals for a community health worker (CHW) hang-up visit.
Detailed description
Households were asked to attend a community point distribution of ITNs in one of three zones in Zambia's Eastern Province. Households that had been registered to receive ITNs were then randomized to one of five groups that received a CHW visit at different intervals. Group 1 was visited 1-3 days after distribution, group 2 was visited 5-7 days after, group 3 was visited 10-12 days after, group 4 was visited 15-17 days after, and group 5 did not receive a hang-up visit. Groups 1-4 were categorized as having received a hang-up visit and group 5 was categorized as not having received a hang-up visit. All households in all five groups were visited at 7-11 weeks after the distribution and again at 5-6 months after the distribution to assess short- and medium-term ITN retention and usage.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 - 1-3 days | Experimental | Other: Community point distribution, Other: Community health worker hang-up visitCommunity health worker hang-up visit 1-3 days after the community point distribution |
| Group 2 - 5-7 days | Experimental | Other: Community point distribution, Other: Community health worker hang-up visitCommunity health worker hang-up visit 5-7 days after the community point distribution |
| Group 3 - 10-12 days | Experimental | Other: Community point distribution, Other: Community health worker hang-up visitCommunity health worker hang-up visit 10-12 days after the community point distribution |
| Group 4 - 15-17 days | Experimental | Other: Community point distribution, Other: Community health worker hang-up visitCommunity health worker hang-up visit 15-17 days after the community point distribution |
| Group 5 - No hang-up visit | Placebo comparator | Other: Community point distributionDid not receive any hang-up visit after the community point distribution |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Household was pre-registered by the National Malaria Control Centre to receive ITNs ahead of the start of study activities.
- Household was located in one of the three study areas of Mukonka, Lukwipa, and Chipeketi in Rufunsa District, Zambia
Key exclusion criteria (2 listed)
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
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 |
|---|---|---|
| Community point distributionHouseholds were invited to a central location in their community (i.e. school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities). Households were provided with malaria prevention messaging at the distribution. They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households. | Other | Group 1 - 1-3 days, Group 2 - 5-7 days, Group 3 - 10-12 days, Group 4 - 15-17 days, Group 5 - No hang-up visit |
| Community health worker hang-up visitCHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs. | Other | Group 1 - 1-3 days, Group 2 - 5-7 days, Group 3 - 10-12 days, Group 4 - 15-17 days |
Primary outcome
Community point distribution attendance
Time frame: At time 0
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
Self-installation of ITNs
Time frame: Each group is randomized to receive a community health worker visit after a different duration, an average of 7 days after the point distribution
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
Household ITN retention
Time frame: An average of 9 weeks after community point distribution
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
Household ITN retention
Time frame: An average of 5.5 months after community point distribution
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
Household percentage of ITNs hung
Time frame: An average of 9 weeks after community point distribution
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
Household percentage of ITNs hung
Time frame: An average of 5.5 months after community point distribution
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
Household percentage of sleeping spaces covered
Time frame: An average of 9 weeks after community point distribution
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 7-11 week follow-up.
Household percentage of sleeping spaces covered
Time frame: An average of 5.5 months after community point distribution
The percentage of sleeping spaces in the household that were covered by an ITN distributed during the community point distribution at the 5-6 month follow-up.
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 7 Aug 2015.
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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.
Paul Wang, MPAID/MBA principal investigator
IDinsight
Questions about this trial
What is this clinical trial studying?
A study testing Community point distribution and Community health worker hang-up visit in people with Malaria, run by IDinsight.
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 2 inclusion and 2 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 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Community point distribution attendance (time frame: At time 0). The study lists 8 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 7 Aug 2015.