Community Point Distribution of Insecticide Treated Bed Nets
Primary Purpose
Malaria
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Community point distribution
Community health worker hang-up visit
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring ITNs, malaria prevention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Household was not pre-registered to receive ITNs
- Household was not located in one of the three study areas
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
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
Arm Description
Community health worker hang-up visit 1-3 days after the community point distribution
Community health worker hang-up visit 5-7 days after the community point distribution
Community health worker hang-up visit 10-12 days after the community point distribution
Community health worker hang-up visit 15-17 days after the community point distribution
Did not receive any hang-up visit after the community point distribution
Outcomes
Primary Outcome Measures
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.
Self-installation of ITNs
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
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.
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.
Household percentage of ITNs hung
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
Household percentage of ITNs hung
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
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02517879
First Posted
July 27, 2015
Last Updated
August 4, 2015
Sponsor
IDinsight
Collaborators
National Malaria Control Centre, Zambia, Ministry of Health, Zambia, Clinton Health Access Initiative Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02517879
Brief Title
Community Point Distribution of Insecticide Treated Bed Nets
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IDinsight
Collaborators
National Malaria Control Centre, Zambia, Ministry of Health, Zambia, Clinton Health Access Initiative Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
ITNs, malaria prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 - 1-3 days
Arm Type
Experimental
Arm Description
Community health worker hang-up visit 1-3 days after the community point distribution
Arm Title
Group 2 - 5-7 days
Arm Type
Experimental
Arm Description
Community health worker hang-up visit 5-7 days after the community point distribution
Arm Title
Group 3 - 10-12 days
Arm Type
Experimental
Arm Description
Community health worker hang-up visit 10-12 days after the community point distribution
Arm Title
Group 4 - 15-17 days
Arm Type
Experimental
Arm Description
Community health worker hang-up visit 15-17 days after the community point distribution
Arm Title
Group 5 - No hang-up visit
Arm Type
Placebo Comparator
Arm Description
Did not receive any hang-up visit after the community point distribution
Intervention Type
Other
Intervention Name(s)
Community point distribution
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Community health worker hang-up visit
Intervention Description
CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
Primary Outcome Measure Information:
Title
Community point distribution attendance
Description
The percentage of pre-registered households that collected ITNs at the community point distributions on November 14, 19, and 21, 2013.
Time Frame
At time 0
Title
Self-installation of ITNs
Description
The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.
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
Title
Household ITN retention
Description
The percentage of ITNs distributed to a household that were found still in the household at the 7-11 week follow-up.
Time Frame
An average of 9 weeks after community point distribution
Title
Household ITN retention
Description
The percentage of ITNs distributed to a household that were found still in the household at the 5-6 month follow-up.
Time Frame
An average of 5.5 months after community point distribution
Title
Household percentage of ITNs hung
Description
The percentage of ITNs distributed to a household that were found hanging during the 7-11 week follow-up.
Time Frame
An average of 9 weeks after community point distribution
Title
Household percentage of ITNs hung
Description
The percentage of ITNs distributed to a household that were found hanging during the 5-6 month follow-up.
Time Frame
An average of 5.5 months after community point distribution
Title
Household percentage of sleeping spaces covered
Description
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.
Time Frame
An average of 9 weeks after community point distribution
Title
Household percentage of sleeping spaces covered
Description
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.
Time Frame
An average of 5.5 months after community point distribution
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Household was not pre-registered to receive ITNs
Household was not located in one of the three study areas
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Wang, MPAID/MBA
Organizational Affiliation
IDinsight
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Community Point Distribution of Insecticide Treated Bed Nets
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