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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
IDinsight
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring ITNs, malaria prevention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    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.
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    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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