Community Point Distribution of Insecticide Treated Bed Nets

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.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Other: Community point distribution; Other: Community health worker 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 Type: Interventional
• Enrollment (Actual): 560
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - 1-3 days; Community health worker hang-up visit 1-3 days after the community point distribution	Other: Community point distribution; 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.; Other: Community health worker hang-up visit; CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
Experimental: Group 2 - 5-7 days; Community health worker hang-up visit 5-7 days after the community point distribution	Other: Community point distribution; 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.; Other: Community health worker hang-up visit; CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
Experimental: Group 3 - 10-12 days; Community health worker hang-up visit 10-12 days after the community point distribution	Other: Community point distribution; 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.; Other: Community health worker hang-up visit; CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
Experimental: Group 4 - 15-17 days; Community health worker hang-up visit 15-17 days after the community point distribution	Other: Community point distribution; 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.; Other: Community health worker hang-up visit; CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
Placebo Comparator: Group 5 - No hang-up visit; Did not receive any hang-up visit after the community point distribution	Other: Community point distribution; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At time 0
Self-installation of ITNs	The percentage of ITNs distributed to a household that the CHW found hanging at his/her visit.	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.	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.	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.	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.	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.	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.	An average of 5.5 months after community point distribution

Collaborators and Investigators

• Sponsor: IDinsight
• Collaborators: National Malaria Control Centre, Zambia; Ministry of Health, Zambia; Clinton Health Access Initiative Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: July 27, 2015
• First Submitted That Met QC Criteria: August 4, 2015
• First Posted (Estimate): August 7, 2015

Study Record Updates

• Last Update Posted (Estimate): August 7, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: ITNs; malaria prevention
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: 003 (NuSkin International)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No