Community Point Distribution of Insecticide Treated Bed Nets

Malaria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02517879
• Other study ID #: 003
• Status: Completed
• Phase: N/A
• First received: July 27, 2015
• Last updated: August 4, 2015
• Start date: November 2013
• Est. completion date: May 2014

Study information

• Verified date: August 2015
• Source: IDinsight
• Contact: n/a
• Is FDA regulated: No
• Health authority: Zambia: Ministry of Health
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 560
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
IDinsight	Clinton Health Access Initiative Inc., Ministry of Health, Zambia, National Malaria Control Centre, Zambia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No
Primary	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	No