NCT02517879

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
560

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 7, 2015

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

July 27, 2015

Last Update Submit

August 4, 2015

Conditions

Keywords

ITNsmalaria prevention

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (5)

Group 1 - 1-3 days

EXPERIMENTAL

Community health worker hang-up visit 1-3 days after the community point distribution

Other: Community point distributionOther: 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

Other: Community point distributionOther: 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

Other: Community point distributionOther: 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

Other: Community point distributionOther: 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

Other: Community point distribution

Interventions

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.

Group 1 - 1-3 daysGroup 2 - 5-7 daysGroup 3 - 10-12 daysGroup 4 - 15-17 daysGroup 5 - No 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.

Group 1 - 1-3 daysGroup 2 - 5-7 daysGroup 3 - 10-12 daysGroup 4 - 15-17 days

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Household was not pre-registered to receive ITNs
  • Household was not located in one of the three study areas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Paul Wang, MPAID/MBA

    IDinsight

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2015

First Posted

August 7, 2015

Study Start

November 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

August 7, 2015

Record last verified: 2015-08