NCT03667079

Brief Summary

The overarching goal of this project is the elimination of two neglected tropical diseases (NTD): soil-transmitted helminthiasis and rabies. The specific objective of this pilot study was: To determine whether the integrated delivery platform improved the cost-effectiveness and coverage of MDA targeting STH and rabies; The investigators integrated two public health initiatives: 1) a mass drug administration (MDA) effort to eliminate neglected tropical diseases (NTD) caused by soil-transmitted helminths (STH), with 2) a community-valued mass dog rabies vaccination (MDRV) intervention to eliminate human and animal rabies, also a priority NTD of the World Health Organisation. The goal of MDA efforts targeting STH is to reduce worm burdens to very low levels below which self-sustaining transmission, and the public health consequences of STH, cease. Existing school-based delivery programs fail to reach all affected age groups, however, which results in ineffective coverage levels and persistence of STH. The goal of MDRV is to immunize 70% of dog populations, after which canine-mediated rabies is eliminated. MDRV programs are typically very popular, with all human age groups participating. The objectives of this project were to determine whether supplementing a strictly school-based MDA NTD control program with a community-wide strategy that is coupled to an MDRV program will result in a synergism that (a) improves coverage, reach and cost-effective delivery of MDA targeting STH and (b) improves coverage and cost-effective delivery of dog vaccination. To achieve this, research activities, comprised of post-intervention household questionnaire surveys, were carried out. In addition detailed cost data was collected.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28,143

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
Last Updated

May 1, 2023

Status Verified

April 1, 2023

Enrollment Period

9 months

First QC Date

September 7, 2018

Last Update Submit

April 28, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • proportion of people in each village receiving deworming treatment

    The proportion of people in each village receiving deworming treatment was measured using household questionnaire surveys

    9 months

  • proportion of dogs in each village receiving rabies vaccination

    The proportion of dogs in each village receiving rabies vaccination was measured using household questionnaire surveys

    9 months

Secondary Outcomes (3)

  • cost of delivery

    9 months

  • time people spent traveling

    9 months

  • Comparison with the national school-based deworming program

    9 months

Study Arms (3)

Integrated

EXPERIMENTAL

Intervention 'integrated delivery of deworming and vaccination' will be delivered to this arm of the study

Other: integrated delivery of deworming and vaccination

Deworming only

ACTIVE COMPARATOR

Intervention 'Mass deworming only' will be delivered to villages in this arm of the study

Other: Mass deworming only

Rabies vaccination only

ACTIVE COMPARATOR

Villages assigned to this arm received mass vaccination of dogs against rabies only

Other: Mass vaccination of dogs

Interventions

integrated delivery of mass drug administrations, one targeting humans (deworming) and one targeting animals (rabies vaccination)

Integrated

Delivery of mass deworming to people only

Deworming only

Delivery of mass vaccination of dogs only

Rabies vaccination only

Eligibility Criteria

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

You may qualify if:

  • All healthy non pregnant people

You may not qualify if:

  • Children attending clinics alone
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

Location

Related Publications (1)

  • Lankester F, Davis A, Kinung'hi S, Yoder J, Bunga C, Alkara S, Mzimbiri I, Cleaveland S, Palmer GH. An integrated health delivery platform, targeting soil-transmitted helminths (STH) and canine mediated human rabies, results in cost savings and increased breadth of treatment for STH in remote communities in Tanzania. BMC Public Health. 2019 Oct 28;19(1):1398. doi: 10.1186/s12889-019-7737-6.

MeSH Terms

Interventions

Vaccination

Intervention Hierarchy (Ancestors)

Immunotherapy, ActiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative TechniquesPrimary PreventionPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesCommunicable Disease ControlPublic Health PracticePublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Model Details: Villages were allocated to one of three treatment arms: in Arm 1 villages people received deworming treatment and dogs rabies vaccination through an integrated delivery; in Arm 2 villages only deworming of people occurred; in Arm 3 only dog vaccination occurred. After the study, Arm 2 and 3 villages received rabies vaccination and deworming, respectively.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

September 7, 2018

First Posted

September 12, 2018

Study Start

February 1, 2016

Primary Completion

October 30, 2016

Study Completion

December 31, 2016

Last Updated

May 1, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

No IPD will be shared

Locations