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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02045706
Other study ID # SS 2486
Secondary ID #81090
Status Completed
Phase N/A
First received January 22, 2014
Last updated January 22, 2014
Start date March 2011
Est. completion date March 2012

Study information

Verified date January 2014
Source Omni Med
Contact n/a
Is FDA regulated No
Health authority Uganda: National Council for Science and TechnologyUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

There are many trials measuring the impact of service work on volunteers themselves, but few studies measuring the impact of service on the local people. The purpose of this trial is to determine whether US and Ugandan health volunteers can make a measurable impact on the health of rural Ugandan villagers.


Description:

The goal of this research is to measure a change in the behaviors of local villagers in the Mukono District (just east of Kampala, Uganda) following the implementation of the Ministry of Health's Village Health Team Program facilitated by US Health Volunteers. Our NGO (non-governmental organization), Omni Med, has partnered with the Ministry of Health in Kampala and Mukono to facilitate its Village Health Team (VHT) program. Our volunteers facilitate training of VHTs and then conduct follow up home visits with these VHTs. During the trainings and follow up visits we stress the health practices in the Ministry's training program that have been shown to make the biggest impact on local health such as: exclusive breast-feeding for 9 months, use of oral rehydration therapy (ORT), antibiotics for pneumonia, timely antimalarial use, use of insecticide treated nets (ITNs), clean water, improved sanitation, Vitamin A supplementation and vaccination, antenatal visits and tetanus immunization for pregnant women, etc. Our pre-trial assumption is that local villagers will use this knowledge to improve their own health; and that the VHTs are the ideal messengers to deliver this knowledge. While the Ministry has trained over 83,000 VHTs nationally, there are no objective studies measuring impact on host communities. This will be the first and could prove an important means to promote the program nationally and internationally.

The primary objective of this research is to measure the efficacy of the VHT program in Uganda. While this program has become a priority of the Ministry of Health, there is to date no clear randomized, prospective trial measuring its impact. This will thus fill a current gap using data obtained from 1190 households. A second objective is to demonstrate measurable results of a global service program. There is very little impact data despite huge interest in service from many in the world's wealthiest countries. A third objective is to provide an objective measure of efficacy to the United States Peace Corps, which despite 50 years of activities, has little data demonstrating its true value; several Peace Corps Volunteers are working in this program in Mukono.


Recruitment information / eligibility

Status Completed
Enrollment 1419
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria: Household with children under age five -

Exclusion Criteria: No children under age five in the household

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms

  • Health Knowledge, Attitudes, Practice

Intervention

Other:
Community Health Worker Trainings


Locations

Country Name City State
Uganda Uganda Chartered Health Net Kampala
United States Omni Med Newton Massachusetts

Sponsors (6)

Lead Sponsor Collaborator
Edward O'Neil Jr, M.D. Makerere University, Peace Corps, Uganda Chartered Health Net, University of Illinois at Urbana-Champaign, Washington University School of Medicine

Countries where clinical trial is conducted

United States,  Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Questionnaire on health behaviors before and after implementation of a community health worker program A detailed questionnaire about local health behaviors was employed by Uganda Chartered Health Net in villages randomized to control and intervention areas in two parishes in rural Uganda. Data was collected in both areas before and after implementation of a Ministry of Health mandated community health worker program over a one year period. Key outcome measures were then plugged into the Lives Saved Tool (LIST) to determine changes in infant and under-5 mortality. One year No
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