- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02045706
The Impact of Community Health Worker Training by US Health Volunteers on the Health of Rural Ugandans
A Randomized Prospective Trial to Measure Health-Related Behavioral Changes in Local Villagers Following The Implementation of a Village Health Team Program Facilitated by The Ugandan Ministry of Health and US Health Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kampala, Uganda
- Uganda Chartered Health Net
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Massachusetts
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Newton, Massachusetts, United States, 02468
- Omni Med
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Household with children under age five -
Exclusion Criteria: No children under age five in the household
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Community Health Worker Trainings
Trained community health workers (CHW) (one per 25 households), conducted a focus group and four quarterly meetings.
CHWs were then responsible for 25 households where they would teach preventive health, track health data for the Ministry, and refer sick cases (700 households total).
Staff and volunteers also conducted home visits and handed out printed summaries.
We also worked with the local villagers and community health workers to construct 3 protected water sources in the Intervention areas.
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Other Names:
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No Intervention: Control Group
The Control Group was comprised of similar households to the Intervention Group (n = 700).
In these villages, however, we did not instill the community health worker program until after the trial was completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Questionnaire on health behaviors before and after implementation of a community health worker program
Time Frame: One year
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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.
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One year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Edward J O'Neil Jr, MD, Omni Med
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SS 2486
- #81090 (Other Grant/Funding Number: Award # 81090, Tufts University Charlton Grant)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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