Health Knowledge, Attitudes, PracticeNCT02045706
The Impact of Community Health Worker Training by US Health Volunteers on the Health of Rural Ugandans
A study testing Community Health Worker Trainings in people with Health Knowledge, Attitudes, Practice, run by Edward O'Neil Jr, M.D. at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Health Knowledge, Attitudes, Practice
- What is being tested?
- Community Health Worker Trainings
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,419 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2011to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Inclusion Criteria: Household with children under age five -
Exclusion Criteria: No children under age five in the household
-
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Health Knowledge, Attitudes, Practice
- Being tested
- Community Health Worker Trainings
- Keywords
- Community Health Workers, Service, Volunteerism, Health Behaviors
- Medical subject headings
- Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health Worker TrainingsOther
Also called United States Peace Corps, Uganda Ministry of Health, Village Health Teams
| Study group | Role | What they receive |
|---|---|---|
| Community Health Worker Trainings | Experimental | 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. Receives: Other: Community Health Worker Trainings |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edward O'Neil Jr, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Makerere University, Peace Corps, Uganda Chartered Health Net, University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor-investigator, Edward O'Neil Jr, M.D., Omni Med
- Investigators
- Edward J O'Neil Jr, MD, Principal investigator, Omni Med
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045706
- Sponsor's protocol ID
- SS 2486
- Other IDs
- #81090
- Status last verified
- Jan 2014
- First submitted
- 22 Jan 2014
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02045706
- Acronym / sponsor ID
- SS 2486
- Conditions
- Health Knowledge, Attitudes, Practice
- Keywords
- Community Health Workers, Service, Volunteerism, Health Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,419 participants (actual)
- Lead sponsor
- Edward O'Neil Jr, M.D.University, hospital or other
- Collaborators
- Washington University School of Medicine, Makerere University, Peace Corps, Uganda Chartered Health Net, University of Illinois at Urbana-Champaign
- Study start
- Mar 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Health Worker Trainings | Experimental | Other: Community Health Worker TrainingsTrained 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. |
| Control Group | No intervention | –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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Community Health Worker TrainingsAlso: United States Peace Corps, Uganda Ministry of Health, Village Health Teams | Other | Community Health Worker Trainings |
Primary outcome
Questionnaire on health behaviors before and after implementation of a community health worker program
Time frame: One year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward J O'Neil Jr, MD principal investigator
Omni Med
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Worker Trainings in people with Health Knowledge, Attitudes, Practice, run by Edward O'Neil Jr, M.D. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire on health behaviors before and after implementation of a community health worker program (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2014.