MalariaNCT02374580
Partnership and Dignity: a Mixed-methods Survey on Supporting and Retaining Uganda's Village Health Teams
An observational study of Malaria and Diarrhea, run by George Washington University at 1 site in United States.
Trial summary
For more than a decade, Uganda's Ministry of Health has led a community health worker program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the task of delivering preventative health services and education to their local communities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to May 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of at least 200 individual working VHT members, and at least 10 stakeholders, that is, program managers, administrators, district health officers, and policymakers. Almost all study subjects will be of Ugandan nationality. Some stakeholders may be expatriates.
Who may be able to join
- VHT subjects must have been actively working as a VHT member for at least 6 months. Stakeholders, that is, program managers, health administrators and policy makers, must be involved in managing, administrating, or guiding policy for VHT programs as part of their official job description. These persons must also have been acting in those roles for at least 6 months. All study subjects will be 18 years of age or older. All study subjects will be literate and able to be informed to give or withhold consent of participation.
Who cannot join
- There will be no exclusion or inclusion based on gender, race, tribal or ethnic affiliation, religion, or health status.
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University School of Medicine and Health Sciences
Washington D.C., District of Columbia, 20037
About this study
For more than a decade, Uganda's Ministry of Health has led a community health worker program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the task of delivering preventative health services and education to their local communities. Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health outcomes; however it is known that VHTs are not optimally supported, and there has been VHT attrition in recent years. The Ministry of Health has recognized the inadequate support of VHTs thus far and is aiming to "expand VHTs to all local governments and explore ways of sustaining VHTs." The objective of this study is to evaluate the extent to which material support is a deciding factor in the efficiency and durability of Uganda's VHT initiative. Material support may take the form of monetary stipends, regular payment, transportation assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study will review existing literature and gather novel data through surveys of VHT members and VHT stakeholders. The quantitative and qualitative survey data will be analyzed for trends that may point to a conclusion in the context of existing health policy discourse on community health worker remuneration. The purpose of this study is to strengthen the knowledge base on whether or not the current absence of material support significantly limits the potential for Uganda's VHTs to be sustained and expanded. This information can be used by governmental and non-governmental organizations in their work to strengthen and sustain VHTs throughout the country.
- Medical subject headings
- Malaria, Diarrhea, Pneumonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted longevity related to support sufficiency
This outcome will be measured by asking VHTs to rate aspects of their current support. We will follow up those questions by asking how long they expect to be able to continue in their position as VHTs. The two results will be evaluated for possible trends connecting sufficiency of existing support with predicted longevity.
Measured: Up to 5 months
Secondary outcomes (1)
Predicted longevity of minimum 10 years if current support does not increase
This outcome will be measured by asking the VHTs if they predict being able to continue in their positions for at least 10 more years if their current support does not increase.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Makerere University
- Responsible party
- Sponsor
- Investigators
- William S Schroth, MD MPH, Principal investigator, George Washington University School of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374580
- Sponsor's protocol ID
- VHT_041406
- Status last verified
- Aug 2015
- First submitted
- 4 Dec 2014
- Last updated
- 16 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ministry of Health, Uganda, Education and Promotion Division. Village health team strategy and operational guidelines. 2010.
Brenner JL, Kabakyenga J, Kyomuhangi T, Wotton KA, Pim C, Ntaro M, Bagenda FN, Gad NR, Godel J, Kayizzi J, McMillan D, Mulogo E, Nettel-Aguirre A, Singhal N. Can volunteer community health workers decrease child morbidity and mortality in southwestern Uganda? An impact evaluation. PLoS One. 2011;6(12):e27997. doi: 10.1371/journal.pone.0027997. Epub 2011 Dec 14.
PubMed 22194801Okello D, Floyd K, Adatu F, Odeke R, Gargioni G. Cost and cost-effectiveness of community-based care for tuberculosis patients in rural Uganda. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S72-9.
PubMed 12971657Kalyango JN, Rutebemberwa E, Alfven T, Ssali S, Peterson S, Karamagi C. Performance of community health workers under integrated community case management of childhood illnesses in eastern Uganda. Malar J. 2012 Aug 20;11:282. doi: 10.1186/1475-2875-11-282.
PubMed 22905758Kayemba Nalwadda C, Guwatudde D, Waiswa P, Kiguli J, Namazzi G, Namutumba S, Tomson G, Peterson S. Community health workers - a resource for identification and referral of sick newborns in rural Uganda. Trop Med Int Health. 2013 Jul;18(7):898-906. doi: 10.1111/tmi.12106. Epub 2013 Apr 2.
PubMed 23551394Ministry of Health Uganda. Annual Health Sector Performance Report: Financial Year 2012/2013. 2013.
Ministry of Health Uganda. The second national health policy. 2010.
Perry, H, et al. How effective are community health workers? an overview of current evidence with recommendations for strengthening community health worker programs to accelerate progress in achieving the health-related millennium development goals. Johns Hopkins University Bloomberg School of Public Health. 2012.
Lehmann U., Sanders D. Community health workers: what do we know about them? The state of the evidence on programmes, activities, costs and impact on health outcomes of using community health workers. (2007) Geneva: World Health Organization. Available at: <http://www.who.int/hrh/documents/community_health_ workers.pdf>
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnership and Dignity: a Mixed-methods Survey on Supporting and Retaining Uganda's Village Health Teams
- ClinicalTrials.gov ID
- NCT02374580
- Acronym / sponsor ID
- VHT_041406
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Makerere University
- Study start
- Feb 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Mar 2015 (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.
For more than a decade, Uganda's Ministry of Health has led a community health worker program model in which Village Health Teams (VHTs), cadres of unpaid volunteers, are assigned the task of delivering preventative health services and education to their local communities. Studies have demonstrated the effectiveness of Uganda's VHTs in improving certain health outcomes; however it is known that VHTs are not optimally supported, and there has been VHT attrition in recent years. The Ministry of Health has recognized the inadequate support of VHTs thus far and is aiming to "expand VHTs to all local governments and explore ways of sustaining VHTs." The objective of this study is to evaluate the extent to which material support is a deciding factor in the efficiency and durability of Uganda's VHT initiative. Material support may take the form of monetary stipends, regular payment, transportation assistance, or nonfinancial materials such as bicycles or mobile phone airtime. This study will review existing literature and gather novel data through surveys of VHT members and VHT stakeholders. The quantitative and qualitative survey data will be analyzed for trends that may point to a conclusion in the context of existing health policy discourse on community health worker remuneration. The purpose of this study is to strengthen the knowledge base on whether or not the current absence of material support significantly limits the potential for Uganda's VHTs to be sustained and expanded. This information can be used by governmental and non-governmental organizations in their work to strengthen and sustain VHTs throughout the country.
Study design
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of at least 200 individual working VHT members, and at least 10 stakeholders, that is, program managers, administrators, district health officers, and policymakers. Almost all study subjects will be of Ugandan nationality. Some stakeholders may be expatriates.
Key inclusion criteria (1 listed)
- VHT subjects must have been actively working as a VHT member for at least 6 months. Stakeholders, that is, program managers, health administrators and policy makers, must be involved in managing, administrating, or guiding policy for VHT programs as part of their official job description. These persons must also have been acting in those roles for at least 6 months. All study subjects will be 18 years of age or older. All study subjects will be literate and able to be informed to give or withhold consent of participation.
Key exclusion criteria (1 listed)
- There will be no exclusion or inclusion based on gender, race, tribal or ethnic affiliation, religion, or health status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predicted longevity related to support sufficiency
Time frame: Up to 5 months
This outcome will be measured by asking VHTs to rate aspects of their current support. We will follow up those questions by asking how long they expect to be able to continue in their position as VHTs. The two results will be evaluated for possible trends connecting sufficiency of existing support with predicted longevity.
1 secondary outcome
Predicted longevity of minimum 10 years if current support does not increase
Time frame: Up to 5 months
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 16 Jun 2016.
- BackgroundMinistry of Health, Uganda, Education and Promotion Division. Village health team strategy and operational guidelines. 2010.
- Background: PubMed 22194801Brenner JL, Kabakyenga J, Kyomuhangi T, Wotton KA, Pim C, Ntaro M, Bagenda FN, Gad NR, Godel J, Kayizzi J, McMillan D, Mulogo E, Nettel-Aguirre A, Singhal N. Can volunteer community health workers decrease child morbidity and mortality in southwestern Uganda? An impact evaluation. PLoS One. 2011;6(12):e27997. doi: 10.1371/journal.pone.0027997. Epub 2011 Dec 14.
- Background: PubMed 12971657Okello D, Floyd K, Adatu F, Odeke R, Gargioni G. Cost and cost-effectiveness of community-based care for tuberculosis patients in rural Uganda. Int J Tuberc Lung Dis. 2003 Sep;7(9 Suppl 1):S72-9.
- Background: PubMed 22905758Kalyango JN, Rutebemberwa E, Alfven T, Ssali S, Peterson S, Karamagi C. Performance of community health workers under integrated community case management of childhood illnesses in eastern Uganda. Malar J. 2012 Aug 20;11:282. doi: 10.1186/1475-2875-11-282.
- Background: PubMed 23551394Kayemba Nalwadda C, Guwatudde D, Waiswa P, Kiguli J, Namazzi G, Namutumba S, Tomson G, Peterson S. Community health workers - a resource for identification and referral of sick newborns in rural Uganda. Trop Med Int Health. 2013 Jul;18(7):898-906. doi: 10.1111/tmi.12106. Epub 2013 Apr 2.
- BackgroundMinistry of Health Uganda. Annual Health Sector Performance Report: Financial Year 2012/2013. 2013.
- BackgroundMinistry of Health Uganda. The second national health policy. 2010.
- BackgroundPerry, H, et al. How effective are community health workers? an overview of current evidence with recommendations for strengthening community health worker programs to accelerate progress in achieving the health-related millennium development goals. Johns Hopkins University Bloomberg School of Public Health. 2012.
- BackgroundLehmann U., Sanders D. Community health workers: what do we know about them? The state of the evidence on programmes, activities, costs and impact on health outcomes of using community health workers. (2007) Geneva: World Health Organization. Available at: <http://www.who.int/hrh/documents/community_health_ workers.pdf>
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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.
William S Schroth, MD MPH principal investigator
George Washington University School of Medicine and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malaria and Diarrhea, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Predicted longevity related to support sufficiency (time frame: Up to 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02374580, which also lists 9 linked publications.
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 16 Jun 2016.