Patient Care Clinical Trial
— BHOMAOfficial title:
CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)
Verified date | February 2017 |
Source | University of North Carolina, Chapel Hill |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
BHOMA Interventions
The purpose of this study is to assess the impact of the BHOMA intervention on health in 3
rural districts of Zambia.
Status | Completed |
Enrollment | 207517 |
Est. completion date | August 2016 |
Est. primary completion date | August 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: Intervention Sites The intervention will involve all of the health facilities in the Chongwe, Kafue and Luangwa districts. Exclusion Criteria Hospitals will be excluded from the intervention as they do not have discrete catchment populations. The intervention will be implemented by 6 teams each of which will use 1 facility as a pilot site to test out the intervention. The pilot sites will be excluded from the evaluation. Health facilities with catchment populations exclusively serving the armed forces will be excluded. Inclusion Criteria - All enumerated adults who are able to give written, informed consent. If an adult is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form. - All adolescents 10-17 years and children 5 years or less who have a parent or responsible guardian who is able to give written, informed consent. If the parent or guardian is illiterate they may be asked to give consent providing the information is read to them and it is established that they fully understand its contents and there is a witness available to witness the understanding of the information and the fingerprinting of the consent form. Exclusion Criteria - Any adult who is unable to give informed consent due to mental or other disability - Any adolescent or child who has no responsible parent or guardian - Any household member who has been absent from the house for more than 72 hours |
Country | Name | City | State |
---|---|---|---|
Zambia | Center for Infectious Disease Research in Zambia | Lusaka |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | Doris Duke Charitable Foundation |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Age standardized mortality rates in those aged <60 years. | The sample size is based on a mortality rate for those aged<60 years of 20/1000 person years, each of 3 cross sectional surveys recruits 150 households of whom 6 members are aged <60 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 87% power. | 4 years | |
Secondary | Mortality in those aged <5 years. | The sample size is based on a mortality rate for those aged<5 years of 35/1000 person years (equivalent to under-5 mortality of 168/1000), each of 3 cross sectional surveys recruits 150 households of whom 2 members are aged <5 years, and births and deaths within the household in the last 12 months are ascertained. For a values of k between 0.2 and 0.3 there is at least 90% power to detect a 35% reduction in mortality, and for k=0.35 there is approximately 84% power. | 4 years |
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