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Better Health Outcomes Through Mentoring and Assessment (BHOMA) (BHOMA)

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ClinicalTrials.gov Identifier: NCT01942278
Recruitment Status : Completed
First Posted : September 13, 2013
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Doris Duke Charitable Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Brief Summary:

BHOMA Interventions

The purpose of this study is to assess the impact of the BHOMA intervention on health in 3 rural districts of Zambia.


Condition or disease Intervention/treatment Phase
Patient Care Other: BHOMA Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207517 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: CIDRZ 1229- Better Health Outcomes Through Mentoring and Assessment (BHOMA)
Actual Study Start Date : January 2011
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Arm Intervention/treatment
No Intervention: Usual Care
Care is delivered according to baseline standard practice
Experimental: BHOMA
Care is delivered according to the BHOMA intervention
Other: BHOMA
A complex health systems, clinical care, and community intervention to improve outcomes




Primary Outcome Measures :
  1. Age standardized mortality rates in those aged <60 years. [ Time Frame: 4 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.


Secondary Outcome Measures :
  1. Mortality in those aged <5 years. [ Time Frame: 4 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942278


Locations
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Zambia
Center for Infectious Disease Research in Zambia
Lusaka, Zambia
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Doris Duke Charitable Foundation
Investigators
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Principal Investigator: Jeffrey Stringer, MD UNC at Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01942278     History of Changes
Other Study ID Numbers: CIDRZ 1229
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: February 2017
Keywords provided by University of North Carolina, Chapel Hill:
Healthcare
Patients