NCT01942278

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207,517

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

April 14, 2017

Status Verified

February 1, 2017

Enrollment Period

5.6 years

First QC Date

September 10, 2013

Last Update Submit

April 12, 2017

Conditions

Keywords

HealthcarePatients

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mortality in those aged <5 years.

    4 years

Study Arms (2)

Usual Care

NO INTERVENTION

Care is delivered according to baseline standard practice

BHOMA

EXPERIMENTAL

Care is delivered according to the BHOMA intervention

Other: BHOMA

Interventions

BHOMAOTHER

A complex health systems, clinical care, and community intervention to improve outcomes

BHOMA

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Intervention Sites The intervention will involve all of the health facilities in the Chongwe, Kafue and Luangwa districts.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Infectious Disease Research in Zambia

Lusaka, Zambia

Location

Related Publications (5)

  • Mutale W, Ayles H, Lewis J, Bosompraph S, Chilengi R, Tembo MM, Sharp A, Chintu N, Stringer J. Protocol-driven primary care and community linkage to reduce all-cause mortality in rural Zambia: a stepped-wedge cluster randomized trial. Front Public Health. 2023 Aug 31;11:1214066. doi: 10.3389/fpubh.2023.1214066. eCollection 2023.

  • Mutale W, Cleary S, Olivier J, Chilengi R, Gilson L. Implementing large-scale health system strengthening interventions: experience from the better health outcomes through mentoring and assessments (BHOMA) project in Zambia. BMC Health Serv Res. 2018 Oct 19;18(1):795. doi: 10.1186/s12913-018-3619-3.

  • Mwanza M, Zulu J, Topp SM, Musonda P, Mutale W, Chilengi R. Use of Lot quality assurance sampling surveys to evaluate community health worker performance in rural Zambia: a case of Luangwa district. BMC Health Serv Res. 2017 Apr 17;17(1):279. doi: 10.1186/s12913-017-2229-9.

  • Yan LD, Chirwa C, Chi BH, Bosomprah S, Sindano N, Mwanza M, Musatwe D, Mulenga M, Chilengi R. Hypertension management in rural primary care facilities in Zambia: a mixed methods study. BMC Health Serv Res. 2017 Feb 3;17(1):111. doi: 10.1186/s12913-017-2063-0.

  • Mutale W, Stringer J, Chintu N, Chilengi R, Mwanamwenge MT, Kasese N, Balabanova D, Spicer N, Lewis J, Ayles H. Application of balanced scorecard in the evaluation of a complex health system intervention: 12 months post intervention findings from the BHOMA intervention: a cluster randomised trial in Zambia. PLoS One. 2014 Apr 21;9(4):e93977. doi: 10.1371/journal.pone.0093977. eCollection 2014.

Study Officials

  • Jeffrey Stringer, MD

    UNC at Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

January 1, 2011

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

April 14, 2017

Record last verified: 2017-02

Locations