{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T12:11:08Z","timestamp":1790856668749,"version":"4.1.0"},"reference-count":34,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2023,8,31]],"date-time":"2023-08-31T00:00:00Z","timestamp":1693440000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Public Health"],"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p>While tremendous progress has been made in recent years to improve the health of people living in low- and middle-income countries (LMIC), significant challenges remain. Chief among these are poor health systems, which are often ill-equipped to respond to current challenges. It remains unclear whether intensive intervention at the health system level will result in improved outcomes, as there have been few rigorously designed comparative studies. We present results of a complex health system intervention that was implemented in Zambia using a cluster randomized design.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>BHOMA was a complex health system intervention comprising intensive clinical training and quality improvement measures, support for commodities procurement, improved community outreach, and district level management support. The intervention was introduced as a stepped wedge cluster-randomized trial in 42 predominately rural health centers and their surrounding communities in Lusaka Province, Zambia. Baseline survey was conducted between January\u2013May 2011, mid-line survey was conducted February\u2013November, 2013 and Endline survey, February\u2013November 2015.The primary outcome was all-cause mortality among those between 28\u2009days and 60\u2009years of age and assessed through community-based mortality surveys. Secondary outcomes included post-neonatal under-five mortality and service coverage scores. Service coverage scores were calculated across five domains (child preventative services; child treatment services; family planning; maternal health services, and adult health services). We fit Cox proportional hazards model with shared frailty at the cluster level for the primary analysis. Mortality rates were age-standardized using the WHO World Standard Population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Mortality declined substantially from 3.9 per 1,000 person-years in the pre-intervention period, to 1.5 per 1,000 person-years in the post intervention period. When we compared intervention and control periods, there were 174 deaths in 49,230 person years (age-standardized rate\u2009=\u20094.4 per 1,000 person-years) in the control phase and 277 deaths in 74,519 person years (age-standardized rate\u2009=\u20094.6 per 1,000 person-years) in the intervention phase. Overall, there was no evidence for an effect of the intervention in minimally-adjusted [hazard ratio (HR)\u2009=\u20091.18; 95% confidence interval (CI): 0.88, 1.56; value of <jats:italic>p<\/jats:italic> =\u20090.265], or adjusted (HR\u2009=\u20091.12; 95% CI: 0.84, 1.49; value of <jats:italic>p<\/jats:italic> =\u20090.443) analyses.<\/jats:p><jats:p>Coverage scores that showed some evidence of changing with time since the cluster joined the intervention were: an increasing proportion of children sleeping under insecticide treated bed-net (value of <jats:italic>p<\/jats:italic> &amp;lt; 0.001); an increasing proportion of febrile children who received appropriate anti-malarial drugs (value of <jats:italic>p<\/jats:italic> =\u20090.039); and an increasing proportion of ever hypertensive adults with currently controlled hypertension (value of <jats:italic>p<\/jats:italic> =\u20090.047). No adjustments were made for multiple-testing and the overall coverage score showed no statistical evidence for a change over time (value of <jats:italic>p<\/jats:italic> =\u20090.308).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We noted an overall reduction in post-neonatal under 60 mortality in the study communities during the period of our study, but this could not be attributed to the BHOMA intervention. Some improvements in service coverage scores were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Clinical Trial Registration<\/jats:title><jats:p><jats:ext-link>clinicaltrials.gov<\/jats:ext-link>, Identifier NCT01942278.<\/jats:p><\/jats:sec>","DOI":"10.3389\/fpubh.2023.1214066","type":"journal-article","created":{"date-parts":[[2023,8,31]],"date-time":"2023-08-31T12:03:36Z","timestamp":1693483416000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":5,"title":["Protocol-driven primary care and community linkage to reduce all-cause mortality in rural Zambia: a stepped-wedge cluster randomized trial"],"prefix":"10.3389","volume":"11","author":[{"given":"Wilbroad","family":"Mutale","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Ayles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Lewis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samuel","family":"Bosompraph","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roma","family":"Chilengi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret M.","family":"Tembo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ab","family":"Sharp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namwinga","family":"Chintu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Stringer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2023,8,31]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"e1000059","DOI":"10.1371\/journal.pmed.1000059","article-title":"Global health actors claim to support health system strengthening: is this reality or rhetoric?","volume":"6","author":"Marchal","year":"2009","journal-title":"PLoS Med"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"1423","DOI":"10.1016\/S0140-6736(17)32336-X","article-title":"Measuring progress and projecting attainment on the basis of past trends of the health-related sustainable development goals in 188 countries: an analysis from the global burden of disease study 2016","volume":"390","author":"Collaborators","year":"2017","journal-title":"Lancet"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"3027","DOI":"10.1016\/S0140-6736(16)31593-8","article-title":"Global, regional, and national causes of under-5 mortality in 2000\u201315: an updated systematic analysis with implications for the sustainable development goals","volume":"388","author":"Liu","year":"2016","journal-title":"Lancet"},{"key":"ref4","doi-asserted-by":"publisher","first-page":"1084","DOI":"10.1016\/S0140-6736(17)31833-0","article-title":"Global, regional, and national under-5 mortality, adult mortality, age-specific mortality, and life expectancy, 1970-2016: a systematic analysis for the global burden of disease study 2016","volume":"390","author":"Collaborators","year":"2017","journal-title":"Lancet"},{"key":"ref5","volume-title":"Global sustainable development report 2019: The future is now \u2013 Science for achieving sustainable development","year":"2019"},{"key":"ref6","doi-asserted-by":"publisher","first-page":"e1196","DOI":"10.1016\/S2214-109X(18)30386-3","article-title":"High-quality health systems in the sustainable development goals era: time for a revolution","volume":"6","author":"Kruk","year":"2018","journal-title":"Lancet Glob Health"},{"key":"ref7","doi-asserted-by":"publisher","first-page":"439","DOI":"10.1111\/jep.12354","article-title":"Application of systems thinking: 12-month postintervention evaluation of a complex health system intervention in Zambia: the case of the BHOMA","volume":"23","author":"Mutale","year":"2017","journal-title":"J Eval Clin Pract"},{"key":"ref8","doi-asserted-by":"publisher","first-page":"S7","DOI":"10.1186\/1472-6963-13-S2-S7","article-title":"Protocol-driven primary care and community linkages to improve population health in rural Zambia: the better health outcomes through mentoring and assessment (BHOMA) project","volume":"13","author":"Stringer","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"ref9","doi-asserted-by":"publisher","first-page":"960","DOI":"10.1186\/s12889-015-2259-3","article-title":"Frequency of HIV-testing and factors associated with multiple lifetime HIV-testing among a rural population of Zambian men","volume":"15","author":"Hensen","year":"2015","journal-title":"BMC Public Health"},{"key":"ref10","doi-asserted-by":"publisher","first-page":"8","DOI":"10.1186\/1478-4491-11-8","article-title":"Measuring health workers' motivation in rural health facilities: baseline results from three study districts in Zambia","volume":"11","author":"Mutale","year":"2013","journal-title":"Hum Resour Health"},{"key":"ref11","doi-asserted-by":"publisher","first-page":"112","DOI":"10.1111\/jep.12160","article-title":"Application of system thinking concepts in health system strengthening in low-income settings: a proposed conceptual framework for the evaluation of a complex health system intervention: the case of the BHOMA intervention in Zambia","volume":"22","author":"Mutale","year":"2016","journal-title":"J Eval Clin Pract"},{"key":"ref12","doi-asserted-by":"publisher","first-page":"291","DOI":"10.1186\/1472-6963-13-291","article-title":"Systems thinking in practice: the current status of the six WHO building blocks for health system strengthening in three BHOMA intervention districts of Zambia: a baseline qualitative study","volume":"13","author":"Mutale","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"ref13","doi-asserted-by":"publisher","first-page":"S9","DOI":"10.1186\/1472-6963-13-S2-S9","article-title":"Improving health information systems for decision making across five sub-Saharan African countries: implementation strategies from the African health initiative","volume":"13","author":"Mutale","year":"2013","journal-title":"BMC Health Serv Res"},{"key":"ref14","doi-asserted-by":"publisher","first-page":"795","DOI":"10.1186\/s12913-018-3619-3","article-title":"Implementing large-scale health system strengthening interventions: experience from the better health outcomes through mentoring and assessments (BHOMA) project in Zambia","volume":"18","author":"Mutale","year":"2018","journal-title":"BMC Health Serv Res"},{"key":"ref15","doi-asserted-by":"publisher","first-page":"e58650","DOI":"10.1371\/journal.pone.0058650","article-title":"Measuring health system strengthening: application of the balanced scorecard approach to rank the baseline performance of three rural districts in Zambia","volume":"8","author":"Mutale","year":"2013","journal-title":"PLoS One"},{"key":"ref16","doi-asserted-by":"publisher","first-page":"277","DOI":"10.1186\/s12889-017-4187-x","article-title":"Exploring community participation in project design: application of the community conversation approach to improve maternal and newborn health in Zambia","volume":"17","author":"Mutale","year":"2017","journal-title":"BMC Public Health"},{"key":"ref17","doi-asserted-by":"publisher","first-page":"34","DOI":"10.1186\/1472-698X-13-34","article-title":"Measuring governance at health facility level: developing and validation of simple governance tool in Zambia","volume":"13","author":"Mutale","year":"2013","journal-title":"BMC Int Health Hum Rights"},{"key":"ref18","doi-asserted-by":"publisher","first-page":"e93977","DOI":"10.1371\/journal.pone.0093977","article-title":"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","volume":"9","author":"Mutale","year":"2014","journal-title":"PLoS One"},{"key":"ref19","doi-asserted-by":"publisher","first-page":"279","DOI":"10.1186\/s12913-017-2229-9","article-title":"Use of lot quality assurance sampling surveys to evaluate community health worker performance in rural Zambia: a case of Luangwa district","volume":"17","author":"Mwanza","year":"2017","journal-title":"BMC Health Serv Res"},{"key":"ref20","doi-asserted-by":"publisher","first-page":"721","DOI":"10.1089\/tmj.2013.0240","article-title":"A mobile phone-based, community health worker program for referral, follow-up, and service outreach in rural Zambia: outcomes and overview","volume":"20","author":"Schuttner","year":"2014","journal-title":"Telemed J E Health"},{"key":"ref21","doi-asserted-by":"publisher","first-page":"933","DOI":"10.1186\/s12889-015-2258-4","article-title":"Prevalence of hypertension and its treatment among adults presenting to primary health clinics in rural Zambia: analysis of an observational database","volume":"15","author":"Yan","year":"2015","journal-title":"BMC Public Health"},{"key":"ref22","doi-asserted-by":"publisher","first-page":"111","DOI":"10.1186\/s12913-017-2063-0","article-title":"Hypertension management in rural primary care facilities in Zambia: a mixed methods study","volume":"17","author":"Yan","year":"2017","journal-title":"BMC Health Serv Res"},{"key":"ref23","doi-asserted-by":"publisher","first-page":"6","DOI":"10.1186\/1741-7015-12-6","article-title":"Integrated care as a means to improve primary care delivery for adults and adolescents in the developing world: a critical analysis of integrated Management of Adolescent and Adult Illness (IMAI)","volume":"12","author":"Vasan","year":"2014","journal-title":"BMC Med"},{"key":"ref24","doi-asserted-by":"publisher","first-page":"571","DOI":"10.4269\/ajtmh.94-3intro2","article-title":"Integrated community case Management of Childhood Illness: what have we learned?","volume":"94","author":"Daelmans","year":"2016","journal-title":"Am J Trop Med Hyg"},{"key":"ref25","doi-asserted-by":"publisher","first-page":"S46","DOI":"10.1016\/j.ijgo.2015.03.007","article-title":"Essential basic and emergency obstetric and newborn care: from education and training to service delivery and quality of care","volume":"130","author":"Otolorin","year":"2015","journal-title":"Int J Gynecol Obstet"},{"key":"ref26","doi-asserted-by":"publisher","first-page":"1460","DOI":"10.1016\/S0140-6736(05)67599-X","article-title":"Co-coverage of preventive interventions and implications for child-survival strategies: evidence from national surveys","volume":"366","author":"Victora","year":"2005","journal-title":"Lancet"},{"key":"ref27","doi-asserted-by":"publisher","first-page":"78","DOI":"10.1186\/s12978-019-0741-6","article-title":"Factors associated with use of injectables, long-acting and permanent contraceptive methods (iLAPMs) among married women in Zambia: analysis of demographic and health surveys, 1992-2014","volume":"16","author":"Bakibinga","year":"2019","journal-title":"Reprod Health"},{"key":"ref28","volume-title":"Cluster randomised trials, second edition","author":"Hayes","year":"2017"},{"key":"ref29","doi-asserted-by":"publisher","first-page":"e000674","DOI":"10.1136\/bmjgh-2017-000674","article-title":"Impact of a health system strengthening intervention on maternal and child health outputs and outcomes in rural Rwanda 2005-2010","volume":"3","author":"Thomson","year":"2018","journal-title":"BMJ Glob Health"},{"key":"ref30","doi-asserted-by":"publisher","first-page":"e000762","DOI":"10.1136\/bmjgh-2018-000762","article-title":"Early changes in intervention coverage and mortality rates following the implementation of an integrated health system intervention in Madagascar","volume":"3","author":"Garchitorena","year":"2018","journal-title":"BMJ Glob Health"},{"key":"ref31","doi-asserted-by":"publisher","first-page":"e0218025","DOI":"10.1371\/journal.pone.0218025","article-title":"The child survival impact of the Ghana essential health interventions program: a health systems strengthening plausibility trial in northern Ghana","volume":"14","author":"Bawah","year":"2019","journal-title":"PLoS One"},{"key":"ref32","doi-asserted-by":"publisher","first-page":"1764","DOI":"10.1016\/j.socscimed.2010.03.051","article-title":"\u201cThese are not good things for other people to know\u201d: how rural Tanzanian women\u2019s experiences of pregnancy loss and early neonatal death may impact survey data quality","volume":"71","author":"Haws","year":"2010","journal-title":"Soc Sci Med"},{"key":"ref33","doi-asserted-by":"publisher","first-page":"89","DOI":"10.1016\/j.jclinepi.2018.11.013","article-title":"Systematic review showed that stepped-wedge cluster randomized trials often did not reach their planned sample size","volume":"107","author":"Eichner","year":"2019","journal-title":"J Clin Epidemiol"},{"key":"ref34","doi-asserted-by":"publisher","first-page":"55","DOI":"10.1016\/j.cct.2015.07.006","article-title":"Current issues in the design and analysis of stepped wedge trials","volume":"45","author":"Hughes","year":"2015","journal-title":"Contemp Clin Trials"}],"container-title":["Frontiers in Public Health"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2023.1214066\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,31]],"date-time":"2023-08-31T12:03:40Z","timestamp":1693483420000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fpubh.2023.1214066\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,31]]},"references-count":34,"alternative-id":["10.3389\/fpubh.2023.1214066"],"URL":"https:\/\/doi.org\/10.3389\/fpubh.2023.1214066","relation":{},"ISSN":["2296-2565"],"issn-type":[{"value":"2296-2565","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,8,31]]},"article-number":"1214066"}}