The implementation and effectiveness of multi-tasked, paid community health workers on maternal and child health: A cluster-randomized pragmatic trial and qualitative process evaluation in Tanzania.

Community health worker programs have proliferated worldwide based on evidence that they help prevent mortality, particularly among children. However, there is limited evidence from randomized studies on the processes and effectiveness of implementing community health worker programs through public health systems. This paper describes the results of a cluster-randomized pragmatic implementation trial (registration number [ISRCTN96819844][1]) and qualitative process evaluation of a community health worker program in Tanzania that was implemented from 2011-2015. Program effects on maternal, newborn and child health service utilization, childhood morbidity and sick childcare seeking were evaluated using difference-in-difference regression analysis with outcomes measured through pre- and post-intervention household surveys in intervention and comparison trial arms. A qualitative process evaluation was conducted between 2012 and 2014 and comprised of in-depth interviews and focus group discussions with community health workers, community members, facility-based health workers and staff of district health management teams. The community health worker program reduced incidence of childhood illness and improved access to timely and appropriate sick childcare; however, there was no effect on maternal, newborn and child health service utilization. The positive outcomes occurred because of high levels of acceptability of community health workers within communities, as well as the durability of community health workers’ motivation and confidence. Implementation factors that generated these effects were the engagement of communities in program startup; the training, remuneration and supervision of the community health workers from the local health system and community. The lack of program effects on maternal, newborn and child health service utilization were attributed to lapses in the availability of needed care at facilities and of working materials among community health workers. Strategies that strengthen and align communities’ and health systems core capacities, and their ability to learn, adapt and integrate evidence-based interventions, are needed to maximize the health impact of community health workers. ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN96819844 ### Clinical Protocols ### Funding Statement Funding from this work came from the Doris Duke Charitable Foundation (grant number DDCF2009058a) and Comic Relief UK (grant number 112259). The funders played no role in the research, program implementation and analysis described in this paper. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Approval for this study was granted by the ethical review boards of the IHI (IHI/IRB/No. 16-2010), the National Institute for Medical Research of Tanzania (NIMR/HQ/R.8a/Vol.IX/1203), and the Institutional Review Board of Columbia University Medical Center (Protocol AAF3452). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data cannot be shared publicly but can be made available subject to the approval of a material transfer agreement between parties interested in obtaining the data and the National Medical Research Coordinating Committee of the National Institutes of Medical Research of Tanzania. The MTA and application instructions are available at: https://healthresearchwebafrica.org.za/files/MTA.pdf). Those interested in obtaining the data should also contact the corresponding author for assistance with the Material Transfer Agreement. Powered [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN96819844