Whidden 2019a.

Study name	Proactive community case management and child survival: protocol for a cluster randomised controlled trial
Methods	Unblinded, cluster‐randomized controlled trial
Participants	Children aged < 5 years and their caregivers
Interventions	Intervention Proactive iCCM: LHWs (CHWs) conduct daily proactive case‐finding home visits and deliver doorstep counsel, care, referral and follow‐up "In clusters assigned to the intervention arm, CHW(s) will be trained and deployed to conduct proactive case finding, door‐to‐door home visits for at least 2 hours each day, 6 days a week, with the goal of visiting each household at least two times each month. During the home visit, CHWs will screen all household members for recent illness or symptoms and provide services at the home, including follow‐up for sick children and adults, pregnant women, newborns and postpartum mothers. In addition to home visits, ProCCM CHWs will provide care at their community health site for at least 2 hours a day, 6 days per week, according to a calendar shared with the community. At the health site, CHWs will provide the same services as those offered by CHWs in the control arm to care‐seeking patients." P. 4. Comparison Usual health services, including iCCM by CHWs at fixed sites within communities
Outcomes	Primary outcome Under‐5 mortality: deaths among children aged < 5 years per 1000 person‐years at risk of mortality Secondary outcomes Infant mortality (deaths per 1000 live births among children aged 0–11 months) Newborn mortality (deaths per 1000 live births among children aged 0–28 days) Pregnancy‐related mortality ratio (number of deaths among women while pregnant or within 42 days of delivery or termination per 100,000 live births per year) if there is sufficient and robust data to do so. Receipt of ORS and zinc within 24 hours of diarrhoea onset among children aged < 5 years Receipt of diagnostic testing or effective treatment (or both) for malaria within 24 hours of fever onset among children aged < 5 years Evaluation by a qualified provider within 24 hours of symptom onset among children aged < 5 years with cough or fast breathing (or both) Receipt of ≥ 3 doses of sulphadoxine–pyrimethamine as intermittent preventive treatment during a woman's most recent pregnancy Comparison Usual health services, including iCCM by CHWs at fixed sites within communities
Starting date	Baseline: December 2016 to February 2017 Implementation: February 2017
Contact information	Caroline Whidden; cwhidden@musohealth.org
Notes	Objective: to generate evidence on the efficacy, cost‐effectiveness and equity of door‐to‐door proactive case detection by CHWs on access to care and child mortality. P. 1. Location: 69 village clusters (intervention arm) and 68 village clusters (control arm) in Bankass health district of the Mopti region in Mali. Funding source: resources received by Muso though unrestricted funding as well as dedicated research funding from Child Relief International Foundation, Grand Challenges Canada, Johnson & Johnson Foundation and USAID Development Innovation Ventures. Child Relief International Foundation serves as the nonlegal sponsor of the trial." P. 8. Other notes: original protocol published as: Whidden 2019a at ClinicalTrials.gov: NCT02694055; subsequently the protocol was published as: Whidden C, Treleaven E, Liu J, et al. Proactive community case management and child survival: protocol for a cluster randomised controlled trial BMJ Open 2019;9:e027487. doi: 10.1136/bmjopen‐2018‐027487.

ASHA: Accredited Social Health Activists; CCM: community case management; CHW: community health worker; iCCM: integrated community case management; IMCI: integrated management of childhood illness; LHS: lady health supervisor; LHW: lady health worker; ORS: oral rehydration salts; UNICEF: United Nations Children's Fund; USAID: United States Agency for International Development; WHO: World Health Organization.