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A Cluster-Randomized Controlled Trial of Handrubs for Prevention of Infectious Diseases Among Children in Colombia

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A Cluster-Randomized Controlled Trial of Handrubs for Prevention of Infectious Diseases Among Children in Colombia Investigación original / Original research A cluster-randomized controlled trial of handrubs for prevention of infectious diseases among children in Colombia Juan C. Correa,1 Diana Pinto,2 Lucas A. Salas,1 Juan C. Camacho,1 Martín Rondón,3 and Juliana Quintero 4 Suggested citation Correa JC, Pinto D, Salas LA, Camacho JC, Rondón M, Quintero J. A cluster-randomized controlled trial of handrubs for prevention of infectious diseases among children in Colombia. Rev Panam Salud Publica. 2012;31(6):476–84. ABSTRACT Objective. To evaluate the effectiveness of alcohol-based handrubs (ABH) in reducing acute diarrheal diseases (ADD) and acute respiratory infections (ARI) among children 1–5 years of age in childcare centers with limited tap water. Methods. This was the first cluster-randomized controlled trial in a developing country. The study took place at 42 childcare centers with sporadic and limited water availability in six towns in Colombia. Participants were randomly assigned to use ABH as a complement to handwashing (intervention arm: 21 centers/794 children); or to continue existing hand- washing practices (control arm: 21 centers/933 children). ADD and ARI cases were identified through teacher-reported signs and symptoms of illness. Adverse events were monitored. Hazard ratios (HR) were obtained using Cox proportional hazards multivariate regression shared frailty models. Results. Child-days of surveillance totaled 336 038. Loss to follow up was 14.5%. For both ADD and ARI, there were no differences in hazard ratios during the first trimester of the study. In the second and third trimesters, significant reductions in the risk of ADD were found in the intervention compared to control arm (HR = 0.55, P < 0.001 and HR = 0.44, P < 0.001, respectively). There were also significant risk reductions for ARI in the second trimester (HR = 0.80, P < 0.05) and in the third trimester (HR = 0.69, P < 0.001). No adverse events occurred. Conclusions. ABH effectively prevent ADD and ARI, and are safe. Colombia’s national public health policies for prevention of these diseases should include use of ABH, especially in settings where handwashing with soap and water is limited by water availability. Trial registration. Clinical Trials.gov ID: NCT00963391. Key words Handwashing; anti-infective agents, local; gastrointestinal diseases; respiratory tract infections; diarrhea; ethanol; child, preschool; developing countries; randomized controlled trials as topic; Colombia. 1 División de Salud Comunitaria, Fundación Santa Fe de Bogotá, Bogotá, Colombia. Send correspon- In the developing world, acute diar- years (DALYs) to the global burden of dence to Juan C. Correa, [email protected] rheal disease (ADD) and acute respira- disease in 2000, and ADD, another 45 2 Fedesarrollo, Bogotá, Colombia. 3 Departamento de Epidemiología Clínica y tory infection (ARI) are leading causes million (2). In Colombia, these diseases Bioestadística, Pontificia Universidad Javeriana, of morbidity and mortality in children ranked among the first five causes of Bogotá, Colombia. 4 Centro de Estudios e Investigaciones en Salud, under 5 years of age (1). ARI contrib- DALYs in the 0–4 year age group (3). Fundación Santa Fe de Bogotá, Bogotá, Colombia. uted 67 million disability adjusted life Increased efforts to prevent and control 476 Rev Panam Salud Publica 31(6), 2012 Correa et al. • Handrubs for infectious disease prevention among children in Colombia Original research these diseases are needed to achieve the ban settings in Colombia. The study pro- participation was requested. A baseline Millennium Development Goal of re- tocol was approved by the Institutional survey of child and household risk fac- ducing under-5 child mortality rates by Review Board of the Fundación Santa Fe tors for ADD and ARI was administered two-thirds (4). de Bogotá, Code No. 0000 8353 (Bogotá, to the principal caregiver. Hands are one of the most important Colombia). The protocol included a pilot transmission routes for ADD and ARI (5, study conducted in two childcare centers Intervention 6). Handwashing with soap and water during 2007 to field test the study instru- (HSW) is a key practice in preventing ments adapted from previous work (13, The trial ran from 16 April to 18 De- these illnesses (7, 8). Unfortunately, a 16), to test trial procedures, and to obtain cember 2008. For centers assigned to large proportion of the population bur- estimates for sample size parameters. No the intervention arm, ABH and training dened by these diseases lives in places pilot centers participated in the trial. on proper use were provided to staff where water is either a scarce natural re- and children. One ABH dispenser was source or availability is limited by infra- Participants installed in each center with fewer than structure deficiencies (9, 10). Therefore, 14 children; in larger centers, one dis- identifying hand hygiene (HH) alterna- Eligible childcare centers were either penser was installed per classroom, plus tives for these scenarios is a priority. “community homes” or preschools li- an additional one for common areas in The practicality of HSW in high- censed to care for 12 or more children those centers with more than 28 children. demand settings, such as schools, poses 1–5 years of age for 8 hours a day, 5 Dispensers were refilled continuously barriers to HH. In Bogotá, Colombia, a times per week, and where availability throughout the trial with ethanol 62.0% study of determinants of HH behavior of tap water was limited. Limited tap (Purell®, GOJO Industries, Akron, Ohio, of 6th–8th grade students in 25 schools water availability was defined as inter- United States), which was chosen be- found that less than one-third of the ruptions in water provision lasting 24 cause it has been used in other commu- students practiced HH recommenda- hours or more at least once a week, or nity interventions and is available in Co- tions, and adoption of HSW was affected lasting several hours per day every day. lombia. Proper use of ABH was ensured by irregular availability of soap and “Community homes” were homes of by: (i) a pre-trial ABH use workshop that proper functioning of hand sinks (11). local caregivers trained in basic child- followed recommended HH teaching In the health care community, where care, where a maximum of 14 children techniques (6, 8, 17–20) and instructed HH is recognized as essential for infec- spend the day in a dedicated room with teachers to add ABH to routine HH and tion prevention, international literature a bathroom, often without a hand sink. give preference to HSW if hands were has shown that failure to adhere to HH Preschools have two to eight age-specific visibly soiled; (ii) location of visual re- guidelines is common, requiring adop- classrooms (maximum 32 children) over- minders on ABH technique in bathrooms tion of a wide array of strategies to im- seen by teachers with formal training. and next to dispensers; and (iii) provision prove compliance (12). These facilities had one or more bath- of monthly 30-minute ABH technique Alcohol-based handrubs (ABH) could rooms with hand sinks that were often refresher workshops (eight per center). be an option for the above situations. In- non-functioning. Prior to trial initiation, skin sensitivity tervention studies examining the impact A total of 46 eligible centers were tests for ABH were applied to all staff of ABH with and without HSW have identified in 2007 by administering an and children. Adverse reactions were been conducted in North America and HH infrastructure and practices survey monitored and upon suspicion, children Europe. Although positive effects were to all 82 institutions listed in the official were examined by a physician. Safety found, methodological shortcomings of preschool database of Bogotá and five conditions, proper use of each dispenser, these studies preclude conclusions about neighboring towns: Anapoima, Espinal, and amount of ABH used were moni- the effectiveness of ABH (5, 13). ABH La Mesa, Melgar, and Soacha. Within tored bi-weekly. The amount of ABH have not been tested as a strategy for HH centers, eligible children were those 1–5 used was quantified by recording the in developing countries, though there years of age as of January 2008, with no volume supplied to each center. is evidence of their efficacy in reduc- previous history of chronic illness pre- Centers assigned to the control arm ing microbiological burden in secondary disposing to infectious disease. were simply told to continue their cur- schools and in community settings in Recruitment of trial participants began rent practices; placebo was not provided Africa and Asia (14–15). The study objec- in January 2008. Approval to conduct the as it would be unethical to use an inac- tive was to evaluate the effectiveness of trial was obtained from the respective tive HH product. ABH availability and training in its use national and local education authorities. on ADD and ARI incidence among chil- Agreement to participate was requested Sample size dren 1–5 years of age in childcare centers from center directors during an intro- with limited tap water. ductory meeting conducted with all cen- Target sample sizes of 147 children per ter staff during which trial procedures ADD arm and 62 children per ARI arm METHODS were explained and general information were determined based on requiring about HH (germ theory, hand washing 80% power to detect a 30% reduction in Study design technique, and key HH moments) was ADD and ARI based on incidence den- provided. Each parent/guardian was sities observed during the pilot study A cluster-randomized control trial was contacted through the childcare center (1.23 ADD and 2.91 ARI cases per child- conducted in childcare centers in six ur- and informed-consent for the child’s year). A test of 5.0% significance level Rev Panam Salud Publica 31(6), 2012 477 Original research Correa et al.
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