Study Procedures
illness
TYPHOID FEVER, RESPIRATORY SYNCYTIAL VIRUS (RSV), INFLUENZA
Before enrollment, each patient provided written informed consent to participate in this study. For children aged 7 years and younger, a parent/guardian provided consent on their behalf. Children aged 8–17 years provided assent and their parent/guardian gave consent as well. Patients 18 years and older provided informed consent for themselves.For each of the 3 study sites, throughout the study all patients randomized to the intervention arm were seen by a clinical officer (prescriber) and a laboratory technologist hired by the study team. The intervention-arm prescribers and laboratory technologists were trained on aspects of the protocol—including informed-consent procedures, enrollment, randomization, how to use the diagnostic and treatment algorithm, how to use the POCTs, and delivering the T&C package—for 1 week prior to enrollment, and study co-investigators reinforced training messages and addressed questions during regular site visits and communication with intervention-arm staff during the course of the study. Patients randomized to the control arm received the standard-of-care from clinical officers (usually 1 to 3 in number depending on staffing norms at each site and on each day) and laboratory staff employed by the participating health facilities, who requested and performed laboratory testing and prescribed medicines according to their routine standard practice. The control-arm staff were aware that the study was being conducted but were not trained in intervention-arm procedures.The day of enrollment was designated as day 0. Eligible patients who consented were enrolled into the study and randomized to either the intervention arm or the control arm. In both study arms, vital signs were measured and a clinician took a history of the patient's illness, performed a physical exam, and recorded a preliminary diagnosis. In the intervention arm, the clinician applied the diagnostic and treatment algorithm (Point-of-care tests for the intervention arm included the following: Test-it Typhoid fever IgM rapid test kit (Life Assay Diagnostics); SD Bioline influenza Antigen A/B/A (H1N1) pandemic rapid test kit (Alere/Abbott); Alere BinaxNow respiratory syncytial virus (RSV) card; Streptococcus A test kit (Sekisui OSOM); Patients in both study arms received prescribed medicines free of charge from the dispensary at each health center, according to the government supplies and standard practice. All patients were asked to return to the health center 7 days after enrollment for assessment of the outcome of their illness and of adherence to the day 0 prescription. Adherence to prescription was assessed through pill counts conducted by study clinicians and in-depth interviews conducted by social science research assistants.