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Rapid diagnostic tests (RDTs) have the potential to identify infectious diseases quickly, minimize disease transmission, and could complement and improve surveillance and control of infectious and vector-borne diseases during outbreaks. The U.S. Defense Threat Reduction Agency's Joint Science and Technology Office (DTRA-JSTO) program set out to develop novel point-of-need RDTs for infectious diseases and deploy them for home use with no training. The aim of this formative study was to address two questions: 1) could community members in Iquitos, Peru and Phnom Penh, Cambodia competently use RDTs of different levels of complexity at home with visually based instructions provided, and 2) if an RDT were provided at no cost, would it be used at home if family members displayed febrile symptoms? Test kits with written and video (Peru only) instructions were provided to community members (Peru [n = 202]; Cambodia [n = 50]) or community health workers (Cambodia [n = 45]), and trained observers evaluated the competency level for each of the several steps required to successfully operate one of two multiplex RDTs on themselves or other consenting participant (i.e., family member). In Iquitos, >80% of residents were able to perform 11/12 steps and 7/15 steps for the two- and five-pathogen test, respectively. Competency in Phnom Penh never reached 80% for any of the 12 or 15 steps for either test; the percentage of participants able to perform a step ranged from 26–76% and 23–72%, for the two- and five-pathogen tests, respectively. Commercially available NS1 dengue rapid tests were distributed, at no cost, to households with confirmed exposure to dengue or Zika virus; of 14 febrile cases reported, six used the provided RDT. Our findings support the need for further implementation research on the appropriate level of instructions or training needed for diverse devices in different settings, as well as how to best integrate RDTs into existing local public health and disease surveillance programs at a large scale. Author summary: Rapid diagnostic tests (RDTs) are becoming increasingly available and are useful during outbreaks of infectious and vector-borne diseases. This study set out to answer two questions regarding the use of RDTs in community settings. First, how well could community members at two diverse sites–Iquitos, Peru and Phnom Penh, Cambodia–perform an RDT on themselves and willing family members with only written and/or video instructions, and with two tests of different complexity? Second, and only in Iquitos, if RDTs were made widely available at no cost to households, would residents choose to use one for a family member showing febrile symptoms? In Peru, 202 community members were provided written and/or video instructions and a test kit, and then were observed operating the RDT on themselves or family members in their own homes. In Cambodia, 45 Community Health Workers and 50 community members were provided only written instructions at a local health center and asked to carry out the test. In both locations, trained observers scored each of the 12–15 steps necessary to conduct the test on a 3-point scale (1 being lowest proficiency level, 3 being highest), for one of the two RDTs in this study. In Iquitos, >80% of residents were able to perform 11/12 steps and 7/15 steps for the two- and five-pathogen test, respectively. Competency in Phnom Penh never reached 80% for any of the 12 or 15 steps for either test, with the percentage of participants demonstrating high competency ranging from 26–76% and 23–72%, for the two- and five-pathogen tests, respectively. Finally, in Iquitos, RDTs were distributed to households with earlier confirmed cases of dengue or Zika virus: about half of all household members that developed fevers were self-tested or tested by another family member. This study is consistent with our earlier findings from focus group discussions suggesting that implementation of simple home-based rapid diagnostic devices, could be used in different settings, but further research is needed to determine the best type and level of instructions to do this. [ABSTRACT FROM AUTHOR]

In 2012, the U.S. Defense Threat Reduction Agency Joint Science and Technology Office initiated a program to develop novel point-of-need diagnostic devices for surveillance of emerging infectious diseases including dengue, malaria, plague, and melioidosis. Prior to distribution of devices to observe their correct use among community members in Iquitos, Peru, and Phnom Penh, Cambodia, research was conducted to: 1) assess acceptability of use, including the motivation to use a rapid diagnostic test (RDT) before or instead of seeking care at a health facility, 2) explore comprehension of RDT use instructions, and 3) examine possible strategies for large scale RDT distribution and use at each site. In February 2014, 9 focus group discussions (FGD) with community members and 5 FGD with health professionals were conducted in Iquitos, and 9 FGD with community members and 9 in-depth interviews with health professionals in Phnom Penh. In both places, participants agreed to use the device themselves (involving finger prick) or could identify someone who could do so in their home or neighborhood. The main incentive to RDT use in both sites was the ability for device results to be used for care facilitation (post confirmatory tests), specifically reduced wait times to be seen or obtain a diagnosis. Comprehension of RDT use instructions was assessed in Iquitos by asking some participants to apply the device to research team members; after watching a short video, most steps were done correctly. In Phnom Penh, participants were asked to describe each step after reading the instructions; they struggled with comprehension. Health professionals' main concerns in both sites were their community's ability to accurately use the test, handle complicated instructions, and safety (i.e., disposal of lancets). Health system structure and ability to use home diagnostic devices varied in the two disease endemic sites, with substantial challenges in each, suggesting the need for different strategies for RDT large scale community use, and illustrating the value of formative research before deployment of novel technologies. Development and use of devices to diagnose infectious diseases outside of health facilities (i.e., at home or in remote areas) continues to increase, providing new options for the follow up and treatment options of individuals, depending on the diseases. In this qualitative study, researchers in Iquitos, Peru, and Phnom Penh, Cambodia explored what local people thought about the possible availability of such a device to diagnose dengue and malaria in their own houses, and what would motivate them to use such a device instead of going directly to a health facility for the diagnosis. Participants reported being willing to use device on themselves and were motivated by the possibility that, by using this diagnostic device and taking the result to their health facility, they might be able to obtain quicker and more optimized attention at the health facility; for example, by obtaining a positive result to dengue or malaria on the rapid diagnostic device, they are aware they might still need confirmatory tests, but they would be able to reduce the wait time for obtaining a definitive diagnosis and starting treatment by a full day. Questions regarding accuracy of tests, complicated instructions and safety of using these devices in the community were brought up by participants—individuals living in the communities and local health professionals. Also, in this study, it was clear that if these devices were to be made available in Peru and Cambodia, different strategies for disseminating and using these in the communities would be needed to accommodate for different health infrastructure in both sites. [ABSTRACT FROM AUTHOR]