Background SARS-CoV-2 infection rapidly spreads in populations due to the high rates of community transmission. Interrupting the shedding of SARS-CoV-2 may reduce the incidence of Coronavirus Disease 19 (COVID-19). Herein we provide a protocol for a cluster randomized trial that will examine the effectiveness of treatment with interferon (IFN) ß-1a compared to standard of care in limiting the transmission of SARS-CoV-2. Co-primary objectives are to determine whether IFN therapy reduces (a) the proportion of infected cases shedding SARS-CoV-2 at day 11 post randomization and (b) the incidence of transmission of SARS-CoV-2 infection from index cases to treatment-eligible household post-exposure contacts at day 11 after randomization. Secondary objectives include assessing the impact of IFN treatment on duration of viral clearance, hospitalizations and fatalities, and evaluating the safety of IFN treatment. Methods Three hundred and ten households, each including an index case with a recent COVID-19 diagnosis and at least one asymptomatic treatment-eligible household contact, will be randomized to receive 3 doses of 125 μg IFN ß-1a by subcutaneous administration (days 1, 6, and 11), or standard of care. All participants will be followed until day 29. Discussion The results from this trial will identify whether IFN ß treatment of mild or moderate COVID-19 cases accelerates viral clearance and prevents disease progression and whether IFN ß treatment of post-exposure contacts of COVID-19 cases reduces transmission of infection. Trial Registration: This trial is registered at ClinicalTrials.gov NCT04552379; date of registration September 17, 2020.
Substance use is a signi cant global concern. Strengthening parenting in families with adolescents has been shown to reduce substance use initiation. The ¡Vamos por Más! (¡VxM!) program is a positiveparenting program developed in Chile to improve family relations and reduce adolescent substance use that combines in-person school workshops, multimedia messaging and personalized support. ObjectiveThis manuscript reports a mixed-methods evaluation of the pilot implementation of the ¡VxM! program utilizing the Consolidated Framework for Implementation Research and Proctor's taxonomy for process outcomes. MethodsAn explanatory sequential design was used. Quantitative methods evaluated program use, acceptability, appropriateness, and delity, and were followed by qualitative focus groups (FGs) to assess the implementation process and understand these outcomes. Thirteen FGs strati ed by school and role, including school leaders (n = 7), program facilitators (n = 19), participants (n = 36), and researchers (n = 4), were conducted. ResultsThe program was implemented in three schools, reaching 253 families with in-person workshops (40.5% of potential participants), 257 parents who viewed on average 72.1% of sent multimedia messages, and 2 families who used the personalized support (0.3%). Overall, the program was viewed as acceptable and appropriate by participants and implementers due to the high quality of program materials, targeted content, and activities. Implementation differed by schools. Key implementation factors were the outer context, inner school setting, and implementation processes. ConclusionThis comprehensive evaluation, including both intervention implementers and participants, identi ed implementation facilitators, barriers, and outcomes. Future ¡VxM! implementations should alter program components of schools with lower engagement to improve program implementation and outcomes.implemented. These ndings are essential for the implementation of parenting programs in new settings and contribute to the larger implementation evaluation literature.
Introduction: Substance use is a significant global concern. Strengthening parenting in families with adolescents has been shown to reduce substance use initiation. The ¡Vamos por Más! (¡VxM!) program is a positive-parenting program developed in Chile to improve family relations and reduce adolescent substance use that combines in-person school workshops, multimedia messaging and personalized support. Objective This manuscript reports a mixed-methods evaluation of the pilot implementation of the ¡VxM! program utilizing the Consolidated Framework for Implementation Research and Proctor’s taxonomy for process outcomes. Methods An explanatory sequential design was used. Quantitative methods evaluated program use, acceptability, appropriateness, and fidelity, and were followed by qualitative focus groups (FGs) to assess the implementation process and understand these outcomes. Thirteen FGs stratified by school and role, including school leaders (n = 7), program facilitators (n = 19), participants (n = 36), and researchers (n = 4), were conducted. Results The program was implemented in three schools, reaching 253 families with in-person workshops (40.5% of potential participants), 257 parents who viewed on average 72.1% of sent multimedia messages, and 2 families who used the personalized support (0.3%). Overall, the program was viewed as acceptable and appropriate by participants and implementers due to the high quality of program materials, targeted content, and activities. Implementation differed by schools. Key implementation factors were the outer context, inner school setting, and implementation processes. Conclusion This comprehensive evaluation, including both intervention implementers and participants, identified implementation facilitators, barriers, and outcomes. Future ¡VxM! implementations should alter program components of schools with lower engagement to improve program implementation and outcomes.
Summary In Chile, the prevalence of tobacco, alcohol and drug use among adolescents is very high. Decades of research indicate that parenting interventions reduce these risky behaviors. However, there are no parenting interventions validated in Chile to prevent adolescent substance use. This article reports the development of the ¡Vamos por Mas! (¡VxM!) program following the recommendations of the Medical Research Council’s framework for designing and evaluating complex interventions. After identifying key intervention components, a preliminary version of a substance-use prevention program was designed. The preliminary intervention targeted families with adolescents in fifth and sixth grade and had four components: personalized feedback, in-person workshops, virtual engagement, and family support, to deliver positive-youth development and family-strengthening content. Then, students, guardians, school staff and community experts from different school systems (N = 111) evaluated the preliminary version of the program through a convergent parallel mixed methods study, including focus groups (N = 14) and surveys (N = 101). In general, all participants had positive perceptions of the program and valued its purpose, strategies, objectives and contents. Suggestions included expanding the purpose to promote healthy relationships, focusing on schools with low and intermediate socioeconomic vulnerability, including self-control content, removing the personalized feedback component and adding two additional components: school partnership and external supervision, among other improvements. With this information, the final version of the ¡VxM! program was developed. After a rigorous intervention development process, the ¡VxM! program is ready to be piloted and evaluated in a randomized trial.
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