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Abstract Background The emergency set-up and implementation of outpatient clinical trials on epidemic emerging infectious diseases such as COVID-19 raise many issues in terms of research structuration, regulations, and health systems organization. We aimed to describe the experience and points of view of different stakeholders involved in a French home-based outpatient trial on COVID-19 and to identify the early barriers and facilitators to the trial implementation. Methods We conducted a mixed-methods study in July 2020. A self-administered questionnaire was emailed to 213 clinical, operational and research stakeholders involved in the Coverage trial; individual semi-directed interviews were conducted among 14 stakeholders. Questionnaire data and written interview notes are presented together by key theme. Results One hundred fifty six stakeholders responded to the questionnaire. 53.4% did not have prior experience in clinical research. The motivation of most stakeholders to participate in the Coverage trial was to feel useful during the pandemic. 87.9% agreed that the trial had an unusual set-up timeframe, and many regretted a certain lack of regulatory flexibility. Mobile medical teams and specific professional skills were perceived as instrumental for outpatient research. Conclusions The implementation of a home-based outpatient clinical trial on COVID-19 was perceived as relevant and innovative although requiring important adaptations of usual professional responsibilities and standard research procedures. Lessons learned from the Coverage trial underline the need for improved networks between hospital and community medicine, and call for a dedicated and reactive outpatient research platform on emerging or threatening infectious diseases.

Abstract Objectives To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation. Trial design Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial. Participants Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate 5.5 mmol/L or

Abstract Background Couples HIV counseling and testing is essential for combination HIV prevention, but its uptake remains very low. We aimed to evaluate factors associated with couples HIV counseling uptake in India, Georgia and the Dominican Republic, as part of the ANRS 12127 Prenahtest intervention trial. Methods Pregnant women ≥15 years, attending their first antenatal care (ANC) session between March and September 2009, self-reporting a stable partner, and having received couple-oriented post-test HIV counseling (trial intervention) were included. Individuals and couple characteristics associated with the acceptability of couples HIV counseling were assessed using multivariable logistic regression for each study site. Results Among 711 women included (232, 240 and 239 in the Dominican Republic, Georgia and India, respectively), the uptake of couples HIV counseling was 9.1% in the Dominican Republic, 13.8% in Georgia and 36.8% in India. The uptake of couples HIV counseling was associated with women having been accompanied by their partner to ANC, and never having used a condom with their partner in the Dominican Republic; with women having been accompanied by their partner to ANC in India; with women having a higher educational level than their partner and having ever discussed HIV with their partner in Georgia. Conclusion Couple HIV counseling uptake was overall low. Strategies adapted to local socio-cultural contexts, aiming at improving women’s education level, or tackling gender norms to facilitate the presence of men in reproductive health services, should be considered. Trial registration ClinicalTrials.gov Identifier: NCT01494961 . Registered December 15, 2011. (Retrospectively registered).