ABSTRACT
BACKGROUND: Since the beginning of the COVID-19 pandemic, no direct antiviral treatment is effective as post-exposure prophylaxis (PEP). Lopinavir/ritonavir (LPV/r) was repurposed as a potential PEP agent against COVID-19. METHODS: We conducted a pragmatic open-label, parallel, cluster-randomised superiority trial in four sites in Switzerland and Brazil between March 2020 to March 2021. Clusters were randomised to receive LPV/r PEP (400/100 mg) twice daily for 5 days or no PEP (surveillance). Exposure to SARS-CoV-2 was defined as a close contact of >15 minutes in <2 metres distance or having shared a closed space for ≥2 hours with a person with confirmed SARS-CoV-2 infection. The primary outcome is the occurrence of COVID-19 defined by a SARS-CoV-2 infection (positive oropharyngeal SARS-CoV-2 PCR and/or a seroconversion) and ≥1 compatible symptom within 21 days post-enrolment. ClinicalTrials.gov (Identifier: NCT04364022); Swiss National Clinical Trial Portal: SNCTP 000003732. FINDINGS: Of 318 participants, 157 (49.4%) were women; median age was 39 (interquartile range, 28-50) years. A total of 209 (179 clusters) participants were randomised to LPV/r PEP and 109 (95 clusters) to surveillance. Baseline characteristics were similar, with the exception of baseline SARS-CoV-2 PCR positivity, which was 3-fold more frequent in the LPV/r arm (34/209 [16.3%] vs 6/109 [5.5%], respectively). During 21-day follow-up, 48/318 (15.1%) participants developed COVID-19: 35/209 (16.7%) in the LPV/r group and 13/109 (11.9%) in the surveillance group (unadjusted hazard ratio 1.44; 95% CI, 0.76-2.73). In the primary endpoint analysis, which was adjuted for baseline imbalance, the hazard ratio for developing COVID-19 in the LPV/r group vs surveillance was 0.60 (95% CI, 0.29-1.26; p =0.18). INTERPRETATION: The role of LPV/r as PEP for COVID-19 remains unanswered. Although LPV/r over 5 days did not significantly reduce the incidence of COVID-19 in exposed individuals, we observed a change in the directionality of the effect in favour of LPV/r after adjusting for baseline imbalance. LPV/r for this indication merits further testing against SARS-CoV-2 in clinical trials. FUNDING: Swiss National Science Foundation (project no.: 33IC30_166819) and the Private Foundation of Geneva University Hospitals (Edmond Rothschild (Suisse) SA, Union Bancaire Privée and the Fondation pour la recherche et le traitement médical).
ABSTRACT
BACKGROUND: Globally, there is an excess of 68.5 million people who have been forced to leave their homes and seek sanctuary elsewhere because of poverty, persecution, conflict, violence, and human rights violations. Although international humanitarian responses usually focus on ensuring that the basic needs of these people are being met, there is growing attention on the role that development-oriented interventions can play in the longer term. Higher education in a refugee context is one such intervention that can equip refugees with the knowledge and skills they need to serve their communities and move forward. OBJECTIVE: This study aims to evaluate the outcomes and effectiveness of the University of Geneva InZone-Raft Basic Medical Training Course in the Kakuma refugee camp in Kenya compared with a previous incarnation of the same course in the Dadaab refugee camp in Kenya. METHODS: We used a quasi-experimental design to compare the posttest scores of both inequivalent student groups: control group (n=18) and intervention group (n=16). Factors that influenced refugee students' knowledge acquisition, the amount of knowledge they acquired, and their academic outcomes were assessed, and the pedagogical evolution of the project is presented. RESULTS: We found that the Kakuma intervention course yielded better outcomes and was more effective in terms of learning than the Dadaab control course. Of the 16 students who took part in the intervention course, 10 (63%) completed the program successfully and received accreditation from the University of Geneva. We observed that they received new knowledge well and scored higher on all learning modalities than those in the control course. Comparison of written and oral examinations between the courses showed statistical significance for the intervention group in written and oral exams (two-tailed: P=.006 and P=.05; one-tailed: P=.003 and P=.03, respectively). The Kakuma course was not effective in addressing electricity and internet access problems, nor in reducing the challenge of tight deadlines in the syllabus. Pedagogical adjustments to the intervention course improved student involvement, with higher participation rates in quizzes (10/11, 91%), and overall satisfaction and learning. CONCLUSIONS: The intervention group-with an improved mode of delivery, better contextualized content, and further interaction-reached a higher level of medical knowledge acquisition and developed more complex questions on medical topics than the control group. The positive outcome of this project shows that given the right resources and support, refugees can contribute to the improvement and development of health care in their communities. Nonetheless, a more focused effort is necessary to meet the educational needs of refugee learners and better understand their living conditions.
Subject(s)
Learning , Refugees , Research Design , Humans , Kenya , StudentsABSTRACT
This study aims to assess the immunological response and impact on virological control of the mRNA vaccines for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among people living with HIV (PLWH). In this single-center observational study, all PLWH were offered vaccination with mRNA1273 or BNT162b2. Both anti-N and anti-S1-receptor binding domain (RBD) antibodies were measured together with HIV-1 RNA levels after the first dose (M0) and then at 1 (M1), 2 (M2) and 6 (M6) months later. A total of 131 individuals (median age: 54 years [IQR: 47.0-60.5]; male: 70.2%; median baseline CD4 T-cell: 602/µl [IQR 445.0-825.5]; median nadir CD4 T-cells 223/µl [IQR 111.0-330.0]) were included. All participants were positive for anti-RBD antibodies at 30 days, 60 days and 6 months after the first dose, with no statistical difference between those with HIV-1 RNA below or >20 copies/ml. HIV-1 RNA data were collected for 128 patients at baseline and 30 days after the first dose; for 124 individuals, 30 days after the second dose; and for 83 patients, 6 months after the first dose. Nineteen (14.8%) of 128 had detectable HIV-1 RNA (>20 copies/ml) at M0, 13/128 (10.2%) at M1 (among which 5 were newly detectable), 15/124 (12.1%) at M2 (among which 5 were newly detectable), and 8/83 (9.6%) at M6. No serious adverse effects were reported. All participants elicited antibodies after two doses of mRNA vaccines, with only a minor impact on HIV-1 RNA levels over a 6-month period.
