Background We aimed to assess the efficacy and safety of two neutralising monoclonal antibody therapies (sotrovimab [Vir Biotechnology and GlaxoSmithKline] and BRII-196 plus BRII-198 [Brii Biosciences]) for adults admitted to hospital for COVID-19 (hereafter referred to as hospitalised) with COVID-19. Methods In this multinational, double-blind, randomised, placebo-controlled, clinical trial (Therapeutics for Inpatients with COVID-19 [TICO]), adults (aged ≥18 years) hospitalised with COVID-19 at 43 hospitals in the USA, Denmark, Switzerland, and Poland were recruited. Patients were eligible if they had laboratory-confirmed SARS-CoV-2 infection and COVID-19 symptoms for up to 12 days. Using a web-based application, participants were randomly assigned (2:1:2:1), stratified by trial site pharmacy, to sotrovimab 500 mg, matching placebo for sotrovimab, BRII-196 1000 mg plus BRII-198 1000 mg, or matching placebo for BRII-196 plus BRII-198, in addition to standard of care. Each study product was administered as a single dose given intravenously over 60 min. The concurrent placebo groups were pooled for analyses. The primary outcome was time to sustained clinical recovery, defined as discharge from the hospital to home and remaining at home for 14 consecutive days, up to day 90 after randomisation. Interim futility analyses were based on two seven-category ordinal outcome scales on day 5 that measured pulmonary status and extrapulmonary complications of COVID-19. The safety outcome was a composite of death, serious adverse events, incident organ failure, and serious coinfection up to day 90 after randomisation. Efficacy and safety outcomes were assessed in the modified intention-to-treat population, defined as all patients randomly assigned to treatment who started the study infusion. This study is registered with ClinicalTrials.gov , NCT04501978 . Findings Between Dec 16, 2020, and March 1, 2021, 546 patients were enrolled and randomly assigned to sotrovimab (n=184), BRII-196 plus BRII-198 (n=183), or placebo (n=179), of whom 536 received part or all of their assigned study drug (sotrovimab n=182, BRII-196 plus BRII-198 n=176, or placebo n=178; median age of 60 years [IQR 50–72], 228 [43%] patients were female and 308 [57%] were male). At this point, enrolment was halted on the basis of the interim futility analysis. At day 5, neither the sotrovimab group nor the BRII-196 plus BRII-198 group had significantly higher odds of more favourable outcomes than the placebo group on either the pulmonary scale (adjusted odds ratio sotrovimab 1·07 [95% CI 0·74–1·56]; BRII-196 plus BRII-198 0·98 [95% CI 0·67–1·43]) or the pulmonary-plus complications scale (sotrovimab 1·08 [0·74–1·58]; BRII-196 plus BRII-198 1·00 [0·68–1·46]). By day 90, sustained clinical recovery was seen in 151 (85%) patients in the placebo group compared with 160 (88%) in the sotrovimab group (adjusted rate ratio 1·12 [95% CI 0·91–...

ObjectiveStrategies to increase pre-exposure prophylaxis (PrEP) uptake are needed. We hypothesized that same-day PrEP initiation in a sexually transmitted diseases (STD) clinic would be acceptable, feasible, and safe, and that individuals would engage in ongoing PrEP care.MethodIndividuals aged ≥ 18 years were evaluated for PrEP. Exclusion criteria were HIV, history of renal dysfunction or chronic hepatitis B infection, pregnancy, indications for HIV post-exposure prophylaxis, or positive screen for acute HIV symptoms. One hundred individuals received a free 30-day PrEP starter pack and met with a patient navigator to establish ongoing care. Bivariate analysis and multivariable logistic regression were used to compare individuals who did and did not attend at least 1 PrEP follow-up appointment within 180 days of enrollment. Client satisfaction surveys were given 3 months after enrollment.ResultsThe majority (78%) of participants completed at least 1 PrEP follow-up appointment, and 57% attended at least 2 follow-up appointments. After adjusting for race and ethnicity, age, health insurance status, and annual income, only income was associated with follow-up appointment attendance. Each additional $10,000 increase in income was associated with a 1.7-fold increase in the odds of attending a PrEP follow-up appointment (95% confidence interval, 1.07–2.66, P = .02). The majority (54%) of individuals completed the satisfaction survey and all respondents liked the option of same-day PrEP initiation.ConclusionsOur study suggests STD clinic-based, same-day PrEP initiation is acceptable, feasible, safe, and links a high proportion of individuals into ongoing PrEP care. Additional resources may be needed to support low-income individuals’ retention in care.

Background: Mobile health (m-health) work in low- and middle-income countries (LMICs) mainly consists of small pilot programs with an unclear path to scaling and dissemination. We describe the deployment and testing of an m-health platform for non-communicable disease (NCD) self-management support in Bolivia.Methods: Three hundred sixty-four primary care patients in La Paz with diabetes or hypertension completed surveys about their use of mobile phones, health and access to care. One hundred sixty-five of those patients then participated in a 12-week demonstration of automated telephone monitoring and self-management support. Weekly interactive voice response (IVR) calls were made from a platform established at a university in La Paz, under the direction of the regional health ministry.Results: Thirty-seven percent of survey respondents spoke indigenous languages at home and 38% had six or fewer years of education. Eighty-two percent had a mobile phone, 45% used text messaging with a standard phone, and 9% had a smartphone. Smartphones were least common among patients who were older, spoke indigenous languages, or had less education. IVR program participants completed 1007 self-management support calls with an overall response rate of 51%. IVR call completion was lower among older adults, but was not related to patients’ ethnicity, health status, or healthcare access. IVR health and self-care reports were consistent with information reported during in-person baseline interviews. Patients’ likelihood of reporting excellent, very good, or good health (versus fair or poor health) via IVR increased during program participation and was associated with better medication adherence. Patients completing follow-up interviews were satisfied with the program, with 19/20 (95%) reporting that they would recommend it to a friend.Conclusion: By collaborating with LMICs, m-health programs can be transferred from higher-resource centers to LMICs and implemented in ways that improve access to self-management support among people with NCDs.

Background: While global momentum supporting mobile health (mHealth) research and development is increasing, it is imperative to assess the potential fit of mHealth programs in local settings. We describe the penetration of mobile technologies among Bolivian patients with noncommunicable diseases (NCDs) to inform research on mHealth interventions for the Andean region as well as low-and middle-income countries more generally. Methods: Five-hundred and fifty-nine NCD patients were identified from outpatient clinics affiliated with four hospitals in the cities of La Paz and El Alto. Respondents completed surveys about their use of standard mobile phones and smartphones. Respondents also provided information about their sociodemographic characteristics, health status, and access to care. We used descriptive statistics and logistic regression to understand the variation in mobile phone use across groups defined by patient characteristics associated with health service access and socioeconomic vulnerability.