9 research outputs found
Public Acknowledgement and Investigations of U.S. “Targeted Killings” and Drone Strikes
The United Nations, local and international human rights organizations, and journalists have investigated and reported numerous cases in which there is credible evidence of harm to Yemeni, Pakistani, and other civilians from U.S. strikes carried out in secret, often using drones. The families of those individuals are still seeking redress and accountability, and the continued refusal of your administration even to officially acknowledge their losses compounds their sufferin
NGO Statement on Reported Changes to U.S. Policy on Use of Armed Drones and Other Lethal Force
The Trump administration’s failure thus far to release and explain the changes it has made to a previously public policy is a dangerous step backwards. Transparency around the use of lethal 2 force is critical to allowing independent scrutiny of the lawfulness of operations and to providing accountability and redress for victims of violations of international law. Transparency also helps governments identify and address civilian harm. It enables the public to be informed about some of the most important policy choices the government makes in its name – ones that involve life and death decisions. While transparency can enhance the legitimacy of government actions, secrecy, by contrast, heightens existing concerns and creates new ones
Public Acknowledgement and Investigations of U.S. “Targeted Killings” and Drone Strikes
The United Nations, local and international human rights organizations, and journalists have investigated and reported numerous cases in which there is credible evidence of harm to Yemeni, Pakistani, and other civilians from U.S. strikes carried out in secret, often using drones. The families of those individuals are still seeking redress and accountability, and the continued refusal of your administration even to officially acknowledge their losses compounds their sufferin
NGO Statement on Reported Changes to U.S. Policy on Use of Armed Drones and Other Lethal Force
The Trump administration’s failure thus far to release and explain the changes it has made to a previously public policy is a dangerous step backwards. Transparency around the use of lethal 2 force is critical to allowing independent scrutiny of the lawfulness of operations and to providing accountability and redress for victims of violations of international law. Transparency also helps governments identify and address civilian harm. It enables the public to be informed about some of the most important policy choices the government makes in its name – ones that involve life and death decisions. While transparency can enhance the legitimacy of government actions, secrecy, by contrast, heightens existing concerns and creates new ones
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Rationale and design of the Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE)
BackgroundCardiovascular disease (CVD) is more frequent among people with HIV (PWH) and may relate to traditional and nontraditional factors, including inflammation and immune activation. A critical need exists to develop effective strategies to prevent CVD in this population.MethodsThe Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) (A5332) is a prospective, randomized, placebo-controlled trial of a statin strategy for the primary prevention of major adverse cardiovascular events (MACE) in PWH with low to moderate traditional risk. At least 7,500 PWH, 40-75 years of age, on stable antiretroviral therapy, will be randomized to pitavastatin calcium (4 mg/d) or identical placebo and followed for up to 8 years. Participants are enrolled based on the 2013 American College of Cardiology (ACC)/American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) risk score and low-density lipoprotein cholesterol (LDL-C) level with a goal to identify a low- to moderate-risk population who might benefit from a pharmacologic CVD prevention strategy. Potential participants with a risk score ≤ 15% were eligible based on decreasing LDL-C thresholds for increasing risk score >7.5% (LDL-C <190 mg/dL for risk score <7.5%, LDL-C <160 mg/dL for risk score 7.6%-10%, and LDL-C<130 mg/dL for risk score 10.1%-15%). The primary objective is to determine effects on a composite end point of MACE. Formal and independent adjudication of clinical events will occur using standardized criteria. Key secondary end points include effects on MACE components, all-cause mortality, specified non-CVD events, AIDS and non-AIDS events, and safety.ResultsTo date, REPRIEVE has enrolled >7,500 participants at approximately 120 sites across 11 countries, generating a diverse and representative population of PWH to investigate the primary objective of the trial.ConclusionsREPRIEVE is the first trial investigating a primary CVD prevention strategy in PWH. REPRIEVE will inform the field of the efficacy and safety of a statin strategy among HIV-infected participants on antiretroviral therapy and provide critical information on CVD mechanisms and non-CVD events in PWH
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Cardiovascular Risk and Health Among People With HIV Eligible for Primary Prevention: Insights From the REPRIEVE Trial
Background: In addition to traditional cardiovascular (CV) risk factors, antiretroviral therapy, lifestyle, and human immunodeficiency virus (HIV)-related factors may contribute to future CV events in persons with HIV (PWH). Methods: Among participants in the global REPRIEVE randomized trial, we characterized demographics and HIV characteristics relative to ACC/AHA pooled cohort equations (PCE) for atherosclerotic CV disease predicted risk and CV health evaluated by Life's Simple 7 (LS7; includes smoking, diet, physical activity, body mass index, blood pressure, total cholesterol, and glucose). Results: Among 7382 REPRIEVE participants (31% women, 45% Black), the median PCE risk score was 4.5% (lower and upper quartiles Q1, Q3: 2.2, 7.2); 29% had a PCE score <2.5%, and 9% scored above 10%. PCE score was related closely to known CV risk factors and modestly (<1% difference in risk score) to immune function and HIV parameters. The median LS7 score was 9 (Q1, Q3: 7, 10) of a possible 14. Only 24 participants (0.3%) had 7/7 ideal components, and 36% had ≤2 ideal components; 90% had <5 ideal components. The distribution of LS7 did not vary by age or natal sex, although ideal health was more common in low sociodemographic index countries and among Asians. Poor dietary and physical activity patterns on LS7 were seen across all PCE scores, including the lowest risk categories. Conclusions: Poor CV health by LS7 was common among REPRIEVE participants, regardless of PCE. This suggests a critical and independent role for lifestyle interventions in conjunction with conventional treatment to improve CV outcomes in PWH. Clinical Trials Registration: NCT02344290. AIDS Clinical Trials Group study number: A5332
Successful recruitment of a multi-site international randomized placebo-controlled trial in people with HIV with attention to diversity of race and ethnicity: critical role of central coordination
Background: The Randomized Trial to Prevent Vascular Events in HIV (REPRIEVE) is a multicenter, randomized, placebo-controlled trial, designed to test whether a statin medication can prevent cardiovascular disease in people with HIV. REPRIEVE recently completed enrollment of 7557 participants at over 100 clinical sites globally. Participant groups of focus were women, and racial and ethnic minorities. Objective: To describe recruitment methods and strategies developed by the REPRIEVE Clinical Coordinating Center (CCC) and share best practices learned from the recruitment process. Methods: Enrollment targets were agreed upon with the primary funder, the National Heart, Lung, and Blood Institute (NHLBI) and were milestone driven. Milestones included number of sites activated, number of participants enrolled within specific time frames, and proportion of women and minorities enrolled. Strategies to achieve these milestones included structured interviews with site-designated REPRIEVE Recruitment Champions to develop best practices, development of a multimedia campaign, and site level recruitment support. Results: Recruitment initiated March, 2015 and completed March, 2019. The final accrual target was 7500 participants over 48 months. The trial met this target within the time specified. Overall, 10,613 screens were completed, 48% of participants enrolled from sites outside of North America, 32% were female, 44% were Black or African American, and 25% were Hispanic or Latino. Conclusions: REPRIEVE met its overall projected recruitment goal by using multiple, simultaneous strategies to specifically target a diverse population including minority subgroups. REPRIEVE benefited from the development of recruitment strategies with clear targets and communication of accrual targets to study teams