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Resources and information on the COVID-19 pandemic with a focus on the intersection with the HIV pandemic

COVID-19 and terminology

Coronavirus disease 2019 (COVID-19) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December 2019. The new virus that causes COVID-19 illness has been named severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
According to the World Health Organization: the most common symptoms of COVID-19 are fever, tiredness, and dry cough. Some patients may have aches and pains, nasal congestion, runny nose, sore throat or diarrhea. These symptoms are usually mild and begin gradually. Some people become infected but don’t develop any symptoms and don't feel unwell. Most people (about 80%) recover from the disease without needing special treatment. Around 1 out of every 6 people who gets COVID-19 becomes seriously ill and develops difficulty breathing. Older people, and those with underlying medical problems like high blood pressure, heart problems or diabetes, are more likely to develop serious illness. People with fever, cough and difficulty breathing should seek medical attention.
Background on coronaviruses from the NIH: “Coronaviruses are a large family of viruses that usually cause mild to moderate upper-respiratory tract illnesses, like the common cold, in people. However, three times in the 21st century coronavirus outbreaks have emerged from animal reservoirs to cause severe disease and global transmission concerns.
There are hundreds of coronaviruses, most of which circulate among animals including pigs, camels, bats and cats. Sometimes those viruses jump to humans—called a spillover event—and can cause disease. Seven coronaviruses are known to cause human disease, four of which are mild: viruses 229E, OC43, NL63 and HKU1. Three of the coronaviruses can have more serious outcomes in people, and those diseases are SARS (severe acute respiratory syndrome) which emerged in late 2002 and disappeared by 2004; MERS (Middle East respiratory syndrome), which emerged in 2012 and remains in circulation in camels; and COVID-19, which emerged in December 2019 from China and a global effort is under way to contain its spread. COVID-19 is caused by the coronavirus known as SARS-CoV-2.
Thanks to research investments into the SARS and MERS outbreaks, NIAID scientists and grantees are better prepared to develop diagnostics, therapeutics and vaccines against COVID-19. Included in those projects are basic research to understand how the virus infects cells and causes disease; adapting platforms used to develop diagnostic tests and vaccines; and evaluating treatments such as broad-spectrum antivirals and potentially monoclonal antibodies.”
 

Note: COVID-19 is an emerging, rapidly evolving situation.



The CDC has a FAQ page dedicated to COVID-19: What people with HIV should know.

  • ​The CDC notes that although the risk of serious illness from COVID-19 for people with HIV is not known, people with HIV may have concerns and questions related to their risk. This is an emerging, rapidly evolving situation and the CDC will provide updated information as it becomes available.

 

AIDSinfo

Interim Guidance for COVID-19 and Persons with HIV. This interim guidance reviews special considerations for persons with HIV and their health care providers in the United States regarding COVID-19. Information and data on COVID-19 are rapidly evolving. This guidance includes general information to consider. People with HIV who have COVID-19 have an excellent prognosis, and they should be clinically managed the same as persons in the general population with COVID-19, including when making medical care triage determinations.
Clinicians should refer to updated sources for more specific recommendations regarding COVID-19.
This interim guidance was prepared by the following working groups of the Office of AIDS Research Advisory Council:
·         HHS Panel on Antiretroviral Guidelines for Adults and Adolescents
·         HHS Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV
·         HHS Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission
·         HHS Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in Adults and Adolescents with HIV
·         HHS Panel on Opportunistic Infections in HIV-Exposed and HIV-Infected Children
(Last Updated: June 19, 2020; Last Reviewed: June 19, 2020)
 
NIH HIV/AIDS Clinical Trials Networks
The NIH HIV/AIDS Clinical Trials Networks (ACTG, HPTN, HVTN, IMPAACT and MTN) have all recently issued guidance on the status of new and ongoing studies. They are all listed here. In general, for most studies, ​opening of new studies will be on hold and screening and enrollment in ongoing studies will be paused. Visits in ongoing studies will be continued, subject to local challenges or constraints. For the status of ongoing studies, refer to the guidance. Contact your site or network if you have questions about specific ongoing studies. Additional guidance specific to laboratories is posted here​.
 
EMA
From the European Medicines Agency (EMA) and collaboratorsGuidance on the Management of Clinical Trials during the COVID 19 (Coronavirus) pandemic. (Version 1- 20/03/2020).
FDA
FDA Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Pandemic at: https://www.fda.gov/media/136238/download
 
NIH
Guidance for NIH-funded Clinical Trials and Human Subjects Studies Affected by COVID-19 (Notice Number: NOT-OD-20-87)at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-087.html
Flexibilities Available to Applicants and Recipients of Federal Financial Assistance Affected by COVID-19 (Notice Number: NOT-OD-20-86)at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-086.html
NCI
NCI Interim Guidance for Patients on Clinical Trials Supported by the NCI Cancer Therapy Evaluation Program and the NCI Community Oncology Research Program (NCORP).


 

SAHPRA

SAHPRA Policy on Conduct of Clinical Trials of Health Products During the Current Covid-19 Pandemic. The South African Health Products Regulatory Authority (SAHPRA) is committed to providing timely health products regulatory guidance in support of continuity for stakeholders and appropriate timely regulatory response during the current COVID-19 pandemic. Specifically, this communication provides assistance to sponsors and applicants including clinical research organizations (CROs) in assuring the safety of trial participants, maintaining compliance with current good clinical practice (GCP), and minimising risks to trial integrity during the COVID-19 pandemic. Issued 25 March 2020.


 
World Health Organization key reference links on HIV-COVID-19:

 


 

American Academy of HIV Medicine

Considerations & Suggested Practices for Ambulatory HIV Specialty Care During Covid-19 Pandemic.

 

  • As part of the American Academy of HIV Medicine’s commitment to provide relevant and useful information during the COLVID-19 pandemic, please find attached a Spanish translation of the newly released guidance on COVID-19 and HIV care. Many thanks to Centro Ararat and their Chief Medical Officer and Academy member Dr. Iván Meléndez-Rivera for developing and distributing this useful resource.  Click here to view the downloadable PDF.

 
Infectious Disease Society of America (IDSA)/HIVMA 

From the Infectious Disease Society of America (IDSA) and the HIV Medical Association (HIVMA): COVID-19: Special Considerations for People with HIV (Version: April 17, 2020)

 

From the Infectious Disease Society of the USA (IDSA): a compilation of COVID-related policies and protocols, as well as coverage and payment-related information and will be updated as resources and new information becomes available.

 

IDSA and HIVMA Lead Call for Data-driven Public Health and Medical Responses to COVID-19:
As infectious diseases and HIV specialists on the frontlines of responses to COVID-19 across the country, members of the Infectious Diseases Society of America and its HIV Medicine Association welcome the president's announcement Sunday (March 29, 2020) that he has amended his projected duration for stay-at-home and physical distancing guidelines to last at least through April based on medical and public health guidance. With a letter signed by 60 organizations representing health professionals, patients, and advocates, and with a petition signed by more than 2,000 individuals to date, IDSA and HIVMA are leading a call for President Trump to ensure that all of his administration’s responses to the ongoing public health crises posed by the spread of COVID-19 are based on the most current medical and public health guidance available. As health professionals confronting the grim and tragic consequences of uncontained and escalating outbreaks of a new virus for which no vaccination or proven treatment yet exist, we are urging the President and Vice President Pence to continue to respond, and, where needed and advised, strengthen responses to scientific expertise and to data showing:
  • Continuing needs for rigorous public health measures that include consistent and effective social distancing guidelines, and measures that support and enforce their uniform compliance;
  • For the equipment necessary to protect health workers, treat patients and save lives;
  • And to reinforce responses with meaningful economic, nutritional and educational support for all Americans whose lives and livelihoods are disrupted by efforts to control this pandemic.
The organizational letter and the public petition were presented to the President on March 30, 2020. The IDSA continues to gather signatures on the petition. This is the IDSA link to considering adding your name.

 

From the British HIV Association: (8 April 2020)
We understand that some people living with HIV have received text messages advising them to shield and completely self-isolate for three months. We are currently investigating who received these messages and why this has happened. In the meantime, the British HIV Association (BHIVA) has contacted all members and added a message to the BHIVA website to reassure people living with well controlled HIV that they are not at any greater risk of COVID-19. There is no evidence, nor guidance, that people with well controlled HIV should shield. BHIVA and the Terrence Higgins Trust recommend that only people whose immune system is known to be very weak as shown by a CD4 count of less than 50, or who have had a serious illness due to suppression of the immune system in the last 6 months, should be encouraged to follow the shielding advice. These are anxious times for everyone, but we are urging people living with HIV not to panic. We will continue to monitor the latest developments and provide updated guidance if and when necessary.

 
 
Case series of HIV-patients with COVID-19 have been published from China, Spain, Germany, Italy and the United States. So far there is no clear evidence for a higher COVID-19 infection rate or different disease course in people with HIV than in HIV-negative people. Of note, most HIV case series report a younger age in their study population than in HIV-negative hospitalised COVID-19 patients but comparable rates of comorbidities. In a UK cohort study reporting outcomes on 16,749 hospitalised patients with COVID-19 only 1% involved PLWH, but HIV did not adversely impact survival.
Current evidence indicates that the risk of severe illness increases with age, male gender and with certain chronic medical problems such as cardiovascular disease, chronic lung disease, obesity and diabetes. Although people with HIV who are on treatment with a normal CD4 T-cell count and suppressed viral load may not be at an increased risk of serious illness, many people with HIV have other conditions that increase their risk. Indeed, almost half of people living with HIV in Europe are older than 50 years and chronic medical problems, including cardiovascular and chronic lung disease, are more common in people living with HIV. Smoking is a risk factor for respiratory infections; smoking cessation should therefore be encouraged for all patients. Influenza and pneumococcal vaccinations should be kept up to date.
It has to be assumed that immune suppression, indicated by a low CD4 T-cell count (<200/µl), or not receiving antiretroviral treatment, will also be associated with an increased risk for a more severe disease presentation. Data in such patients however, is sparse as most HIV-coinfected COVID-19 patients so far have been under antiretroviral therapy and successfully treated with mostly suppressed HIV-RNA levels. For patients with low CD4-counts (<200/ml), or who experience a CD4-decline during a COVID-19 infection, remember to initiate opportunistic infection (OI) prophylaxis. This is not aiming at preventing a more severe course of COVID-19 but rather complications through additional opportunistic infections. More information regarding recommendations for prophylaxis and treatment of specific opportunistic infections can be found in the BHIVA/EACS guidelines for HIV/AIDS.
The ongoing discussion about potential COVID-19 vertical transmission remains controversial. Although few case reports have claimed perinatal transmission several other large case series could not find any case of vertical transmission. Pregnant women with critical COVID-19 who deliver during their disease course mostly deliver preterm via caesarean section. So far clinical outcome of the newborn however, has been uneventful.
Existing national guidelines should be followed in terms of reducing risk for acquiring a COVID-19 infection and managing symptoms.

 

“Beginning in late 2019, the world experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Within a few months, COVID-19 has rapidly disseminated worldwide and the World Health Organization characterized the coronavirus outbreak as a pandemic in March 2020.
There is insufficient information about how people living with, and at high risk for, HIV are affected by SARS-CoV-2. This collection of papers present emerging insights about the epidemiology and biology of SARS-CoV-2, as well as the social and structural factors potentiating spread and responses to contain the pandemic. Unique clinical features of SARS-CoV-2/HIV-1 co-infection are also discussed.
Stay tuned as this Virtual Issue will be continuously updated to include new articles as they are being published.” (July 20, 2020)

 

HIV Treatment Bulletin (HTB)

 The 27 March 2020 edition of HIV TREATMENT BULLETIN (HTB) is on the global health crisis related to the new coronavirus (SARS CoV-2) and COVID-2019 and the effect it will have for people living with HIV. HTB notes that “given the rapid pace of information, advice, research and recommendations about COVID-19, many of the links and information might either soon be outdated – or superseded. As with all health information, please check the date. The importance of updating information online, even after it has been published, means that this issue includes many links, rather than using current online text. i-Base also has a COVID-19 page for new links and updates over the coming weeks and months. www.i-Base.info/covid-19The selected links are just a small selection and they will likely only have a limited shelf-life. We have only included research that is available as open access papers. And it is notable that the urgency of the crisis has called for all papers to become open access. Thanks especially to Lynda Dee, Richard Jefferys, Jules Levin, Michael Louella, Jeff Taylor and Nelson Vergel. Community forums include: AIDS Treatment Activist Coalition (ATAC), European AIDS Treatment Group (EATG), ATAC Immune-Based Treatment (ATAC-IBT), International Treatment Preparedness Coalition (ITPC) and the UK Community Advisory Board (UK-CAB).”

 
NAM
From NAM’s aidsmap.comNo increased coronavirus risk for people with well-controlled HIV say WHO, but how will health systems cope? “The first data from Wuhan, China suggest that people living with HIV suffered no worse a coronavirus epidemic than other people in the city, confirming the World Health Organization’s position that people with well-controlled HIV do not appear to be at elevated risk of coronavirus infection or severe disease. Nonetheless, the risk of disruption to HIV services is significant, especially as the new coronavirus spreads to countries with fragile health systems. “We are bracing ourselves for an even larger pandemic in lower and middle-income countries,” Dr Meg Doherty, the new director of HIV programmes at the World Health Organization (WHO) told a webinar organised by the International AIDS Society yesterday.”
References listed in the NAM article:
​​​​​​​​​

Positive Women’s Ne​twork-USA

#WeGotThis: To Our PWN Family Regarding the Coronavirus Epidemic (March 13, 2020)

 

POZ Magazine

​From POZ Magazine: What People With HIV Need to Know About the New Coronavirus

What People With HIV Need to Know About the New Coronavirus?

 

HIV and SARS-CoV-2: What Are the Risks?
Josep M. Llibre, MD, PhD (April 1, 2020)- posted in full on the Clinical Care options website.
HIV and COVID-19 Risk
There are basically 3 categories of patients with HIV to consider in terms of COVID-19 risk: 1) of COVID-19 risk: 1) those with unsuppressed HIV viremia, 2) those with suppressed HIV viremia but immune discordance (generally defined as having a CD4+ cell count < 350 cells/mm3 despite suppressed HIV-1 RNA), and 3) those with suppressed HIV viremia and acceptable immune reconstitution (CD4+ cell count > 350 cells/mm3).
In Spain, we have sadly surpassed 100,000 cases of COVID-19 at the time of this writing (April 1, 2020), with a mortality rate of 8.9% among those diagnosed. Quite unexpectedly, we have seen that PLWH are not at increased risk of acquiring COVID-19 or of progressing to acute respiratory distress syndrome (ARDS) once infected, across the 3 risk classes defined above. For reasons that are as yet unknown, it appears that their risk may even be lower than that of the general population.
It is also not yet known whether HIV PIs could effectively inhibit the 3- chymotrypsin-like and papain-like proteases of SARS-CoV-2. Nevertheless, many PLWH are receiving ART regimens based on INSTIs rather than PIs. Therefore, potential protection from the use of HIV PIs does not seem to be a plausible explanation for the apparent decreased risk.
Viral Pathogenesis of Coronaviruses vs HIV
The absence of an increased risk for COVID-19 among PLWH is surprising because dysregulation of the immune response, particularly by T lymphocytes, seems to be highly involved in the pathologic process of COVID-19, and lymphocytopenia is a well identified risk factor for ARDS and death among individuals with COVID-19. Viral host receptors are important determinants of viral pathogenicity, tissue tropism, and host range. The key functional host receptors used by human pathogenic coronavirus surface structural spike glycoprotein (S) include angiotensin- converting enzyme 2, and the viral machinery used during cleavage and binding at the cell surface seems to be independent of the CD4 receptor and, therefore, distinct from HIV. Another difference between coronaviruses and HIV relates to viral assembly and budding. With HIV, assembly and budding take place at or near the plasma membrane, whereas coronaviruses carry out these processes at the endoplasmic reticulum.
 Therefore, currently available data on host cell entry mechanisms and the intracellular pathways harnessed by each virus suggest that HIV and coronavirus do not show cooperative pathogenesis. This information coupled with early observations suggesting that HIV infection is not associated with increased risk for SARS-CoV-2 infection or for more severe COVID-19 manifestations is very reassuring for our PLWH. This is particularly true because previous studies showing that human APOBEC3G, a member of the APOBEC3 cytidine deaminase family, was able to associate with both HIV and SARS-CoV structural proteins through a potentially similar, RNA-mediated mechanism raised concerns for potential shared pathogenesis.
 
COVID-19 in People With HIV: Commonly Asked Questions (posted on Medscape)
Paul E. Sax, MD (April 03, 2020)
Hello. This is Dr Paul Sax from Brigham and Women's Hospital and Harvard Medical School. If you're like me and you follow a panel of people with HIV, you've no doubt received many questions from them about COVID-19. Luckily, the Department of Health and Human Services has just issued an interim guidance that gives us some responses to those queries.
Although many of the statements in this guidance could apply to anyone, whether HIV-positive or HIV-negative, there are certain HIV-specific items that deserve emphasis. I'll summarize some of the most common questions I've been receiving and highlight where the guidance is particularly useful.
 
'Is COVID-19 a more severe disease in people with HIV?'
This is obviously a concern for people who have HIV, since HIV is known to be an immunosuppressive illness. However, as the guidance notes, the limited data currently available do not indicate that the disease course of COVID-19 in person with HIV differs from that in persons without HIV. And that's particularly the case for people who are stable on antiretroviral therapy (ART).
Remember, though, that about half the people with HIV in the United States are over the age of 50 and being older than 60 is considered a risk factor for severe disease, as are medical comorbidities such as diabetes and hypertension, which are increasingly common in our older HIV patients.
What about people who have more severe immunodeficiency, with a CD4 cell count < 200? Here, we'd have to assume that COVID-19 would be a more severe disease, even though we're learning that some of the disease manifestations of COVID-19 are actually immune-mediated. Nonetheless, this population is at greater risk for severe infections across the board, so they should be particularly careful to avoid exposure. The key thing for this population is to get on ART and improve their immune function.
 
'Do I need an extra supply of my medications?'
In these uncertain times, I would say it makes sense for people to have an extra supply of their antiretroviral medications. Many payers are now approving a 90-day prescription. And that makes a lot of sense for our patients on stable ART because they can avoid having to leave their house to go to pharmacies—and they can actually do what we're recommending, which is social distancing. I did check with the manufacturers of several of the more commonly used antiretroviral agents, and none of them have expressed any concern about shortages.
 
'Do I need to come in for my regular blood tests and checkups?'
Well, here, COVID-19 might be exposing an area where perhaps we may have been a little wasteful, in that probably for many of our stable HIV patients, a twice-yearly visit with blood testing is not really necessary. It has been sort of a socially nice thing to do, and you can certainly check in on other factors, but do they actually need to have their HIV viral load checked twice a year to document that they still have viral suppression? For many of them, I don't think it's necessary. And here is one of those situations where the guidance is helpful. They specifically say that for persons who have had suppressed HIV viral load and are in stable health, routine medical and laboratory visits should be postponed to the extent possible.
 
'Do my antiretroviral medications protect me from getting COVID-19?'
This question is not specifically covered in the guidance, but I've received it from several of my patients. They point out that SARS-CoV-2 is a virus and HIV is a virus, and they think maybe their antivirals could protect against SARS-CoV-2 also. In fact, one of the people who asked me this question is a doctor himself, although he's not an infectious disease doctor.
We have to point out that there is no evidence right now that these antiretrovirals protect against COVID-19. We also might want to point out that the initial enthusiasm about lopinavir/ritonavir being a possible treatment for this condition does not seem to be founded, at least on the basis of one randomized study that has been published.
So that's a quick summary of the interim guidance for people with HIV in the COVID-19 era, as well as some of the more common questions I've been receiving. Thank you very much for listening.
 
The Wellcome Trust has developed a COVID-19 section on their website. “We want to help the world overcome the COVID-19 pandemic. We're supporting research and development, and working to make sure that any new vaccines, tests and treatments are mass-produced quickly and reach everyone who needs them.”
The National Congress of American Indians has developed a COVID-19 Resource Center. Included are Tribal Advocacy Materials for Implementing COVID-19 Funding: NCAI and partner organizations have drafted and submitted a number of letters to support tribal nations during the COVID-19 pandemic.

 

Tuberculosis and COVID-19

 
The Union published a statement regarding COVID-19 on 13 March 2020. They also have developed answers to a series of Frequently Asked Questions about the intersection between tuberculosis (TB) and COVID-19. These include information about the similarities between the two diseases, and guidance for how COVID-19 affects people on TB treatment or people who have recently recovered from TB. (Version 1, 25 March 2020). 
 
(Note: The mission of the Union is to promote national autonomy within the framework of the priorities of each country by developing, implementing and assessing anti-tuberculosis, lung health and non-communicable disease programmes as well as other public health issues.)

 

Behavioral and  Mental Health Care Resources

 

Behavioral Insights for People With COVID-19 As Well As Those Living With HIV.

 

From the NIH: Since the COVID-19 pandemic began, researchers with existing longitudinal cohorts and survey samples have been developing and fielding new survey items assessing various COVID-19 specific domains such as symptoms, knowledge and attitudes, adherence to various mitigation behaviors, social impacts, and economic impacts. Efforts to standardize or harmonize COVID-19 survey items, however, did not appear feasible given the urgency to field items as early as possible during the pandemic.

 

To minimize the proliferation of one-off survey items, encourage comparisons across samples, and facilitate data integration and collaboration, a trans-NIH working group co-led by the National Institute on Aging (NIA) and the Office of Behavioral and Social Sciences Research (OBSSR) worked to make existing COVID-19 survey items and investigator contact information available in a survey item repository. Two NIH-supported survey item platforms have made this expanding list of survey items available as a resource for researchers interested in assessing COVID-19 specific domains.

   

            NIH Public Health Emergency and Disaster Research Response (DR2): The National Institute of Environmental Health Sciences (NIEHS) and the National Library of Medicine (NLM) host the DR2 site which now includes a list of COVID-19 surveys and the domains assessed in the surveys. In addition to this COVID-19 list, DR2 provides a wide array of data collection tools and resources used in other public health emergencies and disasters, providing researchers with a rich repository of survey and other measurement tools that are applicable to the COVID-19 pandemic.  

 

            PhenX Toolkit: The PhenX Toolkit now includes a list of COVID-19 related measurement protocols drawn from the surveys listed in DR2. These COVID-19 survey protocols have not been vetted as per the PhenX consensus process but are made available for other researchers to consider, and to test as needed, before incorporating in their research studies. The PhenX Toolkit, funded by the National Human Genome Research Institute (NHGRI) and other NIH Institutes and Centers, has a large collection of well-established and vetted measurement protocols suitable to incorporate into studies involving COVID-19. 

    

Researchers addressing COVID-19 questions, whether population-based or for clinical research, are encouraged to consider these COVID-19 specific survey item repositories and select existing survey items or protocol modules currently being fielded. Researchers with additional survey items about to be fielded are encouraged to make them public for other researchers to consider by submitting the survey to NIHCOVID19Measures@nih.gov 

    

This COVID-19 Quantitative Questionnaire was developed for MTN042/MTN-043, two trials in sub-Saharan Africa with pregnant (MTN-042/ Deliver) and breastfeeding (MTN-043/ B-protected) women.

 

COVID19 Interview Items for Vulnerable Populations. Compiled by the Center for Drug Use and HIV|HCV Research. (April 11, 2020). This site includes the following items:

·      Gwadz Qualitative Interview Guide

·      Harkness, A. (2020). The Pandemic Stress Index. University of Miami

·      Kalichman Covid-19 Assessment

·      Bennett and Elliot Qualitative Interview Guide

·      Stanford

·      COVID-19 Pandemic Social Distancing Event Items

·      N2 COVID-19 Check-in Survey Items (phone interview)

·      Benoit OTP Staff Survey

·      Benoit OTP Patients Focus Group Guide

·      Benoit People Who Use Drugs and Not Currently in Treatment Focus Group Guide

·      ATN

·      University of Miami School of Nursing and Health Studies Center of Excellence for Health Disparities Research: Measures Library - COVID-19

·      PhenX Toolkit COVID-19 Protocols

·      National Library of Medicine Disaster Research Resource

·      Gwadz Qualitative Interview Guide

 

The Pandemic Stress Index is a measure of behavior changes and stress related to the COVID-19 pandemic developed at the University of Miami. Harkness, A., Behar-Zusman, V., & Safren, S.A. (in press). Understanding the impact of COVID-19 on Latino sexual minority men in a US HIV hot spot. AIDS and Behavior. doi: 10.1007/s10461-020-02862-w.


A group of researchers from Nemours, CHOP and Cincinnati have developed a questionnaire designed for insertion into ongoing and new child health studies where aspects of the COVID-19 pandemic may impact study findings. The COVID-19 Exposure and Family Impact Survey (CEFIS-19), in English and Spanish.  There are also have REDCap versions. While designed for research, there may also be clinical applications. There is no charge for use, but we do ask that you register with us as this work is covered by our SAMHSA-funded Center for Pediatric Traumatic Stress in the National Child Traumatic Stress Network. Our website has COVID related materials that we have updated and, in some cases, newly developed. We hope that CEFIS and all our materials will be helpful. Please feel free to circulate these materials.  

Shared by Anne E. Kazak, Ph.D., ABPP, Director, Center for Healthcare Delivery Science, Nemours Children’s Health System, Co-Director, Center for Pediatric Traumatic Stress (www.healthcaretoolbox.org), Professor, Department of Pediatrics, Thomas Jefferson University

Editor-in-Chief, American Psychologist.

 

SURVEY TOOL AND GUIDANCE: Rapid, simple, flexible behavioural insights on COVID-19. This document provides guidance to Member States in the WHO European Region that wish to conduct behavioural insights studies related to COVID-19.  The COVID-19 pandemic outbreak is placing an overwhelming burden on health systems and authorities to respond with effective and appropriate interventions, policies and messages. A poorly timed and managed pandemic response or transition phase can threaten the gains collectively achieved. The pandemic and its restrictions may have affected mental and physical well-being, social cohesion, economic stability as well as individual and community resilience and trust. In this complex context, understanding how, why and the context in which humans and communities respond allows to

1)  anticipate unwanted scenarios and initiate mitigating measures; and

2)  implement pandemic response measures that are better informed, situated, accepted and thus more effective.

Population surveys can explore perceptions, acceptance of restrictions, mental and physical health, behaviours, information needs, misperceptions and more.

 

Adolescent Trials Network (ATN) COVID Questionnaire Draft​  (Revised 4.8.20)

What is the goal of these questions?

-           Important to know how the standard of care is being affected by the pandemic.

-           Is COVID-19 affecting the specific behaviors we are looking at for our study outcomes?

-           How much of the effect is biasing away from the null?

-           This would give information into the dips or rise that we may see into different behaviors.

 

The Burden of COVID‐19 in People Living with HIV: A Syndemic Perspective. The emergence of the novel coronavirus disease known as COVID-19 creates another health burden for people living with HIV (PLWH) who face multiple morbidities and may be at heightened risk for severe physical health illness from COVID- 19. Our abilities to address these morbidities in PLWH must be considered alongside the socially-produced burdens that both place this population at risk for COVID-19 and heighten the likelihood of adverse outcomes. These burdens can affect the physical, emotional, and social well-being of PLWH and interfere with the delivery of effective healthcare and access to HIV treatment. We posit that a syndemic framework can be used to conceptualize the potential impact of COVID-19 among PLWH to inform the development of health programming services. AIDS Behav. 2020 Apr 18. doi: 10.1007/s10461-020-02871-9. [Epub ahead of print].

 

 COVID-19 Excel spreadsheet (with resources on two tabs)

 Courtesy of:

Richelle Allen, Ph.D., Assistant Professor

Director, The Safran Center for Psychological Services

Assistant Director of Clinical Training, The New School for Social Research

 

The Massachusetts General Hospital Psychiatry Department has an excellent set of comprehensive collated set of materials for COVID mental health generally. It isn’t like specific to living with HIV, though, but more just general public. 
 
The University of Miami CENTER for HIV and RESEARCH in MENTAL HEALTH (CHARM) also has an excellent list of COVID-19 Mental Health Resources.
 
Abstract: The COVID-19 pandemic is reinforcing health inequities among vulnerable populations, including men who have sex with men (MSM). We conducted a rapid online survey (April 2 to April 13, 2020) of COVID-19 related impacts on the sexual health of 1051 US MSM. Many participants had adverse impacts to general wellbeing, social interactions, money, food, drug use and alcohol consumption. Half had fewer sex partners and most had no change in condom access or use. Some reported challenges in accessing HIV testing, prevention and treatment services. Compared to older MSM, those 15–24 years were more likely to report economic and service impacts. While additional studies of COVID-19 epidemiology among MSM are needed, there is already evidence of emerging interruptions to HIV-related services. Scalable remote solutions such as telehealth and mailed testing and prevention supplies may be urgently needed to avert increased HIV incidence among MSM during the COVID-19 pandemic era. Sanchez, T.H., Zlotorzynska, M., Rai, M. et al. April, 29,2020. AIDS Behav (2020).

 

World Health Organization

The WHO Comprehensive Mental Health Action Plan 2013-2020  is the global plan that sets out the indicators that all WHO Member states have agreed to deliver in order to improve mental health for all.  This plan will be updated over the course of this year and Ministers of Health will approve the new plan for 2021-2030 in May 2021 at the World Health Assembly. 

In the coming weeks and months, the WHO will be leading discussions with governments at regional and country level on the new plan and with stakeholders more broadly. The WHO is also holding two periods of online consultation on the updates to the plan. The first opened March 9 and runs until March 22nd 2020. See here for more information. A second online consultation will be held later this year.

Mental health and COVID-19: WHO is publishing resources on mental health and COVID-19, please visit this link: https://www.who.int/docs/default-source/coronaviruse/mental-health-considerations.pdf?sfvrsn=6d3578af_10.

 

WHO also has a guide to addressing stigma associated with COVID-19: https://www.who.int/docs/default-source/coronaviruse/covid19-stigma-guide.pdf.

 

NIH Director's Blog

From Dr. Francis Collins’ NIH Director’s Blog: Dealing with Stress, Anxiety, and Grief during COVID-19. This is a discussion with Dr. Joshua Gordon, Director of NIH’s National Institute of Mental Health, about how physical distancing can affect our mental well-being during the COVID-19 pandemic. (Posted April 7, 2020).
 
Webinars of interest (Mental Health and Stress Management):
 
Caring for Yourself & Others during the Covid-19 Pandemic: Managing Healthcare Workers’ Stress. Patricia Watson, PhD, National Center for PTSD. (March 24, 2020).
 
Coping with the stress of coronavirus. Luana Marques, PhD, Harvard Medical School. (April 1, 2020).
 
Managing Anxiety Related to Taking Care of Patients during the COVID-19 Pandemic. Presented by Cheryl Gore-Felton, PhD,  Debra Kaysen, PhD and Mickey Trockel, MD, PhD., Stanford Medicine. (April 3, 2020).
 
Finding the middle ground: Managing stress and anxiety while providing clinical care during the COVID-19 crisis. Presented by Steven A. Safren, PhD, ABPP, Professor of Psychology and Deborah Jones Weiss, PhD, Professor of Psychiatry and Lunthita Dutherly, EdD, University of Miami. (April 15, 2020).
 

Network and other COVID-19 Related Studies                                                                                                   

 

The following studies for hospitalized people are sponsored by Novartis and are being conducted by many ACTG sites around the country.
  
HAT-COVID is a placebo-controlled, phase 3 randomized trial of hydroxychloroquine (HCQ) alone vs HCQ + azithromycin (HCQ/Azi) vs placebo in hospitalized people with COVID-19. The primary outcome is discharge and vital status at Day 15 and will enroll people from acute care floors.
 
RUX-COVID is a placebo-controlled, phase 3 randomized controlled trial of ruxolitinib (RUX, a JAK 1/JAK 2 inhibitor) to prevent cytokine storm and respiratory failure.  The primary objective is death or need for ventilatory support by Day 29.  ICU status people on supplemental oxygen, but not intubated, are allowed to enter this study. 
 

Novartis initiated a Phase III clinical trial to study canakinumab in patients with COVID-19 pneumonia. The CAN-COVID trial will examine the efficacy of utilizing canakinumab, an interleukin (IL)-1β blocker, to treat a type of severe immune overreaction called cytokine release syndrome (CRS) in people with COVID-19 pneumonia. CRS could lead to life-threatening complications in patients with COVID-19. The study builds on early evidence from lab tests of COVID-19 patients who showed elevated IL-1β levels, among other cytokines. Novartis aims to rapidly enroll 450 patients at multiple medical centers across France, Germany, Italy, Spain, UK and the US and randomize them to receive either canakinumab or placebo on top of standard of care (SoC). The primary objective of the study is to demonstrate the benefit of canakinumab in combination with SoC in increasing the chance of survival without the need for invasive mechanical ventilation among patients with COVID-19 pneumonia. Top-line results are anticipated late summer 2020. 

 

HVTN 405/HPTN 1901: The NIH-funded HIV Vaccine Trials Network (HVTN) and HIV Prevention Trials Network (HPTN) have initiated their first clinical trial in response to COVID-19. The study, called HVTN 405/HPTN 1901, is underway at clinical trial sites across North and South America and will describe immune responses in study participants with a history of infection with SARS-CoV-2, the virus that causes COVID-19. HVTN 405/HPTN 1901 aims to enroll approximately 400 study participants aged 18 and older who tested positive for SARS-CoV-2 and have since recovered. Participants will have one required clinic visit and will have the option to participate in additional clinic visits two, four and twelve months after the initial visit. Each visit includes a blood draw and optional nasal sampling procedures. Individuals who still have symptoms of infection or asymptomatic individuals less than two weeks from the date of their last positive test will not be enrolled (May 14, 2020)

 

COVID-19 Potential Therapies​

 

COVID-19 Resources: Experimental Agent Review- Members from the Society of Infectious Diseases Pharmacists have prepared brief, evidence-based reviews of potential pharmacotherapeutic treatment options for COVID-19. These video presentations and handouts will be updated regularly as new data emerge on each of these experimental therapies.

 

COVID-19 vaccine and therapeutic research. The Milken Institute is currently tracking the development of treatments and vaccines for COVID-19 (coronavirus). Per the Milken Institute: "This document contains an aggregation of publicly-available information from validated sources. It is not an endorsement of one approach or treatment over another, but simply a list of all treatments and vaccines currently in development. Given the immediacy of the current public health emergency, we believe it is important to make the data accessible to the public in its current form. This overview will be updated as new findings come to light. We ask that you check this page on a regular basis."

 

There were reports that lopinavir/ritonavir (Kaletra) might have some anti-coronavirus activity. However, a paper published in the New England Journal of Medicine on March 18, 2020 reported that in hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir–ritonavir treatment beyond standard care. An accompanying editorial was published on March 18, 2020, at NEJM.org that provided important context and observations for this and future trials for people with COVID-19 disease.

 

From the Gilead website: Gilead has initiated two Phase 3 clinical studies to evaluate the safety and efficacy of remdesivir in adults diagnosed with COVID-19 following the U.S. Food and Drug Administration’s (FDA) rapid review and acceptance of Gilead’s investigational new drug (IND) filing. These randomized, open-label, multicenter studies began enrolling patients in March 2020 and will enroll a total of approximately 1,000 patients in the initial phase of the studies, in countries with high prevalence of COVID-19. The first of two studies will evaluate the safety and efficacy of both a 5-day and a 10-day dosing duration of remdesivir, in addition to standard of care, for patients with severe manifestations of COVID-19. The second study will evaluate the safety and efficacy of the same dosing regimens of remdesivir in addition to standard of care for patients with moderate manifestations of COVID-19, compared with standard of care alone. (Accessed March 24, 2020)
 
FDA Actions:
EUA granted for remedesivir. On May 1, 2020, the U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
 
EUA withdrawn for hydroxychloroquine: On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.
 
Interactions with experimental COVID-19 therapies. The Liverpool Drug Interaction Group (based at the University of Liverpool, UK), in collaboration with the University Hospital of Basel (Switzerland) and Radboud UMC (Netherlands), have produced various materials in PDF format to aid the use of experimental agents in the treatment of COVID-19. Please check this site regularly for updates and additional information. 

 

COVID-19 in patients with HIV: clinical case series. (From Lancet HIV-April 15, 2020)

Our preliminary experience highlights several issues. First, patients with HIV accounted for almost 1% of patients with COVID-19 who required admission to hospital in Barcelona. We only observed the infection in people younger than 50 years, who identified as MSM, and who have a COVID-19 clinical pictures resembling the general population. None of these five patients has died, although we admitted two to intensive care, where one remains. More studies of COVID-19 in patients with HIV are needed in the older MSM population, drug users, and heterosexual men and women in middle-income and lower-income settings. Second, two patients who were MSM were sex workers, one reporting participating in a chemsex party 6 days before admission to hospital. During this pandemic, implementing health education programmes is very important to explain that such activities as these could cause clusters of SARS-CoV-2 transmission. Third, we adapted ART in all patients to a regimen based on protease inhibitors: three patients were given lopinavir-boosted ritonavir and two were given darunavir-boosted cobicistat. In the past month, a clinical trial4 found that lopinavir-boosted ritonavir was ineffective as a monotherapy against severe pneumonia associated with COVID-19 in China. Therefore, investigation of the efficacy of this treatment in patients with COVID-19 in combined therapy in earlier stages of the disease is needed. Additionally, Janssen reported on March 18, 2020, that darunavir was ineffective against SARS-CoV-2 due to low affinity to coronavirus protease. Fourth, we did not give our patients remdesivir, the most active in-vitro and in-vivo antiviral drug against coronavirus to date,5 and is currently only available through clinical trials or for compassionate use. This drug has no pharmacokinetic interactions with any medication including ART drugs. Finally, in advanced patients (ie, late presenters), we must ensure differential diagnosis and initial antimicrobial treatment to address pulmonary opportunistic infections (eg, Pneumocystis jirovecii, as seen in patient 5) presenting with similar clinical and radiological symptoms. This pandemic is a challenge affecting everyone. By generating information such as we present here, the management and prognosis of patients co-infected with HIV and SARS-CoV-2 might be improved.Our preliminary experience highlights several issues. First, patients with HIV accounted for almost 1% of patients with COVID-19 who required admission to hospital in Barcelona. We only observed the infection in people younger than 50 years, who identified as MSM, and who have a COVID-19 clinical pictures resembling the general population. None of these five patients has died, although we admitted two to intensive care, where one remains. More studies of COVID-19 in patients with HIV are needed in the older MSM population, drug users, and heterosexual men and women in middle-income and lower-income settings. Second, two patients who were MSM were sex workers, one reporting participating in a chemsex party 6 days before admission to hospital. During this pandemic, implementing health education programmes is very important to explain that such activities as these could cause clusters of SARS-CoV-2 transmission. Third, we adapted ART in all patients to a regimen based on protease inhibitors: three patients were given lopinavir-boosted ritonavir and two were given darunavir-boosted cobicistat. In the past month, a clinical trial4 found that lopinavir-boosted ritonavir was ineffective as a monotherapy against severe pneumonia associated with COVID-19 in China. Therefore, investigation of the efficacy of this treatment in patients with COVID-19 in combined therapy in earlier stages of the disease is needed. Additionally, Janssen reported on March 18, 2020, that darunavir was ineffective against SARS-CoV-2 due to low affinity to coronavirus protease. Fourth, we did not give our patients remdesivir, the most active in-vitro and in-vivo antiviral drug against coronavirus to date,5 and is currently only available through clinical trials or for compassionate use. This drug has no pharmacokinetic interactions with any medication including ART drugs. Finally, in advanced patients (ie, late presenters), we must ensure differential diagnosis and initial antimicrobial treatment to address pulmonary opportunistic infections (eg, Pneumocystis jirovecii, as seen in patient 5) presenting with similar clinical and radiological symptoms. This pandemic is a challenge affecting everyone. By generating information such as we present here, the management and prognosis of patients co-infected with HIV and SARS-CoV-2 might be improved."

 

Childs K et al. Hospitalized patients with COVID-19 and HIV: a case series. Clinical Infectious Diseases, online ahead of print, 27 May 2020.
“Compared to our whole HIV outpatient cohort, those hospitalized with COVID-19 were more likely to be of black ethnicity (odds ratio [OR], 12.22 [95% confidence interval {CI}, 1.62–92.00]) and to have lower median CD4 cell counts (395 vs 573, P = .03) (Supplementary Table 1). There was a trend toward more common use of protease inhibitor–containing antiretroviral regimens among those with COVID-19 (OR, 2.43 [95% CI, .94–6.29]).
Our data indicate that, in contrast to earlier reports [1, 2], there may be substantial morbidity and mortality from COVID-19 among PWH, even among those on suppressive ART. Black PWH appear to be at substantially increased risk of severe disease, and darunavir (or any other class of ART) does not appear to provide protection against moderate/severe COVID-19. If confirmed, African regions with a high prevalence of HIV infection.”
 
Vizcarra P et al. Description of COVID-19 in HIV-infected individuals: a single-centre, prospective cohort. Lancet HIV, online ahead of print, 28 May 2020.
“HIV-infected individuals should not be considered to be protected from SARS-CoV-2 infection or to have lower risk of severe disease. Generally, they should receive the same treatment approach applied to the general population.”
 
Julia del Amo et al. Incidence and Severity of COVID-19 in HIV-Positive Persons Receiving Antiretroviral Therapy. Annals of Internal Medicine , 26 June 2020. "HIV-positive patients receiving TDF/FTC have a lower risk for COVID-19 and related hospitalization than those receiving other therapies. These findings warrant further investigation in HIV preexposure prophylaxis studies and randomized trials in persons without HIV."

These nice summaries are written  by Liz  Highleyman, of NAM AIDSMAP, of studies presented at AIDS 2020 (Virtual).

New York studies look at COVID-19 outcomes and immune function among people with HIV. “People living with HIV spent a similar amount of time in hospital as HIV-negative COVID-19 patients and had a comparable death rate during the height of the outbreak in New York City, but they were more likely to be put on ventilators.”

“A related study showed that people with HIV had higher levels of inflammation, indicating that they are capable of mounting a strong inflammatory response to the new coronavirus and remain at risk for severe COVID-19 despite taking antiretroviral therapy (ART).”

Patel VV et al. Clinical outcomes by HIV serostatus, CD4 count, and viral suppression among people hospitalized with COVID-19 in the Bronx, New York. 23rd International AIDS Conference, abstract OABLB0102, 2020.

Ho H et al. Immunologic characteristics of acute COVID-19 in people with HIV. 23rd International AIDS Conference, abstract OABLB0104, 2020.

In another study presented at AIDS 2020: “An analysis of the largest cohort of people living with HIV in the United States found that they were not more likely to contract the new coronavirus, and those who did so were not more likely to develop severe COVID-19.”

Park LS et al. COVID-19 in the largest US HIV cohort. 23rd International AIDS Conference, abstract LBPEC23, 2020.

 

Stability of SARS-CoV-2 (COVID-19 virus) on Surfaces

 

study published on March 17, 2020 in the NEJM found that aerosol and fomite transmission of SARS-CoV-2 is plausible, since the virus can remain viable and infectious in aerosols for hours and on surfaces up to days (depending on the inoculum shed). This study reinforces the importance of hand washing in addition to social distancing to reduce coronavirus transmission.

 

Webinars of Interest

 
AVAC was joined by Dr. Carl Dieffenbach, Director of the Division of AIDS (DAIDS) at the NIH, and other partners, to answer questions about what we do and don’t know about COVID-19 and HIV, how to track research developments on the HIV front, what this new pandemic might mean for ongoing HIV research, and how the HIV community can contribute to the fight against COVID-19.
 
COVID-19 & HIV Full Meeting (March 24, 2020)
The University of Washington AIDS Clinical Trials Unit’s Community Advisory Board (UW ACTU CAB) held an online meeting on March 24, 2020 focused on the COVID-19 pandemic. Dr. Rachel Bender Ignacio, Associate Director of the UW ACTU, presented and her excellent slides can be downloaded here: https://bit.ly/3bnvGZi.

 
​The Office of HIV/AIDS Network Coordination (HANC) hosted a webinar featuring Dr. Carl Dieffenbach​, Director of the Division of AIDS (DAIDS) at the National Institute of Allergy and Infectious Diseases; Dr. Sarah Read, Deputy Director of the DAIDS; Manizhe Payton, Director of the Office of Clinical Site Oversight (OCSO) at DAIDS; and Dr. Jeffrey Schouten, HANC Director, in an effort to inform network stakeholders and community about the impact of COVID-19 on HIV research.
 
COVID-19: A clinical update for HIV care providers. (April 1, 2020) (hosted by the American Academy of HIV Medicine (AAHIVM) and Association of Nurses in AIDS Care (ANAC)). 
Finding the Middle Ground: Managing Stress and Anxiety During the COVID-19 Crisis. (May 7, 2020) Dr. Steven Safren and Dr. Deborah Jones Weiss from the University of Miami discuss stress and anxiety management strategies for providers during the COVID-19 epidemic. 
AVAC hosted an excellent webinar with Science Magazine’s Jon Cohen. (May 13, 2020) Jon talked about the fast-growing pipeline of vaccine candidates for COVID-19, how COVID-19 research is evolving and building on HIV vaccine research and more. The recording and terrific slides have been posted by AVAC.

The International AIDS Society (IAS) is organizing a series of webinars on the topic of COVID-19 and HIV to discuss the pandemic and its impact on people living with HIV. Through these webinar sessions, the IAS would like to provide an opportunity for discussion around the latest science, in addition to sharing learning and best practices in relation to COVID-19 and HIV between countries at different stages of the pandemic, especially in lower- and middle-income countries.​ Find links to the webinars here​

Dr. Anthony Fauci, Director of NIAID, NIH gave a talk to HIV network CABS on June 10,2020, the recording is available here: https://youtu.be/kvbVTn7edKk  . Here is a link to his excellent slide presentation
 
Follow-up Discussion with Dr. Dieffenbach on COVID for NIAID CABs”. Steve Wakefield moderated a webinar discussion with Dr. Carl Dieffenbach on June 23, 2020.
 
The University of Washington’s AIDS Clinical Trials Unit Associate Director, Dr. Rachel Bender Ignacio, presented a webinar on COVID-19 and People Living with HIV to the ACTG’s Global Community Advisory Board (June 18, 2020).
 
 

Remembering Gita Ramjee​ - From the MTN

We are writing to share the sad news about the passing of one of our very dearest colleagues, Gita Ramjee. The cause of death is from complications of COVID-19.
 
image-20200331192450-1 
 
Words cannot express the sorrow we feel. Gita was a tremendous force within the field and was part of the MTN family from day one. As you all know she directed the MRC CTU in Durban for many years, and in May 2019 refocused her efforts toward spending more time with her sons living in London and enjoying her grandson who is about 6 months old. Gita had a tremendous passion for HIV prevention and she cared deeply about addressing the disparities in HIV incidence in young women. It wasn’t too long ago that she wrote in an email, “It has been a long road with many ups and downs but we have forged along with strong determination.” She was always impeccably dressed. She always had a beautiful manicure. She always had a big smile. We will always appreciate her role in the MTN family.
 
We will miss Gita and wish her family comfort during this time of unfathomable loss.
 
Stay well, stay safe.
 
Warmest wishes to all of you in this difficult time.
Sharon Hillier and Jared Baeten
(Posted  March 31, 2020)
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