VOLUME 20, ISSUE 2: DECEMBER 2020 Image: Volunteers of the COVID-19 Volunteer Screening Registry TOGETHER WE WILL FIND VACCINES FOR COVID-19 1 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 LETTERwe at the HVTN remain committed Wakefield (who prefers to go by just to our pursuit to find safe and “Wakefield”) in July 2020. Wakefield effective preventive HIV vaccines was not only one of the initial hires that have global application. of the HVTN, but has helped to lead and fortify community engagement I believe we will see an end to the within the network, and in COVID-19 pandemic, but we cannot communities globally. achieve this end ethically by leaving anyone behind, or without ensuring Please help us ensure that this that appropriate efforts are focused publication is representative of our on those who are most vulnerable. entire global HVTN community! There are many stakeholder HVTN members (who have access mobilization efforts happening in to the HVTN member’s website) Dr. Stephaun E. Wallace, Editor-in-Chief local and national settings around can use our submission page that [email protected] the world with goals of raising offers the ability to submit content Welcome to the latest edition of the awareness about these issues, and and articles for inclusion in future HIV Vaccine Trials Network (HVTN) ensuring resources and solutions issues. More information about this Community Compass. are inclusive of those most impacted follows on the “Meet the Community and vulnerable. We are a global Compass Team” page. In this issue, we highlight some community; let us work together in of the efforts of our clinical trial response to this pandemic. Thank you for your continued sites and updates from the HVTN support of the HVTN wherever you Leadership and Operations Center The Mosaico Study, also known as are in the world, for the work that (Core), including a special article HVTN 706/HPX 3002, was previously you do in whatever role you have that describes how and why the paused in response to COVID-19. in the HVTN community, and for Network and other collaborators The study team wanted to ensure the impact we have been able to have pivoted our attention the safety and health of participants make in our collective history and to respond to COVID-19. The and study staff. We are in the process communities, together. Though we COVID-19 Prevention Network of working with regulatory groups have come very far in response to (CoVPN) has been organized and clinical trial sites to ensure a the HIV epidemic, we have so much at the direction of Dr. Anthony safe restart to the study globally. further to go to achieve a globally Fauci, leveraging the clinical Our other HIV vaccine and antibody effective HIV vaccine. The HVTN trials, laboratory, community concept proposals and protocols are Community Compass team wants engagement, and statistical/data starting to reopen now. to be everywhere you are, so please management expertise of key share with us what’s happening at NIAID clinical trials networks to test Change is said to be the only your research sites, institutions, and vaccines and monoclonal antibodies constant in our lives. 2020 has in your communities, so that we can that are designed to protect people brought about significant change to share it with the world. from COVID-19 disease. For more me personally and professionally, to information on the CoVPN and to my colleagues and our community Be well, learn more about the clinical trials, partners, and I am certain to all of Stephaun E. Wallace visit www.PreventCOVID.org. you. One of the significant changes Stephaun E. Wallace, Ph.D. that we touch on in this issue is the Though we have pivoted our efforts Editor-in-Chief, HVTN Community Compass in response to COVID-19, retirement of our very own Steven HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 2 CONTENTS Meet The Community Compass Team 4 Building an Investigative Army in 100 Days 5 COVID-19 Prevention Network Active Studies Recruiting Volunteers 10 The CoVPN Faith Initiative 11 Upcoming Meetings/Conferences/Awareness Days 14 HIV Prevention Efficacy Trial Designs of the Future 15 Community Engagement Manuscript Published 16 After 20 Years, Wakefield Retires from HIV Vaccine Trials Network 18 Harmonizing Efforts to Conduct Large Scale COVID-19 Vaccine Efficacy Trials 21 HVTN Responds – No Justice, No Progress 22 Staffing Updates at HVTN Core 23 Understanding the Socio-Behavioral Dynamics of the Transgender Population in an Under-Resourced Setting in South Africa 25 “Banda Mole” is Also Prevention! 30 CoVPN Profiles 31 COVID-19 and HIV: What You Need to Know 39 Keeping Our Eyes on Sexual and Reproductive Health in the Middle of a Pandemic in Zimbabwe 44 Discovering the Necessity for ‘Meaningful Community Engagement’ in the Face of the COVID-19 Pandemic in Kenya 45 3 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Our vision is an informed HVTN community that is aware of current events and activities relating to the HVTN network and its sites, advances in the field of HIV prevention and vaccination, as well as community priorities. We work to accomplish this by providing relevant information and updates to promote awareness, understanding, and support for HIV prevention and HIV vaccines, reaching global communities invested in the response to the HIV epidemic. We welcome submissions of articles on any topic for publication that is relevant to the HVTN community. Submissions must be exclusive to us, and not appear in any other publication. Submissions must be 500 words or less to comply with our layout and design requirements.Due to space limitations, we may need to hold publishing your article for a future issue. To submit articles for Community Compass, please go to the HVTN Members Site homepage, click on “About”, then click “Community Compass”, then click on “Submit to Community Compass”. Stephaun E. Wallace, Ph.D. Cody Shipman, Nina Feldman, Editor-in-Chief Layout & Design Production & Distribution Aziel Gangerdine, Gail Broder, MHS Contributor Contributing Editor HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 4 Feature Article BUILDING AN INVESTIGATIVE ARMY IN 100 DAYS By: Mindy Miner, PhD, HVTN Core, Seattle, WA, USA WHY/HOW WAS THE Institute of Allergy and Infectious the HVTN’s infrastructure and Diseases (NIAID) Director Tony experience became priceless. Two CoVPN DEVELOPED? Fauci was on television every decades of developing vaccine day as part of the White House and monoclonal antibody clinical The birth of a network Coronavirus Task Force and his trial protocols. Two decades conversations with Corey were of building relationships with The first week of March 2020 reminiscent of those 20 years ago physician-scientists, pharmacists, brought several changes to the when the HVTN began. Mainly, that and clinic staff. Two decades Seattle area. HVTN workers were we (the nation) needed a seamless of community engagement ordered by Fred Hutch to work infrastructure to get these vaccines programs collaborating with remotely. Conferences, such as tested as soon as humanely local advocacy groups to reach the large annual HIV meeting possible. John Mascola, director of people most burdened by disease. CROI, went virtual. And infectious the National Institutes of Health Two decades of immunology lab disease physicians and scientists (NIH) Vaccine Research Center assays perfected and Federal Drug everywhere started focusing on (VRC), and Fauci became Corey’s Administration (FDA)-approved. what they could do about severe most frequent cell phone and text Two decades of statistical expertise acute respiratory syndrome– contacts on the development of analyzing large datasets. coronavirus 2 (SARS-CoV-2) and an NIH/Biomedical Advanced the disease it causes, COVID-19. Research and Development “This expertise in HIV needs to HVTN Principal Investigator Authority (BARDA) infrastructure, and can be leveraged,” Corey said. Larry Corey’s weekly calendar and conversations on how to “Our faculty site investigators are shifted from meetings about build a nationwide investigative all interested in and affected by HIV antigens and monoclonal organization to handle this task this epidemic. There is universal antibodies to how to combat the were initiated. Confidentiality support for doing this.“ SARS-CoV-2 epidemic in Seattle agreements to allow access to and how to develop what he knew information were signed and the The first HVTN COVID-related was the burgeoning scientific task began in earnest. protocol, which opened May 13, infrastructure and initiative on 2020, was HVTN 405/HPTN 1901: developing vaccines to the new When a global catastrophe like characterizing SARS-CoV-2- pathogen. By then, National the COVID-19 pandemic hit, specific immunity in convalescent 5 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 individuals (convalescent means a vaccine to billions of people is, in There the challenge laid: a new someone who recovered from a word, complicated. [Read a recent disease, a new demographic(s). The disease). The time of concept viewpoint in Science Magazine team consulted with expert panels sheet (initial protocol idea) to trial (https://science.sciencemag.org/ for recommendations on engaging opening (screening participants) content/368/6494/948.long) by priority communities, mainly was 1 month. The median for HVTN Corey et al to go into depth.] That is African American/Black, Latinx, trials has been well over a year. just for one vaccine. Now multiply Native/Indigenous and older adult Before the US government’s (USG) that by four or five different populations. The team developed Operation Warp Speed was even companies and things get crazy. It a suite of materials in record created, before the Network had was apparent to CoVPN leadership time.