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. A website was built (www. even been given the official gracing that these efficacy trials, involving PreventCOVID.org). Informational of a new name, the Network was as many as 30,000 people each, videos were produced. Flyers, operating at ‘warp speed.’ It’s a would need to be harmonized posters and brochures received tribute to the staff that they could – something pharmaceutical Institutional Review Board approval and did embrace the mantra of companies haven’t historically and hit the streets. In addition, the quality and speed to this task. worried about. But in order to make CoVPN received federal funding This does not mean corners were sense of results, sample collection, to develop and produce a series cut; only that this trial was the lab assays and statistical analyses of public service announcements priority for everybody – HVTN, would need to be consistent across (PSAs) in both English and Spanish HPTN, Division of AIDS, etc. all trials. The CoVPN is making sure aimed at recruiting Americans for There was no longer a delineation that happens. the vaccine trials. between weekdays and weekends. The HVTN saw early on how The CoVPN developed a Volunteer Engaging the nation the pandemic would cripple the Screening Registry, led by HVTN economy and society, much like a The HVTN/CoVPN Community Executive Director Jim Kublin, World War, and therefore all hands Engagement Team, led by Michele that allows people interested in were on deck to end it as quickly Andrasik, faced a formidable volunteering for a trial to sign-up. as possible. challenge on participant Within a week of going live on July recruitment. The group couldn’t just 7, 2020, more than 91,000 people The new COVID-19 Prevention repurpose the HVTN’s longstanding had signed up. As of late October, Network (CoVPN) was born, HIV materials. A simple ‘find/ the number rose to over 407,000, with Corey and Kathy Neuzil replace’ for ‘HIV/SARS-CoV-2’ in with now more than 515,000. Many (from the Infectious Diseases an informed consent form would of the CoVPN clinical research sites Clinical Research Consortium not be adequate. Not only are have used the registry to prioritize and University of Maryland) as the viruses, and the respective those populations that have been head of the operations center and diseases they cause, extremely disproportionately impacted by the HPTN’s Mike Cohen and Emory different, but so are the target national epidemic. Participants in University’s David Stephens audiences for educational materials. the registry have also contributed leading the monoclonal antibody Historically, when participants to a public service announcement program. The NIAID oversight volunteered for an HVTN Phase narrated by Harrison Ford, and team included Emily Erbelding, 1 study, they often commented the registry will continue to Carl Dieffenbach, Mary Marovich, their participation stemmed from a provide participants for all efficacy and Mascola. “This is not business passion for stopping a disease that trials regardless of vaccine or as usual” became the new mantra affected them or their communities monoclonal antibody developer. around the remote office. “We’re personally. But now, with a global Continued on the next page... building the plane as we fly it” was pandemic that has infected 40 another favorite analogy at the million people worldwide and killed time. Trial names would not begin more than 1 million in under a year, with ‘HVTN,’ but now have people who may have never thought ‘CoVPN’ numbers. twice about infectious disease or public health have become the Finding an efficacious vaccine target demographic. Nursing home wasn’t the only problem. The residents, grocery store clerks, logistics of manufacturing, and bus drivers are examples of packaging, and distributing populations at risk for COVID-19.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 6 Feature Article WHAT PRODUCTS ARE BEING TESTED, AND WHICH COMPANIES ARE INVOLVED?

The CoVPN is currently involved in five COVID-19 vaccine efficacy trials, which are scheduled to open approximately one per month for the remainder of the year (Figure 2). All these vaccines have advantages and disadvantages with regard to speed of manufacturing, Figure 1. Rapid site expansion both within the US and internationally. scalability, type of immune response, and target population. Expanding the reach also prepare longstanding HVTN sites for the era of COVID. Site Moderna The Network (HVTN-now-CoVPN) preparation visits were restructured increased its number of US clinical to be virtual. Running clinical trials The first trial to open, the COVE trials sites from 62 in June 2020 during a pandemic is logistically Study, used a two-dose nucleic to 151 in September: more than complex. Sites needed personal acid-based approach developed by doubling its national footprint in a protective equipment for safe clinic the company Moderna (modernatx. mere few months (Figure 1). This reopening, educational materials com/cove-study). This vaccine new cadre of sites included for the for volunteer recruitment, nasal uses the relatively novel platform first time Veterans Administration swabs and PCR machines for of messenger RNA (mRNA) that Facilities, Historically Black Medical testing. At least 29 of these sites, encodes for the main surface Colleges, and the Indian Health according to Eaton, will most likely protein of SARS-CoV-2, the spike Service. The Site Operations Team, employ one or more temporary protein. Advantages of this vaccine led by Niles Eaton, worked tirelessly locations, such as a mobile clinic, include speed of production, ability to not only onboard new sites in trailer, or tent, to reach individuals to deliver multiple antigens at the the US and internationally, but in remote locations. same time, and durable antibody

Figure 2. Expected course of Phase 3 clinical trials.

7 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 responses. Although many Phase the HIV efficacy trials HVTN 705 1 studies using mRNA vaccines (Imbokodo) & 706 (Mosaico). This have shown promise, none have trial was also temporarily put on reached licensure. The SARS- safety pause for approximately KEEP YOUR CoV-2 viral genome sequence was 10 days in October in response published January 10, 2020 and the to adverse events. It has FAMILY’S COVE Study opened 6 1/2 months since resumed. later on July 27, 2020. This speed FUTURE SAFE. is unparalleled in history. It usually Novavax & Sanofi Pasteur takes decades between deciphering what pathogen causes disease to Two more trials are in the process Volunteer for a vaccine a vaccine efficacy trial. of being developed, one by the company Novavax and the other study today. AstraZeneca by Sanofi Pasteur, scheduled to open in November and December The second CoVPN trial to open of this year. Both vaccines will was a vaccine developed by Oxford be two-dose and use traditional University and subsequently sold recombinant protein technology to the company AstraZeneca. to deliver the spike protein. Protein The vaccine regimen, also two- vaccines are widely used globally dose, uses a viral vector from a and given to people of all ages, chimpanzee adenovirus (Ad) that something important to consider does not cause disease in humans. if COVID vaccination plans in the This vaccine, like the Moderna future include children. vaccine, encodes for the SARS- CoV-2 spike protein. The trial One important point is that these began in August 2020 and was companies would, under normal subsequently put on hold due to circumstances, never produce adverse events. The hold was lifted millions of doses of a vaccine in late September in Europe/Brazil/ before FDA approval and licensure, South Africa, where a parallel trial much less concurrent with the is being conducted, and the FDA efficacy trial. The reason they are approved restart in the US doing so in this case is because the on October 23, 2020. USG has agreed to purchase those doses, regardless of whether they Janssen show efficacy, resulting in minimal risk to the company. This is why The third trial to begin was another the field has made such strides adenovirus vector vaccine, this so quickly. time using human Ad26 as the Continued on the next page... backbone delivering the spike protein antigen and developed by Janssen (part of Johnson & Johnson). One aspect of the ENSEMBLE Trial is that the regimen includes one dose, as opposed to two doses for each of the other Learn more at vaccine trials. A one-dose regimen PreventCOVID.org is advantageous logistically, especially if hundreds of millions of people need to be vaccinated. Help end the The Ad26 backbone was recently uncertainty. shown to be safe and stimulate a robust immune response against Ebola and is the platform used in

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 8 Feature Article HOW MANY PEOPLE WHAT IS THE In summary

ARE NEEDED FOR STATUS OF The HVTN/CoVPN is in the middle of the most important health crisis EACH STUDY? EACH STUDY? of the last century. Not since the 1918 influenza pandemic have Approximately 30,000 participants Table 1 lists the CoVPN studies and we seen such rapid morbidity are needed for each vaccine trial their status as of October 2020. In and mortality from an infectious in order to have what statisticians addition to the five Phase 3 vaccine disease. Unlike the 1918 flu, when call “power” to determine whether trials mentioned above, the CoVPN approximately 1/3 of the world’s the vaccine provides any benefit or is involved in several monoclonal population was infected and ~50 efficacy against COVID-19 disease. antibody studies as well as million people died, the COVID-19 Based on current epidemiological observational studies to learn pandemic is occurring at a time of projections and what is known about disease prevalence and unparalleled biomedical advances about disease progression, the immune responses. and information technology. CoVPN can assume that for each Humanity’s ability to join together 30,000-person trial, it will take and overcome this virus will be approximately 24 weeks from something never forgotten. trial opening to accrue enough Dr. Mindy Miner is the Science Writer/ “endpoints” to determine efficacy. Editor of the HVTN. Dr. Larry Corey An endpoint is COVID-19 disease. and Dr. Jim Kublin, HVTN Principal Investigator and HVTN Executive Director, respectively, contributed to this article.

CoVPN Study Type Short Description Company Status Trial Number mRNA-1273 Phase 3, the Enrollment complete, 3001 Moderna COVE study in follow-up AZD1222 (ChAdOx1 nCoV- 3002 AstraZeneca Open and enrolling 19) Phase 3 Vaccine Ad26 Phase 3, the Ensemble 3003 Janssen Open and enrolling study 3004 Protein Phase 3 Novavax In development 3005 Protein Phase 3 Sanofi Pasteur In development -SARS-CoV-2 antibody 3501 α Eli Lily Open and enrolling Phase 3, the BLAZE-2 study -SARS-CoV-2 antibody Monoclonal α 3502 cocktail Phase 3, the REGN- Regeneron Open and enrolling antibody COV study -SARS-CoV-2 antibody 3503 α Vir/GSK In development Phase 2/3 Acute immune responses to 5001 N/A Open and enrolling Observational SARS-CoV-2 infection 5002 SARS-CoV-2 prevalence N/A In development Screening registry for par- Operational 6001 N/A Open and enrolling ticipation in CoVPN trials Table 1. CoVPN pipeline of studies and status.

9 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Feature Article cause COVID-19. The ENSEMBLE The REGN10933 and REGN10987 study aims to test Janssen’s antibodies are designed to bind investigational vaccine in many to SARS-CoV-2 and prevent the COVID-19 different populations across virus from entering healthy cells. the globe. The antibodies were made in a lab Prevention by the pharmaceutical company Visit ClinicalTrials.gov - Regeneron. REGN10933 and Network Active NCT04505722 for additional details. REGN10987 cannot give you SARS- Studies Recruiting CoV-2, nor will they make you sick AstraZeneca Study of AZD1222 with COVID-19. Volunteers AZD1222 is an investigational Visit www.regeneron.com/ vaccine being developed by covid19 or ClinicalTrials.gov AstraZeneca to prevent COVID-19, - NCT04452318 for additional Pfizer & BioNTech’s mRNA the disease caused by the SARS- information about the study. CoV-2 virus. Vaccine Study BNT162b2 is an investigational The vaccine is based on a Eli Lilly’s LY3819253 Antibody, mRNA vaccine being developed weakened version of a common the BLAZE-2 Study by Pfizer and BioNTech to help cold (adenovirus) virus. The BLAZE-2 is testing the LY3819253 prevent COVID-19, the disease adenovirus vaccine has been antibody. It will be enrolling staff caused by the SARS-CoV-2 virus. changed so that it can’t replicate and residents in skilled nursing The purpose of the study is to inside your body. It presents part of and assisted living facilities with test how well the investigational the COVID-19 spike protein to the a high risk of exposure to SARS- vaccine works at preventing body so that an immune response CoV-2. The study questions are: COVID-19 disease and evaluate can be made to it. The purpose of • Does the antibody prevent the whether it is safe for adults and the study is to test how well the acquisition of SARS-CoV-2? adolescents. BNT162b2 contains investigational vaccine works at a small part of the genetic code preventing COVID-19 disease and • Does the antibody help to for the SARS-CoV-2 spike protein. how safe it is. prevent the development of BNT162b2 does not contain any more severe COVID-19, or does live virus. It cannot give you SARS- Visit ClinicalTrials.gov - it reduce the symptoms? CoV-2 infection, nor will you get NCT04516746 for additional details. The study will be conducted in COVID-19. the United States with up to 2,400 Regeneron’s 10933 and participants. LY3819253 is designed Visit ClinicalTrials.gov - 10987 Antibodies, the to bind to SARS‑CoV-2 and prevent NCT04368728 for additional details. the virus from entering healthy REGN-CoV2 Study cells. LY3819253 was developed in a The ENSEMBLE Study with REGN-CoV-2 is testing a lab by the pharmaceutical company Janssen’s Ad26.CoV2.S combination of two antibodies Eli Lilly. LY3819253 cannot give you called REGN10933 and REGN10987 Investigational Vaccine SARS-CoV-2, nor will it make you to see whether they are able to sick with COVID-19. The Ad26.COV2.S investigational prevent acquisition of SARS- vaccine is being developed to CoV-2. This study will enroll Visit blaze2study.com or prevent or lessen the severity of approximately 2,000 adults in the ClinicalTrials.gov - NCT04497987 COVID-19, the disease caused United States who are living in for additional details. You may by Severe Acute Respiratory the same household as a person also call the BLAZE-2 Call Center Syndrome Coronavirus-2 who has recently tested positive at 718-210-9713 from 9 a.m. to 5:30 (SARS-CoV-2). The Ad26.COV2.S for SARS-CoV-2. This will include p.m. Eastern Time Monday through investigational vaccine includes about 1,700 participants who test Friday. bits of genetic material copied SARS-CoV-2 negative at enrollment from the spikes of the SARS-CoV-2 and about 300 participants who For more information about the virus. The goal is for the body to be have a positive SARS-CoV-2 COVID-19 Prevention Network, immunized against COVID-19. The test result but do not have any go to: www.PreventCOVID.org. investigational vaccine does not COVID-19 symptoms. contain the actual virus and cannot

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 10 Feature Article THE CoVPN FAITH INITIATIVE

By: Stephaun Wallace, PhD, HVTN Core, Seattle, WA, USA

With many communities across the Engaging the Media and I, will leverage what we have U.S. disproportionately impacted learned to build trust and “engage by the COVID-19 pandemic, the The CoVPN Faith Initiative was everyone so that when a COVID-19 COVID-19 Prevention Network announced at a virtual press vaccine is approved, it is effective for (CoVPN) is very excited to share conference on Sept. 9 and attended all people,” noted Rev. Sanders. Key that we have launched a new, by more than a dozen national efforts will include involving and national faith-based program reporters from major news outlets expanding existing faith networks to called the CoVPN Faith Initiative such as the Atlanta Journal- help conduct educational webinars, to build trust and engage diverse Constitution, the Wall Street Journal, community town hall meetings and populations about COVID-19 and the New York Times, and Science. share information through existing CoVPN clinical trials. This initiative Following the press conference, a faith gatherings, programs and is one of many strategies we have news release was issued to media support groups. deployed to meaningfully engage outlets across and include communities in the the country. To date, six Faith Ambassadors have research process. been named, as follows: Speakers at the press conference Rev. Edwin C. Sanders, II, head included Rev. Sanders, two • Khadijah Abdullah, Executive of the Metropolitan International Faith Ambassadors: Bambi Director of Reaching All HIV+ Church in Nashville, TN, will lead Gaddist, DrPH, CEO & Founder Muslims in America (RAHMA), the CoVPN Faith Initiative and and Executive Director of the Washington, DC coordinate the work of seven Faith South Carolina HIV Council in • Bishop Oliver Clyde Allen Ambassadors and more than 30 Columbia; Ulysses W. Burley III, III, Senior Pastor and Founder clergy-consultants from Black, MD, Founder of UBtheCure, in of The Vision Cathedral of Latinx and American Indian/Alaska Chicago, IL; and myself. Here are Atlanta., Atlanta, GA Native communities throughout a couple of stories that have run to • Ulysses W. Burley III, M.D., the nation. date: Scripps Newswire (includes Founder of UBtheCure, approximately 60 TV stations in Charged with implementing a Chicago, IL. 42 markets), www.youtube.com/ faith-focused COVID-19 and watch?v=xYliKEuB9jI, and CBS This • Bambi W. Gaddist, DrPH, CEO CoVPN education program that Morning, www.cbsnews.com/video/ & Founder and Executive supports inclusive engagement covid-19-vaccine-trials-volunteer- Director of the South Carolina of members in key communities, demographics-reveal-need-for- HIV Council in Columbia, SC the Faith Ambassadors will expand greater-racial-diversity/. existing faith networks to conduct • Rev. Kamal Hassan, Pastor of educational webinars, community Sojourner Truth Presbyterian CoVPN Faith Ambassadors: town hall meetings and share Church, Richmond, CA information through existing With decades of experience in the • Rev. Bertram G. Johnson, faith gatherings, programs and fight against HIV/AIDS, Rev. Sanders, Union Theological Seminary, support groups. each of the seven Faith Ambassadors, New York, NY

11 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 HELP BUILD A SAFER TOMORROW. Volunteer for a vaccine study today.

Call to Action As stakeholders, our readers play an important role in educating your respective organizations and communities on the vital work of the CoVPN, including the CoVPN Faith Initiative. It’s important that we listen, learn and develop the partnerships that enable us to enhance trust and meaningfully engage key communities.

To assist you in your efforts, we’ve provided helpful information on the COVID-19 Prevention Network’s website (www.PreventCOVID.org), including COVID-19 clinical studies, how people can volunteer, and a detailed “FAQ,” or most frequently asked questions about the studies.

Should you have any questions or need further information about the CoVPN Faith Initiative or other CoVPN stakeholder engagement strategies and programs, please do not hesitate to reach out to me directly.

Stephaun E. Wallace, PhD Director of External Relations, COVID-19 Prevention Trials Network (CoVPN)/HVTN Staff Scientist, Vaccine and Infectious Disease Division, Fred Hutch Clinical Assistant Learn more at Help end the Professor, Department of Global Health, PreventCOVID.org University of Washington uncertainty. Director, Office of Community Engagement, UW/Fred Hutch Center for AIDS Research

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 12 ONE SHOT CAN CHANGE THE PANDEMIC Volunteer for a vaccine study today.

Learn more at Help end the PreventCOVID.org uncertainty.

13 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 UPCOMING MEETINGS/CONFERENCES/AWARENESS DAYS 2021 NATIONAL AFRICAN AMERICAN MSM LEADERSHIP CONFERENCE Virtual, 15-16 January 2021, www.naesm.org

2021 HIV RESEARCH FOR PREVENTION (HIVR4P) CONFERENCE Virtual, 27-28, January & 3-4 February 2021, www.hivr4p.org

2021 IAS COVID-19 CONFERENCE Virtual, 2 February, https://covid19.iasociety.org CONFERENCE ON RETROVIRUSES AND OPPORTUNISTIC INFECTIONS (CROI) 6-10 March 2021, www.croiconference.org

U.S. NATIONAL BLACK HIV/AIDS AWARENESS DAY 7 February

U.S. NATIONAL WOMEN & GIRLS HIV/AIDS AWARENESS DAY 10 March

U.S. NATIONAL NATIVE HIV/AIDS AWARENESS DAY 21 March

IAPAC FAST TRACK CITIES CONFERENCE 2021 Lisbon, Portugal 22-25 March 2021 www.iapac.org/conferences/fast-track-cities-2021/

U.S. NATIONAL YOUTH HIV/AIDS AWARENESS DAY 10 April

U.S. NATIONAL TRANSGENDER HIV TESTING DAY 18 April

2021 HVTN FULL GROUP MEETING Washington, DC, USA 5-7 May 2021 www.hvtn.org

HIV VACCINE AWARENESS DAY 18 May

U.S. NATIONAL ASIAN & PACIFIC ISLANDER AMERICAN HIV/AIDS AWARENESS DAY 19 May

HIV LONG TERM SURVIVORS DAY 5 June

U.S. NATIONAL HIV TESTING DAY 27 June

Editors Note: Many of these meeting dates have changed prior to print, and it is unclear if they will change again. Please use the above links to determine the most accurate dates of the meetings, and to determine if they will be in person or virtual.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 14 Special Feature HIV Prevention Efficacy Trial Designs of the Future The “HIV Prevention Efficacy Trial Designs of the Future” workshop, organized by the Global HIV Vaccine Enterprise in partnership with the HIV Vaccine Trials Network (HVTN), the HIV Prevention Trials Network (HPTN) and the Forum for Collaborative Research, is currently in progress. This workshop is a series of live events supported by pre-recorded presentations. These short-pre-recorded presentations (10-15 minutes) will be made available prior to each live event. It will be possible, and we encourage you to do so, to ask questions through our online platform ahead of and during the live events.

These presenters will then join us to answer your questions during the live events as listed below. The full schedule of events is as follow: Dates Event Launch by Email Friday 16 October Pre-recorded presentations for Session 1 will made available online on the Enterprise website (see below) Tuesday 27 October Live Session 1 – Panel discussion (60 minutes)

8AM PDT Current design approaches - challenges & lessons learned 11AM EDT Session 2 pre-recorded presentations made available online on the Enterprise website 4PM CET Confirmed presenters: Jared Beaten, Eduard Grebe, Sinead Delany-Moretlwe, David 5PM SAST Radley, Mia Moore, Jeff Eaton Friday 06 November Live session 2A – Panel discussion (60 minutes)

8AM PST Future design approaches for settings where all study participants are on active HIV 11AM EST prevention – ARV based prevention 5PM CET Confirmed panelists: Jeremy Sugarman, Sheena McCormack, Mike Robertson, David 6PM SAST Glidden, Thamban Valappil, Grace Kumwenda Wednesday 18 November Live session 2B – Panel discussion (60 minutes)

8AM PST Future design approaches for settings where all study participants are on active HIV 11AM EST prevention – Vaccines 5PM CET Confirmed panelists: Cathy Slack, Glenda Gray, Hanneke Schuitemaker, Georgia 6PM SAST Tomaras, Carol Weiss, Dean Follman, Rob Newells

Wednesday 02 December (TBC) Live session 2C – Panel discussion (60 minutes)

8AM PST Future design approaches for settings where all study participants are on active HIV 11AM EST prevention – Monoclonal antibodies 5PM CET 6PM SAST Live session 3 (60 minutes)

January 2021 Panel Discussion 1: A critical investigation into new methodological approaches. Panel Discussion 2: Community engagement and involvement in clinical trial design. Regulatory Forum organized by the Forum for Collaborative Research Additional details and updates are on the Enterprise Website (https://vaccineenterprise.org). We look forward to an exciting series of events, and do not hesitate to share the events with your networks.

On behalf of the Organizing Committee: Roger Tatoud, Holly Janes, Deborah Donnell, Veronica Miller, Stephaun Wallace, and Linda-Gail Bekker

15 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Special Feature Community Engagement Manuscript Published By: Gail Broder, HVTN Core, Seattle, WA, USA

A manuscript in the works for over without concern about copyright https://journals.plos.org/ a year was published in September or confidentiality. plosone/article?id=10.1371/ 2020, entitled “Standardized journal.pone.0239276 metrics can reveal region-specific Many of the HVTN’s and HPTN’s opportunities in community community educators and CAB Gail Broder is a Senior Community engagement to aid recruitment members contributed to this effort Engagement Project Manager with the HVTN. in HIV prevention trials.” It by providing us with their sites’ describes the HPTN’s and HVTN’s screening and enrollment data, commitment to Good Participatory and many are members of the Practice (GPP), how the Networks AMP Community Working Groups approached recruitment efforts that provided input into our study in the AMP Studies, and what we parameters. Thank you to all of you observed about how these efforts for your contributions! differ in various regions. We had presented initial data about this We think that this information work at the HIVR4P conference may be meaningful to consider as in Madrid in 2018, and this paper sites are thinking about COVID-19 now presents the full analysis. study recruitment efforts, so we The paper can be accessed at the wanted to share the paper with link below. This journal is “open that in mind. access,” which means that you are welcome to share this information

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 16 We're Looking For: Cisgender men who have sex with cisgender men Trans men and trans women who have sex with cisgender men and/or transgender people 18 – 60 years old

HIV-negative

When you participate in this study, you CANNOT get HIV from the study vaccines, and you may be compensated for your time.

A JOURNEY TOWARDS A GLOBAL HIV VACCINE

17 HIV VACCINE TRIALS NETWORKwww. | COMMUNITYmosaicostudy COMPASS | VOLUME 20,.com ISSUE 2: DECEMBER 2020 Special Feature After 20 Years, Wakefield Retires from HIV Vaccine Trials Network ‘He created the DNA of our organization’ By: Sabin Russell / Fred Hutch News Service Fond words and accolades are rolling in for Steven Wakefield, who retired June, 2020 from Fred Hutchinson Cancer Research Center after 20 years of bridge- building between vaccine researchers and underserved communities in Seattle and around the globe.

As external relations director for the HIV Vaccine Trials Network, Wakefield traveled to 32 nations to develop ties between the Hutch- headquartered operator of clinical trials and the communities where volunteers roll up their sleeves to test potential vaccines to stop HIV/AIDS.

“What I can do at the age of 67 is not what I could have done as a younger man,” he said. “My cardiologist has become my interior decorator: My first week of retirement I will get rid of either my sofa or my La-Z-Boy and replace it with an indoor bike.”

It is a change of pace earned from a lifetime of activism.

“He has been, for me, a moral compass, a wise adviser and a close friend,” said former Fred Wakefield has retired after 20 years at the Hutch-based HIV Vaccine Hutch president and director Dr. Trials Network. Larry Corey, who cofounded the Photo courtesy of Wakefield HVTN. When the organization received funding from the National Institute of Allergy and Infectious our organization. No one has by the single name “Wakefield,” Diseases in 2000, Wakefield was had more of an impact on how had been an activist since he was a key initial hire. we operate.” an 8-year-old member of the Rev. Jesse Jackson’s Operation A lifetime of activism “His values, his voice and his Breadbasket, which later became intellect just don’t permeate our Wakefield, who long ago dropped Operation PUSH, in Chicago. culture — he created the DNA of “Steven” and prefers to be known Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 18 As a young man he began “His vision and passion for Africa Corey has named Dr. Stephaun volunteering in a storefront resulted in a vibrant and highly Wallace to succeed Wakefield clinic that provided testing and successful program. He rejected as Director of External Relations, treatment for gay men with sexually the concept of Afro-pessimism a selection Wakefield transmitted diseases, and showing and helped promote the growth heartily applauds. that penchant for leadership, of science in Africa. For that I will he became chair of its board of always be grateful,” she said. directors. When HIV emerged a mortal threat to his community, Wakefield’s retirement is a he helped to secure one of the bittersweet moment for those who first publicly funded AIDS have worked closely with him. research grants. Kimberly Louis, outreach manager for the Seattle Vaccine Trials Unit, By the time Corey began setting part of HVTN’s web of clinical trials up HVTN as the world’s largest sites for vaccines for HIV (and now publicly funded collaborative for COVID-19), called Wakefield “the Dr. Stephaun Wallace has been development of HIV vaccines, godfather of the community work named to succeed Wakefield Wakefield had already co-founded for the network.” as Director of External Relations AVAC, a New York-based global for HVTN. advocacy group for HIV vaccine “He taught me that outreach was a research. (Wakefield only conversation. Before you can make Photo courtesy of Stephaun Wallace recently retired from AVAC’s an ask of recruitment to a vaccine board of directors.) trial, there has to be education. There Wallace has more than 25 years has to be reciprocity. You can’t go of social justice and community He had been working in South into communities asking them to mobilization experience. He joined Africa, helping epidemiologists support us without giving them HVTN as a community engagement develop volunteer community something back,” she said. project manager in 2016 and advisory boards, before returning was affiliated with the network to Chicago and learning about Dr. Michele Andrasik, senior staff for more than a decade through Corey’s newly funded HVTN. Soon scientist in the Hutch’s Vaccine collaborations with the clinical he began shaping its outreach and Infectious Disease Division, research site at the University and communications programs, said Wakefield was “always making of Rochester in New York. forging critical ties between vaccine connections, opening doors and researchers and the people from ensuring that those doors stay open.” “He is no stranger to the hard-hit communities they needed organization,” Wakefield said. to recruit from for clinical trials. Dr. George Counts, a retired “I believe that he and Larry University of Washington professor [Corey] will develop the kind of As Corey told Fred Hutch News of medicine, said working with relationship that ensures the work Service’s Mary Engel (on the Wakefield in South Africa and that I’ve done — the sweat equity, occasion of Wakefield being named Botswana were among the most the years of investment — will a grand marshal of the 2018 Seattle memorable moments of his career. continue to pay dividends.” Pride Parade), “He understands science, he asks hard questions and “He has extraordinary people Wallace called Wakefield, whom pushes back when anything doesn’t skills,” said Counts. “He earned the he has known for nearly ten years, seem right or principled.” respect of scientists at the highest both a mentor and a friend. level of government, academia Renowned HIV researcher Dr. and industry.” “He has a very strong sense of self,” Glenda Gray, leader of the South Wallace said. “He has a very warm African Medical Research Council After 20 years, Wakefield said it was personality, and when he walks and co-principal investigator for time for a younger person to take into a room, everyone just feels HVTN, said Wakefield helped to on the grueling hours required for better.” expand clinical trial capacity in her such work, which now encompasses country through his skill in working the crash effort to run massive As Wakefield pondered the two with both scientists and clinical trials of potential decades of work at Fred Hutch, community advocates. COVID-19 vaccines. he said he is pleased by the

19 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 recent emphasis on diversity and inclusion at the organization.

“My first week at the Hutch, I remember writing to a friend that said, ‘I am so glad I have a mirror, otherwise I would not have seen another Black man all week,’” Wakefield said. “And just last week, I got to join those hoisting the Black Lives Matter banner at the Hutch.

“I really think that the organization has made a new commitment to transparency, and a new commitment to change and responsiveness. It just makes it that much harder to leave.” Sabin Russell is a staff writer at Fred Hutchinson Cancer Research Center. For two decades he covered medical science, global health and health care economics for the San Francisco Chronicle, and wrote extensively about infectious diseases, including HIV/ AIDS. He was a Knight Science Journalism Fellow at MIT, and a freelance writer for the New York Times and Health Affairs. Reach him at [email protected]. Editors note: This article has been reprinted with permission. The original article was published July 2020 and can be found here: https://www.fredhutch.org/en/news/center- news/2020/07/wakefield-hvtn-hiv-vaccine. html

A JOURNEY TOWARDS A GLOBAL HIV VACCINE www.mosaicostudy.com

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 20 Special Feature Harmonizing Efforts to Conduct Large Scale COVID-19 Vaccine Efficacy Trials COVID-19 Prevention Network named SEATTLE, JULY 9, 2020 – A clinical may move between groups if their CoVPN 5001 and CoVPN Senior trial called CoVPN 5001 will help the symptoms worsen over the course Community Engagement Project newly formed COVID-19 Prevention of the study. Manager at Fred Hutch. Network (CoVPN) understand early SARS-CoV-2 infection and the body’s Six study visits spread over one The CoVPN will use existing clinic early immune responses to the month will be conducted at either and laboratory infrastructure to virus that causes COVID-19 illness. a participating trial site, hospital, capture clinical and immunologic Gathered from diverse populations or at the place where the study information among persons with worldwide, the data obtained participant resides. Samples to be acute SARS-CoV-2 infection. CoVPN through this study will describe viral collected from participants include 5001 will take place across more progression and immunological blood samples, nasal samples, saliva than 58 participating trial sites in the characteristics of early infection samples, and urine samples. The United States, South America and with SARS-CoV-2. Information about collection of stool samples will be sub-Saharan Africa. the clinical course of SARS-CoV-2 optional. These sample collections infection, especially during its early may be done either by clinic staff or CoVPN 5001 is sponsored by NIH’s stage, is needed to close knowledge the study participant themselves. National Institute of Allergy and gaps and will potentially suggest Blood samples will only be collected Infectious Diseases. Interested markers of protection that could be by clinic staff. A final study visit individuals can email used in evaluating the efficacy of to check on the health of study [email protected] future COVID-19 vaccine candidates. participants will be conducted for more information. approximately two months “The CoVPN 5001 study is the after enrollment. first study conducted under About The COVID-19 Prevention Network (CoVPN) the aegis of the CoVPN, and is SARS-CoV-2 is the most infectious The COVID-19 Prevention Network (CoVPN) was formed by the National Institute of Allergy designed to develop the clinical of three coronaviruses that have and Infectious Diseases (NIAID) at the US and laboratory pipelines for the caused recent epidemics resulting in National Institutes of Health to respond to the rapid implementation of future significant morbidity and mortality global pandemic. Through the CoVPN, NIAID is COVID vaccine efficacy trials leveraging the infectious disease expertise of its in humans in the past 20 years. existing research networks and global partners while conducting groundbreaking Since declared a pandemic by the to address the pressing need for vaccines and scientific investigations,” said Will World Health Organization on antibodies against SARS-CoV-2. CoVPN will work Hahn, M.D., Protocol Chair for to develop and conduct studies to ensure rapid and March 11, COVID-19 has claimed a thorough evaluation of vaccines and antibodies CoVPN 5001 and staff scientist at significant number of lives. A safe for the prevention of COVID-19. The CoVPN is Fred Hutchinson Cancer Research and effective vaccine [to prevent headquartered at the Fred Hutchinson Cancer Center. “The protocol is explicitly the acquisition and transmission of Research Center designed to be a ‘dry run’ for pivotal SARS-CoV-2] is necessary to reduce About Fred Hutch: trials testing the efficacy of a COVID morbidity and mortality and aid At Fred Hutchinson Cancer Research Center, vaccine,” Hahn concluded. the global community to return home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new to a thriving social and economic and innovative ways to prevent, diagnose and CoVPN 5001 is designed to follow global infrastructure. treat cancer, HIV/AIDS and other life-threatening an estimated 800 study participants diseases. Fred Hutch’s pioneering work in bone marrow transplantation led to the development of aged 18 years or older who have “The participants in this study will immunotherapy, which harnesses the power of the tested positive for SARS-CoV-2 give us a unique opportunity to immune system to treat cancer. An independent, infection. Study participants will be understand the natural immune nonprofit research institute based in Seattle, Fred enrolled into one of three groups: Hutch houses the nation’s first National Cancer responses in the early stage of Institute-funded cancer prevention research those showing no symptoms, those infection. Without the community’s program, as well as the clinical coordinating center of showing mild symptoms, and those support, science can’t move the Women’s Health Initiative and the international showing severe symptoms that forward,” said Gail Broder, MHS, headquarters of the NIAID-funded HIV Vaccine Trials Network and the newly formed COVID-19 require hospitalization. Participants Community Engagement Lead for Prevention Network (CoVPN).

21 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Special Feature HVTN Responds – No Justice, No Progress A statement by HVTN leadership, June 2020

George Floyd, Gabriella Nevarez, Michelle Cusseaux, Alexia Christian, Breonna Taylor, Trayvon Martin, Michael Brown, Charlena Lyles, Stephon Clark, Terence Crutcher, Alton Sterling, Philando Castile, Che Taylor, Eric Garner, Mi’Chance Dunlap-Gittens, Laquan McDonald...the list of Black/African American people murdered continues to grow. This is unacceptable.

Epidemics and pandemics are magnifying glasses for tragedies. Those of us who have fought to address the biological outcomes of racial injustice work every day in communities where the human cry of “no justice, no peace” is resonating off the walls. It echoes with us as we try to work in a world where structural racism and discrimination consistently highlight difference.

Racism and discrimination against Black/African Americans cannot continue to be normalized. We must shift how institutional policies are created, how policies and laws are enforced, and how we create spaces and environments that are welcoming, inclusive and support equity. This must happen at the community-level, institutional-level, and policy-level. America must be transformed in order for the senseless murders of Black/ African Americans to stop. Transformation to truly bring about racial equity and justice must be guided by leaders who believe in human rights, anti-racism, and socio-economic equality for all citizens of this country. We who are involved in bettering humanity from diseases such as HIV must be leaders in achieving racial transformation in American society.

George Floyd’s fate at the hands of police in Minneapolis could be described as just the latest in a series of Black fatalities brought about by overzealous policing or racial profiling. We stand today with those who recognize these are times that call on us to examine our individual responses and corporate responsibilities. It is not possible to list in a brief statement the extent of the injustice. We urge all of us to reflect on what actions we can take to ensure a focus on anti-racism and continue to find a way forward that reverberates with the clarion cry “NO JUSTICE, NO PROGRESS.”

This call to activism about social justice in America was written by S. Wakefield, Michele Andrasik, Stephaun Wallace and Aziel Gangerdine and endorsed by the Executive Management Team of the HIV Vaccine Trials Network

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 22 HVTN Core Update Staffing Updates at HVTN Core New Hires Jasmin Aina, HVTN & CoVPN Community Engagement Project Coordinator Jasmin joined the HVTN & CoVPN in July as a Project Coordinator for the SBS/CEU team. She brings with her a wealth of experience in community engagement in various settings. She started her career in rural emergency health care staffing and recruitment at Acute Care Inc. in Des Moines, IA. In her role as Regional Coordinator for Acute Care Inc., she managed the recruitment of emergency healthcare providers and emergency room staffing for 30 hospitals in her region, continuing education programs, and the establishment of partnerships with key stakeholders and organizations. After moving to Seattle in 2015, Jasmin served as Grade School Director with Quest Church where she worked to provide faith-based education and training to grade school-aged students, their families, volunteers, and community partners. Jasmin earned a Bachelor of Arts degree in Health Sciences from the University of Iowa, and is excited to return to her roots and take on this new challenge in public health with the Community Engagement Unit.

Louis Shackelford, HVTN & CoVPN External Relations Project Manager Louis Shackelford joined the HVTN on September 15, 2020. As External Relations Project Manager, Louis is the newest member of the External Relations Unit based in the HVTN Leadership and Operations Center (Core) at Fred Hutchinson Cancer Research Center in Seattle, WA. Louis’ primary focus will be implementing stakeholder engagement strategies domestically and globally. These strategies create opportunities for consultation with key stakeholders and communities to inform the design and implementation of Network studies. Consultations will optimize the inclusion and participation of populations and communities who bear the greatest burden of HIV and COVID-19.

Louis joins the HVTN with a wealth of experience in community and stakeholder engagement in clinical research settings and health education. He spent nearly eight years at the Harlem Prevention Center (HPC) clinical research site, based in Columbia University’s Mailman School of Public Health, where he served in various roles. His most significant role at HPC was Community Education Coordinator, managing outreach and education programs, including establishing partnerships and strategic alliances with key groups, organizations, and stakeholders. Most recently, Louis served as Project Manager with the Office of HIV/AIDS Network Coordination (HANC) Legacy Project, where he worked across all five of the DAIDS-funded clinical trials networks to support increased engagement and enrollment of historically underrepresented populations in HIV clinical research. Always seeking new opportunities to serve others, Louis enlisted in the U.S. Air Force Reserves as a Medic in 2019, and is currently assigned to McChord Air Force Base, Joint Base Lewis-McChord, Washington. Louis earned a Bachelor of Arts degree from Columbia University, and is currently a student at Florida Agricultural and Mechanical University (FAMU), completing his Master’s degree in Public Health. Louis is extremely excited to join the External Relations Unit, and we are thrilled to have him on board.

23 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Promotions Francisco Rentas, MAT, HVTN & CoVPN Community Engagement Project Manager Francisco began his work with the HVTN in January 2018 as Program Assistant with the travel team. He joined the SBS/CEU team as a Project Coordinator in June 2019, and we are thrilled to announce his promotion to Project Manager in August 2020. Francisco has been an active part of the Seattle LGBTQ community for the past 13 years, in particular as a theater artist and singer with the Seattle Men’s Chorus. His professional life began as a public school teacher in middle and high school English/ Language Arts and Theater Arts classrooms in Texas and Washington. After receiving his Master’s degree in Teaching from the University of Washington, a unique opportunity presented itself at Fred Hutch as a cancer educator and tobacco cessation counselor. Meanwhile, his participation as a study participant in the HVTN 505 vaccine trial solidified his interest in the world of research. Francisco had his eye on the HVTN with the goal of eventually working there in some capacity having to do with community engagement, and he feels incredibly humbled to see that goal come to fruition, thanks in large part to his mentors along the way. Francisco was born into a Puerto Rican, US military household in Germany and spent most of his childhood moving around, which he credits as molding him into the confused but culturally-aware person he is today. Linda Oseso, MPH HVTN and COVPN Social and Behavioral Sciences Project Manager and Research and Mentorship Program (RAMP) Program Manager Linda Oseso began her work with the HVTN in September 2015 as a subcontractor focusing on moving the AMP animated video project forward. In just three short months, and during her graduate public health studies at the University of Washington, she was hired as a research assistant to coordinate the expansion of the AMP video project for the sub-Saharan Africa and South American sites. Linda’s drive, motivation and commitment to the work were instantly apparent and within six months of joining the Social and Behavioral Sciences Research team, she was promoted to Project Coordinator II. Although Linda’s initial responsibilities focused on coordinating the AMP behavioral sub-study and our social behavioral research efforts, she was soon coordinating production of other video projects. In this position she excelled and has become an expert in Community-Based Participatory Research (CBPR) approaches, utilizing them to enhance the HVTN’s community engagement educational materials as well as relationships with stakeholders and community members. Two years after her promotion to Project Coordinator II, Linda was promoted to Project Manager, where she led a research study looking at site level barriers and facilitators to engaging transgender participants in the AMP studies in the USA and Peru. In September 2019, her scope of work was expanded exponentially and she is now managing the Research and Mentorship Program (RAMP), where she works tirelessly to ensure that our Latinx and African American/Black scholars have a meaningful research experience that opens them to considering HIV prevention research as a viable career path. Linda is now actively considering entering into a PhD program. Her goals are to continue contributing to the HVTN’s efforts of finding an HIV vaccine and facilitating opportunities for African/Black and Latinx medical students to gain exposure to the possibilities of careers as physician scientists dedicated to the search for a safe and effective HIV vaccine. She is also excited to be bringing her experience with video projects to the CoVPN’s efforts, and is currently managing the production of 8 animated videos to address frequently asked questions and myths surrounding clinical research.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 24 Site Update Understanding the Socio-Behavioral Dynamics of the Transgender Population in an Under-Resourced Setting in South Africa

By: Dr Shapo Annah Pitsi, Neo Buthuma, Kagiso Mothwa, Tercia Makhaphiedza, and Lebogang Mpete of the Setshaba Clinical Research Site, Soshanguve, South Africa

Background SRC aimed to understand the Outcomes impact of stigma, increased The transgender population risk of violence, and economic 1. How participants described experiences many challenges vulnerability among the the transgender population in in society when they identify transgender population prior to with and express a different the community embarking on research studies gender that is not congruent Transgender was defined by the among this population. As part to social expectations for their participants as identifying as a of community engagement and sex assigned at birth. The South person of a different gender than enhancing researchers’ knowledge African transgender population is the sex assigned at birth. One is of the transgender population, no exception to these challenges either trans woman, trans man the SRC hosted a participatory (Sithole, 2015). or gender fluid. However, the consultative workshop in respondents reported that locally, it Soshanguve. In South Africa (SA), where was easier for them to say that they transgender populations are are gay, as that is the term most marginalized, there is limited Process people understood and are familiar understanding of the community’s In March 2020, a group of seven with in their community rather behavioral dynamics. Limited participants (4 trans women than the term transgender. The access to socio-economic and 3 cisgender homosexual vernacular or slang name used to opportunities, psychosocial men) were invited by the SRC describe them is ‘’Isitabane”, which support, and health care are key through a partnership with the is a local description for gay people. issues that impact on the wellbeing OUT organization that provides Participants did clarify that being of the transgender population. support to the LGBTQI community. gay is about sexual orientation Their vulnerability to infectious The 4-hour long workshop was while transgender is about gender diseases such as HIV, set against facilitated by Dr. Pitsi in English identity and expression irrespective the backdrop of limited access based on the participants’ preferred of one’s sexual orientation. They to healthcare programs, is of language. All attendees provided all mentioned that they knew that particular concern. voluntary informed consent they were transgender from as to be part of the discussions. early as their preteen years. Most The Setshaba Research Centre Participants narrated their personal of them received family support (SRC), based in the under- experiences, with site staff asking in their ‘coming out’, while others resourced community of for questions and clarifications. struggled to disclose or did not Soshanguve, Tshwane, South The consultation discussed their get support after disclosure. One Africa, has been conducting responses to questions regarding participant reported that her mom prevention and socio-behavioral how they define transgender, realized that as a kid he liked his studies in this community with safety and disclosure, sexual sister’s clothes and dressed him in a focus on HIV and TB for over orientation and behavior, gender women’s clothes from a young age, 15 years. These studies were transition, healthcare access and which made sense later on when primarily amongst cisgender utilization, psychosocial support, the family accidentally found out heterosexual participants with employment, and interest in their son was trans female. Coming limited studies among the clinical trial participation. out was unplanned for some marginalized LGBTQI population. attendees, as they did not know how to approach family members

25 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 and were unsure of how they would be received. It was mentioned that acceptance is easier with immediate family members than with extended family members. Uncles were reported to be the least accepting.

The community was generally receptive of attendees as trans women, with the exception of a few people who insist on addressing them as men (mfana/buti) which are terms used to describe a young man/brother. Pronouns were very important to the attendees, who expressed a preference for using she/her pronouns.

Bullying was experienced at school from peers and teachers alike. This led to some dropping out of school as they were told that they were not wanted, and they felt forced to wear boys’ uniforms per the school regulations. Such discrimination led to several attendees using recreational drugs as their way of coping with the stigma they experienced with regard to their From the top left: Dr Shapo Annah Pitsi, Sub-Investigator; Neo gender identity. One participant Buthuma, Transgender participant; Kagiso Mothwa, Community ended up as a street kid for 10 years Liaison Officer; bottom center: Tercia Makhaphiedza, Pharmacist; and after being chased out of three bottom right: Lebogang Mpete, Participant Engagement Supervisor. schools and the family home. shift with regard to issues of there are other people nearby for The attendees have chosen a safety when in public. Safety her protection, in case an assault feminine gender expression. concerns were more prominent arises from the disclosure. In some They wear women’s clothes and in the older participants based instances, attendees have had use make-up. They make use of on their experiences, whilst to resort to physical violence to women’s toilets where they are not younger participants felt they were protect themselves. Incidences of frowned upon. Gender-specific generally safe. “corrective rape,” which is when protocols are observed in social someone who does not conform settings; for example, the 4 trans Disclosing transgender status to gender norms is raped to women are expected to dress in provides safety while posing risk “cure”them of their homosexuality funeral-appropriate attire for women of victimization at the same time. or transgender identity, were which includes covering the head Violence can erupt following reported. Participants also and shoulders, or else they are not discovery of trans status by a reported incidences of corrective allowed to enter a burial site. Given potential sexual partner. As one initiations; where a man is forced the cultural significance of a male participant mentioned, it is to undergo circumcision at a role in this community, it would be very important to be upfront, as traditional initiation as part of a interesting to find out if trans men she knew of friends who were transitional rite of passage from are limited in their male roles. brutally assaulted and killed for boyhood to manhood. One trans not disclosing their status. She woman participant reported an 2. Safety and Disclosure mentioned that she prefers to incident where she was arrested disclose her gender status where There seems to be a generational Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 26 with fellow trans people at a club, Transactional sex occurs a lot, surgical procedures done. One and through it all she was paraded which fuels promiscuity. Alcohol participant was in transition for >10 in front of everyone at the police was mentioned as a factor driving years and ended up being excluded station. Some mentioned that risky sexual behaviors. Money is from further transition due to his they find it difficult to disclose needed for maintenance of their age and chronic conditions that to everyone as they are afraid of lifestyle, which they describe as came with aging. people’s reactions. Others choose high maintenance. According to to confront incidences of trans hate them, they would rather starve than 5. Health care access and and transphobia as they believe it not have make-up or hair weaves. utilization is an opportunity to educate others, If a man is known to have a lot of because they believe that silence money, they will target that man All attendees accessed health care perpetuates discrimination. They for transactional sex even if they through public health facilities. regard themselves as activists for know he has multiple partners. Healthcare access was described the LGBTQI community. as not challenging. They freely 4. Gender Transition consult anywhere and felt that their 3. Sexual orientation and needs were being addressed by Participants were aware of only health care providers. No hostility/ behavior one referral hospital in the discrimination was reported. The Sexual orientation is diverse province, the Steve Biko Academic usual practice is to disclose that amongst transgender people. The Hospital, which offered gender they are transgender to avoid four trans women present engaged transition services. Most of them awkwardness during consultations. in sexual activity with males, expressed the desire for a full They were not aware of any private including men who do not identify transition, i.e. social and physical. general practitioners who offered as transgender or gay. There are One participant reported social hormone therapy for transitioning apparently many married men transitioning only. She reported purposes, and indicated that even who have an attraction to trans that for her it is important to be if hormone therapy was available women. They attribute this partly recognized for her gender identity through private practitioners, they to curiosity, and the so-called and did not see the need for would not be able to afford these “after nines” who are in the closet physical transition to achieve that. services. about their transgender or gay No fears of the hormones, side identity. These men live their lives effects or surgery were reported. 6. Psychosocial support as married straight men during One participant was undergoing the day, but come out at night to hormonal transition only, and LGBTQI organizations explore their sexuality and gender another two were on hormones identity. Anal sex is practiced since and awaiting surgeries. They Three organizations were reported none of them have had vaginal expressed frustrations with the to be providing support to the construction surgery. There are system with regard to the process. transgender community, and it is different sexual preferences, which Getting the first appointment through these organizations that need to be disclosed to potential at the hospital can take several they are linked to health services partners: top, bottom or verse months. It takes a long time to get including HIV testing, treatment, (versatile), depending on whether approval in the public sector to and prevention; sexual health they prefer to be on top, bottom, or initiate the transition process, as and STI treatment; and gender either top or bottom during sex. this involves psychiatric evaluation transition services. In addition, for a minimum of 6 months prior they organize various events Promiscuity is common until to appearing before a panel of where HIV counselling and testing people find someone they feel like medical experts (psychiatrist, is always offered by nurses. This settling down with. Attendees were endocrinologist, plastic surgeon, is also a platform where they divided as to whether they engage urologist, gynecologist, and socialize and get introduced to in risky sexual behaviors more than another physician) who assess other members of the LGBTQI cisgender heterosexual people do. suitability for transition. Once the community. The use of social The general feeling was that they process has been initiated, it takes media platforms for transgender are riskier than heterosexuals, a long time to move from one support or services is not common. while some believed risky behavior stage of transition to the next due They generally use social media to is the same in both groups to long waiting lists, e.g. initiation find sexual partners. since it is an individual choice. of hormonal therapy to having

27 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Home affairs 8. Interest in clinical trial Acknowledgements: None of the attendees had changed participation We would like to acknowledge the their gender identification with Some of the participants were transgender women and cisgender the local Home Affairs Department. familiar with the clinical trials at men who participated in the They were aware of the availability our research center, with one being workshop for sharing their stories of the service but report being a participant in an HIV vaccine and experiences. A special thank discouraged by the requirements trial. They expressed willingness you to contributing co-author and long process. Some indicated to participate in clinical trials, Neo Buthuma, a trans female that they do not feel the need especially ones that would address participant in the workshop. We to change identity documents. their needs. They felt there was appreciate the site management However, they did note the issue greater need for education on and staff for organizing and of travelling challenges, with one transgender issues at schools and participating in the workshop and attendee describing how she was in the community. When asked to those who contributed to the delayed at the airport because the about biological sampling, they write-up of the article. ticket was issued for a woman and indicated that they did not have her identity document indicated objections to blood and rectal We also acknowledge Dr she was man. She was not allowed sampling. No concerns were Athmanundh Dilraj and Neetha to board the plane until it was raised regarding clinical trials and Morar for their valuable guidance, corrected. She remarked that voluntary participation. input and review of this report. she could not imagine what international travel would be like. Next steps and Future References: They felt privileged to live in a country where their rights are direction Sithole, S. 2015. Challenges faced by gay, lesbian, bisexual and protected. Access to other services, Going forward, the site plans transgender (glbt) students at a such as church and police services, to engage the local LGBTQI South African university. The were reported to be without hassles. organizations to foster Journal for Transdisciplinary collaborations, to develop an Research in Southern Africa, understanding of their social 7. Employment 11(4):193-219. dynamics, and to get more Only one of the participants insight into the role they play in was employed. Reasons for Dr Shapo Annah Pitsi is the Sub-Investigator, the community. In addition, we unemployment were reported Neo Buthuma is a transgender study aim to obtain input from trans to be the same as for the general participant, Kagiso Mothwa is the Community men, trans women and gender Liaison Officer, Tercia Makhaphiedza is population and not completely fluid individuals to broaden our the Pharmacist and Lebogang Mpete is the related to being transgender. scope and understanding of these Participant Engagement Supervisor at the Challenges with getting jobs as a Setshaba CRS. marginalized populations. It is trans person included confusion also crucial to include transgender at interviews, as the identity persons in Community Working documents indicate a different Groups (CWGs) or Community gender than their appearance at Advisory Boards (CABs), and to the interview, amongst others. support employment opportunities Some were told at interviews that through networking with NGOs. they could not be offered the job as it required a specific gender The public sector hospitals and due to the type of job, e.g. lifting social services will be engaged heavy objects, amongst other to understand their role in the reasons. Attendees were financially services offered and processes dependent on their families. followed for community members Those in stable relationships in gender transition. Thus, we will were financially dependent on be able to design interventions their partners. Some engaged in and conduct studies that will transactional sex for financial contribute to overcoming some of support, thus placing themselves at the community’s challenges and risk of STIs and HIV. enhance their wellbeing.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 28 A JOURNEY TOWARDS A GLOBAL HIV VACCINE

29 HIV VACCINE TRIALS NETWORKwww. | COMMUNITYmosaicostudy COMPASS | VOLUME 20,.com ISSUE 2: DECEMBER 2020 Site Update “Banda Mole” is Also Prevention! By: Jeferson Fonseca Carvalho, Luciana Branco Gravito, Lucas Emanuel Braz, Marciley “Max” Nunes de Andrade Ferreira, Belo Horizonte CRS, Brazil Banda Mole is a traditional carnival parade that takes place in the city of Belo Horizonte, in the state of Minas Gerais, Brazil. The traditional Banda Mole brightened Avenida Afonso Pena, one of the main streets of the city, on February 15, 2020. The theme of the parade was “educação” (education), satirizing the last acts of Minister Abraham Weintraub, the current Minister of Education, and also marking the celebration of the 45th anniversary of the event. Taking advantage of pre-carnival festivities, it was also the ideal time for preventive educational activities about STIs, AIDS, and HIV.

Joining forces with diverse partners such as Família+ and BH de mãos dadas among other groups, together with the support of the City Hall of the City of Belo Horizonte - Prefeitura de Belo Horizonte (PBH), it was possible to promote the distribution of condoms, lubricants and information pamphlets.

A tent was set up in front of the PBH, serving as a shelter for the team of volunteers to assemble kits to facilitate the distribution of condoms among the revelers. In addition to the distribution in front of the tent, the volunteers circulated along the block, approaching the revelers to distribute preventive informational material and also clarifying doubts and myths.

It was a successful festive event, and an appropriate environment for the dissemination of information about healthy practices.

Team of Community Educators of the Mosaico Team of Community Educators of the Mosaico Study, Study, Belo Horizonte, Brazil, working on an based in the city of Belo Horizonte, Brazil, working educational action for HIV prevention during in an educational action on HIV prevention during a a pre-carnival event, February 2020. Left to pre-carnival event, February 2020. Left to Right: Lucas Right: Max Nunes (CER), Jeferson Fonseca Emanuel (CER), Jeferson Fonseca (CER), Luciana Gravito (CER), Luciana Gravito (CAB member), and (CAB member), and Max Nunes (CER). Lucas Emanuel (CER.)

Jeferson Fonseca is the Community Engagement Coordinator, Marciley “Max” Nunes de Andrade Ferreira and Lucas Emanuel are the Community Educators, and Luciana Gravito is a CAB Member of the Belo Horizonte CRS in Brazil.

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 30 CoVPN Profiles

CoVPN Native & Indigenous Expert Panelists

Alika Maunakea (Native Matthew Anderson (Eastern Hawaiian), PhD Band Cherokee Nation), PhD Associate Professor-Department Assistant Professor, of Native Hawaiian Health Microbiology and Microbial Epigenomics, University of infection & Immunity The Ohio Hawaiʻi State University

Bonnie Duran (Co-Chair, Michelle Johnson-Jennings Opelousas/Coushatta (Choctaw Nation Tribal descendent), Dr.PH Member), PhD Professor, Schools of Social Tenured Associate Professor, Work and Public Health, Scientific Director, and Canada University of Washington Research Chair Indigenous Community Engaged Research

Dave Wilson (Ex-Officio, Naomi Lee (Seneca Nation), PhD Dine´), PhD Assistant Professor, Department Director, National Resource of Chemistry and Biochemistry Center on Native American Northern Arizona University Aging, Center for Rural Health University of North Dakota School of Medicine & Health Sciences

Denise Dillard (Inupiaq Rodney C. Haring (Beaver Eskimo), PhD Clan), PhD, MSW Research Director, Southcentral Director, Center for Indigenous Foundation (SCF) Cancer Research, Roswell Park Comprehensive Cancer Center

Karina L. Walters (Co-Chair, Tommi Lynn Gaines (Navajo/ Choctaw Nation of Oklahoma), Dine’), DrPH PhD, MSW Associate Professor, Professor, School of Social Department of Medicine, Work, University of Washington University of California San Diego

Lonnie Nelson (Eastern Band of Cherokee descent), PhD Assistant Professor, Department of Nursing, Washington State University

31 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 CoVPN African American & Black Expert Panelists

Cyril Engmann, M.D., FAAP Orlando Harris, PhD, FNP, MPH Clinical Prof, Global Health; Clinical Prof, Associate Professor, Department of Pediatrics - Neonatology Global Prog Community Health Systems, School of Leader/Director; Maternal, Newborn, Nursing University of California, San Child Health & Nutrition; PATH, Attending Francisco. Neonatologist, Pediatrics, School of Medicine, UW & Seattle Children’s Hosp

Ernest Hopkins Rachel Issaka, M.D. Director of Legislative Affairs, San Assistant Professor-Gastroenterology and Francisco AIDS Foundation (SFAF) Hepatology Clinical Research Division, Founder & Board Chair of the National Joint Assistant Professor Health Sciences Black Gay Men’s Advocacy Coalition Division, Assistant Professor Hutchinson Institute for Cancer Outcomes Research (HICOR), Fred Hutch

Errol Fields, M.D., MPH, PhD, Robert Fullilove (Ex-Officio), EdD Assistant Professor of Pediatrics, Professor Sociomedical Sciences, Columbia Department of Pediatrics Division of University Medical Center Associate Dean, Adolescent/Young Adult Medicine, Johns Community and Minority Affairs Hopkins School of Medicine

Gregorio Millett, MPH Sharon Morrison, PhD Vice President, amfAR- Foundation for Associate Professor, Public Health AIDS Research Director, amfAR Public Education, University of North Carolina Policy Office, D.C. at Greensboro

LaRon Nelson, PhD, RN, FAAN Valerie Montgomery Rice, M.D. Associate Dean, Global Affairs & President & Dean, Morehouse School Planetary Health Independence of Medicine Foundation Professor & Associate Professor of Nursing Yale School of Nursing

Marlon M. Bailey, PhD, MFA Vivian Carter (Co-Chair), PhD Associate Professor of Women and Chair, Department of Psychology and Gender Studies, and African and Sociology Deputy Director for Community African American Studies School of Engagement Tuskegee University Health Social Transformation at Arizona State Disparities Institute, Tuskegee University University

Obinna Nnedu (Co-Chair), M.D. Infectious Disease Physician, Ochsner Clinic Foundation in New Orleans, LA

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 32 CoVPN Profiles

CoVPN LatinX Expert Panelists

Adrian Dominguez, MS Julie Levison, M.D., MPhil, MPH Director of Informatics and Epidemiology, Assistant Professor of Medicine at Urban Indian Health Institute Harvard Medical School

Carlos Rodriguez-Diaz, PhD Kiyomi Tsuyuki, PhD, MPH Associate Professor, Department of Assistant Adjunct Professor, Medicine Prevention and Community Health Milken University of California, San Diego Institute School of Public Health, George Washington University

Carmen Zorrilla (Chair), MD Leandro Mena, MD, MPH Professor of Obstetrics and Gynecology, Associate Professor-Division of University of Puerto Rico School of Infectious Diseases, The University of Medicine Mississippi Medical Center

Robert Valdez, PhD, MHSA Ligia Peralta, M.D., FAAP RWFJ Professor, Family & Community Massachusetts Institute of Technology Medicine and Economics, University Sloan Fellow; President, Casa Rubén of Mexico Foundation Scientist, University of Maryland Baltimore County

Efrén Pérez, PhD Omar Martinez, JD, MPH Full Professor of Political Science and Associate Professor, Temple University Psychology at UCLA School of Social Work

Jorge Santana, MD Sandra Echeverria, PhD, MPH Professor of Medicine/Infectious Disease, Associate Professor, Department of Director-Investigator University of Puerto Public Health Education School of Health Rico, School of Medicine & Human Sciences, The University of North Carolina at Greensboro

José Cordero (Ex-Officio), M.D., MPH Souhail Malavé-Rivera, PhD Patel Distinguished Professor of Public Adjunct Professor & Co-Director, Health; Department Head, Epidemiology Sex+ TEAM Center for Evaluation and and Biostats College of Public Health, Sociomedical Research School of Public University of Georgia Health, University of Puerto Rico-Medical Sciences Campus

33 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 CoVPN Older Adult & VA Expert Panelists

Amy C. Justice, M.D., PhD Marianne Shaughnessy, PhD CNH Long Professor of Medicine and Director, Geriatric Research, Education Public Health, Yale University Staff and Clinical Centers (GRECC), VA Office Physician, VA Connecticut Healthcare of Geriatrics & Extended Care, Veterans System Health Administration

Arun Karlamangla, PhD, M.D. Michi Yukawa, M.D. Professor of Medicine in Residence, Professor of Medicine Department of Division of Geriatrics UCLA School of Medicine Division of Geriatrics, San Medicine Francisco VAMC

Collette Adamsen, PhD Sandra Crouse-Quinn, PhD Director, National Resource Center on Professor and Chair, Department of Native American Aging, Center for Rural Family Science Senior Associate Director, Health University of North Dakota School Maryland Center for Health Equity of Medicine & Health Sciences School of Public Health, University of Maryland

Fayron Epps, PhD, RN Tanya R. Gure, M.D. Assistant Professor at Emory University, Associate Professor of Clinical Medicine, Nell Hodgson Woodruff School of Nursing Section Chief of Geriatrics, Ohio State University Wexner Medical Center

Jan Busby-Whitehead, M.D. Tara A. Cortes, PhD, RN, FAAN Division Chief; Professor; Director, Executive Director Professor, Hartford Division of Geriatric Medicine Center for Institute for Geriatric Nursing, New Aging and Health, UNC Chapel Hill York University Rory Meyers College of Nursing

Janiece Taylor, PhD, MSN Ugochi Ohuabunwa, M.D. FAAN, Assistant Professor Center Associate Professor of Medicine, Emory for Innovative Care and Aging, Johns University Division of General Medicine Hopkins School of Nursing and Geriatrics

Kathryn E. Callahan, M.D., MS Wayne McCormick, M.D., MPH Geriatrician, Winston Salem, NC Professor of Medicine at the University of Washington, Department of Medicine, Division of Gerontology and Geriatric Medicine, Harborview Medical Center

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 34 CoVPN Profiles

CoVPN Community Working Group

Jonathan Lucas, MPH Noshima Darden-Tabb, MSW, Bob Bucklew Nicholas Maurice Community Research Project LCSW Outreach Coordinator Community Advisory Board Manager, CoVPN, FHI 360 Community Engagement Manager Case Western Reserve/ Member UNC Global HIV Prevention & University Hospitals Clinical Fred Hutch/Seattle Vaccine Trials Treatment Clinical Trials Unit Research Site Unit

Marco Castro-Bojorquez Ro Yoon Rona Siskind, MHS Danielle M. Campbell, MPH HIV Racial Justice Now, Community Engagement Project Health Specialist Clinical Research Associate Co-Chair Manager, Fred Hutch/Seattle Division of AIDS, NIAID, NIH University of California, Los Vaccine Trials Unit Angeles

Maria del Rosario (MaR) Leon Shelly Karuna, MD, MPH Rhandomy, MSc(c) Senior Staff Physician & Head of the Community Principal Investigator, Fred Engagement Unit, Impacta Hutchinson Cancer Research Salud y Educación Center

35 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 CoVPN Community Working Group (continued)

Gail B. Broder, MHS Rafael Gonzalez, BA Jontraye M. Davis, MHA, Rondalya DeShields, MSN, RN Senior Community Engagement Community Programs Manager PMD Pro Director, Clinical and Research Project Manager, CoVPN, Fred Bridge HIV - San Francsico Community Programs Associate, Programs, Rutgers New Jersey Hutchinson Cancer Research Dept. of Public Health CoVPN, FHI 360 Medical School Center

Stephaun E. Wallace, PhD, MS Louis Shackelford Michele Andrasik, PhD Alfred L. Forbes, MBA Director of External Relations, External Relations Project Director of Social & Behavioral Community Advisory Board CoVPN, Fred Hutchinson Manager, CoVPN, Fred Sciences and Community Chair Project WISH, University Cancer Research Center Hutchinson Cancer Research Engagement, CoVPN, Fred of Illinois at Chicago Center Hutchinson Cancer Research Center

Valarie Hunter Melissa M. Turner, MSW, MPA Clinical Research Coordinator Community Advisory Board Emory University School of Member, George Washington Medicine University Public Health Research Clinic

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 36 CoVPN Profiles

CoVPN Faith Initiative Team

Rev. Edwin Sanders, Khadijah Abdullah, Dr. Ulysses W. Burley III, Senior Servant and Founder of Executive Director of Reaching Founder of UBtheCure, Metropolitan Interdenominational All HIV+ Muslims in America Chicago, Illinois Church in Nashville, Tennessee (RAHMA), Washington, District (initiative leader) of Columbia

Bishop Oliver Clyde Allen III, Dr. Bambi W. Gaddist, Rev. Kamal Hassan, Senior Pastor and Founder CEO and Founder, Executive Pastor of Sojourner Truth of The Vision Cathedral of Director of the South Carolina HIV Presbyterian Church, Atlanta, Georgia Council – Wright Wellness Center Richmond, California in Columbia, SC

Rev. Bertram G. Johnson, Union Theological Seminary, New York, New York

37 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 A JOURNEY TOWARDS A GLOBAL HIV VACCINE

HIV VACCINE TRIALSwww. NETWORK |mosaicostudy COMMUNITY COMPASS | VOLUME.com 20, ISSUE 2: DECEMBER 2020 38 Updates from the Field COVID-19 and HIV: What You Need to Know People living with HIV are learning how to cope with a new pandemic.

By: Liz Highleyman, for POZ outbreak first emerged late last In one of the first reports about year, indicated that people with COVID-19 in people with HIV, immune suppression were more researchers contacted 1,178 HIV- likely to become seriously ill if they positive people in Wuhan, China. acquired the coronavirus. Eight people with symptoms were found to have COVID-19. What’s more, nearly half of people Six of them had mild cases, one living with HIV are over 50—the had severe disease and one risk of severe COVID-19 rises with died. Among the remaining age—and many have underlying asymptomatic people, just one health conditions associated with of the nine individuals known 3D print of a SARS-CoV-2 virus worse outcomes, such as diabetes, to have had close contact with particle, the virus that causes high blood pressure, chronic lung COVID-19 patients tested COVID-19. disease or cardiovascular disease. positive for SARS-CoV-2. Courtesy of NIH Image Gallery But so far, experts agree that people In another early report, Spanish For many people with HIV, the on antiretroviral treatment who researchers found that among COVID-19 pandemic seems have an undetectable HIV viral load the first 543 people admitted all too familiar: the fear, the and a near-normal CD4 count do to a Barcelona hospital with stigma, the loss of loved ones, not appear to be at higher risk than the new coronavirus, five were the disproportionate impact on their HIV-negative counterparts. HIV positive. Three had mild marginalized communities and a or moderate disease, and they federal government that has failed “My sense from the accumulating recovered and were released from to adequately respond to the crisis. evidence is that incidence rates the hospital within about a week. might be lower than expected,” One person, who was not on HIV “Again, there’s a sense of existential says Steven Deeks, MD, a professor treatment and had a CD4 count of dread—a low-grade panic,” says of medicine at the University of 13, received supplemental oxygen blogger and activist Mark S. King. California at San Francisco. “I and recovered. The oldest man personally think that’s because (age 49) was put on a ventilator This fear is compounded by people with HIV were well aware and remained hospitalized. uncertainty. People with HIV of how to protect themselves and wonder whether they’re more educated about the nature of the A related study from Italy identified likely to contract the coronavirus epidemic, and they responded 47 people known or suspected to (officially known as SARS-CoV-2) pretty quickly.” have the coronavirus out of nearly or are at greater risk of becoming 6,000 people with HIV followed at seriously ill. Will the crisis affect a hospital in Milan. They were less their ability to access HIV care likely to have advanced respiratory and services? And how will they disease or to be hospitalized than deal with the disruption of normal HIV-negative people, and only two life, the social isolation and the died. But the researchers noted that financial fallout of the pandemic? the HIV-positive group was about 10 years younger, on average, HIV and COVID-19 Risk than HIV-negative patients with severe COVID-19. Typically, people with compromised immune systems In contrast, a report from Germany are more susceptible to a variety Steven Deeks, MD described 33 HIV-positive people of infections. Early reports from Courtesy of Jan Brittenson diagnosed with COVID-19; all of China, where the COVID-19 them were on antiretrovirals with

39 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 an undetectable or low HIV viral Francisco General Hospital, Preliminary data suggested that load. Fourteen were hospitalized, where most patients have well- some HIV medications might six required intensive care and controlled virus. help control the new coronavirus, three died—higher rates than those as certain antiretrovirals have observed for German COVID-19 Taken together, these early studies shown activity against SARS- patients overall—but ultimately, and anecdotal reports suggest CoV-2 in the laboratory. Tenofovir 91% recovered. that HIV-positive people—at least disoproxil fumarate (one of the those on effective antiretroviral drugs in Truvada, used for HIV Turning to the United States, therapy—are not a high-risk group treatment and PrEP) appears to researchers identified 43 HIV- based on their HIV status alone. have both antiviral and immune- positive people (0.8%) among As a result, interim guidance from modulating effects. And during the 5,700 patients hospitalized with the Department of Health and 2003 SARS outbreak, caused by a COVID-19 in New York City—where Human Services states, “People related coronavirus, some patients about 1% of the population is living living with HIV who are diagnosed improved after being treated with with HIV—indicating that HIV itself with COVID-19 have an excellent the protease inhibitor combination does not appear to be a risk factor. prognosis, and they should be Kaletra (lopinavir/ritonavir). A separate analysis compared 21 clinically managed the same as HIV-positive and 42 HIV-negative persons in the general population But so far, studies in humans people with COVID-19. Although with COVID-19, including when have not yielded much evidence the HIV group had somewhat making medical care triage that this is the case. In fact, most higher rates of intensive care determinations.” HIV-positive people who have admission, use of ventilators and developed severe COVID-19 were death, these differences were The World Heath Organization on antiretroviral treatment. not statistically significant, (WHO) concurs: “At present, meaning they could have there is no evidence that the risk One of the first randomized clinical been due to chance. of infection or complications trials of Kaletra for COVID-19 found of COVID-19 is different among that it is no more effective than “We thought maybe we were going people living with HIV who are standard supportive care, although to see it more in people living clinically and immunologically it may offer some benefit for those with HIV because there are these stable on antiretroviral treatment treated early. And the company that clear risk factors, but we haven’t when compared with the manufactures darunavir (Prezista seen people with HIV coming general population.” and Prezcobix) cautioned that it into the hospital more or having is unlikely to have much activity more severe COVID-19 at all,” However, the jury is still out on against SARS-CoV-2. says Monica Gandhi, MD, MPH, people with HIV who are not the medical director of Ward 86, taking antiretrovirals and those Nonetheless, at least a dozen the HIV clinic at Zuckerberg San who are on treatment but have not clinical trials of antiretrovirals for experienced good CD4 recovery. COVID-19 are underway, including Around 40% of diagnosed HIV- WHO’s large Solidarity trial and a positive people in the United States Spanish study evaluating whether do not have viral suppression, and Truvada might help prevent SARS- the 15% of individuals who remain CoV-2 infection or lessen disease undiagnosed are, of course, severity in health care workers. not on treatment. Until more is known, experts advise Are People with against switching antiretrovirals HIV Protected? in an effort to prevent or treat COVID-19, and they stress that Findings like these actually raise people living with HIV and those the opposite question: Are people using PrEP should take all the same living with well-controlled HIV— precautions recommended for and potentially those taking the general population to guard antiretrovirals for pre-exposure against the coronavirus. Monica Gandhi, MD prophylaxis (PrEP)—somehow Courtesy of UCSF protected against COVID-19? Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 40 Updates from the Field COVID-19 and Your you want a better response and infusion, though injectable and Immune System perhaps too much poorly regulated inhaled formulations are being inflammation on the other studied. Hydroxychloroquine, Another avenue of exploration end when you want things an old drug touted by President relates to the fact that COVID- to calm down.” Trump, appears to have modest 19’s serious lung and other organ activity at best, and it can cause damage is largely caused by the Both T cells and B cells play a fatal heart problems. Medications immune system’s response rather role in fighting SARS-CoV-2, but that dampen the immune response than by the coronavirus itself. In antibody production is currently can help some people with the most severe cases, an immune what’s on everyone’s mind. If advanced disease, but it would be overreaction known as a cytokine antibodies can prevent reinfection, better to prevent cytokine storms storm floods the body with that could allow people who have in the first place. chemical messenger proteins that become immune to safely resume trigger excessive inflammation. social and economic life. COVID-19 PrEP also holds potential. If the immune system is causing “In a prevention setting, you the damage, some wonder, could “So far, it looks like anyone who might see a fair amount of benefit modest immune suppression has been exposed probably is with drugs that only have modest actually be an advantage? going to get antibodies,” says activity,” Deeks says. “It may be that Gandhi, “but it’s possible that for prevention, you don’t really “Some people have speculated in immunosuppressed patients— need something super powerful that maybe it even helps to not and even people living with just to block transmission.” have your immune system work well-controlled HIV—this may Although they would be more perfectly,” Gandhi says. “Maybe if take longer.” difficult and expensive to produce you’re a little immunosuppressed, and administer than pills, Deeks your inflammatory response may Scientists have already made thinks long-acting antibodies not be as crazy and out of control.” remarkable progress in against SARS-CoV-2 might be “the understanding COVID-19, but kind of thing that you’d want to But it’s too simple to talk about much remains to be learned. “We give a health care worker in the strong or weak immunity overall. don’t know what kind of antibody middle of a hot zone.” The immune system is made up response is protective. We don’t of multiple parts, and they do not know what kind of responses we Don’t Neglect HIV always work in sync. want to generate with vaccines. We don’t know how long they’ll COVID-19 is currently the hot topic Natural killer cells, macrophages last. And we don’t know whether for virologists, immunologists and and other first responders provide or not people with HIV or cancer epidemiologists worldwide. In fact, the initial line of defense against are going to have a less robust many of the top names in the HIV invaders. CD4 or helper T cells—the antibody response,” says Deeks. field—all the way up to National familiar targets of HIV—orchestrate “These are the billion-dollar Institute of Allergy and Infectious immune responses, while CD8 questions that the world is Diseases director Anthony Fauci, or killer T cells attack virus- trying to answer.” MD—are applying the lessons infected cells, and B cells produce they’ve learned from HIV to the latest antibodies. Cytokines released by When it comes to treatment, he pandemic. immune cells serve as the means adds, “The ideal thing would be a of communication to coordinate benign, orally available drug that “The massive investments that the the whole process. has a potent effect on the virus, is National Institutes of Health has safe and is not susceptible to viral made into HIV research are paying “Everything I know about how resistance and that can be made off in amazing ways in terms of HIV affects the immune system for pennies and would be easy to our capacity to deal with this new suggests that people with HIV distribute widely. We don’t have epidemic,” Deeks notes. would be more likely to have poor anything on the shelf like that, so control of the coronavirus early we need to start at the beginning.” But many researchers, public health on and have more inflammation- officials and advocates are concerned associated problems later,” Deeks The antiviral drug furthest along about the diversion of resources explains. “There is immune in the pipeline, Gilead Sciences’ from the domestic and global HIV/ suppression on one end when remdesivir, must be given by IV AIDS response to COVID-19.

41 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 WHO and the Joint United Jeff Taylor, a longtime treatment But his experience living with HIV Nations Programme on HIV and activist and advocate for long-term for three decades stood him in AIDS (UNAIDS) have warned that survivors, is working on a study good stead. disruptions in HIV services and that aims to follow a cohort of HIV- access to antiretrovirals could lead positive and well-matched HIV- “One of the things about being to more than half a million extra negative people age 50 or older HIV positive is that we know our AIDS-related deaths, an increase to see who gets the coronavirus, bodies. We know when something is in new HIV infections and a what kind of immune responses wrong,” Jackson says. “I’ve been very steep rise in mother-to-child HIV they mount and what the course of proactive about my health. When transmission in sub-Saharan Africa disease looks like over time. I started getting congested in my by the end of next year. chest, I said, ‘This is not cool.’” “An important part of that will be “The COVID-19 pandemic must not studying the psychosocial impact be an excuse to divert investment of COVID-19 to see if this triggers from HIV,” says UNAIDS executive posttraumatic stress disorder from director Winnie Byanyima. “There the AIDS pandemic, how well is a risk that the hard-earned people cope and if there are unique gains of the AIDS response will kinds of stigma associated with be sacrificed to the fight against COVID-19 among people who are COVID-19, but the right to health more vulnerable and may need means that no one disease should to continue to remain socially be fought at the expense of the isolated even after things reopen,” other.” Taylor says.

In the United States, in an effort to Gandhi is also worried about the Art Jackson both protect patients and reduce financial impact of the shutdown Courtesy of Jillian Clark the demand on health care systems, and the effects of social isolation— experts initially urged people especially on older people and After a friend he had spent time with HIV to utilize telemedicine those struggling with mental with about a week and a half earlier and minimize in-person medical health or substance use issues—as got sick and tested positive for the visits—for example, by delaying well as the reemergence of the new coronavirus, he got tested too, viral load monitoring. But this is same disparities long familiar to with the same result. not a viable long-term approach as people living with HIV. the COVID-19 pandemic stretches “My congestion started getting into its sixth month. “COVID-19 has basically proven really bad when the sun was about again that we haven’t fixed our to go down, and by the time it “People with HIV went into hiding, structural inequities, structural was dark, it felt like someone was but we need to get them back into racism, homelessness and all of the standing on my chest,” he recalls. the clinics. We need to start doing other unfair things that happen “My body was hurting from the viral load measurement and make in society,” she says. “We’ve been toes on up.” sure they have access to treatment. shouting this from the rooftops We need a balance between staying since the beginning of HIV. It’s Jackson, who has long had out of the health care system and important for all of us as advocates undetectable HIV and a high CD4 engaging with the health care to change the equation.” count, participated in telemedicine system,” says Deeks. “I think we’ll visits with his doctor via Zoom, but be doing a lot more telemedicine CATCHING A BREAK he didn’t want to go to the hospital in the future, and for a lot of my because “friends who were going interactions with my patients, it’s Art Jackson’s experience living in were dying.” Instead, his doctor been fine. But I know people who with HIV has helped him face the or a nurse would call to check on I should be seeing in person much challenges of COVID-19. his breathing every few hours. more frequently.” He managed his symptoms with On the first weekend in March, Art over-the-counter medications and Numerous efforts are underway Jackson, 55, lost his sense of taste. breathing in steam from a pot of to learn more about COVID-19 He soon started to have intense hot water with lemons. in people with HIV. For example, headaches and chest congestion. Continued on the next page...

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 42 Updates from the Field “A couple nights, I really thought He’s also felt the financial impact of I wasn’t going to make it. It took the pandemic. After waiting weeks all my energy just to go into the for unemployment assistance with kitchen,” he says. “The virus wanted no relief in sight, Jackson, who me to lie down, so I said I’m going recently moved from Indianapolis to get up and walk and try to give to Charlotte, North Carolina, landed my lungs a chance. I thought about a new job as an HIV prevention my grandmama and mama and coordinator with the Carolinas aunties and their home remedies, CARE Partnership. and I did what I knew I had to do.” “I’m not a religion person, but I Jackson, who lives alone, also knew believe in faith and grace, and I’m to call on loved ones for support. grateful for my blessings,” he says. “People in my life weren’t going “Sometimes it seems unfair. I’ve to let me go under,” he says. “I have lived with HIV longer than I lived an amazing family and a network without it, and I wonder, When can of people who love and care about I catch a break? But my break was me. I have some amazing friends to make it through, because many who called me in the middle of the people didn’t.” night and made me laugh. They knew I needed that connection Editors Note: This article, published and needed to hear they cared June 2020, was reprinted with about me.” permission from POZ, an award- winning print and online brand for After about seven days, his people living with and affected by symptoms started to ease up. But HIV/AIDS. things still are not back to normal. “I still feel a little off-kilter. I still get www.poz.com/article/covid19-hiv winded. Even now, I would say I’m at about 80%. It’s a gradual process,” he says.

In addition to his own battle with the coronavirus, Jackson has lost three family members and four friends to COVID-19.

“It’s brought back so much of the trauma of HIV in the ’80s and ’90s—the stigma, the fear, but especially the deaths,” he says. “It’s brought back survivor’s guilt and wondering why I’m still here. For others, this is new, but we’ve dealt with a plague before.”

What’s more, Jackson has faced hurtful attitudes from others about JOIN US IN THE having had COVID-19. “Fear just FIGHT AGAINST HIV breeds stigma,” he says. “Now we’ve got to educate people. For some reason, this is something I’ve been charged to do, and I’m OK with that.” A JOURNEY TOWARDS A GLOBAL HIV VACCINE www.mosaicostudy.com

43 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 Updates from the Field Keeping our eyes on sexual and reproductive health in the middle of a pandemic in Zimbabwe

By: Munashe Mhaka, sexual reproductive and health rights advocate, Africa free of New HIV infections (AfNHi) Youth Cohort As I got off the call with Spiwe*, my The outbreak of COVID-19 has seen initiatives that address other heart sank, and my mind struggled a gigantic shift in the lifestyle of public health issues such as HIV, to focus, knowing that my young the entire globe. Since the disease TB, domestic violence, and sexual friend could be in real physical is spread through respiratory and reproductive health. While the danger and there was not much droplets in the air at close range world focuses on preventing deaths I could do about it. She had been with an infected person and from the new pandemic, we should enduring physical abuse at home on surfaces, the World Health not risk losing lives due to lack for the past three months and had Organization (WHO) recommended of appropriate medical, physical, called to tell me she was thinking measures to limit people’s physical and psychosocial support for about ending her life. interactions. Sadly, the restriction conditions we already know exist. on travel, banning of social Spiwe’s mother had remarried soon gatherings, and lockdowns have * Name has been changed to after the death of her father and she resulted in an increase of intimate protect this individual’s privacy. and her stepfather never saw eye partner abuse and domestic to eye. Most of the time, their paths violence as women, children, and Editors Note: This story was did not cross much because she other at-risk persons are locked originally published in IAVI Voices was away at boarding school but down with their aggressors. An Newsletter, Issue 6. This story following the reporting of the first upsurge of HIV transmission was reprinted with permission case of COVID-19 in Zimbabwe, and unplanned pregnancies are from IAVI. the government, like many other expected as vulnerable individuals governments worldwide, took find it even more difficult to https://www.iavi.org/news- measures to curb the spread of the negotiate safe sex. The idle time resources/voices-newsletter/ disease, including a nationwide from being out of schools and issue-6-keeping-all-eyes-on- lockdown. This meant that, unable colleges is pushing young people the-target-to-end-hiv-despite-a- to retreat to the refuge of school deeper into drug abuse and risky pandemic and without the excuse of going for sexual encounters, due to anxiety church youth meetings, Spiwe, like about the pandemic and personal many other victims of domestic vulnerability. abuse, was trapped with her abusers — her stepfather and For my friend Spiwe, physical her mother. abuse is not the only trauma she has been enduring. Her stepfather has taken to sexually molesting her every night her mother is away on night duty at the hospital. Her phone call was to let me know that she was considering ending her life because she could not take any more physical and emotional pain. Fortunately, I was able to convince her to call a hotline where she could get counselling and possibly options on how to get to safety.

The attention and resources devoted to the COVID-19 response has shifted community Munashe Mhaka, youth advocate engagement away from from Zimbabwe conversations and existing

HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 44 Updates from the Field Discovering the necessity for ‘meaningful community engagement’ in the face of the COVID-19 pandemic in Kenya

By: Munashe Mhaka, sexual reproductive and health rights advocate, Africa free of New HIV infections (AfNHi) Youth Cohort. Co-authors: Jane Ng’ang’a, community liaison officer, KAVI-ICR; Fredrick Oyugi, community advisory board member, Kangemi; Stephen Anguva, community advisory board member, Kangemi

travelling long distances across In addition to supporting the the city to jobs that provide a identification of deserving daily wage. As the COVID-19 beneficiaries, CAB members have pandemic has progressed in Kenya, used the food distribution rounds it is increasingly clear that the as an opportunity to educate the already vulnerable communities community on the importance of in Kangemi and other informal social distancing and maintaining settlements are being hard hit by high standards of hygiene to avoid the measures that have been put COVID-19 infection. They have also in place to try to curb the spread conducted HIV vaccine research of the disease. The countrywide literacy and distributed relevant restriction on movement and social information, education, and gatherings has resulted in loss communication (IEC) materials. of income for many households. Many have also had their access to While the initiative has proved to treatment for existing conditions be successful and continues to interrupted. The requirement for receive in-kind and moral support regular handwashing with soap from friends and well-wishers, and usage of face masks in public the KFS is not without challenges. presents a challenge, as many of Owing to the low income of most the settlements have limited access of the households, the community Rose Mahira from KAVI-ICR to running water at home and for has largely looked to the team demonstrates handwashing them the purchase of extra soap, to provide face masks. Another techniques to community water, and masks is too expensive. major shortcoming has been the members in Nairobi, Kenya inadequate supply of IEC materials Since the opening of a clinical In keeping with the principle of to educate the community on research site in Kangemi in leaving communities where studies COVID-19. However, on the more 2003, the Kenya AIDS Vaccine are conducted better off as a result hopeful side, the community has Initiative – Institute of Clinical of its research activities, the KAVI- indicated a willingness to participate Research (KAVI-ICR) team has ICR community liaison team was in COVID-19 vaccine trials if and built a strong relationship of inspired to find innovative ways of when they do happen. This can trust with the communities in helping the community find home- only be attributed to the significant the surrounding low-income grown solutions to address the new investment in time and resources settlements. The nearly two challenges. In partnership with that has been made over the years decades long partnership has community-based organizations, to develop a truly meaningful seen the establishment of a robust KAVI-ICR established the Kangemi engagement with the community. Community Advisory Board (CAB), Family Support (KFS), which a critical link between researchers identifies and rallies support for the Editors Note: This story was and the community, which has most vulnerable families. Bringing originally published in IAVI Voices enhanced HIV prevention research together the Ngao Society, Strings Newsletter, Issue 6. This story literacy and the willingness of For Life Kenya, Betty Adera was reprinted with permission community members to participate Foundation, and several individual from IAVI. in HIV vaccine clinical trials. well-wishers, KFS has mobilized food support for 45 households, https://www.iavi.org/news- Located on the outskirts of 129 children, and 200 beneficiaries resources/voices-newsletter/ Nairobi, Kangemi, is home to across Kangemi within the first two issue-6-keeping-all-eyes-on- nearly 100,000 people reliant on weeks of its existence. the-target-to-end-hiv-despite-a- subsistent wages often earned by pandemic

45 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 HIV VACCINE TRIALS NETWORK | COMMUNITY COMPASS | VOLUME 20, ISSUE 2: DECEMBER 2020 46 The HIV Vaccine Trials Network is an international multi–disciplinary collaboration. Support for the HVTN comes from the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health, an agency of the U.S. Department of Health and Human Services. The Network and NIAID have a close, cooperative working relationship, with shared attention to intellectual and scientific issues.

ABOUT COMMUNITY COMPASS The Community Compass aims to keep the HVTN community informed about the Network’s research, site activities, and advances in the field of HIV prevention and vaccination. We encourage community members to submit news and event reports to this magazine and make this a true community sharing platform.

Translations in Spanish, Portuguese and French provided by Northwest Translations, Inc. www.nwtranslations.com

Editor-in-Chief: Stephaun E. Wallace, Ph.D. Layout & Design: Cody Shipman Production & Distribution: Nina Feldman Contributor: Aziel Gangerdine Contributing Editor: Gail Broder

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