HANC Newsletter  |  November 2021

Land, Labor, and Justice Acknowledgements

We acknowledge the land we occupy today as the traditional home of the Duwamish, Tulalip, Muckleshoot, and Suquamish tribal nations, the original caretakers of this land who are still here. Without them we would not have access to this working, teaching, and learning environment. We commit to conducting ourselves with dignity and treating this land and all the life it sustains with respect. We ask you to join us in this commitment, wherever you may reside. We also acknowledge exploited labor and ongoing struggle​s for justice on this land. We reflect on the ancestors of our various peoples, nations, tribes, and families; ancestors whose struggles, pain, power, privilege, and strivings we hold in our very bodies.

HANC offices are located at Fred Hutch campus in Seattle, WA.

H=H, the H is for Human Launches!

The HANC Legacy Project is excited to launch H=H, the H is for Human, the podcast that centers on the human in HIV. The H is for Human presents content on the human side of HIV research education, affirming Black, Indigenous, and other People of Color (BIPOC), and sexual gender minority communities disproportionately impacted by HIV. The H is for Human will interconnect communities, HIV/AIDS Research Networks, the Division of AIDS (DAIDS), and the Office of HIV/AIDS Network Coordination (HANC).

We invite you to listen to the first episode, subscribe, and share with your friends, family, and colleagues. Listen online at RedCircle or Spotify.
 

New Opportunity: Community Engagement Project Coordinator to support the Black AIDS Institute’s Training Program for Students from HBCUs

The Black AIDS Institute (BAI) was the sole recipient of the  Health Resources & Services Administration - HIV/AIDS Bureau’s (HRSA/HAB) eight million dollar grant for a biomedical justice initiative. This four-year project led by BAI, in partnership with Cardea and the Legacy Project, aims to develop a national training program for students from Historically Black Colleges and Universities (HBCUs) to expand and diversify a strong pipeline of HIV advocates and leaders equipped to end the HIV epidemic. As part of this effort, the Legacy Project will be hiring a Legacy Community Engagement Project Coordinator to develop campus-specific strategies to address knowledge gaps around HIV acquisition and prevention and develop educational opportunities at HBCUs through academic and community-based partnerships.
 
Join us in recognizing the following HIV/AIDS Awareness Days:

December 1: World AIDS Day

The 2021 global World AIDS Day theme is End Inequalities. End AIDS. End Pandemics. First observed in 1988, World AIDS Day was the first international day for global health. Each year, organizations and individuals come together to bring attention to the HIV epidemic, increase awareness of the impact of HIV on people's lives, and speak out against HIV stigma.
Last month, the ACTG announced the new leadership of the transformative science groups. Read more in the ACTG Newsletter - November issue.

On October 21, the ACTG announced the graduation of the investigational inhaled COVID-19 treatment, SNG001, to phase 3 study in ACTIV-2. Read the full press release on the ACTG website.
 
HPTN 2019-2020 Domestic Scholar Dr. Derek T. Dangerfield II, along with co-mentors Dr. Irene Kuo, and Dr. Manya Magnus, published an article in the Archives of Sexual Behavior entitled "Sexual Risk Profiles Among Black Sexual Minority Men: Implications for Targeted PrEP Messaging." The article highlights important data explorations of HPTN 073 and supports the need for culturally relevant, tailored, and targeted PrEP messaging for Black men who have sex with men. Dr. Dangerfield is an assistant professor at the Johns Hopkins University School of Nursing in Baltimore.
 
Dr. Colleen Kelley, HPTN 083 and HPTN 083-02 protocol team member, and associate professor of medicine at Emory University School of Medicine in the Division of Infectious Diseases in Atlanta, recently received the 2021 HIVMA Research Award. She was recognized for her outstanding contributions to HIV research, including significant contributions in understanding how the mucosal inflammatory milieu mediates the risk of HIV acquisition.
 
Dr. Brandon Brown, a current member of the HPTN Ethics Working Group and HPTN 2015-16 Domestic Scholar, has been named a 2021 Emerging Leader in Health and Medicine Scholar by the National Academy of Medicine. Dr. Brown is one of only ten emerging leaders chosen this year, all of whom are early- to mid-career professionals from a wide range of health-related fields. He is also an associate professor in the Department of Social Medicine, Population and Public Health in the School of Medicine at the University of California, Riverside.
 
New study demonstrates community engagement efforts are critical to ensuring the equitable inclusion of BIPOC communities in vaccine clinical trials
A team of research experts from the COVID-19 Prevention Network (CoVPN) has demonstrated that through robust community engagement, equitable inclusion in vaccine clinical trials can make a powerful impact in the health of underrepresented communities. The new study, published in the journal PLOS ONE, discusses the need for engagement of BIPOC communities in infectious disease research as a critical component in efforts to increase vaccine confidence, acceptability and uptake of future approved products. “There has been discourse stating that it is challenging and there are too many barriers to engaging with BIPOC communities,” said Dr. Michele Andrasik, a senior staff scientist at Fred Hutch and lead author of the study. “We are hoping that this shows these are surmountable barriers, and it is possible to overcome them through long-term investments in relationships within the community and by building reputations of trustworthiness as researchers and institutions.”

The CoVPN: Organizational Impact Winner at 2021 Global Health Impact Awards
The COVID-19 Prevention Network (CoVPN) received the Organizational Impact Award at the 2021 Global Health Impact Awards by helping build the infrastructural capacity to rapidly implement five large efficacy trials testing COVID-19 vaccines in the past year. This award is given to an organization making an exceptional impact in improving global health equity. CoVPN’s Mindy Miner accepted the award virtually during the ceremony on October 14. To watch the full award ceremony, click here.
 
IMPAACT 2019 Completes Accrual
On 30 September 2021, following final review of dose confirmation data, the IMPAACT 2019 team announced the study successfully completed accrual as of 28 June. IMPAACT 2019 is a Phase I/II open-label, multicenter, multiple dose study of abacavir/dolutegravir/lamivudine fixed dose combination tablets in treatment-experienced and treatment-naïve children living with HIV who are less than 12 years old. The study is taking place in Botswana, South Africa, Thailand, and the United States.

Learn more about the preliminary results here.

IMPAACT 2023 Finalized as Version 1.0
IMPAACT 2023 was finalized as Version 1.0 and distributed to sites on 25 October 2021. IMPAACT 2023 is a Phase I, multi-centered study of infants born to mothers living with HIV. The study is designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of dolutegravir (DTG) given to infants during the first 4-6 weeks of life, with two sequential dosing cohorts stratified by maternal use of DTG.

The study is taking place in Brazil, South Africa, Thailand, and the United States.
 
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group is looking for a new date to hold a half-day virtual meeting. The group will likely meet in early 2022 and consider holding a face-to-face meeting later in the year.

The Youth Prevention Research Working Group recently completed the draft report from the site survey that was sent out earlier in the year. The report is being finalized and it will be made available to HANC collaborators in the near future. 

The COVID-19 CAB Coalition has posted new videos from the CoVPN on the COVID-19 Resource Page, under the COVID-19 CAB Coalition Partners heading.
 
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners is delighted to announce the following new members to Community Partners:
  • Rafael Gonzalez has been selected as the HVTN staff representative.
  • Jan Kosmyna, Hilda Fredericks, and Ruben Vidales have been selected to represent the ACTG.
 
L to R: New CP members Rafael, Jan, Hilda, and Ruben.
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Site Coordinators Working Group (SCWG) discussed the SCWG workplan for 2022, identifying several topics of focus including audit preparedness, site activation processes, training tracking, management of local essential files, e-consent implementation, and roll-out of new DAIDS policies such as the Electronic Information Systems (EIS) policy and Co-Enrollment Prevention requirements.

The Cross-Network Data Management Working Group (DMCWG) discussed recent experiences with audits, implementation of new modules for inventory management, and refined the 2022 DMCWG workplan.

The IT Best Practices Working Group (ITBPWG) continues to meet to develop IT guidelines and best practices for DAIDS sites and laboratories. The proposed guidelines follow a risk-assessment based approach to help sites through the process of identifying, protecting, detecting, responding, and recovering from cybersecurity risks, and are expected to be published near the end of 2021/early 2022.

DAIDS Co-enrollment Prevention Requirement Updates
Examples of site co-enrollment prevention SOPs have been added to the Site Management Resources page on the HANC website. A summary of the Q&A portion of the September 28th webinar is still in development. Please refer to the DAIDS SCORE Manual site and the DAIDS Resources page on the HANC website for the latest resources related to the DAIDS Co-Enrollment Prevention Requirement.

 
Laboratory Coordination

Tyler Brown, HANC Project Manager
The Laboratory Technologists Committee (LTC) held a conference call with voting protocol support members to review committee nominations for the upcoming term. Eight vacancies are to be filled for the new term, which begins December 1, 2021.

The HANC-LTC SOP Working Group re-convened and held three conference calls in October to continue developing a new Lab Processing Chart Standard Wording Guidance Chart.

In October the Virology Quality Assurance (VQA) Program held their second annual VQA Annual Review Meeting. The two-day virtual meeting provided an overview of the VQA proficiency testing (PT) programs, data management practices, and updates from VQA SARS-CoV-2 activities. Other highlights of the meetings included presentations from VQA collaborators, Kilimanjaro Christian Medical Centre and Vitalant Research Institute, who provided an overview of efforts to create quality control material being used to support VQA laboratory sites.

In October the CPQA Cross-Network Clinical Pharmacology Forum (CNCPL Forum) held a meeting focused on qualitative ARV pharmacology assays. The call featured a presentation by Lubbe Wiesner from University of Cape Town (UCT), which described UCT’s objective adherence assays ARVs, second line tuberculosis drugs, and cardiovascular drugs.

The CPQA Advisory Board (CPQAAB) met in October to discuss the CPQA Program’s proposal to change their proficiency testing acceptability window from 20% to 15%.

The Lab Focus Group (LFG) met with the DAIDS Clinical Laboratory Oversight Team (DCLOT) in October to discuss site requirements for GCLP training, GCLP audit procedures, and updating the HANC-LFG PNL Assignments List.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
Oct 15: For National Latinx HIV/AIDS Awareness Day, the New Investigators Working Group and the Latinx Caucus organized “A Conversation with Latinx Researchers.”  30 people attended. The recording of the webinar is now available

Nov 1: H=H, the H is for Human, the podcast that centers on the human in HIV launched Episode 1. We invite you to listen to this first episode.

Nov 4: "A Conversation with Black and African American Researchers" is the third edition of the New Investigators Working Group Webinar Series. Register for the webinar now

Nov 15: Addictophobia in HIV/AIDS Clinical Research - Part 2 Webinar. Register now.
Before joining, take the Implicit Association Survey to measure your implicit bias regarding people who inject drugs.

Dec 1: World AIDS Day, a day to raise awareness about the epidemic and for people to get involved in the fight against HIV. Check out the World AIDS Day issue of our Be the Generation newsletter.

Dec 2-3: The United States Conference on HIV/AIDS. Join us for our workshops on December 3:
  • 1:15-2:15 pm ET: “Respuesta Comunitaria al COVID-19 en Latinx en los Estados Unidos” (Community Response to COVID-19 in Latinx in the United States)
  • 2:30-3:30 pm ET: “It’s About Time: HIV Research Just for Transgender Women

Featuring HPTN 094 Bridge Fellowship Scholars
Dr. Amaya Perez-Brumer is an Assistant Professor in the Division of Social and Behavioural Health Science at the University of Toronto. She earned her Ph.D. in Sociomedical Sciences and Sociology from Columbia University. Dr. Perez-Brumer’s scholarship integrates social science theory with innovative mixed methodological approaches to improve HIV prevention intervention implementation and acceptability among people of diverse genders and sexualities. She also holds an academic affiliation with the AIDS Clinical Trials Network on A5403, the GET IT RIgHT Study”.  

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Children 5 through 11 Years of Age

October 29, 2021
The U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include children 5 through 11 years of age.
  • Effectiveness: Immune responses of children 5 through 11 years of age were comparable to those of individuals 16 through 25 years of age. In addition, the vaccine was found to be 90.7% effective in preventing COVID-19 in children 5 through 11.
  • Safety: The vaccine’s safety was studied in approximately 3,100 children age 5 through 11 who received the vaccine and no serious side effects have been detected in the ongoing study.
Read the full press announcement on the FDA website.

Pfizer and BioNTech Announce Phase 3 Trial Data Showing High Efficacy of a Booster Dose of their COVID-19 Vaccine

October 21, 2021
Pfizer Inc. and BioNTech SE announced topline results from a Phase 3 randomized, controlled trial evaluating the efficacy and safety of a 30-µg booster dose of the Pfizer-BioNTech COVID-19 Vaccine in more than 10,000 individuals 16 years of age and older. In the trial, a booster dose administered to individuals who previously received the Pfizer-BioNTech primary two-dose series restored vaccine protection against COVID-19 to the high levels achieved after the second dose, showing a relative vaccine efficacy of 95.6% when compared to those who did not receive a booster.

These are the first efficacy results from any randomized, controlled COVID-19 vaccine booster trial during a period when Delta was the prevalent strain. Companies plan to submit these data to FDA, EMA and other regulatory agencies to further support licensure in the U.S. and other countries. Read the full statement from Pfizer.

FDA Takes Addditional Actions on the Use of a Booster Dose for COVID-19 Vaccines

October 20, 2021
The U.S. Food and Drug Administration expanded the use of a booster dose for COVID-19 vaccines in eligible populations, amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:
  • The use of a single booster dose of the Moderna COVID-19 Vaccine that may be administered at least 6 months after completion of the primary series to individuals:
  • 65 years of age and older
  • 18 through 64 years of age at high risk of severe COVID-19
  • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • The use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
  • The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different available COVID-19 vaccine.
  • To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine may be administered at least 6 months after completion of the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
Read the full press announcement on the FDA website.

Merck and Ridgeback's Investigational Oral Antiviral Molnupiravir Reduced Risk of Hospitalization or Death by 50 Percent for Patients with Mild or Moderate COVID-19 in Positive Interim Analysis

October 1, 2021
Merck, known as MSD outside the U.S. and Canada, and Ridgeback Biotherapeutics announced that molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine, significantly reduced the risk of hospitalization or death at a planned interim analysis of the Phase 3 MOVe-OUT trial in at risk, non-hospitalized adult patients with mild-to-moderate COVID-19. 

At the interim analysis, 7.3 percent of patients who received molnupiravir were hospitalized through day 29, compared with 14.1 percent of placebo-treated patients who were hospitalized or died. Merck plans to seek Emergency Use Authorization in the U.S. as soon as possible and to submit applications to regulatory agencies worldwide. If authorized, molnupiravir could be the first oral antiviral medicine for COVID-19. Read the full news release from Merck.
 

Upcoming Webinars

A Conversation with Black and African American Researchers

November 4, 2021 at 11:00am PDT / 2:00pm EDT     
The New Investigators Working Group is pleased to announce the new edition of its webinar series “A Conversation with Black and African American Researchers”. This webinar will feature the professional trajectory of three outstanding investigators in the fields of HIV, social determinants of health and health disparities.

Join the conversation with Greg Millet, Dr. LaRon Nelson and Dr. Darren Whitfield. The webinar will be moderated by Dr. Typhanye Dyer, co-Chair of the New Investigators Working Group and Christopher Hucks-Ortiz, Chair of the HPTN Black Caucus. Register for the webinar now.

Addictophobia in HIV/AIDS Clinical Research - Part 2

November 15, 2021 at 9:00am PDT / 12:00pm EDT     
The Legacy Project invites you to participate in the second webinar of the Addictophobia in HIV/AIDS Clinical Research series. Dr. Steve Shoptaw will present on non-injection drug use, HIV transmission, and similar constructs regarding biases that are used to exclude participation in HIV/AIDS clinical trials. Dr Shoptaw will also highlight strategies used in the HPTN 094-INTEGRA study to bring stigma-free HIV prevention, harm reduction, and supportive services to PWUD/PWID. Dr. Alex Dubov will also discuss the use of the validated Implicit Bias Test for PWID.

Moderated by Dr. Jeffrey Schouten, HANC Director, this webinar will raise critical questions related to addictophobia and implicit bias in HIV/AIDS clinical research and offer guidance for how the networks can re-imagine harm reduction. Register for the webinar now. Before joining, please take the Implicit Association Survey to measure your implicit bias regarding people who inject drugs.
 

Conferences & Meetings

November 7-9, 2021
Adherence 2021 (Hybrid: Orlando, FL USA)
December 2-3, 2021
February 12-16, 2022
June 4-8, 2022
HPTN Annual Meeting (Hybrid: Washington, DC USA)
June 13-17, 2022
Annual ACTG Network Meeting (Washington, DC USA)
 

Publication Highlights

Scheidell et al

Leddy et al

Irvin et al

Andrasik et al

Stoner et al

Dangerfield II et al