HANC Newsletter  |  February 2022

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.

Welcome Tasia Baldwin!

We are delighted to announce that Tasia Baldwin has joined HANC as our Community Engagement Officer - Project Coordinator to support the partnership between The Legacy Project and Black AIDS Institute for the project Building the HIV Workforce and Strengthening Engagement in Communities of Color (B-SEC) (HRSA-21-124). In this new role, Tasia will engage Minority Serving Institutions to integrate the National HIV Curriculum (NHC) and the HIV Prevention Research Module (HPR) into course curriculum. This role also seeks to expand access to mentorship, research, and other professional development opportunities.

Tasia brings several years of community engagement experience, serving multiple terms as a co-chair for the HVTN/HVTU community advisory board, global community advisory board, and most recently as a HANC Community Partners member. Tasia has a broad set of project management skills. Tasia is currently finishing a Master of Science in Biomedical Sciences at California University of Science and Medicine and holds a Master of Art in Management and Social Sustainability at Seattle Pacific University. Tasia enjoys gardening, crafts, and anything sports.

Please join us in welcoming Tasia to our HANC team!

HIV/AIDS Clinical Trials Network Sessions at CROI 2022

The Conference on Retroviruses and Opportunistic Infections (CROI) 2022 begins February 12-16 as a fully virtual conference. The conference program includes various sessions from the HIV/AIDS Clinical Trials Networks, which will be collectively listed on the HANC website by February 9. Check back under the HANC website Announcements next week, and learn more about the full conference program by visiting the CROI website.
Join us in recognizing the following HIV/AIDS Awareness Days this month:

February 7: National Black HIV/AIDS Awareness Day

National Black HIV/AIDS Awareness Day is an annual opportunity to help reduce HIV among African Americans by promoting HIV prevention, testing, and treatment. National HIV prevention efforts are reducing the burden of HIV infection among some African Americans, but more progress is needed.

On February 7, from 2:00PM - 2:30PM U.S. Eastern Time, the HHS Office of Infectious Disease and HIV/AIDS Policy will host a Live with Leadership webinar to focus on how communities, the Ending the HIV Epidemic initiative, and the National HIV/AIDS Strategy prioritizes ending the HIV epidemic in Black communities. Register for the session here.
The ACTG congratulates the A5386 study team as the first participant was randomized on January 13! A5386 is a phase 1 HIV cure study evaluating two promising therapies. A5386 will study whether N-803 (a clinical-stage biologic also called Anktiva™) can control HIV alone or together with combination broadly neutralizing antibodies (bNAbs) after participants stop their antiretroviral therapy (ART) and they are carefully monitored. Read more about the study HERE .

The ACTG is happy to announce the publication of the primary manuscript for A5360 (MINMON), "A Minimal Monitoring Approach for the Treatment of Hepatitis C Virus Infection: A Phase 4 Open-label, Single-arm Trial", in The Lancet Gastroenterology and Hepatology! The study found that the approach with sofosbuvir–velpatasvir treatment was safe and achieved SVR comparable to standard monitoring observed in real-world data. Coupled with innovative case finding strategies, this strategy could be crucial to the global Hepatitis C virus elimination agenda. Congratulations to the team and study authors! You can read the full manuscript HERE.
In late December 2021, the U.S. Food and Drug Administration approved long-acting cabotegravir, or CAB-LA, injections for pre-exposure prophylaxis (PrEP) to reduce the risk of HIV acquisition among adults and adolescents weighing at least 35 kg. The approval was based primarily on efficacy data from HPTN 083 and HPTN 084. Additional safety and acceptability data are being collected through open-label study extensions and two adolescent sub-studies, HPTN 083-01 and HPTN 084-01. Marketed by ViiV Healthcare under the brand name Apretude, CAB-LA offers adults and adolescents a new PrEP option for HIV prevention.

The HIV Vaccine Trials Network (HVTN) launched a newly redesigned website on February 4. The website features a modernized and user-friendly interface that communicates the science of the HVTN, telling the story of the network’s impact on people and how communities empower its mission.

The presentations that are slated for CROI are:
  • SYMPTOMS DURATION IN COVID-19 CONVALESCENT PATIENTS: REGIONAL & CLINICAL ASSOCIATIONS Jorge A. Gallardo-Cartagena, Juan J. Montenegro-Idrogo, Sue Li, Jiani Hu, Abhishek B. Amin, Portia Hunidzarira, Paul Goepfert, Megan Jones, Vicky Kim, Robert De La Grecca, Azwi Takalani, Simbarashe Takuva, Lawrence Corey, Shelly Karuna, for HVTN 405/HPTN 1901 study team
  • PHASE 1 STUDY OF COMBINATION ANTI-HIV NEUTRALIZING ANTIBODIES IN HIV NEGATIVE ADULTS Magdalena E. Sobieszczyk, Sharon Mannheimer, Yunda Huang, Carmen A. Paez, Theresa Gamble, Deborah A. Theodore, Wairimu Chege, Margaret  Yacovone, Chenchen Yu, Lily Zhang, Jack Heptinstall, Kelly Seaton, Georgia Tomaras, David C. Montefiori, for the HVTN 130/HPTN 089 Study Team
The IMPAACT Network will present 16 abstracts from 11 studies (3 oral presentations, 13 poster presentations) at the Conference on Retroviruses and Opportunistic Infections (CROI) 2022.

Once available, presentations can be found at www.impaactnetwork.org/news/2022/impaact-croi-2022.

Study Updates
IMPAACT 2009 has opened the PrEP Comparison Component as of 13 January 2022. The study team is working with sites to complete all requirements to begin enrollment into this component. IMPAACT 2009 is a two-part trial evaluating the feasibility, acceptability, and safety of oral PrEP in pregnant and postpartum adolescents and young women (16 to 24 years of age) in sub-Saharan Africa.

IMPAACT 2032 has successfully completed accrual as of 29 December 2021, enrolling 28 non-pregnant participants and 26 pregnant participants to evaluate the pharmacokinetics and safety of remdesivir for COVID-19 treatment. Women hospitalized for COVID-19 and receiving remdesivir as part of their clinical care (i.e., outside of the study) were enrolled at study sites located in the United States.
The HANC-facilitated COVID-19 CAB Coalition (CCC) formed in September 2020 to share information, share resources, and advocate on behalf of COVID-19 research efforts. Members represent the COVID-19 Prevention Network (CoVPN) Community Engagement Working Group, the ACTG's ACTIV-2 CAB, AVAC's COVID Advocates Advisory Board, the CFAR National CAB Coalition, the COVID-19 CAB at Stony Brook, DAIDS, and Community Partners.

Updates from the CCC are shared below:
COVID-19 CAB Coalition Update
On the last COVID-19 CAB Coalition (CCC) call, the group continued the discussion about the need for general materials that explain how science is an evolutionary process and that knowledge changes overtime. HANC staff reviewed the HANC basic scientific literacy training and drafted short scripts based on the training module. The CCC has formed an ad-hoc group to review the scripts before moving forward with creating videos. The group is considering having short white board/story board videos created that can be shared via social media. More information will be available after the ad-hoc working group meets.
Novavax Seeks US FDA Emergency Use Authorization
On January 31, 2022, Novavax announced it has submitted a request to the US FDA for emergency use authorization for its COVID-19 vaccine candidate for immunization of individuals 18 years of age and older against SARS-CoV-2.
COVID-19 Antibody Drugs vs. Omicron
On January, 24, the AP (US) reported that, "COVID-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday. The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with COVID-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use." Read more here.
AVAC's Weekly COVID News Brief
Read week-by-week updates on the latest COVID-19 news here.
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Financial Disclosure Working Group is discussing including CoVPN investigators in the annual solicitation. The group has started reviewing the SOP for the 2022 annual solicitation. 

A few members of the Youth Prevention Research Working Group (YPRWG) met on Thursday, February 3 to discuss the recommendations document that will be attached to the YPRWG site survey report. The final report and the recommendations document will be shared with Network Leadership soon.

The Behavioral Science Consultative Group (BSCG) is tentatively scheduled to meet in-person on March 11, 2022, in Seattle, WA. The BSCG is working on the agenda for the F2F meeting. The group has not met in person since 2019.
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners is delighted to announce the following Community Research Advisors Group (CRAG) members will serve on Community Partners:
  • Cynthia Chirwa
  • Godfrey Mbulelo Tabata
The CRAG is an international, community-based advisory body that works to ensure the meaningful representation and engagement of affected communities in research conducted by the United States Centers for Disease Control’s Tuberculosis Trials Consortium (TBTC). One goal of the CP/CRAG partnership is to help educate TB community members and researchers about HIV and to help educate HIV community members and researchers about TB and how the two diseases are connected. We are excited for this on-going collaboration.

Community Partners has been invited to present to the ACTG and HVTN GCABs in February.
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Communications Working Group (CWG) discussed network communications priorities for 2022, upcoming conference engagements, and planning for the 2022 annual network meetings.

The Cross-Network Data Management Center Working Group (DMCWG) shared updates on COVID-19 studies, DMC priorities for 2022, and ongoing pilot initiatives.

The Cross-Network Site Coordinators Working Group (SCWG) discussed updates to template ICF language, requirements for documenting single IRB approvals, and suggestions to address ongoing pandemic-related challenges and staff fatigue.

IT Security Best Practices for Sites and Labs
The newest version of the IT Security Best Practices for NIH HIV/AIDS Clinical Research Network Sites and Labs is now published. The document is available online on the HANC website. The IT Security Best Practices (v5.0) outlines a recommended approach for research sites and labs to manage information technology and cybersecurity risks. The framework is intended to complement existing site and institutional processes for cybersecurity risk management and provides a standard process to help sites 1) Describe their current cybersecurity position; 2) Describe their target state for cybersecurity; 3) Prioritize opportunities for improvement; 4) Assess progress; and 5) Communicate with stakeholders about cybersecurity risks. This document was created by the HANC-facilitated IT Best Practices Working Group, and its development informed by the July 2021 DAIDS Site IT Survey. 
Laboratory Coordination

Tyler Brown, HANC Project Manager
The CPQA Advisory Board (CPQAAB) met in January to discuss and seek feedback on current CPQA Program activities. The meeting featured a virtual presentation by Dr. David W. Haas (Vanderbilt University School of Medicine) which provided updates on selected aspects of HIV and TB pharmacogenomics.

The Lab Focus Group (LFG) in January held a meeting with the DAIDS Clinical Laboratory Oversight Team (DCLOT) to discuss and address challenges that sites are having procuring unexpired control samples. The LFG held a second meeting in January focused on addressing the current lab supply and staff shortages.

The HANC-CPQA Qualitative Assay Working Group met in January to continue developing a new set of guidelines for qualitative ARV pharmacology assays – guidelines are expected to be published in the first half of 2022.

The HANC-LTC SOP Working Group met in January to continue drafting a new standard wording guide for ACTG and IMPAACT protocol Lab Processing Charts (LPCs) – the new guide is expected to be published by April 2022.
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
Feb 1: Tasia Baldwin joined the Legacy Project as a Project Coordinator who will be focused on engaging Minority Serving Institutions to integrate the National HIV Curriculum (NHC) and HPR module into course curriculum.

Feb 3: Brian Minalga presented on the Representative Studies Rubric to the ACTG Underrepresented Populations Committee.

Feb 7: Legacy Project recognizes National Black HIV/AIDS Awareness Day

Feb 15: Episode 4 of the “H=H the H is for Human” will be devoted to the health of transgender people.  You can access the podcast on February 15 here.

Feb 18: Submissions for the Be the Generation eNewsletter are due from the HPTN, HVTN, and MTN to Brian Minalga.

Mar 1: The latest issue of BTG News will be available, bringing the community the latest in HIV prevention research from the HPTN, HVTN, and MTN.


DAIDS Applied Research Training (DART) 2.0 Global Announcement

The Division of AIDS (DAIDS) is pleased to announce our second DAIDS Applied Research Training (DART) 2.0 event, which will be held in September 2022 for our HIV/AIDS Network sites in the Latin American and Caribbean region.

Given the current situation with the global pandemic, we have decided to conduct a hybrid event that will incorporate applied Good Clinical Practice compliance at our clinical research sites. This further aligns with DAIDS efforts to strengthen regulatory compliance across the HIV/AIDS Network enterprise. In addition, we will incorporate content to include communication and quality management skills on a systems level with an emphasis on implementation and process improvement.

We will be limiting overall attendance of the event to ensure that we maintain the small group atmosphere for effective virtual learning experiences.

We will be reaching out to potential DART 2.0 participants shortly. For more information contact the DART support team at DAIDS_CRSS_DART_2.0@mail.nih.gov.

Conferences & Meetings

February 12-16, 2022
May 4-6, 2022
HVTN Full Group Meeting (Washington, DC USA)
June 4-8, 2022
HPTN Annual Meeting (Hybrid: Washington, DC USA)
June 13-17, 2022
Annual ACTG Network Meeting (Washington, DC USA)
June 28-July 1, 2022
IMPAACT Annual Meeting (Hybrid: Washington, DC USA)