HANC Newsletter  |  April 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.
 

H=H Episode 5: Transgender Women's Health Research

Episode 5 of the H=H the H is for Human podcast aired on March 8, 2022. Continuing with the health of transgender people, this episode is devoted to research being conducted about the health of transgender women in the context of the Division of AIDS research agenda. Featuring Rona Siskind, Health Specialist with the Division of AIDS; Dr. Tonia Poteat, HPTN researcher and principal investigator of the I Am (HPTN 091) study; and Dr. Jordan Lake, ACTG researcher and principal investigator of the Get it Right study, our three guests discuss the way that the Division of AIDS approaches research pertaining transgender people issues, and talk to us about their studies with transgender women and sponsored by the HIV/AIDS research networks.

Coming soon: Episode 6 of H=H, the H is for Human launches on April 15. Episode 6 will highlight topics from the National Latinx Conference on HIV/HCV/SUD.

 
Join us in recognizing the following HIV/AIDS Awareness Days this month:

April 10: National Youth HIV & AIDS Awareness Day

National Youth HIV & AIDS Awareness Day (NYHAAD) educates the public about the impact of HIV/AIDS on youth and highlights the work youth do to strengthen the fight against the HIV/AIDS epidemic.
 
 
Last month, the ACTG and Shionogi announced that the FDA has cleared the investigational new drug application for S-217622, a novel COVID oral antiviral therapy, enabling the global phase 3 trial to proceed as part of the ACTIV-2 program for COVID-19. You can read the full press release here!
 
Congratulations to the HPTN Soweto CRS team for transitioning its first two study participants to the cabotegravir long-acting injectable open label extension (OLE) for HPTN 084. HPTN 084 study participants are given the choice to stay on their current study product or switch to the other study product. By offering participants a choice of study products in the OLE, researchers will learn about preferences for PrEP products.
 
The annual HVTN/CoPVN Full Group Meeting will convene May 4th-6th at the Omni Shoreham Hotel in Washington D.C., with virtual options to connect remotely. If you’ve received an invitation and not yet registered, please note the online registration deadline is April 26th: https://helpendhiv.wufoo.com/forms/q159s5ed17t9otw/

For more information, please visit https://www.hvtn.org/events.html. For any questions about the meeting, please email vtn.travel@hvtn.org.
 
IMPAACT 2014 Informs U.S. FDA’s Approval for Use of Doravirine in Pifeltro® and Delstrigo® Among Children
Based on data from IMPAACT 2014 the U.S. FDA has approved doravirine (DOR, Pifeltro®) and a fixed-dose combination of doravirine/lamivudine/tenofovir disoproxil fumarate (DOR/3TC/TDF, Delstrigo®) for treatment of HIV in children weighing 35 kg or greater.  

On 27 January 2022, the U.S. FDA approved two supplements for doravirine (as Pifeltro® and Delstrigo®), which expanded the labels to include a new indication for use of doravirine in pediatric patients 35 kg or greater with HIV and an update to the clinical pharmacology to include data on pharmacokinetics in pediatric patients. Updates were based on results from the IMPAACT 2014 study. See full details of the FDA approvals on Drugs@FDA.

In addition, on 24 February 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorization for the medicinal products DOR (Pifeltro®) and DOR/3TC/TDF ( Delstrigo®). The extension would expand the current indication to include adolescents aged 12 years and older weighing at least 35 kg. The European Commission (EC) will make a decision in the near future regarding a change to the marketing authorization in European Union countries.  


IMPAACT 2017 (MOCHA) Cohort 1 Closed to Accrual
IMPAACT 2017, also known as MOCHA (More Options for Children and Adolescents), has met the protocol-specified requirements to permanently close Cohort 1 to accrual. Cohort 2 is currently open to accrual for participants who previously took part in Cohort 1 and it is anticipated that data will soon be available to inform enrollment of other adolescents into Cohort 2.  

The study team thanks the participating sites for all their work and is eager to review the Cohort 1 data to inform the full opening of Cohort 2.  

Learn more about IMPAACT 2017 and the CROI 2022 findings here
IMPAACT 2028 Now Enrolling
IMPAACT 2028, an observational study to characterize a cohort of children who may participate in future research related to HIV remission or cure, is now enrolling. 
Children in this study will have previously received early or very early treatment for HIV in other IMPAACT studies or other studies sponsored by the NIH. Children in this study will complete study visits approximately every six months at which key clinical, immunologic, and virologic outcomes will be assessed for a period of up to seven years. 

Congratulations to the Pediatric Perinatal HIV NICHD CRS (Site 5127) for enrolling the first participant into the study. The study is taking place at 33 sites in Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, the United States, and Zimbabwe.
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
The COVID-19 CAB Coalition formed an ad-hoc group to draft scripts for brief whiteboard videos on understanding science. The group is finalizing the scripts the first week in April. The scripts will be developed into brief whiteboard videos to share on social media. 
Omicron BA.2 Now Most Common in the US
Omicron BA.2 is now the dominant variant in the US. A report on NPR states, "the CDC estimates that the BA.2 strain now accounts for more than half — 54.9% — of coronavirus infections nationwide, according to new data. It's even more prevalent in certain parts of the country. For example, over 70% of COVID-19 cases in the Northeast are BA.2, the CDC estimates." Continue reading here.
CDC Recommends Additional Boosters for Certain Individuals
On March 29, the CDC released a statement recommending additional COVID-19 boosters for individuals over the age of 50. Boosters are recommended especially for those 65 and older and those 50 and older with underlying medical conditions that increase the risk for severe disease from COVID-19. 
Ivermection Among Patients with COVID-19
A study published in the New England Journal of Medicine this week has shown that Ivermectin does not reduce the risk of hospitalization from COVID-19. Read more here.
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) met in-person on March 11, 2022 for the first time since 2019 in Seattle, WA. One session in the meeting included a discussion with ACTG Chair, Dr. Judith Currier. The BSCG is finalizing the meeting report.

The Youth Prevention Research Working Group (YPRWG) recently released the final report from the 2021 site survey the group conducted. The report includes an executive summary, key findings, and recommendations to increase adolescent research in the Networks. The YPRWG plans to present the findings to Network Leadership on an upcoming call. Read the report here
 
Community Partners

Russell Campbell, HANC Deputy Director
The Community Research Advisors Group (CRAG) is an international community-driven advisory body that works to ensure the meaningful representation and engagement of affected communities in the Tuberculosis Trials Consortium (TBTC), a TB research network funded by the U.S. CDC. As part of the on-going collaboration between Community Partners (CP) and the CRAG, CP is excited to have a representative on the CRAG. This is an amazing opportunity to bring community perspectives into the research program of one of the world's leading TB research networks to ensure the next 10 years of TBTC is responsive to the needs and priorities of people affected by TB.

The US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet) Recruitment and Retention Working Group and Community Partners is excited to announce a new Community Engagement Partnership. The objectives of the collaborative Community Engagement Partnership are to review and discuss each ULACNet study in the context of community engagement efforts, and develop study-specific community engagement plans that:
  • Are inclusive of the community in all aspects of the clinical research efforts
  • Take into consideration community norms and the historical perspective of research within the community
  • Best ensure strong community/researcher stakeholder engagement
  • Ensure that the research is addressing specific health concerns of the community
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Electronic Informed Consent (eConsent) webinar series aired in March, featuring speakers from the U.S. Food and Drug Administration (FDA), Division of AIDS (DAIDS), and clinical research sites. The two-part webinar series focused on the regulatory considerations for implementing eConsent in clinical research, as well as considerations for real-world implementation of eConsent in trials during the COVID-19 pandemic. Recordings and slides from both webinars are available on the HANC website .

The Cross-Network Communications Working Group (CWG) debriefed on highlights from CROI 2022 and discussed network social media strategies. Major news from IMPAACT included the first known case of a woman with HIV remission, while the HPTN presented final data from the long-acting cabotegravir study in cisgender men and transgender women (HPTN 083). The ACTG and HVTN also received media coverage from the conference. The full list of network presentations at CROI 2022 is available on the HANC website, and presentation slides/recordings of network specific sessions are posted on the IMPAACT and HPTN websites, respectively.

The Cross-Network Data Management Center Working Group (DMCWG) met to discuss updates on COVID-19 studies, ongoing efforts related to electronic trial master files and remote source data verification, as well as specimen repository guidelines.

The Cross-Network Evaluation Working Group (EWG) met with representatives from DAIDS OCSO to address expectations for this year's site performance evaluation reports and discussed a new effort to increase alignment of network metrics for site performance.

The Cross-Network Protocol Deviation Working Group (PDWG), which began as a collaboration between the DAIDS and SDMCs in March 2021, received approval from DAIDS leadership to move forward with an interim proposal for collecting major protocol deviations uniformly across the networks. The proposal presents a common definition for protocol deviations, using the terms minor, major, and critical to classify protocol deviation severity; and relies on using a common eCRF to capture and report major and critical protocol deviations. Additional communications, training, and outreach regarding this change are expected to follow in the coming month.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
New Release of Web LDMS: On March 20, 2022 Frontier Science released Web LDMS version 10.0. All databases were automatically updated from version 9.1 to version 10.0. More information about version 10.0, including detailed release notes and the 10.0 user manual, are available on the LDMS website: https://www.ldms.org/news/2022/03/20/ldms-web-10-0-release/ 

The Lab Focus Group (LFG) held a meeting in March to continue developing site-level guidance materials that are aimed at mitigating lab supply and reagent shortages. These materials are being developed in collaboration with lab quality assurance providers and DAIDS, and are expected to be available for public access on hanc.info in the coming weeks.

The HANC-CPQA Qualitative Assay Working Group met in March to continue drafting a new set of guidelines for testing and validating qualitative ARV pharmacology assays – these guidelines are expected to be published by this summer.

The Lab Technologists SOP Working Group held four meetings in March to update the ACTG/IMPAACT Shipping Evaluation SOP and ACTG/IMPAACT Lab Processing Chart Template. New versions of these documents will be available on hanc.info in the coming weeks.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
March 21: In observance of the National Native HIV/AIDS Awareness Day 2022, the American Indian/Alaska Native Working Group in coordination with the New Investigators Working Group held the webinar “A Conversation with Native Researchers” featuring the professional journey of native researchers Julie A. Baldwin, Harlan Pruden and Delight Satter.  You can access the webinar here

March 23: Russell Campbell presented the HBCU HPR module as part of the inaugural Evidence2Practice (E2P) workshop March 23-25 hosted at Voorhees College in South Carolina. E2P is an interactive 3-day workshop aimed at recruiting Black undergraduate students to careers in HIV science, through introduction to the basic concepts of implementation science and HIV epidemiology and prevention strategies. The program is funded by the NIH Centers for AIDS Research (CFAR) Diversity, Equity and Inclusion Pipeline Initiative (CDEIPI). 

March 24: Rafael Gonzalez (HVTN) and Pedro Goicochea (HANC) presented the session “Community Involvement in HIV Prevention Clinical Research” on behalf of the Latinx Caucus at the National Latinx Conference on HIV/HCV/SUD 2022.  

April 15: H=H, the H is for Human, Episode 6 will highlight some of the topics of the “National Latinx Conference on HIV/HCV/SUD” and you will be able to access it here.
Long-Acting Antiretroviral Injectables Information Sheet
The Legacy Project Working Group has updated the information sheet about the use of Long-Acting Injectables for treatment and prevention based on recent developments.  The information sheet  has been designed for sites to download and use them on their social media outlets or to print if needed. The information sheets can be accessed here
 

Training

Wednesday, May 18, 2022 at 1:00pm - 4:00pm ET
The NIDA HIV Research Program invites you to a symposium with awardees of the Avant-Garde Award Program for HIV/AIDS and Substance Use Disorder Research, supporting innovative research into new areas of HIV prevention and treatment among people who use drugs. This symposium will feature Dolores Albarracin, Ph.D. (University of Pennsylvania - Annenberg School for Communication); Jeremy Luban, M.D. (University of Massachusetts Medical School); Eric Verdin, M.D. (Buck Institute for Research on Aging); and Tariq Rana, Ph.D. (University of California, San Diego - Institute for Genomic Medicine). Learn more about the NIDA Avant-Garde Award and register for the symposium now.
Various Dates, February - July 2022
The UW/Fred Hutch Center for AIDS Research (CFAR), UW Indigenous Wellness Research Institute (IWRI), and the University of Hawaii (UH) have launched a new project titled “Building Indigenuity, Generating HIV Science: HIV/AIDS Research Training (BIG HART).” This exciting new training opportunity will be led by Karina Walters, MSW, PhD (Choctaw Nation of Oklahoma), Co-Director of IWRI, Professor and Associate Dean in the School of Social Work, and Jen Balkus, PhD, MPH, CFAR DEI Lead and Assistant Professor in the Department of Epidemiology in the School of Public Health.  

BIG HART will host a six-part seminar series for Indigenous undergraduate and graduate students at UW and UH who are interested in learning more about HIV research and the various ways the epidemic impacts Indigenous communities across North America. The series will feature both scientists and practitioners working across the spectrum of HIV science, including former scholars from the Indigenous HIV/AIDS Research Training Program (IHART). The monthly sessions will be held in February through July of 2022. Among those who attend at least one session, interested students will be given the opportunity to participate in a one-on-one mentorship session with an IHART mentor and/or CFAR investigator. In addition, up to 10 graduate students will also have the opportunity to participate in the UW Principles of HIV/STI Research and Public Health Practice Course.

Interested students can join this BIG-HART listserv to stay up to date on all BIG HART activities and opportunities. The speaker list and schedule will be made available on the website once finalized, and Zoom registration is now open to all! Please reach out to Jen Balkus (jbalkus@uw.edu) or Karina Walters (kw5@uw.edu) with any questions about the project, or Anya Lewin (lewina@uw.edu) with any administrative questions.  
 

Conferences & Meetings

April 20-21, 2022
May 4-6, 2022
HVTN Full Group Meeting (Hybrid: Washington, DC USA)
June 4-8, 2022
HPTN Annual Meeting (Hybrid: Washington, DC USA)
June 13-17, 2022
Annual ACTG Network Meeting (Hybrid: Washington, DC USA)
June 28-July 1, 2022
IMPAACT Annual Meeting (Hybrid: Washington, DC USA)
July 11-13, 2022
Adherence 2022 (Hybrid: Washington, DC USA)