HANC Newsletter  |  July 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. The podcast that centers the human in HIV

In July, the HANC Legacy Project will be launching the podcast “H=H | The H is for Human.  The podcast that centers the human in HIV”  The podcast will transmit content on the human side of research, health, wellbeing and community. The podcast will air programs on HIV research, affirming Black, Native Americans and other people of color (BIPOC), sex positivity, and sexual and gender minority communities that are disproportionately impacted by HIV. Stay tuned for the upcoming first episode of H=H.  
 

Congratulations to Joan Dragavon on her retirement!

Longtime HANC collaborator and University of Washington CRS Laboratory Manager Joan Dragavon announced her retirement in June, concluding a decades long career in which she made a tremendous impact on network clinical trials and HANC laboratory working groups.

Joan served as the Chair and Vice-Chair of the ACTG-IMPAACT Lab Technologists Committee (LTC), as a voting member of the Virology Quality Assurance Advisory Board, and provided invaluable support as a member of other cross-network groups including the PBMC SOP Working Group, Lab Processing Chart Working Group, Cross-Network Lab Interest Group, LTC Hepatitis Working Group, and Data Availability Reports Working Group. 

As a HANC working group and committee member, Joan played an instrumental role in the development of countless cross-network laboratory operating procedures. Her boundless knowledge on lab operations, tireless commitment to HIV research, and kind and approachable nature made her an outstanding colleague. Please join HANC in thanking and congratulating Joan on her remarkable career and wishing her a wonderful retirement. 
The ACTG issued several press releases this month announcing news about its clinical trials, including study launches, additions, and publications:
  • Findings from a substudy of REPRIEVE (A5332/A5322s) were published in the Journal of the American Medical Association Network Open (JAMA Network Open). Read more HERE.
  • The ACTG honored the 40th anniversary of the initial publication of reports of what came to be known as HIV/AIDS in CDC's Morbidity and Mortality Weekly Report on June 5, 1981. Read more HERE.
  • Two monoclonal antibodies were added to the ACTIV-2 outpatient treatment study for COVID-19 (A5401). Read more HERE
  • The ACTG launched A5386, a phase 1 HIV cure study evaluating two promising therapies. Read more HERE
 
HPTN 094 (INTEGRA) is now open to accrual. The study will investigate whether using mobile vans to deliver integrated health services can improve HIV and substance use outcomes among people with opioid use disorder (OUD) who inject drugs. HPTN 094 aims to enroll at least 25 percent women and 25 percent participants under 30 years of age. Participants enrolled in the study will be followed for one year. HPTN 094 is expected to last for approximately three and a half years. The study is sponsored by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) with funding from the U.S. National Institute on Drug Abuse (NIDA), both part of the U.S. National Institutes of Health. View Press Release.
 
What's the Difference Between HIV and COVID-19 Vaccines?
Sponsored by the HVTN, United We Rise, and BlackDoctor.org, Dr. Stephaun Wallace led a panel discussion on the community considerations regarding the differences between HIV and COVID-19 vaccines and research. The discussion took place on Thursday, May 20 at 3:30 p.m. EST in commemoration of HIV Vaccine Awareness Day and included Matthew Rose (Health GAP), Kieta Mutepfa (Community Advocate), Dr. Bisola Ojikutu (Harvard University), and special guest Dominique Jackson from Pose on FX. You can watch the recording of the session at https://tinyurl.com/4mzrfaa5.

Expanded Prevent COVID U study includes enrolling young adults beyond the university setting
The Prevent COVID U study, which launched in late March 2021 to evaluate SARS-CoV-2 infection and transmission among university students vaccinated with the Moderna COVID-19 Vaccine, has expanded beyond the university setting to enroll young adults ages 18 through 29 years and will now also include people in this age group who choose not to receive a vaccine. Learn more about this study  here.  

COVID-19 and Kids: Impacts, Uncertainties and the Role of Vaccines
Johns Hopkins University and the University of Washington are hosting their second symposium, convening clinical, scientific, regulatory and private sector leaders to discuss the effects of COVID-19 on youth and the role pediatric vaccines may play in the COVID-19 response. “COVID-19 and Kids: Impacts, Uncertainties and the Role of Vaccines" will highlight school-age children, particularly those in the 5- to 12-year-old range, and discuss the pharmaceutical and social strategies that can support kids in the collective fight against COVID-19. Click here to register.
 
2021 IMPAACT Virtual Annual Meeting
The 2021 IMPAACT Annual Meeting was held virtually 22-24 June and featured presentations from an array of speakers including:
  • Carl Dieffenbach, DAIDS Director 
  • Sharon Nachman, IMPAACT Network Chair 
  • Philippa Musoke and Patricia Flynn, IMPAACT Vice Chairs 
  • Salim Abdool Karim, Director of the Centre for the AIDS Programme of Research in South Africa (CAPRISA)
  • Karin Nielsen, Professor of Pediatrics in the Division of Infectious Diseases at UCLA Children's Hospital
  • Shahin Lockman, Associate Professor in the Department of Immunology and Infectious Diseases at the Harvard T.H. Chan School of Public Health
  • Larry Brown, Director of the Division of Child and Adolescent Psychiatry and Vice Chair of the Department of Psychiatry and Human Behavior at Brown University 
  • Lameck Chinula, Assistant Professor in the Department of Obstetrics and Gynecology’s Division of Global Women’s Health at the University of North Carolina (UNC) at Chapel Hill and a Clinical Research Site Leader at UNC Project Malawi 
  • Risa Hoffman- Associate Clinical Professor in the Division of Infectious Diseases at UCLA
  • Tapiwa Mbengeranwa, Sub-Investigator with the University of Zimbabwe Clinical Trials Research Centre 
The Annual Meeting included two days of plenary sessions and one day of scientific committee sessions for the Tuberculosis and Treatment Scientific Committees. The NICHD-affiliated sites and colleagues, as well as the IMPAACT Community Advisory Board (ICAB), met in closed meetings to discuss Network activities and updates.

Recordings of the presentations are available at IMPAACTAnnualMeeting.com.

You may also access presentation slides on the IMPAACT website at www.impaactnetwork.org/news-events/2021-impaact-virtual-annual-meeting. Presentations will be added as they become available.

IMPAACT at HIV Pediatrics Workshop 2021 and IAS 2021
The IMPAACT Network will present eight abstracts at the 2021 International Workshop on HIV Pediatrics and the IAS 2021 conference. The workshop will be held virtually from 16-17 July, and IAS will take place virtually 18-21 July, with a partner hub in Berlin, Germany.

More information will be available soon at www.impaactnetwork.org/impaact-ias-2021.

Abstracts to be presented at the Workshop on HIV Pediatrics include:
 
Abstracts to be presented at IAS 2021 include:
 
The Microbicide Trials Network is beyond excited to share that the DELIVER study of the dapivirine vaginal ring and Truvada as PrEP in pregnancy has “delivered” its first major milestone!  After completing a review of data from the first group of 150 participants, who were 8-9 months pregnant when they joined the study, the Interim Review Panel has found no safety concerns.  The study will now enroll the next group of participants who are 7-8 months pregnant. 

We offer our sincere congratulations to sites and study teams for bringing us all that much closer to HIV prevention options for all.
 
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) is tentatively planning to meet face-to-face on November 10 at the conclusion of the Adherence 2021 Conference in Orlando, FL. The BSCG is also drafting work group guidelines detailing requirements and expectations of group members. 

The Youth Prevention Research Working Group (YPRWG) hosted a webinar with Dr. Daniel Teixeira da Silva on June 11. The webinar, "COVID-19 Vaccine Acceptance Among Sexual and Gender Minority Men and Transgender Women" can be viewed here.

The COVID-19 CAB Coalition (CCC) continues to meet monthly to discuss a variety of issues, both domestic and international. On the May call, representatives from IQ Solutions, the communications agency of record for the federal COVID-19 response focused on promoting the ACTIV clinical trials for COVID-19 treatments, joined the call to discuss their work. IQ Solutions highlighted the  Combat COVID website which is a cornerstone of their communications effort. 
 
Community Partners

Russell Campbell, HANC Deputy Director
June 26: Community Partners facilitated a call with the ATN-YEAH and Soweto Youth CAB members to discuss collaboration ideas around addressing the global needs of youth in HIV/AIDS and TB research.

Community Partners is working on v 2.0 of a cross-network DRAFT “How to Read A Protocol” document to assist CAB and community members in the protocol review process. Community Partners is also in the process of finalizing its Organizational Guidelines.

TBTC CRAG representatives will join the Community Partners July call to provide an update on CRAG and community engagement activities.
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Data Management Center Working Group (DMCWG) discussed ongoing efforts related to bidirectional safety data reconciliation, use of eAdjudication in network studies, and application of the Representative Studies Rubric, a tool to gather data on the inclusion of underrepresented populations developed by the Legacy Project, in network clinical trials.

The DAIDS Electronic Information Systems (EIS) Policy Trainings have concluded, with the third and last session occurring on June 29. Recordings from the training sessions are posted on the HANC website under the DAIDS Resources section. Presentation slides and links to other DAIDS resources for the EIS policy are also provided on the HANC website.

DAIDS OPCRO recently announced the following changes to policies:
In addition, DAIDS OCSO announced minor updates to the DAIDS SCORE Manual Sections relating to Quality Management, Pharmacy Requirements, and Laboratory Requirements. The memo was distributed to network leadership and operations centers and is also posted on the HANC website under DAIDS Resources, OCSO Resources. Direct link here.

The DAIDS Office for Clinical Site Oversight (OCSO) Monitoring and Operations Branch (MOB) recently published a new FAQ for remote source document verification (rSDV). This rSDV FAQ is posted on the HANC website's DAIDS Resources page under the Remote Monitoring and Source Document Verification section.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
The Lab Focus Group (LFG) met in June to discuss the DAIDS Electronic Information Systems Policy requirements for electronic lab systems, and implementation of the new Electronic EQA Investigation Report System, which was launched by pSMILE on June 8th.

The ACTG/IMPAACT Lab Technologists Committee (LTC) held two meeting sessions at the Virtual Annual ACTG Network Meeting. Both sessions focused on laboratory audit preparedness, and included a presentation by DAIDS Clinical Laboratory Operations Team (DCLOT) that discussed the DAIDS laboratory oversight framework and updates included in GCLP Guidelines version 4.1.

The CPQA Cross-Network Clinical Pharmacology Forum (CNCPL Forum) held a call in June featuring a webinar presentation by Howard Gutzman, Lab Data Management System Program Director, which discussed the addition of PK features to Web LDMS. Frontier Science aims to start migrating pharmacology labs to the web LDMS application in the second half of 2021.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
June 25: Russell Campbell, Christopher Hucks-Ortiz, and Dr. Kenric Ware represented the Legacy Project during the launch of the Human Rights Campaign (HRC) Foundation’s Historically Black Colleges and Universities (HBCU) Health Center Directory. The directory was created in partnership with the Black AIDS Institute and the Legacy Project, and supported by Gilead Sciences. This comprehensive guide identifies gaps in service delivery, catalogues existing services and assists with facilitation/linkage to HIV prevention and treatment services for Black college-age students at HBCUs.
 

June 25: Legacy submitted four abstracts to the US Conference on HIV/AIDS:
  • “It’s About Time: HIV Research Just for Transgender Women” submitted in collaboration with the DAIDS Cross-Network Transgender Working Group.
  • “Applying Community-Based Participatory Research to address American Indians and Alaska Natives health needs” submitted in collaboration with the Urban Indian Health Institute.
  • “Community Response to COVID-19 in Latinx Communities in the United States” submitted to “Track en Español” in collaboration with George Washington University, TransLatin@ Coalition, the Latino Commission on AIDS, AIDS Alabama, and Columbia University CRS.
  • “Stakeholder-driven approach to improving HIV PrEP awareness among university students” submitted as part of Legacy’s HBCU engagement efforts.
Abstract notifications will be sent on August 6th. 

 

The 2021 RAMP enrolled 11 scholars in its 2021 cohort 
The HIV Vaccine Trials Network Research and Mentoring Program (RAMP) enrolled 11 African American and Latinx medical students in its 2021 cohort.  RAMP Scholars conduct research projects in areas of basic, clinical, behavioral, laboratory and social science related to the HVTN scientific agenda. Check the 2021 scholar profiles here

Applications for 2020-2021 are now closed. Please check the site in the Fall of 2021 for information on the next round of applications, or email Linda Oseso, RAMP Program Manager (loseso@fredhutch.org) to be notified when applications are open.
A new observational study has begun to evaluate the immune responses generated by COVID-19 vaccines administered to pregnant or postpartum people. Researchers will measure the development and durability of antibodies against SARS-CoV-2, the virus that causes COVID-19, in people vaccinated during pregnancy or the first two postpartum months. Researchers also will assess vaccine safety and evaluate the transfer of vaccine-induced antibodies to infants across the placenta and through breast milk.

The study, called MOMI-VAX, is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. MOMI-VAX is conducted by the NIAID-funded Infectious Diseases Clinical Research Consortium (IDCRC). Read the full news release here.
The National Institutes of Health has started a Phase 1/2 clinical trial in which adult volunteers who have been fully vaccinated against COVID-19 will receive booster doses of different COVID-19 vaccines to determine the safety and immunogenicity of mixed boosted regimens. The National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, is leading and funding the study through the Infectious Diseases Clinical Research Consortium, a clinical trials network that encompasses the Institute’s long-standing Vaccine and Treatment Evaluation Units (VTEUs). Read the full news release here.
 

Upcoming Webinars

July 28, 2021 at 7:00am PT / 10:00am ET      
The HIV Prevention Trials Network (HPTN) Leadership will present their research priorities and goals for the next seven years and highlight how community will be engaged as part of their priorities. This is an excellent opportunity for community to engage and ask questions. Register here.
 

Conferences & Meetings

July 16-17, 2021
July 18-21, 2021
11th IAS Conference on HIV Science (Virtual with local partner hub in Berlin, Germany)
October 18-20, 2021
2021 HVTN Conference (Seattle, WA USA)
October 20-22, 2021
October 28-31, 2021
US Conference on HIV/AIDS (Washington, DC USA)
November 7-9, 2021
Adherence 2021 (Orlando, FL USA)
 

Publication Highlights

Hoffmann et al

Viljoen et al

MacBrayne et al

Libous et al

Celum et al