HANC Newsletter  |  June 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.

Recruitment for next HANC Director

The Office of HIV/AIDS Network Coordination (HANC) is recruiting for its next HANC Director. The HANC Director is responsible for managing and supervising all aspects of the activities of HANC, and reports to the principal investigators of the four NIH-funded HIV/AIDS Clinical Trial Networks and the Director of the Division of DAIDS at NIAID. View more details and apply on the Fred Hutch Careers page. 
 
Join us in recognizing the following HIV/AIDS Awareness Days this month:

June 5: HIV Long-Term Survivors Awareness Day

HIV Long-Term Survivors Awareness Day (HLTSAD) honors long-term survivors of the epidemic and raises awareness of their needs, issues and journeys. The 2022 theme is "Mobilize to Thrive"

June 8: National Caribbean American HIV/AIDS Awareness Day

The goal of the annual observance is to educate Caribbean-Americans about HIV/AIDS and provide resources for HIV testing and treatment.
ACTG Newsletter - June 2022: The June newsletter featured two pieces in honor of HIV Long Term Survivors Awareness Day (June 5), written by ACTG investigators and community members. Two recent publications were featured this month from DR054 and A5341s. Our spotlights this month featured Katharina Bar, MD from Penn Therapeutics, the Chapel Hill CRS, and CAB member, Charles Adams.
 
We are looking forward to a successful meeting using a hybrid format this year. To provide a safe environment for all in-person attendees, we have developed the following protocols to help reduce the risk of getting COVID-19: 
  1. Face masks must always be worn within indoor meeting spaces and meeting rooms. Cloth masks will not be permitted. We will have a variety of CDC-recommended masks available, including KN95 and surgical. You may also bring your own non-cloth mask. 
  2. Eating will not be permitted in plenary or meeting rooms to minimize close contact without masks. Designated eating areas will be clearly marked.
  3. Attendees should test for COVID-19 (PCR or rapid) the day before arriving at the JW Marriott hotel and every morning while attending the meeting.
  4. Attendees will receive COVID-19 rapid test kits at check-in to perform daily testing. Testing should be done at home or in your hotel room before attending any meeting events. Designated testing space is available at the JW Marriott for attendees not staying at the hotel who need a test kit upon arrival.
  5. Attendees will receive a website link each morning at 6 a.m. (EST) to submit daily test results and self-assessments. 
  6. If you have any COVID-19-like symptoms or test positive, medical staff will be available to provide guidance and support (contact details will be provided at check-in).
  7. Seek immediate emergency medical care (dial 911) if you experience any life-threatening COVID-19 symptoms such as trouble breathing, pain or pressure in the chest, or the inability to stay awake.
  8. HPTN Annual Meeting staff will assist any attendee(s) who must quarantine at the JW Marriott while attending the meeting.
  9. Check with your insurance provider (medical or travel) that you are covered if you get sick during the meeting.
  10. Reconfirm whether your COVID-19 vaccine is accepted to enter the U.S. 
  11. Consider your health status before traveling.
Visit the 2022 HPTN Annual Meeting page to access additional meeting details and links to the current CDC COVID-19 vaccines and travel guidelines.
 
HVTN RAMP Scholar Program
This year we accepted 9 scholars for the 2022-2023 general RAMP scholar program Cohort 12!

2022 also marks the launch of the RAMP Scholar Alumni Program, with three scholars serving as returning alumni.

This coming year the RAMP program will also be expanding to invest in African American/Black, Hispanic/Latinx, Native American/American Indian, Native Hawaiian, Asian and Pacific Islander medical students interested in HIV vaccine research. The HIV Vaccine Trials Network, in collaboration with the National Institute of Allergy and Infectious Diseases of the National Institutes of Health, is investing in a young generation of HIV prevention researchers by providing them with opportunities to conduct independent research while receiving mentoring, project and salary funding, training, and professional development opportunities. Scholars will be working on their projects with sites in the US: New York & Seattle, South Africa: Soshanguve and Zimbabwe: Harare.

For more information please visit www.hvtn.org/ramp or contact Linda Oseso, RAMP Program Manager, at loseso@fredhutch.org.

HelpEndHIV.org
In recognition of National HIV Vaccine Awareness Day, May 18, the HVTN launched its Red Ribbon Registry which enables volunteers across the US to join a community of individuals ready help end HIV through the discovery of a preventive HIV vaccine.

On the website, HelpEndHIV.org, volunteers can learn about HIV and progress in vaccine research. Those who are interested in joining a study can complete a survey to join the Red Ribbon Registry, enabling them and sign up to be contacted by clinical research sites about studies in their area for which they could be a good fit.

The fight against HIV has progressed thanks to long-standing collaboration between researchers and community members. With the Red Ribbon Registry and our national advertising campaign, we continue to invite a new generation of community members into the process as important partners in the advancement of science and the ending of suffering and death from HIV-related illnesses.
 
IMPAACT Annual Meeting
The 2022 IMPAACT Annual Meeting will take place as a hybrid conference to include both virtual and in-person participation from 28 June - 1 July 2022. The in-person component will be hosted at the Washington Hilton Hotel in Washington, D.C., USA. All participants attending in-person must be fully vaccinated in accordance with the U.S. Centers for Disease Control and Prevention (CDC) guidelines.

More information, including a registration link, can be found on the Annual Meeting website.

IMPAACT 2032 and IMPAACT 2014 Completed Follow-Up
Two IMPAACT studies have recently completed follow up.
  • IMPAACT 2032 was a Phase IV pharmacokinetic (PK) study of remdesivir in pregnant and non-pregnant women of childbearing potential for treatment of COVID-19. The study was designed to describe the PK of remdesivir, and the safety outcomes through four weeks after the last administration of remdesivir and, for pregnant women, during delivery. IMPAACT 2032 took place at 10 sites in the United States. The study completed follow-up on 13 April 2022. Learn more about IMPAACT 2032 here .
  • IMPAACT 2014 was a Phase I/II open-label PK and safety study of doravirine (Pifeltro) and doravirine/lamivudine/tenofovir disoproxil fumarate (Delstrigo) in adolescents living with HIV. The study was designed to evaluate the PK of doravirine and evaluate the safety and tolerability in adolescents over 96 weeks. IMPAACT 2014 took place at 8 sites in Thailand, South Africa, and the United States. The study completed follow-up on 25 May 2022. Learn more about IMPAACT 2014 here.
Congratulations to both protocol teams and all the sites for successfully completing these important studies. 
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 spent the first half of the year drafting scripts on understanding science. The group hopes to have the scripts developed into brief videos. They are currently waiting for quotes from several video production companies before determining next steps.
Cape Town | As South Africa is in the midst of the fifth wave of COVID-19 infections, the Sisonke Study team are once again rising to the challenge to help bolster efforts to mitigate the effects. 

Canada on Wednesday authorized a single booster shot of Pfizer and partner BioNTech's COVID-19 vaccine for 16- and 17-year-olds. Regulator Health Canada had cleared an extra dose of the vaccine for people 18 and older in November last year. The booster is meant to be administered six months after the primary two-dose series.

The decision was based on data from two studies of the booster shot among individuals 16 and older. The agency said potential risks of inflammatory heart conditions, myocarditis or pericarditis, have been included in the shot's label.
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The co-chairs of the Youth Prevention Research Working Group (YPRWG) are planning to join the June Network Leadership call to present on the responses to the YPRWG site survey that occurred in 2021. You can review the 2021 site survey report and recommendations here.

The Financial Disclosure Working Group finalized the SOP for the 2022 annual solicitation. The annual solicitation is scheduled to occur on September 21, 2022.

During the May meeting, the Behavioral Science Consultative Group was joined by HVTN’s RAMP Scholar Program to review the program and discuss how  the program is being evaluated. The BSCG also reviewed slides and a presentation by BSCG Co-chair, Jane Simoni, who will be presenting on social and behavioral science issues at the upcoming ACTG Annual Meeting.
 
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners representatives will be presenting to the ACTG, IMPAACT and HPTN GCABs to highlight the role of CP and the various community engagement resources developed to assist CABs.

Community Partners decided to postpose hosting  a face-to-face meeting later this year.

On June 6th, Russell Campbell and Rona Siskind will represent Community Partners as part of a new community engagement initiative: ULACNet Initiative tEnhance Community Dialogue (UNITED). The objectives of UNITED 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 
The goals of the effort are to enhance the research quality, to share with ULACNet members knowledge and lessons learned on effective strategies for enhancing recruitment and community engagement, to ensure that research outcomes and benefits are shared with the community, and to build a shared trust between researchers and the community. 
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Site Coordinators Working Group (SCWG) discussed the development of several resources to support clinical research sites, including a site-populated repository of SOPs and other key documents and start-up checklists for new site coordinators or research sites.

The Cross-Network Evaluation Working Group (EWG) began an effort to review network evaluation metrics used to assess site performance and harmonize key metrics across the networks. This effort will be ongoing through June 2023.

New Resource: Upcoming DAIDS Deadlines webpage
A new webpage, Upcoming DAIDS Deadlines, was added to the HANC website. The Upcoming DAIDS Deadlines page summarizes deadlines related to DAIDS requirements and new initiatives, and is intended as a resource for clinical research sites. Find the page by navigating to Resources > DAIDS and selecting the button to "View Upcoming DAIDS Deadlines". This page will be updated as new requirements are released.

DAIDS Memo: Minor Updates to SCORE Manual
A memo from the DAIDS Office of Clinical Site Oversight (OCSO) notes minor updates to the Site Clinical Operations and Research Essentials (SCORE) Manual. These updates affect the following sections: Investigator Responsibilities, Essential Documents, Essential Documents Recordkeeping Appendix, CRS Facility Requirements, Site Activation Process, Source Documentation Requirements Appendix, and Record Retention.

Updated DAIDS Protocol/Sample Informed Consent Template - General Use
A new version of the DAIDS Protocol/Sample Informed Consent Template - General Use is now available on the NIAID website. The template was updated to 1) Ensure consistency with the revised Common Rule, related policies, and best practices 2) Address data-sharing issues, including what type of information may be shared and with whom, and related country-specific consent requirements 3) Include co-enrollment prevention/age and identity verification process information (see the SCORE Manual). This template is intended to be used as a tool to the Requirements for Informed Consent Forms policy.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
Sikhulile Moyo Named One of Time Magazine’s 100 Most Influential People for 2022
Laboratory Technologists Committee (LTC) member Dr. Sikhulile Moyo, whose team at the Botswana Harvard HIV Reference Laboratory helped alert the world about the existence of the Omicron variant, has been named one of TIME magazine’s 100 most influential people of 2022. Congratulations, Sikhulile!
 
 
Availability of Updated Laboratory Policies and Destruction of Specimens SOP
In May the DAIDS Office for Policy in Clinical Research Operations (OPCRO) announced the availability of three updated DAIDS Clinical Laboratory Oversight Team (DCLOT) policies (Requirements for Laboratories Performing Testing for DAIDS-Supported and/or Sponsored Clinical Trials, Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for U.S. Laboratories, and Guidance to Investigators Participating in DAIDS-Sponsored Clinical Trials-Requirements for Non-U.S. Laboratories) and one updated SOP (Destruction of Clinical Research Specimens Owned by NIAID/DAIDS). You can access the 3 policies and 1 SOP on the NIAD website here.

Reminder: In April DAIDS released a shortened version of the DAIDS Good Clinical Laboratory Practice (GCLP) eLearning course. This new course addresses basic principles of GCLP and is designed for non-lab staff (including study nurses) at non-US sites who perform specimen processing and/or testing in a clinic or clinical laboratory. The course takes approximately 1.5 hours to complete. To get started, click here.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
June 1: The Pride edition of the Be the Generation newsletter is now available! Check it out for the latest in biomedical HIV prevention research from the HPTN, HVTN, and HANC. You’ll find it at the bottom of the Be the Generation homepage.

June 5: The Legacy Project recognizes HIV Long-Term Survivors Awareness Day.

June 8: The Legacy Project recognizes National Caribbean American HIV/AIDS Awareness Day.

June 19: The Legacy Project recognizes Juneteenth.

New Investigators Working Group
HVTN Scientific Leadership Development 2022 Awardees
Dr. Gallardo-Cartagena, MD is a junior investigator at the Centro de Investigaciones Tecnológicas, Biomédicas y Medioambientales (CITBM) at Universidad Nacional Mayor de San Marcos (UNMSM) in Lima, Peru. He joined the PERU CTU as a study physician for HVTN trials. In 2018, he was promoted as HVTN Clinic Coordinator responsible for the HVTN 704/HPTN 085 (AMP) study. In 2019, he became Investigator of Record of HVTN706 (MOSAICO) and CoVPN3003 (ENSEMBLE). He is a member of the HVTN Network Evaluating Committee.  Additionally, he is a consulting investigator of the HVTN 804/HPTN 095 Protocol Team.

H=H, the H is for Human podcast.  Your opinion matters 
H=H, the podcast that centers on the Human in HIV" was launched on November 1, 2021, and 6 episodes have aired since then. Please take three minutes to share your opinions and help us produce future episodes:
 

Training

June 14 and July 12, 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.  
 

Job Opportunities

ACTG/IMPAACT Laboratory Center Positions
The Laboratory Center at UCLA is seeking highly motivated, detail-oriented individuals with clinical trials project management experience to assist in laboratory specific regulatory support and oversight of ACTG and IMPAACT clinical trials.  If this is you, please send a copy of your CV to kferbas@milabcentral.org.
The Office of HIV/AIDS Network Coordination (HANC) is recruiting for its next HANC Director. The HANC Director is responsible for managing and supervising all aspects of the activities of HANC, and reports to the principal investigators of the four NIH-funded HIV/AIDS Clinical Trial Networks and the Director of the Division of DAIDS at NIAID. View more details and apply on the Fred Hutch Careers page
 

Conferences & Meetings

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)
July 27-28, 2022
July 29-August 2, 2022
International AIDS Conference (Hybrid: Montreal, Canada)