HANC Newsletter  |  May 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.

Announcement of Jeffrey Schouten's Retirement as HANC Director

Jeffrey Schouten has announced his plan to retire as HANC Director effective June 30, 2022. Under Jeff’s leadership, starting in September 2008, HANC has expanded significantly with the addition of the behavioral and social sciences area of coordination, the site coordinator’s work group, the Legacy Project shifting from the HVTN to HANC and collaborating across all the Networks and expanded collaborations and enhanced support to DAIDS’ OSCO and OPCRO leadership among other programs. Jeff is very grateful to the dedicated, superb HANC staff who have made all this work possible over the past 14 years, and in particular to HANC Deputy Director Russell Campbell, who has been with HANC even longer than Jeff. The search for the next HANC Director will be led by the Network Leadership Group (Network PIs). The job announcement will be posted soon on the HANC website.

Jeff will continue to perform high resolution anoscopy for the University of Washington (UW) at Harborview Medical Center at 30% effort and do research procedural biopsies for ACTG’s UW Positive Research (formerly the UW AIDS Clinical Trials Unit).
 
 

H=H Episode 6: Latinx & HIV

Episode 6: Latinx & HIV reports on the 2022 Latinx Conference on HIV/HCV/SUD that took place on March 20-26 in Albuquerque, New Mexico. This episode includes an interview with conference director, Pedro Coronado, and features three sessions/workshops that include one on Language Justice, one on how to address HIV health care providers training during the COVID-19 epidemic, and the presentation of the National Hispanic/Latinx Health Policy Agenda 2022-2024 produced by the Latino Commission on AIDS.

Your opinion matters. H=H was launched on November 1, 2021, and 6 episodes have been produced and aired since then.  We would like to ask your opinion about the H=H podcast  to help us improve the production of future episodes by answering five questions.  To share your opinion, please click here
 
Join us in recognizing the following HIV/AIDS Awareness Days this month:

May 18: HIV Vaccine Awareness Day

This day is a chance to thank the volunteers, community members, health professionals, and scientists working together to find a safe and effective preventive HIV vaccine. It is also a time to educate communities about the importance of preventive HIV vaccine research.
 

May 19: National Asian & Pacific Islander HIV/AIDS Awareness Day

Founded by the Banyan Tree Project, NAPIHAAD educates the public about the impact of HIV stigma among Asian and Pacific Islander people.
The ACTG May newsletter is now available here: https://bit.ly/3s5oXOt

Last month, the ACTG announced the initiation of study A5383, a clinical trial evaluating whether the anti- cytomegalovirus (CMV) drug letermovir reduces inflammation when given to people who have well-controlled HIV and CMV without symptoms. Congratulations to the study team! Read more here.
 
The 2022 HPTN Annual Meeting will bring together hundreds of researchers, collaborators, community representatives, and government health officials to engage in meaningful discussions regarding the Network’s scientific agenda and current and planned studies. The Annual Meeting features several plenaries, presentations, discussions regarding HIV and COVID-19 prevention research, and interactive question and answer sessions. Study-specific protocol team meetings are also planned. To mitigate COVID-19 risks and reduce crowding in small meeting rooms, we ask that you only attend protocol team meetings for which you are a study team member.
All in-person participants must be fully vaccinated following the U.S. Centers for Disease Control and Prevention (CDC) guidelines and will be required to share proof of vaccination as part of the registration process. If not fully vaccinated, you may register as a virtual attendee and change your registration to in-person once fully vaccinated. All in-person attendees must get tested for COVID-19 the day before arrival in Washington, D.C., and during the Annual Meeting. All in-person meeting spaces require masking. COVID-19 rapid tests and masks will be available for all in-person attendees.
 
Visit the 2022 HPTN Annual Meeting page to access additional meeting details and links to the current CDC COVID-19 vaccines and travel guidelines.  
 
To reserve lodging at the JW Marriott, click here. A limited number of guest rooms are available, so book your room as soon as possible.
 
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 P1093 Data Supports the Use of Dolutegravir Dispersible Tablets for Infants and Children Aged Less than 6 Years Living with HIV
IMPAACT P1093 recently published results in the Lancet HIV based on the 48-week follow-up data for participants who are four weeks to six years old taking the dolutegravir dispersible tablet formulation, contributing to a dramatic change in the landscape for treatment of children living with HIV. IMPAACT P1093 is a Phase I/II multicenter, open-label, non-comparative clinical trial to evaluate the pharmacokinetics, safety, tolerability, and antiviral activity of dolutegravir to treat infants, young children and adolescents living with HIV-1 infection. The results from the six- to 18-year-old populations have been previously reported and were essential for dolutegravir regulatory approval by the FDA and EMA previously.

P1093 is being conducted at 26 sites across Africa, North America, South America, and Asia. Learn more about IMPAACT P1093 here.

IMPAACT 2009 Now Enrolling Into PrEP Comparison Component
IMPAACT 2009, a study of the feasibility, acceptability, and safety of oral pre-exposure prophylaxis (PrEP) during pregnancy and postpartum, is now enrolling into the PrEP Comparison Component. Participants will be enrolled prior to 32 weeks’ gestation in two cohorts: those who agree to initiate PrEP (Cohort 1) and those who decline (Cohort 2). Infants will be enrolled in utero at the same. 

Congratulations to the Shandukani Clinical Research Site for enrolling the first participant into the PrEP Comparison Component. The study is taking place at 7 sites in Malawi, South Africa, Uganda, and Zimbabwe. Learn more about IMPAACT 2009 here.

IMPAACT 2021 Resumed Enrollment
IMPAACT 2021, a respiratory syncytial virus (RSV) vaccine study to assess safety and immunogenicity of live-attenuated RSV vaccine candidates, has resumed enrollment as of 1 April 2022. This study is enrolling RSV-seronegative infants and children 6 to 24 months of age. Learn more about IMPAACT 2021 here.
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 (CCC) recently changed the frequency of the work group meetings. Previously, the group met monthly, but it has decided to meet bi-monthly. The next work group meeting will be at the end of May. An ad-hoc work group of the CCC has finalized five scripts on understanding science that will be used to create whiteboard videos. The group is currently obtaining quotes for video creation.
New variants and subvariants continue to develop
According to the latest data from the CDC, the estimated number of cases linked to the BA.2 subvariant was said to be at 68%, which was actually a decrease from a week prior. Cases of the BA.2.12.1 subvariant, BA.2's own subvariant, rose 9% in the U.S. over a week-long period, as shown by CDC estimates. Learn more here
Fifth COVID-19 Wave in South Africa
South Africa may be entering a fifth COVID wave earlier than expected after a sustained rise in infections over the past 14 days that seems to be driven by the BA.4 and BA.5 Omicron sub-variants, health officials and scientists said. The country that has recorded the most coronavirus cases and deaths on the African continent only exited a fourth wave around January and had predicted a fifth wave could start in May or June, early in the southern hemisphere winter.” Read more.
JHU Coronavirus Resource Center
Johns Hopkins University has created a Coronavirus Resource Center. Find the latest news, numbers, and data visualizations in the JHU CRC.
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) continues to discuss next steps from the groups face-to-face meeting that was held in March. Several BSCG members will be presenting on various social and behavioral science topics at the upcoming Network annual meetings.

The Financial Disclosure Working Group will meet in May to finalize the SOP for the 2022 annual solicitation in September.

As noted in the previous newsletter, the Youth Prevention Research Working Group published the report from its 2021 site survey. The co-chairs plan to attend an upcoming Network Leadership call to discuss the key findings and recommendations from the survey.
 
Community Partners

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

Community Partners is in the process of determining whether members are available to attend a CP Face-to-Face Meeting later this year.
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
In March 2022, HANC hosted a two-part webinar series exploring the regulatory foundations and implementation of electronic informed consent in clinical trials. The recordings and slides from both webinars are now available on the HANC Webinars & Presentations page. In addition, an  extended Q&A recording has been added for Part 2, eConsent in Practice: Perspectives from Sites. The Q&A addresses questions including how each site verified participant ID, what conditions were needed to implement eConsent, and what support is needed to integrate eConsent more broadly into HIV/AIDS clinical trials. 

The Cross-Network Data Management Center Working Group (DMCWG) met to discuss clinical data management training collaboration, ongoing efforts related to electronic trial master files and remote source data verification, and assessment methods for toxicity grading.

Representatives from the Division of AIDS (DAIDS) joined the April Cross-Network Site Coordinators Working Group (SCWG) meeting to address concerns related to site staff morale and fatigue resulting from the pandemic. The group discussed the context for each issue and proposed solutions to alleviate problems within sponsor and site control.  

The Cross-Network Protocol Deviation Working Group (PDWG) continues to move forward with implementation of a cross-network eCRF for protocol deviations in new network studies. This new process introduces a common definition for protocol deviations, using the terms minor, major, and critical to classify protocol deviation severity; and a new protocol deviation eCRF to capture and report major and critical protocol deviations. The Network Data Management Center staff will be following up with relevant protocol teams and clinical research sites regarding additional guidance and training on the protocol deviation eCRF process.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
Announcement: In April DAIDS released a shortened version of the DAIDS Good Clinical Laboratory Practice (GCLP) eLearning course that addresses basic principles of GCLP. The new course 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 HANC-CPQA Qualitative Assay Working Group met in April to continue drafting new guidelines focused on the testing and validation of qualitative ARV pharmacology assays. These guidelines are expected to be published within the next several months.

The CPQA Cross-Network Clinical Pharmacology Forum (CNCPL Forum) held a meeting in April to discuss transitioning the CPQA’s proficiency testing acceptance window from 20% to 15%. This meeting included a presentation by Dr. Susan L. Rosenkranz (of the Statistical and Data Analysis Center) describing the background and rationale for this proposed change. 

The Lab Focus Group (LFG) held a meeting in April to continue developing guidance materials aimed at mitigating lab supply and reagent shortages. These materials are being developed in collaboration with DAIDS, and are expected to be accessible on hanc.info for public access this month. 

The CPQA Advisory Board (CPQAAB) met in April to discuss and seek feedback from AB members on current CPQA Program activities. The meeting featured a virtual presentation by Robert L Murphy, MD (of Northwestern University) on drug development for the treatment & cure of hepatitis B. 
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
April 20 - 21: The Legacy Project had a very successful Biomedical HIV Prevention Summit in Chicago and received great feedback on our workshops:
  • No Data No More: Manifesto Aligns HIV Prevention Research with Transgender and Gender Diverse Realities (40 attendees)
  • Role of Pharmacists along the HIV prevention continuum (40 attendees) 
  • Long-Acting Antiretroviral Injectables and Broadly Neutralizing Antibodies - What’s New? (94 attendees)
  • Addressing “Addictophobia” to Engage MSM Who Use Drugs in PrEP (90 attendees)

April 27 - 29: Russell Campbell attended and presented the HPR Module as part of the Duke CFAR Diversity, Equity, and Inclusion Pipeline Initiative (CDEIPI) at South University. The program is entitled: Evidence2Practice (E2P) and it focuses on leveraging implementation science to recruit HBCU/MSI students into careers in HIV research. E2P is an intensive on-campus workshop-based initiative, anchored by the HPR Module, with the goal of increasing student interest in careers in HIV science, through providing an experience-based introduction to implementation science.

May 1: Episode 6 of H=H, the H is for Human reports on the 2022 National Latinx Conference on HIV/HCV/SUD featuring three presentations including Language Justice, addressing HIV health care providers training during the COVID-19 epidemic and the National Hispanic/Latinx Health Policy Agenda 2022-2024 produced by the Latino Commission on AIDS.  

May 5: Brian Minalga interviewed two HVTN/CoVPN scientists as part of a community-focused video/social media series spotlighting the more human side of researchers. Stay tuned for more information on when and where you can access the series!

May 8 - 10: Brian Minalga is participating in the Stigma and Disparities subcommittee meeting of the President’s Advisory Council on HIV/AIDS (PACHA) in Atlanta, GA. Brian was invited to join this meeting focused on community engagement issues surrounding molecular HIV surveillance and HIV cluster detection and response.

May 10: Russell Campbell and Rona Siskind will present on the Representative Studies Rubric (RSR) at the Community Research Advisors Group meeting of the Tuberculosis Trials Consortium. 

May 12: Brian Minalga will participate in the ACTG’s Underrepresented Populations Committee meeting to offer perspectives on using affirming language in research.

May 18: The Legacy Project recognizes National HIV Vaccine Awareness Day!

May 19: The Legacy Project recognizes National Asian & Pacific Islander HIV/AIDS Awareness Day!

May 20: Submissions from the HPTN and HVTN are due to Brian Minalga for inclusion in the June 2022 Be the Generation newsletter.

New Investigators Working Group
The HVTN Scientific Leadership Development Program has a goal of identifying emerging scientific leaders in the field and committing resources to their professional development. The inaugural cohort of SLD awardees has been selected for a year-long mentored project starting in 2022. Each awardee will develop a project leading to a scientific manuscript, as well as forming a mentorship team and working on career development and leadership skills. 

H=H, the H is for Human podcast.  Your opinion matters 
H=H was launched on November 1, 2021, and 6 episodes have been produced and aired since then. We would like to ask your opinion about the H=H podcast  to help us improve the production of future episodes.  Click here and let us know what you think. Thank you for your feedback.  
 

Trainings

The DAIDS Good Clinical Laboratory Practice (GCLP) Primer eLearning course is now available on the DAIDS Learning Portal. This abbreviated course is comprised of 2 modules that cover GCLP topics and will help to provide an introduction to GCLP and their relationship to clinical research. They are intended for study nurses and other non-lab staff at international sites, who perform specimen processing and/or testing in the clinic or clinical laboratory and are participating in DAIDS-supported and/or sponsored clinical trials. Please note that this primer course is an abridged GCLP course addressing only basic principles of GCLP. For an in-depth knowledge of GCLP processes, trainees should refer to the main GCLP course, and the DAIDS Good Clinical Laboratory Practices Guidelines. To get started click here.

The DLP is available to site staff and affiliated groups working with the Division of AIDS. If you do not already have an account, click on the Log In button at the top right of the screen then the Create New Account button on the right. Fill out the online form and make sure to include your site ID number (a 2-5 digit number created by DAIDS when the grant was awarded). To confirm the ID number, please contact site PI or the site Program Officer.

If you have any questions about the course or access to the DLP, please send an email to our Help Desk.
 

Webinars

May 10, June 14, July 12, 2022
Building Indigenuity, Generating HIV Science: HIV/AIDS Research Training (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 ways the epidemic impacts Indigenous communities across North America. The series will feature scientists and practitioners working across the spectrum of HIV science, including former scholars from the Indigenous HIV/AIDS Research Training Program (IHART). 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.

Join the BIG-HART listserv to stay up to date on all BIG HART activities and register for the webinars now.
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.
 

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)