TABLE OF CONTENTS
HANC ANNOUNCEMENTS
NETWORK ANNOUNCEMENTS
HANC PROGRAM UPDATES
CONFERENCES AND MEETINGS
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Updated NIAID HIV Language Guide
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The continued use of language known to be offensive and stigmatizing is insensitive and disrespectful; it can alienate the very people we want to engage and the communities in which we work.
The NIAID HIV Language Guide is a means to advance the use of person-first, inclusive, and respectful language.
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NIAID is fully committed to encouraging the use of person-first, non-stigmatizing language in all our communications, and we anticipate that you, as our research partners and collaborators, will embrace these efforts as well. With the issuance of this revision to our language guide, we are embarking on a campaign to educate and strongly advocate for its use in all communications, including but not limited to grant applications, contracts, publications, presentations, abstracts, and press materials.
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Community & Stakeholder Input to Inform
the Future of HIV Research Webinar
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Every seven years, the National Institutes of Health (NIH) engages in a process that will help determine the focus and priorities of its global HIV clinical trials research networks. As part of this “network competition,” the NIH reviews the structure and funding of its HIV clinical research networks. A critical part of this process involves community and stakeholder input to help inform future research priorities.
The Office of HIV/AIDS Network Coordination (HANC) hosted conversations with Dr. Carl Dieffenbach, Director of the Division of AIDS (DAIDS) at the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) about the future of global HIV research.
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Dr. Dieffenbach led a robust discussion with topics ranging from structural issues, HIV cure-related research, HIV prevention, aging on ART, funding, the future of bnABs, participant inclusion (specifically PLWH with active alcohol or drug use or pregnant or lactating), and how the Representative Studies Rubric (RSR) addresses questions of representation in terms of age, ethnicity, gender, injection drug use, pregnancy, race, and sex assigned at birth. Watch the full recording for the in-depth conversation.
Stay tuned for future webinars - conversations, with Dr. Carl Dieffenbach.
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ACTG SLIM LIVER Findings Published in Annals of Internal Medicine
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LOS ANGELES, May 10, 2024 (GLOBE NEWSWIRE) -- ACTG, a global clinical trials network focused on HIV and other infectious diseases, today announced the publication of results from SLIM LIVER (also known as A5371) in the Annals of Internal Medicine. “The Effect of Open-Label Semaglutide on Metabolic Dysfunction–Associated Steatotic Liver Disease in People With HIV” demonstrates that semaglutide was highly effective in improving, and in some cases, resolving completely, metabolic dysfunction-associated steatotic liver disease (MASLD, formerly known as non-alcoholic fatty liver disease) among people living with HIV.
SLIM LIVER was the first study evaluating semaglutide as a treatment for MASLD among people living with HIV. MASLD is common among people living with HIV and likely acts synergistically with HIV to accelerate liver injury and organ dysfunction. Semaglutide is a glucagon-like peptide-1 receptor agonist that has been associated with cardiometabolic improvements in the general population through its effects on weight reduction and systemic inflammation.
SLIM LIVER was a phase 2b single-arm, pilot study that enrolled adults living with HIV who were virally suppressed and had central adiposity (increased waist circumference), insulin resistance or pre-diabetes, and steatotic liver disease. All participants received semaglutide for 24 weeks (titrated to 1 mg, dosed subcutaneously every week, by week four). Participants experienced significant improvements in their weight, waist circumference, fasting glucose, BMI, hemoglobin A1C (a blood test that shows the glucose level over a period of three months), ALT (a liver enzyme that can become elevated when liver damage is present), and triglyceride concentrations.
Read the full press release HERE.
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Participant Follow-up Completed in Two IMPAACT Studies
Participant follow-up was successfully completed in IMPAACT 2009 as of 24 February 2024. IMPAACT 2009
was a parallel, observational cohort study of pregnant adolescents and young women (aged 16-24) without HIV. The study was designed to characterize adherence over time among women who initiate once daily oral PrEP during pregnancy and continue in the first 6 months following delivery, and to compare pregnancy outcomes among women who take PrEP and women who decline PrEP during the antenatal period. The study was implemented across eight sites in Malawi, South Africa, Uganda, and Zimbabwe, with 390 pairs enrolled across both components.
Participant follow-up was also completed in IMPAACT 2021 as of 25 April 2024. IMPAACT 2021
was a double-blind, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120 ΔNS2/1030s, RSV 276 or placebo in children confirmed to be RSV-seronegative within 42 days prior to study product administration. The study was implemented across 14 sites in the United States, with 67 children enrolled.
Upcoming Social Behavioral Scientific Core SpotLight Series
The SBSC SpotLight Series is a monthly webinar featuring guest speakers discussing various topics to support research development. Please join us for this month’s discussion:
· 27 June 2024 | 10:00 a.m. ET:
Featuring Rivet Amico, PhD, from the University of Michigan School of Health, presenting on mixed methods research.
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We are thrilled to announce the successful completion of our abstract development program, which guided HVTN Community Educators and Recruiters (CERs) from different regions through idea generation in September 2023 to formulating their ideas into abstracts in May 2024. The journey began with identifying potential conferences and abstract topics, followed by sessions on obtaining and generating data using HVTN resources and local site data. CERs also learned how to navigate internal approvals using HVTN Ancillary Study Requests.
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The program culminated on May 4, 2024, with an intensive training session at the Omni Shoreham hotel in Washington, DC. This final gathering, held after the HVTN Full Group Meeting, allowed CERs to work with HVTN core and CRS investigators to integrate their learnings and refine their abstracts for submission. We applaud the hard work and dedication of all participants and are eager to see the impact of their research in their respective fields.
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Ntando Yola Appointed HPTN
CWG Chair
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Congratulations to Ntando Yola on his recent HPTN Community Working Group (CWG) chair appointment. Ntando is a community engagement lead at the Desmond Tutu Health Foundation (DTHF) in Cape Town, South Africa. He has years of experience working in HIV research and its related facets, advocating for, and mobilizing communities’ participation in these processes. His work includes developing and implementing community engagement strategies and advisory mechanisms and forming partnerships with key stakeholders in advancing HIV prevention research. Seeing communities take empowered ownership of the efforts that seek to achieve AIDS epidemic control, especially in sub-Saharan Africa, is what energizes his work.
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The HPTN CWG is responsible for ensuring the principles of community involvement are the foundation of all community engagement activities at each site and for facilitating community participation throughout the research process. The CWG Chair is a voting member of the HPTN Executive Committee. Network CWG representatives also serve on HPTN science committees, working groups, the Science Review and Performance Evaluation committees, and the HANC Community Partners group.
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Behavioral and Social Sciences
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Greg Davis
HANC
Project Manager
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Behavioral Science Consultative Group: The Behavioral Science Consultative Group continues to move forward with planning its face-to-face meeting taking place in August in Seattle.
Financial Disclosure Working Group: The Financial Disclosure Working Group is preparing for the 2024 annual solicitation. The solicitation will occur on September 20, 2024. The work group is finalizing the SOP for 2024.
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Greg Davis
HANC
Project Manager
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Russell Campbell
HANC Director
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Community Partners: Community Partners will meet in September 2024 in Arlington, VA before the start of the IMPAACT Network meeting. Community Partners Executive Committee will begin planning the agenda in June. An ad-hoc working group also met to prioritize webinar topics. Community Partners plans to resume hosting webinars in the near future.
TB Vaccine Community Engagement Strategy WG: The TB Vaccine Community Engagement Strategy Working Group has rescheduled their standing call due to multiple conflicts. The work group plans to discuss submitting an abstract to the Union World Conference on Lung Health as well as to discuss challenges and best practices when engaging minors in TB trials.
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Cross-Network Coordination
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Kathleen Pescasio
HANC Cross-Network
Project Manager
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The Cross-Network Site Coordinators Working Group (SCWG) continues to discuss remote monitoring visits and how to identify and address site-level issues. The group also recently shared feedback on the Red Ribbon Registry. The SCWG completed the CRS Coordinator Onboarding Checklist, which can be accessed on the HANC website.
The Cross-Network Data Management Center Working Group (DMCWG) continues to discuss recent experiences with changes to survey software tools and study enrollment systems. Frontier Science successfully transitioned to the Rave EDC platform and is continuing to explore additional modules in Medidata. SCHARP has made great progress with the EMR data extraction process and is continuing to explore other ways to extract data from second entities.
The Cross-Network Evaluation Working Group (EWG) continues to discuss standardization for evaluation metrics and reporting within the networks.
The Cross-Network Communications Working Group (CWG) shared engagement at recent conferences and plans for upcoming network annual meetings. The group continues to discuss experiences with communications tools and resources.
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Tyler Brown
HANC Laboratory
Project Manager
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The Laboratory Technologists SOP Working Group held a meeting in May to continue developing the ACTG/IMPAACT PAXgene® Blood RNA Tube Collection, Processing, and Storage Policy. Also in May the group finalized the guidelines for pharmacokinetic (PK) processing in laboratories participating in ACTG and IMPAACT protocols - access the documents
here.
The Lab Focus Group (LFG) held a meeting in May with representatives from the DAIDS Clinical Laboratory Oversight Team (DCLOT) and the Office for Policy in Clinical Research Operations (OPCRO) to discuss the maintenance requirements for lab Trial Master File (TMF) materials. Additionally, efforts to publish a new version of the Cross-Network Peripheral Blood Mononuclear Cell (PBMC) Processing Standard Operating Procedure (SOP) are ongoing.
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Brian Minalga
HANC
Deputy Director
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Cat Banobi
Legacy
Project Manager
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Gabriella Olague
HANC
Project Coordinator
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June 11-16: Brian and Cat will be at the ACTG Annual Meeting in Washington, DC! Join us at the ACTG’s
Global Community Advisory Board meeting, where Brian will be co-facilitating two workshops with Legacy’s good friend, Rona Siskind:
- Tuesday, June 11 from 11 a.m. to 12 p.m.
“Trans & Gender-Diverse Inclusion: Resources for Advocacy”
- Wednesday, June 12 from 9:45 to 11 a.m.
“The Role of Community in HIV Research”
June 14-18: Brian and Cat will be at the HPTN Annual Meeting in
Washington, DC! We will be scouting for social media content, so don’t miss out on a selfie with your Legacy friends from Seattle.
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ACTG Annual Network Meeting (Washington DC, USA)
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HPTN Annual Network Meeting (Washington DC, USA)
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AIDS 2024 (Munich, Germany)
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Community Partners Meeting (Arlington, USA)
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IMPAACT Annual Network Meeting (Arlington, USA)
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