HANC Newsletter | September 2022
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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 struggles 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.
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New Resource: Monkeypox Resources Page
A new Monkeypox Resources
page is now available on the HANC website. This page is intended for clinical research site staff and community members, and serves as a central location to find links to guidelines related to monkeypox from major health agencies. The page also lists links to printable factsheets, graphics, communications toolkits, and training resources related to monkeypox.
Monkeypox Webinar Recording: On August 26, HANC held a webinar entitled Monkeypox: An Overview. The webinar featured a presentation by Dr. Nwora Lance Okeke (of Duke University) that included information about monkeypox symptoms, transmission, treatment and research. A recording of the webinar can be accessed
here.
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Recruitment Open: 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.
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Join us in recognizing the following HIV/AIDS Awareness Days this month:
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National HIV/AIDS and Aging Awareness Day brings attention to the growing number of people living long and full lives with HIV and to their health and social needs.
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The National Association of People with AIDS launched this observance day to recognize the disproportionate impact of the epidemic on gay men. Gay and bisexual men are the population most affected by HIV in the United States, accounting for 69% of the 36,801 new HIV diagnoses in 2019.
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ACTG Monkeypox Treatment Trial: This
month, ACTG and NIAID will launch a clinical trial testing tecovirimat for the treatment of human monkeypox. People with human monkeypox infection, including people living with HIV, are eligible and encouraged to enroll. More than 500 volunteer participants will be randomly assigned to receive either tecovirimat or a placebo at a ratio of two to one. Investigators will be evaluating if those taking tecovirimat heal more quickly than those taking placebo, among other data points. There is an additional segment of the study open to individuals at risk of more severe disease or who are immunosuppressed; pregnant and breastfeeding people and children and all will receive tecovirimat and will be closely monitored for safety. If a positive signal is seen in the study, it will provide the necessary data to make this medicine readily available for treatment of monkeypox disease.
Last month the ACTG announced the launch of ACTIV-2d, a global phase 3 trial of the novel investigational COVID-19 oral antiviral agent S‑217622. Read more here!
This summer ACTG Announced the publication of the ACTIV-2 study in Cell Reports Medicine demonstrating rapid clearance of culturable SARS-COV-2 following monoclonal antibody treatment. Read more here!
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HPTN 096 Peer Support Program Now Available
The HPTN 096 Peer Support Program is a supportive space where Black/African American gay and bisexual men can find support, be in community with one another, and feel welcomed and safe to be their authentic selves. Peer supporters are individuals in your community who can relate and provide real-world support based on their knowledge and experiences. They are available to discuss various sexual health-related matters, including HIV prevention, treatment, and care.
If you live or know someone that lives in Dallas, Texas, or Montgomery, Ala., who wants someone to talk to or needs help finding a place to get HIV-related/sexual health support services (HIV testing, PrEP, etc.) in their community, peer supporters are standing by and ready to assist. Support is free and confidential.
For more information or questions, please contact 096_ps_queries@hptn.org.
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HVTN Community Compass
We are inspired by your continued support of HVTN Community Compass! Each edition is a collection of stories conveying the passion and unwavering commitment of our pursuit for a safe and globally effective preventive HIV vaccine. We hope this edition will be another informative read to grow your knowledge and understanding of the HIV prevention field and to celebrate how you are making an impact!
Community Compass is available in English, Spanish, and Portuguese, and these translations will soon be available online here. Please share this publication with your networks, colleagues, friends and family members. If you are at a clinical trial site/or clinical trial unit, please be sure to share copies of the magazine with your CABs and local communities after you receive them.
In this edition we share and celebrate the we celebrate a recently launched scientific development leadership program under the direction of Dr. Alison Roxby, we revisit the critical role that language and effective community engagement plays in the COVID-19 response, and we recognize the very important role that faith has in many people’s lives and the critical role that faith communities have and continue to play in the HIV response, and much more!
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IMPAACT Social Behavioral Scientific Core “Spotlight” Series
This month, the IMPAACT Social Behavioral Scientific Core “Spotlight Series” will feature a moderated panel discussing mental health and trauma in research and the populations we serve. Panelists include Mary Fabri, PsyD; Geri Donenberg, PhD; and Dorothy Dow, MD, MSc. Hosted by Rivet Amico, Nicole Montañez, and Rachael Jeffrey.
22 September 2022 | 10:00 a.m. EDT via Zoom
Call for Applications
The IMPAACT 2022 Early Career Investigator (ECI) program is now accepting applications. The ECI program aims to support early career investigators in completing a project using data or samples generated by IMPAACT Network studies. Click here for more information.
The IMPAACT Network is pleased to share the request for applications (RFA) for new laboratory-based scientific investigations related to the Network's research agenda using well-characterized biological specimens available in the Network's repositories. Click here for more information.
Study Updates
The IMPAACT Network is pleased to report two newly finalized protocols:
IMPAACT 2034 is a Phase I pharmacokinetic (PK), safety, tolerability, and acceptability study of a single-dose of pretomanid in infants, children, and adolescents less than 18 years of age living with or without HIV and with confirmed or probable rifampicin-resistant tuberculosis. Protocol Version 1.0, dated 15 July 2022, was finalized and issued to sites on 4 August 2022.
IMPAACT 2035/HVTN 604: LEAP (Leveraging Early Adolescence to Prevent TB)
is a Phase I/II study of the novel tuberculosis (TB) vaccine candidate VPM1002 and BCG re-vaccination. The study is designed to evaluate the safety and immunogenicity of VPM1002 vaccination and BCG re-vaccination over 12 months in pre-adolescents living with and without HIV and with and without Mycobacterium TB sensitization who have previously received a birth dose of the BCG vaccine. Protocol Version 1.0, dated 05 July 2022, was finalized and issued to sites on 13 July 2022.
Mark Your Calendars
The 2023 IMPAACT Annual Meeting is set to take place the week of 20 October 2023. More information to follow!
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Behavioral and Social Sciences
Greg Davis, HANC Project Manager
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In July, the COVID-19 CAB Coalition announced the release of an animated educational video series titled Understanding Science. The video series contains five brief videos on various topics that can be difficult to understand. The videos are currently being edited to include Spanish and Portuguese subtitles. The translated videos will be shared on the Understanding Science resource page once available.
The Youth Prevention Research Working Group (YPRWG) has started working on a guidance document on conducting adolescent research for sites that are interested in conducting adolescent research. The guidance document will provide sites with recommended training, reading material, and direct feedback from adolescent trial participants and CAB members. The YPRWG recently met with representatives from the Soweto Youth CAB that provided input to the YPRWG. Members of the CAB will continue participating in the YPRWG calls until the document is finalized.
The Financial Disclosure Working Group is in the final stages of preparing for the annual solicitation. The annual solicitation is scheduled to occur on September 21, 2022.
The Behavioral Science Consultative Group (BSCG) continues to meet monthly. The group has been discussing adherence assessment harmonization and analytical treatment interruption (ATI) partner protection plans.
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Community Partners
Russell Campbell, HANC Acting Director
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Community Partners (CP) is excited to announce that Mandisa Jwara from Johannesburg, South Africa will serve as the new ACTG Community Partners representative!
Community Partners is also excited to welcome Molly Dyer as the new CP staff liaison for the HPTN and IMPAACT networks!
Community Partners reps will be presenting to the ACTG, IMPAACT GCABs to highlight the role of CP and the various community engagement resources developed to assist CABs.
Community
Partners would like to thank Cheryl Blanchette and Rhonda White for serving as CP staff liaisons for the HPTN, IMPAACT and MTN networks over the years. Community Partners and the Global Community have benefitted from their wisdom, kindness, and generosity. It has been a pleasure and learning experience working alongside Cheryl and Rhonda all these years. We wish Cheryl all the best in her new endeavors. While we are glad that Rhonda will still be a part of FHI 360, we will miss her presence and impact on Community Partners calls. We are sad that we didn’t have the opportunity to show our appreciation in person before your departures but know that we cherish you both and we are a stronger group because of your contributions and commitment to this important work!
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Cross-Network Coordination
Milan Vu, HANC Project Manager
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The Cross-Network Pregnancy Outcomes Data Working Group (PODWG) recently completed review of the Cross-Network Pregnancy Data Standards and published updated release notes on the HANC website.
The Pregnancy Data Standards are used by the network data management centers and present a harmonized approach for capturing pregnancy outcome data variables in the clinical database through common identifiers and naming, question text, SDTM annotations, data type, and response options.
The Cross-Network Data Management Center Working Group discussed recent experiences with vendor audits, upcoming updates to the specimen repository website, and applications for Medidata's trial supply management solution.
The Cross-Network Evaluation Working Group continues to discuss opportunities to harmonize network metrics for measuring site performance and how this information is reported to the DAIDS.
New Issue of the OCSO MOB Newsletter
The 18th edition of the DAIDS Office of Clinical Site Oversight (OCSO) Monitoring Operations Branch (MOB) Newsletter is now published. Find the newsletter on the HANC website here.
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Laboratory Coordination
Tyler Brown, HANC Project Manager
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The Lab Technologists SOP Working Group held three meetings in August to update the ACTG/IMPAACT Leukopak PBMC Processing Standard Operating Procedure - a new version will be available on hanc.info in the coming weeks.
The CPQA Cross-Network Clinical Pharmacology Forum (CNCPL Forum) held a meeting in August to discuss current and upcoming CPQA proficiency testing rounds, future network study compounds, and updates on the CPQA AVR/SOP Review Program. The meeting featured a presentation by Dr. Richard W. Browne (of the University at Buffalo, SUNY) on compendial testing of antiretroviral drug standards.
The Lab Focus Group (LFG) held a meeting in August to continue discussing process improvement strategies for the Primary Network Lab (PNL) system and other network lab center QA procedures.
Decision Tree to Mitigate Recurring Reagent and Supply Shortages: The Division of AIDS Clinical Laboratory Oversight Team (DCLOT) and Cross-Network Laboratory Focus Group (LFG) recently published a new guidance document aimed at helping DAIDS-supported and/or sponsored laboratories mitigate reagent and supply shortages. Access this document here.
DAIDS Good Clinical Laboratory Practice Training Related FAQs: As a reminder, DAIDS recently published a new set of guidelines that addresses common questions about GCLP training requirements. Access this document on the NIAID website.
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The Legacy Project
Brian Minalga, Pedro Goicochea, Tasia Baldwin; HANC Community Engagement Officers
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September 13: Legacy will be supporting the PrEP in Black America Summit in Atlanta, GA to help address the disparities in PrEP uptake among Black Americans.
September 18: Legacy recognizes National HIV/AIDS and Aging Awareness Day.
September 27: Legacy recognizes National Gay Men’s HIV/AIDS Awareness Day.
New Investigators Working Group
HVTN Scientific Leadership Development 2022 Awardees
Dr. Valeria Cantos is an infectious disease specialist and since 2017 she has been a clinician and co-investigator at the Emory University Ponce de Leon clinical research site in Atlanta, Georgia. She has served as co-investigator for several HVTN studies, including HVTN 137, HVTN 706 (MOSAICO), and HVTN 704 (AMP study). She has also served as lead site investigator for several inpatient and outpatient COVID-19 studies, as well as scientist-led HIV prevention projects. Dr. Cantos is the lead investigator for the Community Engagement team at her site. She is invested in optimizing representation of Latinx and Black populations in HIV vaccine and prevention clinical trials.
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3D Human Tissue Models for HIV and Related Comorbidities: How Can Organoids and Microphysiological Systems Advance the Field?
September 20-21, 2022
The National Institute of Allergy and Infectious Diseases (NIAID) Division of AIDS (DAIDS), in partnership with other NIH Institutes and Centers, is planning a 2-day workshop entitled “3D Human Tissue Models for HIV and Related Comorbidities: How Can Organoids and Microphysiological Systems Advance the Field?”
This workshop will bring together experts in the HIV and non-HIV fields involved in research with 3D human tissue models to understand potential synergies of interest to academics, industry, and regulators. Through this workshop, we aim to bridge and understand the concepts, translational potential, and opportunities for 3D tissue models to advance basic and translational research for HIV and related comorbidities, including tuberculosis and substance use and dependence, across the age spectrum.
Register here by September 21, 2022.
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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 the job posting here
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