HANC Newsletter | October 2022
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HANC offices are located at the Fred Hutchinson Cancer Center campus in Seattle, WA.
We acknowledge the Coast Salish peoples of this land, the land which touches the shared waters of all tribes and bands within the Duwamish, Puyallup, Suquamish, Tulalip and Muckleshoot nations.
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H=H Episode 8: The Role of the Community in the Development of an HIV Vaccine
This episode of H=H presents the current status of the HIV Vaccine Trials Network (HVTN) research agenda, the role community plays in this process, and the relevance of including diverse populations and vulnerable groups in the conduct of HIV vaccine studies.
We interview Dr. Michele Andrasik, who leads the HVTN's social and behavioral science and community engagement groups.
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Join us in recognizing the following HIV/AIDS Awareness Days this month:
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October 15: National Latinx AIDS Awareness Day
National Latinx AIDS Awareness Day (NLAAD) is observed each year on October 15 to increase awareness of the impact of HIV on the Hispanic/Latino population in the United States. NLAAD is a day to highlight the Latino faces behind the HIV epidemic and unite the Hispanic/Latino community to promote HIV testing, prevention, and education.
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NEW: Redesigned Specimen Repository Website
The website has been completely redesigned with modern data visualizations and dashboards, expanded study and publication search capabilities, a tutorial and links to PubMed and ClinicalTrials.gov. The DMC will continue to add features and search criteria over the upcoming months, and we welcome your feedback as you interact with the new website. Please see the site brochure
to share with investigators who may be interested in the website and encourage the use of repository specimens.
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Announcing the DAIDS Applied Research Training Event (DART 2.0)!
The Division of AIDS (DAIDS) is excited to announce the second DAIDS Applied Research Training Event (DART 2.0) which will take place October 25-27 this year. Given the success of the first regional DART event, which took place in South Africa 2019, we are pleased to be hosting DART 2.0 which is a fully virtual event targeting the Latin America and Caribbean region. The event will be done in a fully 3D immersible environment, allowing for direct learner interaction and activity participation. We look forward to working with this year’s participants!
As part of the first DART event, DAIDS generated training tool kits to assist sites with internal training efforts focused on strengthening Good Clinical Practice (GCP) and International Council for Harmonization (ICH) compliance. These toolkits are now available on the HANC website and accessible to everyone. Click here to access them.
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Last month, the ACTG announced the launch of A5418 or STOMP, a phase 3 clinical trial evaluating tecovirimat as a treatment for monkeypox. You can learn more about the study by checking out the press release or visiting the
study website. You can also tune into an IDSA press briefing on monkeypox treatment trials that featured Dr. Timothy Wilkin, the leader of STOMP, as well as Dr. Carl Dieffenbach, Director of the NIH’s Division of AIDS, and Dr. Demetre Daskalakis, White House National Monkeypox Response Deputy Coordinator.
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Around the globe, researchers, scientists, advocates, healthcare professionals, and community leaders continue to develop and implement strategies to close gaps in access to HIV prevention. The landscape of the global HIV epidemic has begun to shift as researchers remain engaged in discovering additional prevention methods through biomedical and integrated strategies.
An oral HIV pre-exposure prophylaxis (PrEP) product was approved by the U.S. Food & Drug Administration in 2012 and has been approved by many other regulatory agencies since then. The once-daily pill fostered a new era in the fight against the HIV epidemic as an effective drug combination to prevent HIV. Yet despite this innovation, HIV rates persist among underserved populations where more significant disparities in health equity and barriers to access remain.
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HVTN Fall Conference
The HVTN Fall Conference will convene October 17-19, 2022 at the Grand Hyatt Seattle, in Seattle, WA, with virtual options to connect remotely. If you’ve received an invitation and not yet registered, please note the online registration deadline is October 10th. For more information please visit: https://www.hvtn.org/events/hvtn-conference-2022.html. For any questions about the meeting, please email:
vtn.travel@hvtn.org.
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SOCIAL BEHAVIORAL SCIENTIFIC CORE SPOTLIGHT SERIES
On 22 September, the IMPAACT Social Behavioral Scientific Core launched the first webinar in their SpotLight Series titled Mental Health & Trauma in Research and the Populations We Serve. A partial recording of the webinar can be viewed here.
STUDY UPDATES
- IMPAACT 2023, a Phase I study of the safety, tolerability, and pharmacokinetics of dolutegravir in neonates exposed to HIV-1, recently opened to accrual, with CRS 5083 (Rush University Cook County Hospital Chicago NICHD CRS) as the first site activated.
- Three sites were approved to start under Protocol Version 3.0 of IMPAACT 2005, a Phase I/II study of the pharmacokinetics, safety, and tolerability of delamanid in children with multidrug-resistant tuberculosis (MDR-TB) living with and without HIV.
- IMPAACT P1108 Protocol Version 2.0 was finalized and issued to sites on 29 September. P1108 is a Phase I/II study of the pharmacokinetics, safety, and tolerability of bedaquiline in combination with optimized individualized multidrug-resistant tuberculosis (MDR-TB) therapy in HIV-infected and HIV-uninfected infants, children, and adolescents with MDR-TB disease.
- IMPAACT 2036/CRAYON Protocol Version 1.0 was finalized and issued to sites on 4 October. CRAYON (Cabotegravir and Rilpivirine Long-Acting Injections in Young Children) is a Phase I/II study of the safety, tolerability, acceptability, and pharmacokinetics of oral and long-acting injectable cabotegravir and rilpivirine in virologically suppressed children living with HIV-1, two to less than twelve years of age.
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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The Youth Prevention Research Working Group is working on a guidance document for sites that are conducting, or are interested in conducting, adolescent research. The guidance document will provide recommended readings and trainings, along with feedback and recommendations from members of the Soweto Youth CAB. Once the document is finalized, it will be shared with Network Leadership and HANC collaborators.
The COVID-19 CAB Coalition time as a work group is coming to an end. A handful of members of the group volunteered to write a paper on lessons learned during the COVID-19 pandemic from a global community perspective. Work on the paper will likely begin in October.
The Financial Disclosure Working Group (FDWG) kicked off the annual solicitation on September 21. The solicitation period runs through October 21, 2022. HANC would like to thank members of the FDWG for their hard work to ensure a successful solicitation.
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Community Partners
Russell Campbell, HANC Acting Director
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Community Partners is excited to announce that Roseline Jerobon Koskei from Eldoret, Kenya will serve as the new ACTG Community Partners representative!
Community Partners reps will be presenting to the IMPAACT GCABs on October 13th to highlight the role of CP and the various community engagement resources developed to assist CABs.
Community Partners would like to thank Milton Mathonsi for serving as a CP representative for the ACTG network over the past couple years. Community Partners and the Global Community have benefitted from Milton’s wisdom, kindness, and expertise. During his time on CP, Milton has served as one of the CP Co-Chairs. We are appreciative of all the time that Milton has given to CP and we will miss his contributions and commitment to the mission of CP! Thank you for your generosity Milton. You make the South Africa Johannesburg PHRU Soweto site proud!
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Cross-Network Coordination
Milan Vu, HANC Project Manager
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The Cross-Network Data Management Center Working Group discussed changes to survey software tools, roll-out of the A5418 (STOMP) trial, and experiences with regulatory submission studies.
The Cross-Network Evaluation Working Group continues to move forward with discussions regarding opportunities to harmonize network metrics for measuring site performance and how this information is reported to the DAIDS.
The Cross-Network Site Coordinators Working Group (SCWG) shared site experiences with pre-inspection visits, discussed the roll-out of the A5418 study from the site perspective, and reviewed resources available to site coordinators on the HANC website.
New Resources from DART 1.0
Training toolkits from the DAIDS Applied Research Training (DART) pilot event are now available on the HANC website.
The DART curriculum includes 13 training modules focused on strengthening Good Clinical Practice (GCP) and International Council for Harmonization (ICH) compliance at clinical research sites. The curriculum emphasizes small group, application-focused learning experiences and is free for sites to use to support staff training.
New FDA Draft Guidance: Ethical Considerations for Clinical Investigations of Medical Products Involving Children
On September 23, 2022, the U.S. Food and Drug Administration issued a draft guidance
that, when finalized, will provide the agency's perspective on the ethical considerations for including and protecting children in clinical trials. The draft guidance is intended to assist industry, sponsors and institutional review boards (IRBs) when considering the enrollment of children in clinical investigations of drugs, biological products and medical devices.
The public is encouraged to provide comments on the draft guidance. Any comments should be submitted within 90 days to ensure that the agency considers them when finalizing the draft guidance.
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Laboratory Coordination
Tyler Brown, HANC Project Manager
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The Lab Technologists SOP Working Group held four meetings in September to update the Leukopak PBMC Processing Standard Operating Procedure - A new version (v.2.0) will be announced and published on hanc.info in the coming weeks.
The Lab Focus Group (LFG) held a meeting in September to discuss new quality assurance and process improvement measures to support non-US lab sites. The LFG is also working to publish a new version of the Primary Network Lab List by the end of this year.
Now Published: The Division of AIDS Clinical Laboratory Oversight Team (DCLOT) and Cross-Network Laboratory Focus Group (LFG) have published the Decision Tree to Mitigate Recurring Reagent and Supply Shortages, a new guidance document created to help DAIDS-supported and/or sponsored laboratories mitigate reagent and supply shortages. Access this document
here.
Reminder: DAIDS has announced the availability of the DAIDS Good Clinical Laboratory Practice Training Related FAQs, a new guidance document that addresses common questions about GCLP training requirements. Access the GCLP Training Related FAQs 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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Sept 12-13: The HIV Vaccine Trials Network held the 6th Translational HIV Vaccine Early Stage Investigator (ESI) Conference in Portland, Oregon. The goal of the conference is to increase translation of HIV vaccine research in non-human primates (NHPs) and human clinical trials by bringing ESI together and supporting career development. Thirty-six ESIs, from 3 countries and representing 16 institutions, attended the conference. By everyone’s account, it was an extremely successful workshop. Looking forward to holding the conference again next year!
Sept 16: The Legacy Project participated in the first HRSA Region 10 Health Equity Conference, at the University of Washington – Tacoma and virtually on Zoom Events. Legacy presented information focused on addressing why people who inject drugs or people who use drugs are not assessed and/or are excluded from participation in HIV/AIDS clinical research.
Sept 27-29: The Legacy Project participated in the Evidence2Practice (E2P) session at Allen University and presented the HIV Prevention Research Module to HBCU students. E2P is designed to increase interest in HIV science careers for students at Historically Black Colleges and Universities (HBCU) and Minority Serving Institutions (MSI) of higher education.
Oct 8: Pedro and Tasia on behalf of the Latinx Caucus authored an article titled, "How Providers Can Increase Hispanic and Latinx Representation in HIV Clinical Research" that will be featured in the Fall issue of the HIV Specialist
magazine, a quarterly publication of the American Academy of HIV Medicine. The magazine has 14,000 subscribers and it will be distributed at the US Conference on HIV/AIDS 2022.
Oct 8-11: The US Conference on HIV/AIDS in San Juan, Puerto Rico! Join us for our sessions:
- Saturday, Oct 8 from 4 to 6 p.m. “Woke Research: Efforts to Ensure Meaningful Inclusion”
- Sunday, Oct 9 from 8 to 11 a.m. “Long-acting HIV treatment and prevention Regimens: Present and Future”
- Tuesday, Oct 11 from 9 to 11 a.m. “Hard-to-reach vs Hardly reached populations in HIV research”
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Oct 14: Episode 9 of the H is for Human podcast will be dedicated to the Hispanic/Latinx Heritage Month and National Latinx HIV Awareness Day.
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Oct 17 from 6:15 to 7:15 p.m. Legacy Project representatives will be presenting the session “Creating a Legacy of Health Equity by Engaging BIPOC Populations into HIV Clinical Trials” at the HVTN Meeting in Seattle, WA.
Updates from the New Investigators Working Group:
Specimens for Your Research
SpecimenRepository.org is a data visualization tool with the goal of making specimens available to investigators for new and innovative research. The ACTG, the HVTN and the IMPAACT networks contribute to this initiative with nearly 8 million specimens.
HVTN Research and Mentoring Program (RAMP)
The HIV Vaccine Trials Network RAMP is seeking Native American/American Indian, Native Hawaiian, Asian and Pacific Islanders medical students interested in HIV vaccine research. Applications for 2023-2024 are open.
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Senior Clinical Research Coordinator, UCSF Center for Tuberculosis
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