HANC Newsletter  |  August 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.

New Resource: Understanding Science Videos

Why is science essential? And why is research important in science? A new series of short, animated videos answer these questions and more, and aim to help make understanding clinical research easier. These videos were created by the HANC-facilitated COVID-19 Community Advisory Board (CAB) Coalition, a partnership between the Office of HIV/AIDS Network Coordination, representatives from the HIV/AIDS Clinical Trials Networks, AVAC, Community Partners, and local CABs.

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.

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.
Join us in recognizing the following HIV/AIDS Awareness Days this month:

August 20: Southern HIV/AIDS Awareness Day

Southern HIV/AIDS Awareness Day (SHAAD) is an opportunity to bring people together across the country to raise awareness, erase HIV-related stigma and discrimination, and advocate for new and necessary resources and solutions for the Southern HIV/AIDS epidemic.

August 29: National Faith HIV/AIDS Awareness Day

The observance is intended to engage faith communities to work together for HIV/AIDS education, prevention, treatment, care and support, and to reduce and eliminate stigma and discrimination.
ACTG and Combination bNAbs
Combination antiretroviral therapy (ART) revolutionized the treatment of HIV and showed efficacy in prevention, but it doesn’t eradicate established infection and worldwide HIV incidence rates have continued to decline slowly. The search for new prevention and treatment interventions remains a high priority. Antibodies are an attractive new treatment modality against HIV because not only can they directly target specific viral epitopes (parts of HIV), but they also have the potential to harness host immune responses and perturb HIV reservoirs (wake up and target sleeping cells with HIV inside). Single-cell antibody cloning methods enabled the identification and subsequent characterization of broadly neutralizing antibodies (bNAbs) with remarkable potency and breadth compared to previously identified anti-HIV neutralizing antibodies. These highly potent new generation bNAbs are a promising new strategy against HIV. Studies have demonstrated that bNAbs can prevent acquisition of bNAb-sensitive viral strains (stop infection). Two recent clinical trials (Gaebler et al and Sneller et al, Nature 202) also demonstrated that a combination of two bNAbs (3BNC117 and 10-1074) can maintain viral suppression after ART is discontinued in individuals harboring sensitive viruses. In addition, early data suggest that bNAbs can affect reservoir size and modify cellular immune responses in people living with HIV. Altogether, these results support continued investigation of this immunologic approach in different clinical scenarios, alone or in combination with other molecules that have been shown to modulate immune responses and perturb HIV-1 persistence (help the immune system clear sleeping HIV from people).
The ACTG plays an important role in this research, and currently two ACTG studies of bNAbs are open for accrual. A5364 aims to expand on the results showing that long-acting bNAbs can maintain suppression in the absence of ART for prolonged periods of time. A5386 is evaluating the combination of two bNAbs with a molecule called N-803 (an IL-15 superagonist), which has been shown in vitro to activate NK and T cells and interfere with HIV latency. These studies will monitor participants closely during a period of ART interruption (stopping HIV treatment) for the return of viremia. In addition, samples from both studies will be carefully analyzed by a broad variety of assays to dissect the underlying mechanism involved in the long-term virologic control, if this is achieved in at least a subset of participants. These studies also provide an opportunity to understand predictors of viral rebound after stopping ART.
In addition to these studies, other protocols are in late development – including studies to evaluate interventions at ART initiation, among people living with HIV who initiated ART during early infection, and of combinations of bNAbs with vaccines and other immune modulators. The ACTG expects that, collectively, these studies will yield important data to further the development of this promising therapeutic approach and guide strategies to overcome some of the implementation challenges, such as pre-existing resistance to the bNAbs and the cost of manufacturing and delivery.
The HPTN Scholars Program is pleased to announce the next group of talented scholars. During the next 18 months, they will conduct secondary analyses of HPTN study data, working alongside leading HIV prevention researchers affiliated with the Network.
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! 
The IMPAACT Network wrapped up an oral presentation at the 14th International Workshop on HIV & Pediatrics, three poster presentations, and a hybrid satellite symposium at AIDS 2022. Presentations and posters will be shared on the IMPAACT website as available.

Just Published in JAIDS
The Journal of the International AIDS Society announced the launch of a new special issue entitled ‘Approaches to enhance and accelerate investigation of new HIV drugs in pregnancy’ - guest edited by Martina Penazzato (World Health Organization) and Elaine Abrams (ICAP at Columbia University). This work builds on the strong and ongoing collaboration between WHO and IMPAACT, following the Call-to-Action to accelerate the study of new drugs for HIV in pregnancy.

New Meeting Report
The World Health Organization and IMPAACT released a new meeting report following the 2021 virtual workshop on postnatal prophylaxis to reach the elimination of HIV vertical transmission. The report summarizes several implementation strategies and research goals for eliminating vertical transmission globally.

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.

IMPAACT Annual Meeting Recordings Available
Presentations and recordings from the 2022 IMPAACT Annual Meeting are now available on the IMPAACT website.

Mark Your Calendars
The 2023 IMPAACT Annual Meeting is set to take place the week of 20 October 2023. More information to follow!
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) will meet with two NIH Program Officers during the August meeting. This will be the first time the BSCG meets with Program Officers; the BSCG has met with Network Leadership previously.

The Financial Disclosure Working Group is updating Network investigators lists to prepare for the upcoming annual solicitation. The solicitation will occur on September 21, 2022.

The Youth Prevention Research Working Group (YPRWG) met with members of the Soweto CAB in July. The groups began discussing possible ways the groups can collaborate together. The YPRWG has started drafting a recommendations document for sites conducting adolescent research. Feedback from the Soweto CAB will be included in the recommendations document.
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners is excited to announce that Pearson M’modzi, from the Lilongwe, Malawi CRS, will serve as the new HPTN Community Partners Executive Committee representative!

Community Partners reps 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. 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Site Coordinators Working Group discussed the development of a quick-start checklist to help orient new site coordinators to their roles; potential ideas to help reinvigorate community advisory boards; and training/information needs related to monkeypox.

The Cross-Network Data Management Center Working Group discussed the applicability of the new NIH Data Management and Sharing Policy with representatives from the Division of AIDS. The group also discussed changes to survey vendors and upcoming updates to the specimen repository website.

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.

SAHPRA Issues Updated Compensation Guideline
On July 1, 2022, the South African Health Products Regulatory Authority (SAHPRA) issued an updated version of the Guideline for Clinical Trial Participant Time, Inconvenience and Expense (TIE) Compensation Model, which takes effect on August 1, 2022. This document is meant as guidance to sponsors of clinical trials and represents SAHPRA's thinking on participant reimbursement during clinical trial participation.

Clarification of Single IRB Requirements
A new resource, "Information Sheet: Single Institutional Review Board (sIRB) Requirements," is now available on the NIAID website. This document includes information on when the sIRB requirement applies and several scenarios to illustrate the requirement.
Laboratory Coordination

Tyler Brown, HANC Project Manager
New CPQA Contract: In July the University at Buffalo, State University of New York, Clinical Pharmacology Quality Assurance (CPQA) Program announced a successful recompetition for the new DAIDS Clinical Pharmacology Quality Assurance Contract. The purpose of the DAIDS CPQA Program is to provide a comprehensive quality assurance program for clinical pharmacologic laboratories that test samples from subjects enrolled in DAIDS-supported clinical studies. This is accomplished through a multifaceted approach that includes peer- reviewed assay validation reports and standard operating procedures, preparation of laboratories for regulatory audits, technical guidance and an ANAB-accredited proficiency testing program. The CPQA is critical to the scientific integrity of on-going and future DAIDS-sponsored studies assessing prevention and therapeutic measures for HIV and other infectious diseases. The period of the new CPQA contract is May 2022-2029.

Now Published: In July the Division of AIDS Clinical Laboratory Oversight Team (DCLOT) and Cross-Network Laboratory Focus Group (LFG) 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.
The Legacy Project

Brian Minalga, Pedro Goicochea, Tasia Baldwin; HANC Community Engagement Officers
August 2: Tasia and Dr. Kenric Ware presented: Biomedical HIV Prevention Tools for HBCU Students as part of the Human Rights Campaign (HRC) HBCU PrEP Peer Ambassador/Educator program for HBCU students who serve as PrEP peer educators on their campuses beginning this Fall.

August 20: Legacy recognizes Southern HIV/AIDS Awareness Day.

August 23: Submissions from the HPTN and HVTN are due to Brian for inclusion in the September issue of the Be the Generation newsletter.

Legacy Project at AIDS 2022
Brian, Pedro, and Russell had a fun and successful conference in Montreal, where each of us presented in the Global Village on transgender inclusion, indigenous engagement, and inclusion of people who use drugs in HIV research. It was wonderful seeing so many colleagues and friends–and making new ones–in Montreal.

9th International Indigenous Pre-conference on HIV & AIDS (IIPCHA 2022)
The American Indian/Alaska Native Working Group presented on the role of HANC/Legacy Project in HIV/AIDS clinical research. Pedro Goicochea shared the panel with Dr. Charu Kaushic the Scientific Director of the Canadian Institute of Health Research. 

New Investigators Working Group
HVTN Scientific Leadership Development 2022 Awardees
Dr. Rachel Kawalazira, MBBS, MSc, has been a Principal Investigator, Medical Officer and Study Coordinator at the Johns Hopkins Research Project in Blantyre, Malawi since 2008. She has worked with the IMPAACT network, the HVTN, and serves as a local Principal Investigator on a phase 3 efficacy and safety trial of Islatravir for oral PrEP. Dr. Kawalazira has a degree in vaccinology and her research focus is on HIV vaccine research. 


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.

More information will be forthcoming. 

Job Opportunities

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 .

Conferences & Meetings

October 8-11, 2022
October 17-19, 2022
2022 HVTN Conference (Hybrid: Seattle, WA USA)
February 19-22, 2023
CROI Conference (Hybrid: Seattle, WA USA)