HANC Newsletter  |  October 2021

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.

How to Critically (and Quickly) Read a Protocol

Understanding a protocol is important for community members interested in engaging in clinical research. One of the challenges for community and CAB members participating in protocol development is learning how to critically review a protocol from a community perspective.

The How to Read a Protocol document for CABs is designed to help individuals understand the most important components of a protocol, how to critically (and quickly) read a protocol, and provides suggestions to help focus on the most critical areas of the protocol to help save time. The document was recently updated and is now available in English, Spanish, and Portuguese. Community Partners also hosted an accompanying webinar on this topic, with the recording available on the HANC website here.
 
Join us in recognizing the following HIV/AIDS Awareness Days this month:
 

Oct 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. The NLAAD campaign promotes HIV testing and prevention, and provides information on access to care for Hispanic/Latino communities across the nation.
 
On September 27, the ACTG announced the graduation of the novel polyclonal antibody therapy SAB-185 to the phase 3 study of ACTIV-2. Read more HERE

This month, the ACTG announced the presentation of data for the monoclonal antibody combination therapy, BRII-196/BRII-198 from the ACTIV-2 study at the virtual IDWeek 2021 conference. Read more HERE.
 
The first HPTN 084-01 study abstract, “In the Face of a Global Pandemic and Social Barriers, Cisgender Female Adolescents Enroll in HIV Prevention Trial HPTN 084-01 in Sub-Saharan Africa” was accepted as an oral presentation at the upcoming International Workshop on HIV & Adolescence. HPTN 084-01 (The LIFT Study) is a clinical trial examining whether injectable cabotegravir for pre-exposure prophylaxis is safe and acceptable for adolescent females assigned female at birth. LIFT enrolled study participants at sites in South Africa, Uganda, and Zimbabwe.
 
Experimental Phase 2b HIV Vaccine Regimen Provides Insufficient Protection in Preventing HIV
A primary analysis of an experimental HIV vaccine regimen being studied in a high-incidence population of young women in sub-Saharan Africa found the experimental vaccine did not provide sufficient protection against HIV infection. No significant safety concerns were identified, but because the vaccine regimen failed to meet the study’s primary endpoint, with results falling short of statistical significance, the Imbokodo study, also called HVTN 705/HPX2008, will be discontinued. “The study team and entire HVTN operations program thanks everyone who participated in this study, which will continue to provide important data to help drive forward the search for an HIV vaccine,” said Dr. Larry Corey, Principal Investigator, HVTN Leadership Operations Center. Read the full press release here.
 
IMPAACT 2021 Now Open
IMPAACT 2021 is now open under protocol Version 2.0 and will resume enrollments soon. IMPAACT 2021 is a double-blind, randomized, placebo-controlled trial that will evaluate the safety and immunogenicity of recombinant live-attenuated respiratory syncytial virus 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.

First Enrollment for IMPAACT 2026
The IMPAACT 2026 team is delighted to announce the first enrollment for the study. The participant was enrolled at CRS 5092 (Johns Hopkins University) on Wednesday, 1 September.

IMPAACT 2026 is a Phase IV, prospective, pharmacokinetic (PK) study of selected antiretroviral (ARV) and anti-tuberculosis (TB) drugs during pregnancy and postpartum.

IMPAACT P1108 Informs WHO TB Management Recommendation
The IMPAACT P1108 study team is delighted to share that data from IMPAACT P1108 have informed the World Health Organization (WHO) recommendation for use of bedaquiline (BDQ) in children aged below six years, released in the WHO’s “Rapid communication on updated guidance on the management of tuberculosis in children and adolescents,” published on 23 August 2021. This recommendation comes following review of PK and safety data by a WHO-convened Guideline Development Group meeting. 

P1108 is a Phase I/II, open-label, single-arm, exposure-controlled dose-finding modified age de-escalation study of BDQ in infants, children, and adolescents living with and without HIV, with clinically diagnosed or confirmed multidrug-resistant tuberculosis. The study is designed to evaluate the PK, safety, and tolerability of BDQ over 24 weeks from the initiation of study treatment.
 
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) is planning to hold a half-day virtual meeting before the end of the year. Currently, the group is looking at two dates in December. 

The COVID-19 CAB Coalition continues to meet monthly. The group provides updates on major COVID-19 trials and CAB activities. The group recently discussed community messaging and ethical concerns around booster shots.

The Youth Prevention Research Working Group (YPRWG) is finalizing its objectives for the 2022 HANC Work Plan. The YPRWG is also preparing a report from the site survey that was sent out earlier this year.  A draft of the report should be finished before the end of October.
 
HANC would like to thank the members of the Financial Disclosure Working Group for all their work towards the annual solicitation. The annual solicitation was sent to Network investigators on September 21, 2021. Investigators have until October 21, 2021 to submit their statements.
 
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners is delighted to announce that Tasia Baldwin has been selected to represent the HVTN as a member of Community Partners!

Following the Community Partners webinar launching the updated How to Read a Protocol document for CABs, the How to Critically (and Quickly) Read a Protocol document is now available in English, Spanish and Portuguese.
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Communications Working Group (CWG) discussed network presentations at the upcoming US Conference on HIV/AIDS (USCHA) and approaches to communicating about breakthrough COVID-19 cases and booster shots.

The Cross-Network Site Coordinators Working Group (SCWG) shared site approaches to preventing co-enrollment of participants in research studies, highlighting the systems used by the Columbia Collaborative HIV/AIDS CTU, University of Zimbabwe Clinical Trials Research Centre (UZ-CTRC), and Bridge HIV.

The Cross-Network Data Management Working Group (DMCWG) discussed recent experiences with audits, completion of the manual for bidirectional safety data reconciliation, and potential SDMC training collaborations.

New DAIDS Co-enrollment Prevention Requirements
The DAIDS Office of Clinical Site Oversight (OCSO) recently released a new requirement for co-enrollment prevention for all CRSs participating in DAIDS-sponsored research within the DAIDS Clinical Trial Networks. Details of the requirement are noted in a memo dated September 8, 2021 as well as in the DAIDS SCORE Manual. Related content in the DAIDS SCORE Manual can be found under the Screening, Enrollment/Randomization, and Unblinding section, and include expansion of the Co-enrollment Prevention section, addition of 3 new appendices, FAQs, and templates.

A webinar was also held on September 28, 2021 to detail the new co-enrollment prevention requirement. A recording of the webinar, along with the slide deck and summary of the Q&A portion, will be posted on the HANC website once available.

DAIDS Delegation of Duties Log Template Revisions
DAIDS recently revised the DAIDS Delegation of Duties (DoD) Log Template contained in the Clinical Research Site (CRS) Personnel Qualifications, Training and Responsibilities section of the DAIDS SCORE Manual. A memo explaining the revisions was distributed on August 30, 2021.

Note: If you’ve viewed sections of the DAIDS SCORE Manual previously, you may need to clear the cache on your internet browser in order to see the new documents. You will know you need to clear your cache if you click on the link for either of the above sections and the document you see is NOT the August 27, 2021 version.

Expansion of Remote Pharmacy Monitoring
The DAIDS OCSO Monitoring Operations Branch (MOB) released a memo on August 27 announcing the expansion of remote review of pharmacy source documents for DAIDS sponsored trials.

 
Laboratory Coordination

Tyler Brown, HANC Project Manager
The Lab Technologists Committee (LTC) held two meetings in September – the group discussed 2022 LTC committee nominations, FedEx shipping delays, and received an orientation of the new HANC Portal from HANC. 

The Lab Focus Group (LFG) met in September to discuss the LFG’s Work Plan Objectives for 2022, current and upcoming SOP reviews, and PNL Assignments.

HANC VQA Proficiency Testing Lab Reagent Form: In August HANC launched a new version of the online VQA Reagent Order Form. Instructions for submitting orders using the new order form are available online here. Please contact labprojmgr@hanc.info if you have any questions or need assistance setting up a new account.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
Sept 9: The New Investigators Working Group (NIWG) launched its New Investigators Working Group Webinar Series with an extraordinary webinar “A Conversation with Women Researchers” featuring Dr. Lisa Bowleg, Dr. Ayana Elliott and Dr. Hong Van Tieu.  The webinar was co-moderated by Dr. Typhanye Dyer and Dr. Dazon Dixon Diallo.  Click here if you missed the conversation. 

Oct 12: On behalf of the Women’s HIV Research Collaborative, Brian Minalga presents, “The Representative Studies Rubric: 12 Steps to Enhance the Representation of Women and Minorities in HIV Research” at the Inter-CFAR HIV & Women Virtual Symposium

Oct 13: The Legacy Project will be hosting a webinar series, Addictophobia in HIV/AIDS Clinical Research. Presenters of this series will discuss how we can raise awareness and encourage change around including or excluding people who use drugs (PWUD) or people who inject drugs (PWID) in HIV prevention and treatment studies (both clinical and behavioral research). Please join us for the fir webinar in the series featuring Dr. Ricky Bluthenthal who will address the subjectivity or inclusion or exclusion factors in protocols and recommendations for changing the paradigm for PWUD and PWID in clinical and behavioral research. 

Oct 14: The second edition of the NIWG webinar series will host “A Conversation with Latinx Researchers” featuring the professional trajectory of Dr. Brandon Brown, Dr. Moises Huaman and Dr. Amaya Perez-Brumer.  Join the conversation by registering here

Oct 15: Legacy recognizes National Latinx AIDS Awareness Day.

NIWG: featuring scholars and fellows of the HIV/AIDS research networks minority scholar programs 
ACTG Minority HIV Investigator Mentoring Program (MHIMP) scholars for 2021 - 2023:

George Yendewa, MD, MPH, TM is an Assistant Professor at Case Western Reserve University School of Medicine. His program mentor is Dr. Robert Salata, Chairman of Medicine, Principal Investigator of the ID Clinical Trial Unit and senior investigator in the Case ACTG CRS. During the award period, Dr. Yendewa will develop his skills in the design, conduct, management and analysis of HIV-related clinical trials and acquire proficiency in the conduct of HIV/HBV and HIV/HCV-related studies assessing disease progression and clinical outcomes. He will also prepare and submit a concept proposal focusing on the use of long-acting anti-HCV drugs in recently active IV drug users, with the aim of promoting improved adherence to treatment. Dr. Yendewa will also serve as a member of both the Underrepresented Populations Committee and the Hepatitis Transformative Science Group of the ACTG.

Pamela Grace Mukwekwerere, MBChB, MPH works at the University of Zimbabwe-Clinical Trials Research Centre where she has worked in both HIV treatment and prevention studies.  She will increase her expertise in behavioral science and mental health research to guide the development of interventions to improve adherence to ART in young adults. Dr. Mukwekwerere plans to acquire the requisite skills to become an expert independent investigator and an emerging research leader. She will be mentored by Dr. Munyaradzi Madhombirio, Senior Lecturer in the Unit of Mental Health and Department of Primary Sciences. In addition to being a member of the Underrepresented Populations Committee, she will participate in the ACTG Tuberculosis Transformative Science Group. 

FDA Authorizes Booster Dose of Pfizer-BioNTech COVID-19 Vaccine for Certain Populations

September 22, 2021
The U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:
  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19; and 
  • individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA for individuals 16 years of age and older. The authorization was expanded on May 10, 2021 to include those 12 through 15 years of age, and again on Aug. 12, 2021 to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years of age and older. Read the full press announcement here .

Full Approval: What Does FDA Approval for the Pfizer COVID-19 Vaccine Mean for Mandates? Hesitancy? The Fall?

September 8, 2021
Dr. Chris Beyrer pens the latest COVID-19 Vaccine Matters blog entry addressing the implications of full FDA approval for the Pfizer-BioNTech mRNA COVID-19 vaccine for those aged 16 and over. Read the full article here.
 

Upcoming Webinars

Addictophobia in HIV/AIDS Clinical Research

October 13, 2021 at 10:00 am PDT / 1:00 pm EDT
The Legacy Project at the Office of HIV/AIDS Network Coordination invites you to participate in the webinar series Addictophobia in HIV/AIDS Clinical Research. Presenters of this series will discuss how we can raise awareness and encourage change around including or excluding people who use drugs (PWUD) or people who inject drugs (PWID) in HIV prevention and treatment studies (both clinical and behavioral research).

As part of the first webinar in the series, Dr. Ricky Bluthenthal will address the subjectivity of inclusion and exclusion factors in protocols and recommendations for changing the paradigm for PWUD and PWID in clinical and behavioral research. Dr. Bluthenthal will highlight the importance of utilizing a health equity lens while thinking about the degree to which studies may be generalizable when PWID or PWUD are excluded from participation. This webinar will focus on the “culture of knowledge creation”, and how critical it is to deconstruct/reconstruct paradigms about how clinical and behavioral trials are designed and operated. Register here.

A Conversation with Latinx Researchers

October 14, 2021 at 11:00am PDT / 2:00pm EDT     
In observance of the National Latinx HIV/AIDS Awareness Day, the New Investigators Working Group and the Latinx Caucus of the Legacy Project are hosting a webinar featuring Latinx researchers working in academia and conducting HIV research in the United States and Canada. Learn about the professional trajectory and career path of investigators from the United States, Venezuela, and Peru. Join the conversation with Dr. Brandon Brown, Dr. Amaya Perez-Brumer, and Dr. Moises Huaman on Thursday, October 14, 2021. Register here.
 

Training

DAIDS Good Clinical Laboratory Practice (GCLP) eLearning Course Available in Spanish and Portuguese    

The updated Spanish and Portuguese translated versions of the "Good Clinical Laboratory Practice (GCLP v4.1)” training are now available on the DAIDS Learning portal. These trainings are comprised of 10 modules that cover GCLP topics. They are intended for staff at laboratories, who are participating in DAIDS-supported and/or sponsored clinical trials, to provide an introduction to GCLP and their relationship to clinical research. To get started click here for the Spanish version or click here for the Portuguese version.

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

Community Training Modules Now Available

Several training modules for community members are now available on the DAIDS Learning Portal (DLP). The Community Advisory Boards and Research Ethics and Informed Consent modules are newly updated with additional content, and the latest module, Understanding Clinical Research, was recently added. Please feel free to share this broadly with your CABs and communities.
 

Conferences & Meetings

October 18-20, 2021
HVTN Conference (Virtual)
October 20-22, 2021
Fast-Track Cities 2021 Conference (Hybrid: Lisbon, Portugal)
November 7-9, 2021
Adherence 2021 (Hybrid: Orlando, FL USA)
December 2-3, 2021
February 12-16, 2022
 

Publication Highlights

Flynn et al for the PROMISE Study Team

Stranix-Chibanda et al for the PROMISE Study Team

Smith et al

Brown et al for the IMPAACT 2002 Study Team