HANC Newsletter  |  September 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

Ever wonder how to understand a study protocol and be more engaged in protocol development? HANC is hosting a webinar on September 8 for community members to help attendees understand the most important components of a protocol and how to critically review study documents. This webinar is open to anyone interested in learning more about the topic - please register here to attend.

More webinars are coming in September. Check out the Upcoming Webinars section below to register!
Join us in recognizing the following HIV/AIDS Awareness Days this month:

Sept 18: National HIV/AIDS and Aging Awareness Day

September 18 is National HIV/AIDS and Aging Awareness Day—a day to call attention to the growing number of people living long and full lives with HIV and to aging-related challenges of HIV prevention, testing, treatment, and care.

Sept 27: National Gay Men's HIV/AIDS Awareness Day

National Gay Men’s HIV/AIDS Awareness Day (NGMHAAD) is observed each year on September 27 to direct attention to the continuing and disproportionate impact of HIV on gay and bisexual men in the United States.
This month, the ACTG announced the positive data for the monoclonal antibody combination therapy BRII-196/BRII-198 from the ACTIV-2 study. Read more here. Congratulations to the team on this important accomplishment!
The HPTN 083 primary paper and accompanying editorial were recently published in the New England Journal of Medicine. The global randomized, controlled, double-blind study compared the safety and efficacy of long-acting injectable cabotegravir (CAB LA) to daily oral tenofovir/emtricitabine (TDF/FTC) (Truvada) for pre-exposure prophylaxis (PrEP). HPTN 083 demonstrated CAB LA lowered HIV incidence among cisgender men and transgender women who have sex with men. 
Congratulations to the HPTN 084-01 team on reaching 100 percent study enrollment. Launched in November 2020, HPTN 084-01, also known Long-Acting Injectable for Teens (LIFT), examines whether injectable cabotegravir for PrEP is safe, tolerable, and acceptable for adolescents assigned female at birth under 18 years of age. LIFT enrolled study participants at sites in South Africa, Uganda, and Zimbabwe.
In August 2021, the HIV Vaccine Trials Network (HVTN), in partnership with the Black AIDS Institute, Treatment Action Group, and Southern AIDS Coalition, launched the second We The People Research Cohort (WTPRC). The WTPRC is an HIV advocacy training program designed to empower people from marginalized communities across the United States to impact HIV research. Members of the WTPRC will participate in a 20-week program consisting of five online modules developed to equip Black, Indigenous, and People of Color (BIPOC) advocates with the skills needed to engage in critical discussion on HIV biomedical research and the next generation of HIV trial design. Once completed, WTPRC members will receive an HIV Prevention Research Advocate Certificate. Modules in the WTPRC program cover topics such as the State of the HIV Epidemic in the U.S. & Black Medical Mistrust, HIV Basic Science & Introduction to Clinical Research Concepts, and HIV Advocacy in a Digital Era. Each module concludes with a call led by an HIV research expert, allowing cohort members to learn directly from leaders in the field.

For more information on the WTPRC, please contact Louis Shackelford (lshackel@frdhutch.org), Terrell Jackson (tjackso2@fredhutch.org), or Dr. Stephaun Wallace (sewallac@fredhutch.org ) of the HVTN. 
The IMPAACT Network is pleased to report three newly approved protocols are in development:

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.

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.

IMPAACT 2036 is a Phase I/II non-comparative pharmacokinetic (PK) and safety study of cabotegravir (CAB) and rilpivirine (RPV) when taken orally (oral CAB + oral RPV) followed by long-acting injections (CAB LA + RPV LA) in virologically suppressed children living with HIV, aged 2 to less than 12 years of age and weighing 10kg to 50kg. The study is designed to determine the weight band dosing regimen and evaluate the safety, tolerability, PK, and antiviral activity of oral CAB + oral RPV followed by CAB LA + RPV LA.

Dr. Sharon Nachman, IMPAACT Chair, gave a presentation on last month’s ICAB call explaining the COVID-19 pandemic, vaccines, and other important information surrounding both. Watch it here.
To update stakeholders in the countries where DELIVER (MTN-042) and B-PROTECTED (MTN-043) are being conducted, the MTN has partnered with AVAC and local civil society organizations in hosting two virtual meetings. The first, which took place on Sept. 1 for stakeholders from Malawi and Uganda, was attended by more than 50 people, including representatives of IRBs/ECs, ministries of health, normative agencies, advocacy organizations and service providers. The second meeting, which is being held Sept. 9, will be for stakeholders from South Africa and Zimbabwe. Many of those taking part in these virtual discussions had attended face-to-face meetings the MTN has hosted in each of the trial-site countries in 2019 and early 2020.

The MTN has produced an infographic – The DELIVER and B-PROTECTED studies: 3 things you need to know – summarizing the milestones of these studies to date. DELIVER and B-PROTECTED are Phase IIIb studies that are evaluating the safety and acceptability of Truvada as daily oral PrEP and the monthly dapivirine ring in cisgender women during pregnancy and breastfeeding, respectively.  
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) had planned to meet in Orlando, FL for a face-to-face meeting on November 10, but due to the Delta variant, the group has decided to meet virtually instead. The BSCG is currently searching for a date to hold a half day meeting virtually in November.

The Financial Disclosure Working Group is finalizing the investigators list for the upcoming annual solicitation on September 21, 2021. 

The Youth Prevention Research Working Group (YPRWG) did not meet for its scheduled call in July due to scheduling conflicts. The YPRWG will meet again in September and will discuss topics for a webinar in late 2021. 

The COVID-19 CAB Coalition is editing and finalizing videos for the community created by the COVID-19 Prevention Network (CoVPN). The videos will be shared on social media and on the COVID-19 Community Resources page on the HANC public website.
Community Partners

Russell Campbell, HANC Deputy Director
September 8: Community Partners will be hosting a webinar as part of the launch of the updated How to Read a Protocol document for CABs. Dr. Jeffrey Schouten, Neetha Morar and Jan Kosmyna will review and highlight how to critically and quickly review components of a protocol as outlined in the updated How to Critically (and Quickly) Read a Protocol document, which will be available in English, Spanish and Portuguese. Register here.

September 16: HANC/Community Partners will be partnering with NMAC in recognition of National HIV/AIDS and Aging Awareness Day to host NMAC’s Healthy Living Training webinar. This virtual training is designed to help people aging with HIV live a long, healthy and more resilient life. Each participant will receive a $20 incentive after completing a pre and post survey. Register here.
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Evaluation Working Group (EWG) discussed harmonization of network approaches to correcting site performance deficiencies and corrective and preventive action (CAPA) documentation.

The IT Best Practices Working Group (ITBPWG) reviewed the DAIDS IT Site Survey to assess current needs and gaps in technology and security practices. The group will reconvene in October to develop revised IT best practice guidelines for 2021.

The DAIDS Office of Clinical Site Oversight (OCSO) Monitoring and Operations Branch (MOB) recently released the 16th edition of the OCSO MOB Newsletter, covering topics such as the SCORE manual, obsoletion of the DAIDS Critical Events Policy earlier this year, and updates on remote source document verification and monitoring efforts. The newsletter is posted on the HANC website here.

The DAIDS OCSO MOB also released a memo on August 27 announcing the expansion of remote review of pharmacy source documents for DAIDS sponsored trials. Site pharmacists of record should communicate to daidspabpep@mail.nih.gov by September 10, 2021 whether an existing rSDV platform or a different one will be used to facilitate remote pharmacy monitoring. National/Country and IRB/EC approval is required regardless of the selected option for proceeding with rSDV.

Minor updates to the SCORE Manual were announced in a memo on August 30, including revisions to the Delegation of Duties Log template.

The Electronic Information System (EIS) Policy Frequently Asked Questions (FAQs) have been updated as of August 2021. Find the updated FAQs on the NIAID website.
Laboratory Coordination

Tyler Brown, HANC Project Manager
Launch of GCLP v4.1
On August 17 DAIDS announced the launch of DAIDS Good Clinical Laboratory Practice Guidelines (GCLP) Version 4.1. Major changes in GCLP v4.1 are listed in the Version History table on pages 62-63.

GCLP v4.1 FAQ Solicitation
DAIDS in the process of updating the FAQs for the manual and are soliciting comments/queries from staff at DAIDS-sponsored clinical research laboratories to include in the FAQ document.  The final FAQ document will be posted with the GCLP guidelines on the NIAID website.  Please email any comments/queries you have to NIAIDDCLOT@niaid.nih.gov by 16 November 2021.

LTC Membership Solicitation
ACTG/IMPAACT Laboratory Technologist Committee (LTC) is seeking new applicants for the upcoming membership term. The nomination and election process is open to both domestic and international lab staff at funded ACTG and/or IMPAACT-affiliated CTUs and CRSs. Applications are due Monday, September 20, 2021. Email labprojmgr@hanc.info for details on LTC membership position descriptions.

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

September 1: The latest issue of BTG News is now available! This is our quarterly newsletter bringing you the latest community-focused updates in HIV prevention from the HPTN, HVTN, and MTN. You’ll find it and other related news on the homepage of our Be the Generation website .  

New Investigators Working Group Webinar Series.  In September, the New Investigators Working Group is launching the “New Investigators Working Group Webinar Series” aimed at featuring the background, work, and professional trajectory of underrepresented minority researchers in the United States.  For the remainder of 2021 the NIWG will be hosting webinars on women, Latinx and Black and African American researchers. Stay tuned.

September 9: “A Conversation with Women Researchers” is the first of New Investigators Working Group Webinar Series co-organized with the Women’s HIV Research Collaborative.  The webinar will feature the background, work and professional trajectory of Dr. Lisa Bowleg, Dr. Ayana Elliott and Dr. Hong Van Tieu and will be moderated by Dr. Typhanye Dyer and Dr. Dazon Dixon Diallo.  To register click here.   

The ACTG Minority Programs
The ACTG’s Minority HIV Investigator Mentoring Program (MHIMP) is a mentored, competitive scholarship offered to minority junior investigators to help them jumpstart their careers as HIV investigators. The program was established in 1996 and expanded in 2019 to also include an International HIV Investigator Mentored Program (IHIMP) award.  Both are now a two-year award.  For the 2021 cycle, the two selected candidates were: Dr. George Yendewa for the MHIMP and Dr. Pamela Grace Mukwekwerere for the IHIMP.  After the untimely death from COVID-19 of Dr. James Hakim, the IHIMP has been renamed the James Hakim IHIMP

September 18: Legacy recognizes National HIV/AIDS and Aging Awareness Day.

September 27: Legacy recognizes National Gay Men’s HIV/AIDS Awareness Day.

As part of the collaboration between the Human Rights Campaign (HRC) Foundation’s Historically Black Colleges and Universities (HBCU) Initiative, the Legacy Project is in the process of revising the HIV Prevention Research Module to be used as a tool to educate select HBCU students and staff.

FDA Approves First COVID-19 Vaccine

August 23, 2021
The U.S. Food and Drug Administration approved the first COVID-19 vaccine. Known as the Pfizer-BioNTech COVID-19 Vaccine, it will not be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals. Read the full announcement here.

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals

August 12, 2021
The U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals. Read the full announcement here.

NIAID Launches Study of Third COVID-19 Vaccine Dose in Kidney Transplant Recipients

August 10, 2021
A pilot study, called COVID Protection After Transplant (CPAT), has begun to assess the antibody response to a third dose of an authorized COVID-19 mRNA vaccine in kidney transplant recipients who did not respond to two doses of the Moderna or Pfizer-BioNTech COVID-19 vaccine.

The lifelong immunosuppressive therapy that organ transplant recipients must take to prevent organ rejection blunts their immune response to both pathogens and vaccines. Research has shown that many organ transplant recipients do not develop antibodies against SARS-CoV-2, the virus that causes COVID-19, after receiving an authorized COVID-19 vaccine regimen. The purpose of the new study is to determine whether a third dose of one of the mRNA COVID-19 vaccines could overcome this problem for at least some kidney transplant recipients. This is particularly important because this population has a high prevalence of conditions that are risk factors for severe COVID-19, such as cardiovascular disease and diabetes. Read the full news release here.

Upcoming Webinars

How to Critically (and Quickly) Read a Protocol

September 8, 2021 at 12:00 pm PDT / 2:00 pm EDT / 8:00 pm SAST / 9:00pm EAT
Understanding a protocol is important for community members interested in engaging in clinical research. One of the challenges for community members participating in protocol development is learning how to critically review a protocol from a community perspective. CP, a group of community representatives working across the five National Institutes of Health (NIH) HIV/AIDS Clinical Trials Networks, is honored to feature the following panelists to discuss this topic: Neetha Morar, Jan Kosmyna, and Jeffrey Schouten. 

Panelists will review and highlight how to critically and quickly review the components of a protocol. This webinar is open to anyone interested in learning more about this topic. Register here.

A Conversation with Women Researchers

September 9, 2021 at 11:00am PDT / 2:00pm EDT     
The first webinar of the New Investigators Working Group Webinar Series will feature Dr. Hong Van Tieu, Dr. Lisa Bowleg, and Dr. Ayana Elliott, three outstanding women conducting HIV/AIDS research in the fields of basic science, socio-behavioral research, and community engagement. In this conversation, co-moderated by Dr. Dazon Dixon Diallo and Dr. Typhanye Dyer, the panelists will share their background, career stories, and professional trajectories to becoming researchers. Register here.

NMAC HIV 50+ Strong and Healthy & HANC: Healthy Living Training

September 16, 2021 at 10:00am PDT / 1:00pm EDT
HANC/Community Partners will be partnering with NMAC in recognition of National HIV/AIDS and Aging Awareness Day to host NMAC’s Healthy Living Training webinar. This virtual training is designed to help people aging with HIV live a long, healthy and more resilient life. Register here.


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.

New 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
November 7-9, 2021
Adherence 2021 (Orlando, FL USA)
December 2-3, 2021

Publication Highlights