HANC Newsletter  |  December 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.

H=H Episode 2: World AIDS Day

Episode 2 of "The H is for Human" acknowledges World AIDS Day and what it means for HIV therapeutics, prevention and vaccine research in 2021 that marks the 40th anniversary of the CDC's Morbidity and Mortality Weekly report of a disease that later was defined as AIDS.  This episode features Jeff Schouten, the Director of HANC, and the HIV/AIDS research networks leaders: Judy Currier (ACTG), Sharon Nachman (IMPAACT), Wafaa El-Sadr and Myron Cohen (HPTN) and Georgia Tomaras (HVTN). Listen online at RedCircle or Spotify.
 

Abraham Johnson Recognized as 2021 POZ 100 Advocate

Congratulations to Abraham Johnson for being selected for the 2021 POZ 100! The POZ 100 spotlights longtime advocates in the fight against HIV, recognizing their outstanding work and service in the HIV/AIDS community. Abraham is currently the HIV community engagement officer for the Treatment Action Group (TAG), and served as a member of the HANC Legacy Project Working Group under his previous role at FHI 360 as the community programs associate for the HPTN, IMPAACT, and MTN.
 

Thank you to the MTN

November 30 marked the last day of the MTN as an independent HIV/AIDS clinical trials network. Take "A Look Back..." through the stories of the communities, researchers, staff, and study participants who were part of the MTN family over the years, and read the MTN's December update below for a recap of where it all started, and where the MTN will go from here. HANC's Brian Minalga also pens a farewell to the network, reflecting on the MTN's legacy and countless contributions to the field of HIV prevention and social justice.
Last month, the ACTG announced the launch of A5404, a clinical trial studying how prior infection with SARS-CoV-2 and receiving either an investigational COVID-19 therapy or placebo/active comparator affects participants' immune responses to mRNA COVID-19 vaccines. Read more here.

Now enrolling: A5362 (CLO-FAST)! The ACTG announced the launch of A6362 (CLO-FAST), a clinical trial studying a three-month clofazimine- and high-dose rifapentine-containing treatment regiment for people with drug-susceptible tuberculosis. This is the first TB regimen based on preclinical evidence of effectiveness that is less than four-months long to be studied in a clinical trial! Read more here

Congratulations to our very own ACTG Community Members, Danielle Campbell and David Jax Kelly for being recognized among POZ Magazine's Top 100 Black Advocates! Read more here.

The ACTG congratulates the winners of the 2021 ACTG Awards! The winners were announced on November 9, 2021 at the 2021 ACTG Leadership Retreat in Los Angeles, California. If you missed the emotional live presentation, you can view the presentation and listen to remarks from the recipients here!

  • The 2021 James Hakim International Investigator Mentor Award recipient is Patrice Severe, MD from our Les Centres GHESKIO CRS in Haiti.
  • The 2021 Kevin Robertson Memorial Award recipient is Scott Letendre, MD from our UCSD Antiviral Research Center CRS.
  • The 2021 Charles van der Horst Humanitarian Award recipient is Shahin Lockman, MD, MSc from our Botswana-Harvard School of Public Health-AIDS Initiative Partnership CTU.
  • The 2021 John Carey Young Investigator Award recipient is Cecilia Kanyama, MBBS, FCP from our Malawi CRS.
  • The 2021 Constance B. Wofsy Women's Health Investigator Award recipient is Eileen Scully, MD, PhD from our Johns Hopkins University CRS.
  • The 2021 Donna Davis Community Award recipient is Martha Weaver from our Network Coordinating Center.
 
 
Two HPTN Scholars recently participated in a panel discussion at the 2021 International Conference on Stigma entitled “Ending the Epidemic for Who: Considerations for Uplifting Youth Voices.” Dr. Allysha C. Maragh-Bass, a 2018-2019 Domestic Scholar, is a scientist at FHI 360, an adjunct professor at Duke Global Health Institute in Durham, N.C., and a visiting professor at UC San Francisco. Dr. Typhanye V. Dyer, a 2011-2012 Domestic Scholar, is an associate professor in the Department of Epidemiology and Biostatistics at the University of Maryland School of Public Health.
 
HPTN 084 protocol co-chair Dr. Mina Hosseinipour recently completed the Tour of Karamoja, Uganda’s ultimate wilderness bicycle tradition, biking nearly 500 kilometers. She was recognized as the 'youngest rider' and 'strongest female cyclist.' Dr. David Serwadda, HPTN Executive Committee member, joined the second half of the Tour, biking nearly 200 kilometers and using the event to raise money for young girls' education in Karamoja. He took up cycling during the COVID-19 global epidemic. Dr. Hosseinipour reports both she and Dr. Serwadda discussed HIV prevention during evening campfires.
 
IMPAACT 2028 Opens to Accrual
IMPAACT 2028 has opened to accrual. IMPAACT 2028 is an observational study to characterize a cohort of children who may participate in future research related to HIV remission or cure. Children in this study will have previously received early or very early treatment for HIV in other IMPAACT studies or other studies sponsored by the United States National Institutes of Health.

The study is taking place at 33 sites in Botswana, Brazil, Haiti, Kenya, Malawi, South Africa, Tanzania, Thailand, Uganda, the United States, and Zimbabwe.

IMPAACT Hosts Call to Action Webinar with the WHO
On 1 December, World AIDS Day, the IMPAACT Network partnered with the World Health Organization (WHO) to promote a Call to Action – asking key stakeholders to accelerate the study of new HIV antiretrovirals (ARVs) in pregnant women. Learn more and watch the webinar video here.
 
After 15 years (and five months) as an NIH-funded HIV/AIDS Clinical Trials Network, November 30 came the day that the MTN would be no more.

The National Institute of Allergy and Infectious Diseases established the MTN in 2006 with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health. As a network, its mission was to conduct rigorous clinical trials intended to support the potential licensure of microbicides – products used in the vagina or rectum to protect against the sexual transmission of HIV.

Indeed, included among the 43 protocols implemented by the MTN were studies of the monthly dapivirine vaginal ring – the first biomedical prevention product designed specifically for cisgender women which is now under regulatory review in several African countries and been recommended by the World Health Organization as an additional HIV prevention option for women. Its research portfolio also includes the first studies involving pregnant and breastfeeding women and a suite of studies focused on rectal microbicides and delivery methods. From the outset, the MTN sought to integrate social and behavioral research into its scientific agenda, and of its 43 protocols, 34 included a behavioral component or designed specifically for gaining insight into people’s behaviors, needs and preferences for HIV prevention. 

The MTN hasn’t completely closed shop just yet, so save the good-byes! Its DELIVER (MTN-042) study of the dapivirine and Truvada as daily PrEP in pregnant women remains ongoing at four clinical research sites in Malawi, Uganda, South Africa and Zimbabwe and will continue to be supported by DAIDS into the next year through funding being allocated through the HPTN, as will other unfinished business. This includes primary data analysis and dissemination of results of the REACH (MTN-034) and B-PROTECTED (MTN-043) studies; management and destruction of some 350,000 samples still in storage at trial sites and Laboratory Center facilities (more than a million samples were collected during MTN’s tenure) and ensuring all regulatory requirements have been met. 
 
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Youth Prevention Research Working Group is finalizing the report from the site survey that was conducted earlier this year. Once the report is finalized, it will be made available to HANC collaborators on the public website.

The Behavioral Science Consultative Group (BSCG) would like to thank Dr. Carlos del Rio for his contributions to the BSCG. Dr. Carlos del Rio's term with the BSCG ended on November 30, 2021. The BSCG is planning to hold a face-to-face meeting in Q1 2022. The BSCG is currently deciding between two dates and locations for the F2F meeting. 

The COVID-19 CAB Coalition rescheduled its November call until December due to the Thanksgiving holiday in the US. Community COVID-19 resources can be found here. Recently added to the resources are community videos created by the CoVPN. You can find the videos under COVID-19 CAB Coalition Partners.
 
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners is delighted to announce the following new members to Community Partners:
  • Mark  Lungu has been selected to represent the HVTN.
  • Beauty Nerupfunde has been selected to represent the HVTN.
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Communications Working Group (CWG) discussed the transition of MTN activities at the end of this year and plans for annual network meetings in 2022. Known dates for the various network meetings are posted on the Upcoming Events page on the HANC website.

Dr. Jim Kublin, Executive Director of the HVTN and CoVPN, joined the Cross-Network Site Coordinators Working Group (SCWG) in November to present on the Red Ribbon Registry for research volunteers interested in HIV clinical research trials. The SCWG also discussed site interests regarding implementation of electronic informed consent and conducting hybrid or remote study visits.

The Cross-Network Data Management Working Group (DMCWG) discussed updates to ongoing COVID-19 studies, experiences with eCOA, CTMS, TMF, and TSM tools, and other DMC activity updates.

The IT Best Practices Working Group (ITBPWG) is reviewing the draft document outlining IT security best practices for DAIDS sites and laboratories. The proposed guidelines follow a risk-assessment based approach to help sites through the process of identifying, protecting, detecting, responding, and recovering from cybersecurity risks, and are expected to be published near the end of 2021/early 2022.

Minor Updates to the DAIDS SCORE Manual
A memo was released on November 8, 2021 detailing minor revisions to the DAIDS SCORE manual requirements for training documentation. The update also includes a clarification on synchronization of clocks in the SCORE Manual FAQ. Find the memo on the HANC website.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
HANC sends their gratitude to Laboratory Technologists Committee (LTC) member Dr. Sikhulile Moyo and his colleagues at the Botswana Harvard HIV Reference Laboratory for their critical work in the discovery of the Omicron COVID-19 variant – in November Dr. Moyo and his team in Gaborone, Botswana were the first to genetically sequence and alert the world to the variant. Read more here.

In November DAIDS Clinical Laboratory Oversight Team (DCLOT) issued a memo that clarifies Good Clinical Laboratory Practice (GCLP) training requirements for non-lab personnel (such as nurses) who perform specimen processing and/or rapid testing in the clinic or clinical laboratory. Follow this link to access the memo online.

The HANC-LTC SOP Working Group held three conference calls in November to continue developing a new standard wording guide for ACTG and IMPAACT protocol Lab Processing Charts (LPCs) – the new guide is expected to be published by March 2022.

The Lab Focus Group (LFG) met in November to discuss site requirements for GCLP v4.1 audits and Primary Network Laboratory (PNL) assignments - a new version of the PNL Assignments List is expected to be published by the end of 2021. More information about PNLs, as well as the current version of the PNL Assignments List, can be accessed on the PNL Assignments page on the HANC public website.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
Legacy is proud to report some of our achievements this year. We reached over 7,000 stakeholders through approximately 200 activities, including:
  • 17 presentations at local and national conferences
  • 3 publications in academic journals
  • 16 other publications focused on community engagement and building HIV clinical research capacity
  • 2 episodes of the Legacy Project podcast “H=H, the H is for Human, the podcast that centers on the human in HIV” 
  • Creation of the Representative Studies Rubric, a tool to enhance representation in clinical research
  • Over 20,000 hits on our social media pages
Read on to see what we have in store coming up!

Dec 1: The World AIDS Day issue of the Be the Generation Newsletter is available on bethegeneration.org. Check it out for reflections on HIV prevention research, including our farewell to the MTN.

Dec 1: Episode 2 of “H=H, the H is for Human” podcast commemorating World AIDS Day 2021 is available here

Dec 3: The Latinx Caucus of the Legacy Project will be presenting “Respuesta Comunitaria al COVID-19 en Latinx en los Estados Unidos” (Community Response to COVID-19 in Latinx in the United States) at the US Conference on HIV/AIDS at 1:15 pm ET.
 

Training

Frontier Science, the data management center for the ACTG and IMPAACT networks, has released several new eLearnings on the Frontier Science Portal. Courses for new investigators include modules focused on Data Freeze and Data Lock and the Study Build Process. The General Clinical Data Management courses are geared toward clinical site staff, and currently offer the following topics:
  • Electronic Data Capture: Study Start-up and Planning Activities
  • Data Standards Implementation
  • Targeted Source Data Verification
 

Job Opportunities

Applications due January 17, 2022
The Summer HIV/AIDS Research Program (SHARP) is excited to welcome a new cohort of six undergraduate/immediate post-graduate scholars from underrepresented minority backgrounds for a paid, mentored HIV research internship this summer 2022. Applications are now open and accepted until January 17, 2022. See the SHARP flyer for more information and apply on the SHARP website.

SHARP is funded by the National Institute on Drug Abuse (NIDA) and co-hosted by Bridge HIV and local research partners at the San Francisco Department of Public Health (SFDPH) and University of California, San Francisco (UCSF).
The Black AIDS Institute (BAI) was the sole recipient of the  Health Resources & Services Administration - HIV/AIDS Bureau’s (HRSA/HAB) eight million dollar grant for a biomedical justice initiative. This four-year project led by BAI, in partnership with Cardea and the Legacy Project, aims to develop a national training program for students from Historically Black Colleges and Universities (HBCUs) to expand and diversify a strong pipeline of HIV advocates and leaders equipped to end the HIV epidemic.

As part of this effort, the Legacy Project is hiring a Community Engagement Project Coordinator to develop campus-specific strategies to address knowledge gaps around HIV acquisition and prevention and develop educational opportunities at HBCUs through academic and community-based partnerships. Find more details and apply here.
HPTN 096 is a community-randomized study that will evaluate an integrated strategy comprised of four interventions. These interventions aim to increase HIV testing, the use of pre-exposure prophylaxis (PrEP) and viral suppression rates among Black men who have sex with men (MSM) (> 15 years old) living in the southern United States (US).

The HPTN 096 study team is establishing a HIV-status neutral peer to peer support program and is seeking a licensed supervisor, who is familiar with the cultural factors and health disparities that Black MSM face in the South. This position will be responsible for providing training, supervision, coaching, mentoring and oversight to peer support workers, who, in turn, will provide motivational, emotional, and informational support to Black MSM and help them connect with Black MSM-centered health and support services. View the full job description here. To apply, forward a cover letter and resume/CV to 096_PS_Queries@hptn.org with the subject line Clinical Supervisor Position.
 

Conferences & Meetings

December 2-3, 2021
February 12-16, 2022
May 4-6, 2022
HVTN Annual Meeting (Washington, DC USA)
June 4-8, 2022
HPTN Annual Meeting (Hybrid: Washington, DC USA)
June 13-17, 2022
Annual ACTG Network Meeting (Washington, DC USA)
 

Recent Network Publications

Ethics and Models of Care
Prevention
Social and Behavioral Science
Therapeutics