HANC Newsletter  |  August 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.

HANC Portal Launches!

HANC is happy to announce that the new HANC Portal has launched! Communication regarding the launch was sent to HANC collaborators on July 30. The new HANC Portal is built in SharePoint Online and provides HANC-facilitated work groups a collaborative virtual workspace along with other resources not found on the HANC public website, www.hanc.info. HANC upgraded to SharePoint Online due to Microsoft no longer supporting SharePoint 2010. Access to the portal is limited and requires log in credentials. If you're experiencing issues logging in, please contact portalsupport@hanc.info
HANC Portal Homepage

Announcement for VQA PT Labs

A new version of the HANC VQA Reagent Order Form is now available online for labs participating in the VQA Proficiency Testing Program. Instructions for setting up a new HANC Portal account, accessing the VQA Reagent Order Form online, and submitting orders can be accessed here. If you have an questions about the new order form or experience any issues submitting reagent orders, please contact labprojmgr@hanc.info.
 
Join us in recognizing the following HIV/AIDS Awareness Days this month:

August 29: National Faith HIV/AIDS Awareness Day

Faith plays a major role in the lives of many Americans. Many find faith to be a connection to a spiritual being, deity, or creator. Unfortunately for many Americans living with HIV, faith communities can turn from a place of refuge to a source of stigma and turmoil. The goal of National Faith HIV/AIDS Awareness Day is to rally all US communities representative of the Muslim, Christian, Jewish, Buddhist, Sikh, Hindu and Baha’i faiths to take a stand against stigma in their congregations and raise awareness on HIV/AIDS.
This month, the ACTG network launched A5391, the DoIT study, which evaluates the effects of an ARV change among people living with HIV who experience excessive weight gain. To read the press release, please click here.
 
The 11th International AIDS Society (IAS) Conference on HIV Science took place virtually July 18-21. German Chancellor Angela Merkel delivered the opening address. Other keynote speakers included Dr. Anthony Fauci, Director, U.S. National Institute of Allergy and Infectious Diseases, and Tedros Adhanom Ghebreyesus, Director General, World Health Organization. During the four-day conference, HPTN researchers presented seven abstracts showcasing HPTN 061, HPTN 068, HPTN 082, HPTN 083-02, HPTN 084, and HVTN 704/HPTN 085 (AMP). Click here to view presentations.
 
The Mosaico Study, also known as HVTN 706/HPX3002, is a multi-country HIV vaccine study testing whether an investigational HIV vaccine regimen can prevent HIV acquisition in cisgender men and transgender persons who have sex with cisgender men and/or transgender persons. The study is being conducted in Argentina, Brazil, Italy, Mexico, Peru, Poland, Puerto Rico, Spain, and the United States. As of July 2021, the study is over 85% enrolled, and Argentina, Brazil, Mexico, Poland, and Spain have reached their enrollment commitments. The study is expected to complete enrollment September 2021. The communities and research teams involved in this study are hard at work to find an answer to the scientific questions about safety, immune response, comfortability with injections, and efficacy of the vaccine regimen. Answers to these questions are expected in 2024. More information about the Mosaico study can be found at www.mosaicostudy.com.
 
The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network announced the presentation of important findings from IMPAACT 2019 at the International Workshop on HIV Pediatrics 2021 and the 11th IAS Conference on HIV Science.

IMPAACT 2019 is a Phase I/II open-label, multicenter, multiple dose study of dolutegravir/lamivudine/abacavir fixed dose combination tablets in treatment-experienced and treatment-naïve children living with HIV who are less than 12 years old. The study is taking place in Botswana, South Africa, Thailand, and the United States. 

Study Results

The dose of abacavir/dolutegravir/lamivudine provided in each weight band was confirmed. Findings through the first four weeks on-study showed that:  
  • Children are able to take the abacavir/dolutegravir/lamivudine formulations being studied.
  • The abacavir/dolutegravir/lamivudine formulations are safe and well-tolerated in children.
  • The abacavir/dolutegravir/lamivudine formulations achieve targeted pharmacokinetic exposures in children.  
More presentations from the Workshop and IAS 2021 can be viewed here.
 
In case you missed it, interim results of the REACH (MTN-034) study of the dapivirine vaginal ring and oral PrEP in adolescent girls and young women were presented as a late-breaker oral abstract presentation at the IAS 2021 : 11th IAS Conference on HIV Science, held virtually 18-21 July. The study was also featured by IAS in its official press conference on 15 July. (MTN’s press release on REACH interim results can be accessed here). Another highlight of the meeting was a late-breaker ePoster reporting safety data from the first cohort of participants in the DELIVER (MTN-42) study of the ring and oral PrEP in pregnant women.

Just days before IAS, the Medicines Control Authority of Zimbabwe (MCAZ) announced its approval of the dapivirine vaginal ring – the first country to do so!

In other news, as of 30 July, the B-PROTECTED (MTN-043) study has completed accrual with a total of 197 breastfeeding mothers and infant pairs enrolled. Follow-up of participants is expected to be completed in November.
 
Behavioral and Social Sciences

Greg Davis, HANC Project Manager
The Behavioral Science Consultative Group (BSCG) welcomed two new members in July. Dr. LaRon Nelson and Dr. Kenneth Ngure have joined the BSCG and will be participating in the monthly meetings. The BSCG looks forward to collaborating with Drs. Nelson and Ngure. The BSCG is also pleased to announce the publication of its paper, "Individual health behaviours to combat COVID-19 pandemic: Lessons from HIV socio-behavioural science" in the Journal of the International AIDS Society. The article is open access so please share widely with your networks.

The Financial Disclosure Working Group is updating Network investigator lists to prepare for the 2021 annual solicitation. The annual solicitation will occur on or about September 21, 2021.

The Youth Prevention Research Working Group (YPRWG) would like to thank the sites that responded to the site survey on adolescent research earlier this year. The YPRWG is analyzing the results and plan to release a report later this year and it will be shared with HANC collaborators.

The COVID-19 CAB Coalition (CCC) continues to meet monthly to discuss a variety of issues relating to COVID-19. The group provides updates on ongoing studies and community advisory board activities. Recent major topics of discussion include addressing misinformation and the use of vaccine passports. 
 
Community Partners

Russell Campbell, HANC Deputy Director
Community Partners has updated its Organizational Guidelines. CP is also hosting a webinar as part of the launch of the updated How to Read a Protocol document for CABs – Stay tuned for details.

Community Partners has been invited to provide input into the NCI Division of Cancer Prevention (DCP) US-Latin American-Caribbean HIV/HPV-Cancer Prevention Clinical Trials Network (ULACNet)’s Recruitment and Retention Working Group community engagement efforts
 
Cross-Network Coordination

Milan Vu, HANC Project Manager
The Cross-Network Communications Working Group (CWG) reviewed network highlights from the International AIDS Society (IAS) Conference in July 2021. A catalog of all network abstracts presented at the conference is listed here on the HANC website.

The Cross-Network Data Management Center Working Group (DMCWG) discussed ongoing efforts related to bidirectional safety data reconciliation. SDMC members also continue to engage in the Cross-Center Protocol Deviation Working Group in collaboration with DAIDS Office for Policy in Clinical Research Operations (OPCRO) in order to develop a cross-network approach to capture and management of protocol deviations.

The IT Best Practices Working Group (ITBPWG) distributed a survey to DAIDS sites to assess site IT capacity and infrastructure. Thank you to all sites who responded to the survey. Results are being summarized and discussed amongst the working group to determine priority areas for guidance and next steps.

The Cross-Network Site Coordinators Working Group (SCWG) discussed updates on the DAIDS Co-Enrollment Prevention requirements, which is slated to be announced this fall.

Minor updates relating to Quality Management, Pharmacy Requirements, and Laboratory Requirements are now implemented in the DAIDS SCORE Manual. A memo describing these changes was distributed to network leadership and operations centers on June 28th, and is also posted on the HANC website under DAIDS Resources, OCSO Resources.
 
Laboratory Coordination

Tyler Brown, HANC Project Manager
The Clinical Pharmacology Quality Assurance Advisory Board (CPQAAB) met in July to discuss changes to the CPQA Program’s proficiency testing acceptability threshold. The meeting featured a webinar presentation by Dr. Susan Rosenkranz (Frontier Science/SDAC) focused on the implications of changing the acceptability threshold of the CPQA’s Antiretroviral Proficiency Testing Program from 20% to 15%. 

The Lab Focus Group (LFG) met with the DAIDS Clinical Laboratory Oversight Team (DCLOT) in July to discuss lab systems under the DAIDS EIS Policy, audit readiness and training requirements under GCLP v.4.1, and the new pSMILE Web IR System.

The Lab Technologists Committee (LTC) held two meetings in July, which centered on ACTG protocol updates, resolving reagent/lab supply issues, LDMS validation requirements under the DAIDS EIS Policy, and GCLP v4.1 training requirements for lab staff. 

Announcement for VQA PT Labs
A new version of the HANC VQA Reagent Order Form is now available online for labs participating in the VQA Proficiency Testing Program. Instructions for setting up a new HANC Portal account, accessing the VQA Reagent Order Form online, and submitting orders can be accessed here. If you have an questions about the new order form or experience any issues submitting reagent orders, please contact labprojmgr@hanc.info.
 
The Legacy Project

Brian Minalga and Pedro Goicochea, HANC Community Engagement Officers
New Resource: The Representative Studies Rubric (RSR)
The Legacy Project has designed a new tool to address issues of representation in clinical research. Learn more about the RSR on the HANC public website.

HPTN 094 Bridge Fellowship
The Bridge Fellowship is a two-year scientific training focused on the intersection of addiction, infectious diseases, comorbidities, and structural determinants of health through involvement in HPTN 094 “INTEGRA: A Vanguard Study of Integrated Strategies for Linking Persons with Opioid Use Disorder to Care and Prevention for Addiction, HIV, HCV and Primary Care”. The fellowship provides opportunities for early career investigators from underrepresented racial, ethnic, sexual, and/or gender minority communities to participate in the HPTN 094 protocol team and be mentored by established senior scientists, Drs. Nabila El-Bassel and Steve Shoptaw. Fellows are: 
  • Dr. Abenaa Jones, Assistant Professor in the Department of Human Development and Family Studies, Pennsylvania State University; 
  • Dr. Amaya Perez-Brumer, Assistant Professor (tenure-stream) in the Division of Social and Behavioural Health Science at the University of Toronto; 
  • Dr. Sabrina L. Smiley, tenure-track Assistant Professor of Public Health at San Diego State University School of Public Health.

Legacy Project Activities
August 10: HANC staff and the DAIDS Cross-Network Transgender Working Group are convening a call with data managers and clinical staff to discuss toxicity measures for transgender participants in network research. Stay tuned for updates and potential new guidelines.

August 12: Brian Minalga and Russell Campbell will participate in a virtual book release party for Male Same-sex Sexuality and HIV in Sub-Saharan Africa, edited by Dr. Theo Sandfort. Brian and Russell co-authored a chapter in the book, “Conducting HIV Research with Sexual and Gender Minorities in Sub-Saharan Africa: Experiences from Malawi,” along with Daniel Gondwe, Jonathan Lucas, and erica hamilton. The chapter is based on lessons learned from HPTN 075

August 24: Abstracts are due to the 2021 Virtual Inter-CFAR Women & HIV Symposium. The Women’s HIV Research Collaborative plans to submit 1 or 2 abstracts. 

August 25: Updates are due from the HPTN, HVTN, and MTN for inclusion in the quarterly Be the Generation newsletter and website.

August 29: Legacy recognizes National Faith HIV/AIDS Awareness Day.

WHO report on clinical features and prognostic factors of COVID-19 in people living with HIV hospitalized with SARS-CoV-2 infection

HIV was independently associated with a higher risk for severe or critical COVID-19, according to a World Health Organization (WHO) analysis presented at the 11th International AIDS Society Conference on HIV Science (IAS 2021). In a study of people living with HIV in Asia, Europe, Africa, and South America who also were hospitalized for COVID-19, HIV infection was linked with an increased risk of severe or critical COVID-19 presentation (OR 1.13, 95% CI 1.09-1.17), after adjusting for age, sex and comorbidity burden, reported Silvia Bertagnolio, MD, of WHO. 

In addition, HIV was tied to a higher risk of inhospital mortality (adjusted HR 1.30, 95% CI 1.24-1.36), she said during a press conference at the International AIDS Society (IAS) virtual meeting. "This 30% increase risk of dying in the hospital among persons living with HIV is independent of age, gender, severity of disease at admission, and of comorbidity," Bertagnolio explained. IAS President Adeeba Kamarulzaman, MBBS, the press conference moderator, called the inhospital mortality rate "astonishing...this study underscores the importance of countries including all people living with HIV in the list of priority populations for national COVID-19 vaccine programs." Read news coverage here and find the full WHO report here .

SARS-CoV-2 Variants in Patients with Immunosuppression

A Sounding Board article in the NEJM authored by Lawrence Corey, M.D., Chris Beyrer, M.D., M.P.H., Myron S. Cohen, M.D., et al. noted that: Since a large number of persons globally are living with innate or acquired immunosuppression, the association between immunosuppression and the generation of highly transmissible or more pathogenic SARS-CoV-2 variants requires further delineation and mitigation strategies. They conclude that:  Viral adaptation to the human host and viral escape variants are a threat to patient health and Covid-19 pandemic control. Scientific attention to the intersection of SARS-CoV-2 biologic features, host immunologic characteristics, and the unique concerns of immunocompromised hosts is warranted. Additional considerations for immunization and other mitigation strategy guidelines for immunocompromised patients and their close contacts are also needed. Read the full article here.

Vaccines for HIV and SARS-CoV-2: How Can We Build Upon Our Successes and Failures?

The Human Vaccines Project hosted a webinar with Dr. Carl Dieffenbach, Ph.D., Director, Division of AIDS at NIAID on July 15, 2021 to talk about how to leverage our successes and failures in HIV and SARS-CoV-2 vaccine research. Watch the recording here.
 

Training

DAIDS Good Clinical Practice (GCP) eLearning

The new DAIDS GCP eLearning Course is available on the DAIDS Learning Portal. This course fulfills both DAIDS training requirements on Human Subjects Protection (HSP) and Good Clinical Practice (GCP) and is currently available in English.

Spanish and Portuguese offerings of the course will be available soon - stay tuned for a future announcement regarding the release of these translated eLearning courses.
 

Conferences & Meetings

October 18-20, 2021
2021 HVTN Conference (Seattle, WA USA)
October 20-22, 2021
October 28-31, 2021
US Conference on HIV/AIDS (Washington, DC USA)
November 7-9, 2021
Adherence 2021 (Orlando, FL USA)