Additional authors include Pedro Goicochea and Tasia Baldwin.

The Legacy Project at the Office of HIV/AIDS Network Coordination (HANC) has worked to address issues that influence the participation of underrepresented populations in HIV clinical research since 2009. The Legacy Project is led by Russell Campbell and managed by Brian Minalga, Pedro Goicochea and Tasia Baldwin. These are a few highlights of what the Legacy Project has been working on since the last update!

The Representative Studies Rubric

The NIH-funded HIV/AIDS clinical trials networks are leading the way to ensure that underrepresented populations are included in their research. Black, Indigenous, and Latinx people. Youth, cisgender women, and transgender people. People who inject drugs and people who become pregnant. Too often, these populations are excluded, neglected, or otherwise underrepresented in HIV research. And too often, researchers explain this underrepresentation by characterizing these populations as “hard-to-reach” or “mistrustful,” or don’t say anything about them at all. The HANC Legacy Project’s Representative Studies Rubric (RSR) uproots this narrative by using evidence-based methodologies to reveal systemic and institutionalized practices within clinical research that perpetuate the exclusion of underrepresented populations.

Created by the Legacy Project in 2021, the RSR is a tool consisting of a 12-item questionnaire designed to identify the extent to which individual study protocols include and exclude underrepresented populations. Led by Brian Minalga, a group of Legacy Project Working Group members performed an RSR analysis of 100% of studies that were enrolling in the ACTG, HPTN, HVTN/CoVPN, IMPAACT, and MTN in September 2021. This analysis identified gaps in inclusion practices that the Networks are now working to address. Data generated by this analysis have been presented to each Network’s leadership, who in turn have nominated representatives from their Network to join the HANC-facilitated RSR Working Group, with the goal of implementing the RSR as a protocol development tool,  ensuring that questions of inclusion and representation are considered as early as possible and throughout the protocol development process. This includes the recommendation that protocols specify the reason(s) for exclusion of any underrepresented population(s). In 2022, the Legacy Project is dedicated to supporting the Networks and all their study teams in implementing the RSR as a protocol development tool. Legacy Project activities to support RSR implementation include:

• Creating Network-specific reports detailing the performance of each study analyzed in 2021 within each of the RSR’s 12 domains;
•  Meeting with various teams within each of the Networks to present data from the 2021 RSR analysis and support forward-looking implementation;\
  
• Facilitating cross-Network RSR Working Group meetings to strategize and harmonize RSR implementation;
  
• Expanding the reach of the RSR to our partners, collaborators, and colleagues by presenting the RSR at conferences such as the International Workshop on HIV & Women and AIDS 2022.
  

The NIH-funded HIV/AIDS clinical trials networks exemplify dedication to inclusion and representation in HIV research conducted around the world. The Legacy Project team is proud to support the Networks in achieving their mission to end the HIV epidemic for all.

Podcast: H=H, the H is for Human

H=H, the podcast that centers on the human in HIV, is produced by the Legacy Project and presents content on HIV research education, affirming Black, Indigenous, and other People of Color (BIPOC) and sexual gender minority communities disproportionately impacted by HIV. Launched on November 1, 2021, the podcast has aired nine episodes:

• Episode 1: The H is for Human. This initial episode of the “H is for Human” introduces the audience to the Legacy Project, the Office of HIV/AIDS Network Coordination, the Legacy Project working groups, the Division of AIDS (DAIDS) of the US National Institutes of Health and the HIV/AIDS research networks.
• Episode 2: World AIDS Day.  H=H acknowledges World AIDS Day and features Jeff Schouten, the Director of HANC, and leadership members from each of the HIV/AIDS research networks leaders: Judy Currier (ACTG), Sharon Nachman (IMPAACT), Wafaa El-Sadr and Myron Cohen (HPTN), and Georgia Tomaras (HVTN).
• Episode 3: A conversation with Dr. Carl Dieffenbach.  This first episode of 2022 features an exclusive interview with Dr. Carl Dieffenbach, the Director of the Division of AIDS (DAIDS) at the National Institutes of Health. 
  
• Episode 4: The health of transgender people.  Transgender people are one of the groups most impacted by the HIV epidemic and for the longest time, they have been the orphans of the HIV epidemic.  Episode 4 is devoted to the health of transgender people.
  
• Episode 5: Transgender women’s health research.  This episode is devoted to research being conducted with transgender women in the context of the DAIDS research agenda. Our guests discuss how DAIDS approaches research on issues pertaining to transgender people, and talk about their studies with transgender women.
  
• Episode 6: Latinx & HIV. The National Latinx Conference on HIV/HCV/SUD. This episode reports on the 2022 Latinx Conference on HIV/HCV/SUD that took place on March 20-26 in Albuquerque, New Mexico.  We interview the conference director, Pedro Coronado, and feature three workshops that include Language Justice, training of HIV health care providers during the COVID-19 pandemic, and the National Hispanic/Latinx Health Policy Agenda 2022-2024 released by the Latino Commission on AIDS.
  
• Episode 7: Desire, Intimacy, Pleasure, and Sexual Health: An Interview with Jim Pickett. In this episode we speak with Jim Pickett, a long-time HIV/AIDS prevention advocate, who talks to us about desire, intimacy, pleasure, sexual health and new biomedical HIV prevention technologies.
  
• Episode 8: The Present and Future of HIV Vaccines. This episode presents the status of the HIV Vaccine Trials Network (HVTN) research agenda,  the role that the community plays in this process, and the relevance of the inclusion of diverse populations and vulnerable groups in the conduct of HIV vaccine studies.  In Episode 8 we interview Dr. Michele Andrasik, PhD, who leads the Social and Behavioral Science and Community Engagement Unit at the HVTN.
  
• Episode 9: National Latinx AIDS Awareness Day 2022. This episode is dedicated to Hispanic and Latinx Heritage month that is celebrated annually, and that acknowledges the contributions of these communities to the land that they have inhabited for more than five centuries.  We also observe October 15, National Latinx AIDS Awareness Day, to raise awareness of the impact that the HIV epidemic has in these communities.
  

Be the Generation to End the HIV Epidemic

Having led to the approval of pills, rings, and shots that prevent HIV acquisition, biomedical HIV prevention research has never held more promise to end the HIV epidemic. But if we aren’t working to end the HIV epidemic for all, then we’re not really working to end the HIV epidemic. People who are underrepresented in HIV prevention research are also underrepresented among those who benefit from biomedical HIV prevention tools. The Legacy Project’s Be the Generation (BTG) initiative is working to ensure that underrepresented populations have the opportunity to engage in HIV prevention research. Here’s how we’re supporting this generation to be the generation to end the HIV epidemic:

• BTG website: the place to go online for information on biomedical HIV prevention research focused on PrEP, U=U, microbicides, and vaccine research.
  
• BTG newsletter: the Legacy Project’s quarterly online newsletter bringing the latest in biomedical HIV prevention research to the community (sign up by emailing bminalga@fredhutch.org).
  
• BTG trainings: comprehensive training modules that you can download to hold a training in your community on biomedical HIV prevention research—or invite the Legacy Project to do a training for you!
  
• HBCU initiative:
  • Legacy Project representatives attended and presented the HPR Module as part of the Duke CFAR Diversity, Equity, and Inclusion Pipeline Initiative (CDEIPI) at Allen University, Claflin University and Morris College. The program is entitled: Evidence2Practice (E2P), and it focuses on leveraging implementation science to recruit HBCU/MSI students into careers in HIV research. E2P is an intensive on-campus workshop-based initiative, anchored by the HPR Module, with the goal of increasing student interest in careers in HIV science, through providing an experience-based introduction to implementation science.
  • Russell Campbell and Tasia Baldwin are working with and providing expertise to the Black AIDS Institute (BAI) on the Health Resources & Services Administration - HIV/AIDS Bureau’s (HRSA/HAB) $8 million dollar grant for a biomedical prevention 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.

Conferences

2022 HRSA Region 10 Health Equity Conference, Tacoma, Washington:

The Legacy Project participated in the first HRSA Region 10 Health Equity Conference at the University of Washington – Tacoma and virtually on Zoom Events. We presented information focused on addressing why people who inject drugs or people who use drugs are not assessed and/or are excluded from participation in HIV/AIDS clinical research.

US Conference on HIV/AIDS, October 7-11, 2022, San Juan, Puerto Rico:

The Legacy Project team went to San Juan, Puerto Rico, where they presented two workshops and one institute, reaching over 225 participants through the following sessions:

• Woke Research: Efforts to Ensure Meaningful Inclusion
• Long-acting HIV Treatment and Prevention Regimens: Present and Future
• Hard-to-reach vs. Hardly Reached Populations in HIV research

HVTN Conference, October 17-19, 2022, Seattle, Washington:

Legacy Project representatives presented the session “Creating a Legacy of Health Equity by Engaging BIPOC Populations into HIV Clinical Trials” at the HVTN Conference in Seattle.

Gender and Health: Impacts of Structural Sexism, Gender Norms, Relational Power Dynamics, and Gender Inequities:

The Legacy Project presented “The Representative Studies Rubric: 12 Steps to Enhance the Representation of Women and Other Underrepresented Populations in HIV Research” at the NIH Office of Research on Women’s Health Symposium on Gender and Health.

Announcements

In other news, Russell Campbell was promoted to Director of the Office of HIV/AIDS Network Coordination (HANC) effective October 10, 2022. Russell joined HANC in 2008, and for the past seven years has served as HANC Deputy Director, providing oversight and strategic direction for all cross-network coordination activities.

“Representation Matters” is a recent article authored by Pedro and Tasia on behalf of the Latinx Caucus, published in the Fall issue of the HIV Specialist magazine, a quarterly publication of the American Academy of HIV Medicine. The magazine has 14,000 subscribers and was presented at the US Conference on HIV/AIDS 2022.

Russell, Brian, Pedro, and Tasia hope to see you soon!

   Russell Campbell, rcampbel@fredhutch.org
   Brian Minalga, bminalga@fredhutch.org
   Pedro Goicochea, pgoicoch@fredhutch.org
   Tasia Baldwin, tbaldwin@fredhutch.org                       

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