The BRAAVE 2020 Study: Engaging Black American Communities In HIV Clinical Research

By Omoro Omoighe, MPH, and Sean Collins, MD, MS, Gilead Sciences

BRAAVE 2020 is a Phase 3 clinical trial that evaluated the specific treatment responses of virologically suppressed adults living with HIV. The study included people living with HIV who self-identified as Black, African American, or mixed race, including Black (Black, hereafter for this article).

To optimize community participation and engagement, we implemented the following support practices throughout the duration of the study:

1. Convened a meeting of leaders from community organizations across North America focusing on advocacy and care for people living with HIV and communities impacted by HIV.
2. Formed a Study Advisory Committee (SAC) that placed members of the Black HIV advocacy community at its center. Three clinical site-based personnel served on the SAC together with three members from the North American HIV Research Community Advisory Group. The committee provided longitudinal guidance to the sites and served to represent and report to the larger group of community advisors.
3. Embraced person-first communications, which put participants at the center of language used in the study rather than only characterizing participants by their HIV status.
4. Implemented cultural sensitivity training at an investigators kickoff meeting with site principal investigators, site coordinators, SAC members, and other leaders and team members involved with this study in attendance.

We’ll go into more detail about each of these four support practices below.

Meeting Of Leaders From Community Organizations

Members of the advisory convening group were public health professionals and community advocates from diverse racial and ethnic groups, ages, sexual orientations, and gender identities, including representatives of Black subgroups most impacted by HIV. Advisors reviewed and provided input on the development of the BRAAVE Study protocol, strategic site selection, and key design features, including identifying culturally relevant recruitment strategies among Black Americans, focusing on best practices for inclusive engagement of participants by sex assigned at birth (male and female), sexual orientation, and gender identity (transgender, gender-nonbinary, cisgender, among many others).

Study Advisory Committee

The prospective inclusion of the SAC was informed by best practices from our existing North America HIV Research Community Advisory Group (NA-CAG) and experience with other HIV research collaborative groups. This localized, inclusive approach provided an adaptable approach that is being integrated into Gilead’s HIV research moving forward.

The SAC was involved in the study early and often, providing input on protocol development, study implementation, and recruitment materials. The SAC played an integral role in ensuring equitable representation during the study in vital ways:

• Led continued, consistent, and open communication and engagement with community care and advocacy organizations, study sites, and study coordination team members.
• Fostered dialogue and trust amongst study collaborators and mutual appreciation of the various views of the stakeholders.

The power of the SAC’s professional and experiential connection with people living with HIV from an advocacy and clinical care lens created a forum for open discussion and team collaboration. They were included in all investigator meetings and the trust built throughout these relationships helped navigate the daily complexities of the trial in a way that could not have happened without them. But the true triumph was the united recognition of the importance of their recommendations, which will encourage similar approaches to future studies.

The representative community input was not only valued among the BRAAVE study community but also carried merit independent of its association with this particular study. Their influence has allowed Gilead to more quickly implement programmatic changes in our clinical research practice. Many of these changes were more broadly implemented, beyond BRAAVE, and are now standard or more common practice in Gilead HIV, including:

1. Consistent use of participant/person-first language (discussed in more detail in the next section)
2. Updated demographics forms to record self-identifiers in clinical trial participants, including race and gender identity and sexual orientation, and reporting/analysis of these measures in more detail
3. Earlier protocol input from the community
4. Earlier community engagement and longitudinal advisement on specific studies

The BRAAVE Study was a collaboration between 82 clinical trial sites across the U.S.,⁶ with an intentional selection of clinical sites in the Southeast region, 10% of which had never participated in an HIV clinical research study of this kind before. Enrollment was rapid and many sites asked to be permitted to enroll additional participants.

Person-First Communications

The BRAAVE Study team prioritized a person-first approach to communications that put the individual at the center of its messaging for internal and external documents, reflective of our belief that individuals are, and should be, at the center of all clinical efforts. This meant adopting a language style in all study materials and communications, both internal and external with study partners and vendors who provided a specific service to the study, that recognized study participants are not research subjects “infected with HIV.” The use of person-first language aims to encourage connection, approachability, and unity, and play a role in relegating biases, stigma, and devaluing of individuals.⁷ For these reasons, we believe person-first language is important for clinical research, particularly when reaching groups who have historically been marginalized or underserved by medical research and medical care.

Not only did a person-first approach help ensure every communication was rooted in these principles, but it also served to inform how we collect self-identification data for gender, race, ethnicity, sexual orientation, and other key demographics in clinical trials.

Cultural Sensitivity Training

A growing priority among many HIV researchers is this level of active engagement with and understanding of various patient communities, and we see a trend of coordinated efforts to bringing this understanding and connection to the center of clinical efforts. To further improve participant engagement and recruitment for the study, we included a cultural sensitivity and implicit bias training session for the study team at the pre-study investigator meeting. This educational training was tailored toward the specific needs of the BRAAVE Study and drew from well-established literature and gave tangible, evidence-based guidance for improving engagement. As a result, BRAAVE researchers were given the tools to:

• Recognize long-unrecognized bias
• Appreciate diversity among participants and approach individuals with openness to different cultural mores and lived experiences
• Recognize systematic and personal barriers to accessing clinical trials faced by members of the Black community and strategies to improve access at their site
• Recognize knowledge gaps that participants may have regarding clinical trials and how to effectively communicate what clinical trial participation involves

As we look forward to our future, we recognize that we need to act with intention to ensure diversity and inclusion in clinical research to realize our vision of, one day, potentially living in a world without HIV. The design of the BRAAVE 2020 Study can help influence future studies to not only ensure better representation of Black participants in HIV clinical research but also in ensuring all research programs are powered with the voices of all people so that when new treatments and innovations are introduced, they can potentially help those who need them the most.

References

1. New HIV Diagnoses Among the Most-Affected Populations in the US and Dependent Areas, 2018, https://www.cdc.gov/hiv/group/racialethnic/africanamericans/index.html
2. https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-in-the-south-issue-brief.pdf
3. Friedman, S. R., Cooper, H. L. F., & Osborne, A. H. (2009). Structural and Social Contexts of HIV Risk Among African Americans. American Journal of Public Health, 99(6), 1002–1008. https://doi.org/10.2105/ajph.2008.140327
4. J Natl Med Assoc., v.88(10); 1996 Oct., PMC2608128
5. Health Equity Considerations and Racial and Ethnic Minority Groups, https://www.cdc.gov/coronavirus/2019-ncov/community/health-equity/race-ethnicity.html
6. B/F/TAF; bictegravir 50mg, emtricitabine 200mg, tenofovir alafenamide 25mg tablets. JAIDS Journal of Acquired Immune Deficiency Syndromes Publish Ahead of Print; DOI: 10.1097/QAI.0000000000002731
7. Identity-first vs. person-first language is an important distinction, https://healthjournalism.org/blog/2019/07/identity-first-vs-person-first-language-is-an-important-distinction/