By: Aziel Gangerdine, HVTN Core, Seattle, WA, USA
At approximately 8:30 a.m. I stepped into the cool clinic entrance of the Crofoot Research Center, Inc. and was instantly relieved from the city’s humidity, the effects of which had become noticeable by the damp blotches on my dress shirt. I had arrived at one of the more than 50 global clinical trial sites participating in the Mosaico study after my flight from Seattle, Washington landed in Houston, Texas a little shy of 4 hours and 40 minutes. The next 72 hours of invaluable experiences, and what seemed fleeting, were inscribed to my memory.
A milestone, in the phase III HIV vaccine efficacy study announced earlier in July by a consortium of global partners, was scheduled to take place. The study team led by Dr. Gordon Crofoot would inject Mosaico’s first study participant setting in motion the testing of an investigational mosaic-based vaccine regimen with the goal of determining if it is effective in preventing the transmission of HIV infection in men who have sex with men (MSM), and transgender individuals aged 18-60.
During the initial hours of the first 24 I was immersed in facts and the tale of how a legacy was built dating back to 1985 when Dr. Crofoot first started doing research with the initial testing of AZT as a single agent for the treatment of HIV. More than three decades on and the Center is a beacon of hope in the community of Houston offering research and LGBTQ focused healthcare.
In 2017 an estimated 1,133 new HIV diagnoses were documented in the city of Houston of which Black and Hispanic/Latinx communities bear a disproportionate burden, with an estimated 48.2%, 34.8% and 12.9% of new HIV transmissions reported among Black, Hispanic/Latinx, and white communities, respectively1.
“While Houston has some of the leading medical treatment and research facilities in the world, we still bear a disproportionate burden in the amount of persons living with and affected by HIV,” said Maggie White, MPH APRN FNP-BC AAHIVS, study spokesperson for the Crofoot Research Center, Inc. Among transgender communities, 12 transgender men (assigned female at birth) and 252 transgender women (assigned male at birth) were reported to be living with HIV in Houston in 2017 1.
“We hope that by conducting this study in Houston, we can celebrate and reflect the diversity of our city in HIV prevention research”, concluded White.
Time marched on and 48 hours drew close. I listened to more facts and figures at the dinner table and was indulged by the team’s enthusiastic conversation about working with the community they serve. Since 1985, the Center had conducted more than 130 clinical trials, the majority being interventional HIV, hepatitis C virus (HCV), hepatitis B virus (HBV) and some other indications.
I needed to understand how the team earned the support and involvement of the community on their scientific journey to conduct numerous clinical trials.
“We view community engagement as being the tree trunk which supports HIV research,” said Frankie Garcia, Study Coordinator for the Crofoot Research Center, Inc. “The tree trunk has many roots which reaches out to all the different groups representative of our community”, Garcia explained in a pleasant demeanor and warm smile.
“Our networks are strong, and we have been fortunate to have earned the trust of our community over many years of advocacy, love, and mutual respect”, Garcia added.
At approximately 9:30 p.m. (CDT) on Thursday, November 21, 2020 the first study participant enrolled in the Mosaico study was injected at the Crofoot Research Center, Inc. At the time of print, study participants were enrolled across clinical trial sites in the United States, Argentina and Spain. These include Hope Clinic (Atlanta), Fenway (Boston), Orlando (Florida), Philadelphia (Pennsylvania), Rochester (New York), Bridge HIV (San Francisco), Montbau (Barcelona), Buenos Aires (Argentina), Logan Circle (Washington DC), and the Crofoot Research Center, Inc. (Houston).
"For many of us on the team, being part of this endeavor and here for this first injection, is an unimaginable gift,” Charles Sydnor, Project Manager for the Crofoot Research Center, Inc. conveyed as we stood in the clinic hallway having been present for the first study injection. “Whatever the outcome of the study, we all can look back and say we bore witness and were able to contribute to the goals of the study. Being part of this program is one of the highest points in our careers”, Sydnor concluded.
72 Hours - it was fleeting but I recall the friendly introductions, sincere conversations and the abundance of information enthusiastically shared by the Crofoot Research Center, Inc. study team. I will treasure most the moment of audible silence in the clinic’s hallway as we all waited with bated breath to receive confirmation of the first injection, penning a page in history of a study participant and a committed team who are part of a global endeavor to help end HIV.
Profile of Mosaico (HVTN 706/HPX3002)
- Study teams aim to enroll 3,800 cisgender men and transgender people who have sex with cisgender men and/or transgender people between the ages of 18-60 years.
- The study will take place at over 50 trial sites in the U.S., Mexico, Brazil, Peru, Argentina, Poland, Italy and Spain.
- Mosaico will evaluate an investigational mosaic-based vaccine regimen with the goal of determining if it is effective in preventing HIV infection in MSM and transgender individuals.
- Initial results from the study may be available by 2024.
- Public-private partnership making the search for a safe and globally effective preventive HIV vaccine possible
- Mosaico is supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., part of the Janssen Pharmaceutical Companies of Johnson & Johnson; the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH); and the NIAID-funded HIV Vaccine Trials Network (HVTN). Additional partners providing support include the U.S. Army Medical Research and Development Command (USAMRDC).
Responding to challenges to maintain study momentum
On March 11, 2020 the World Health Organization declared COVID-19 a global pandemic following the deaths of a significant number of people around the world. The situation rapidly evolved, and countries responded with unprecedented measures to stop the transmission of SARS-CoV-2 the virus that causes COVID-19.
Within days following the declaration of a pandemic, the HIV prevention research enterprise implemented measures to mitigate the impact of COVID-19 on the conduct of clinical trials. Mosaico is one of the many HIV clinical trials, coordinated by the HIV Vaccine Trials Network (HVTN), that is impacted by COVID-19.
At the time of going to print the leadership of the Mosaico Study implemented measures to minimize the impact of COVID-19 on the study and prioritize the safety of study participants and the clinic team. The leadership held weekly updates with the trial sites to inform decision making as the circumstances evolved.
I reached out to Stephaun Wallace, Ph.D., who is the HVTN’s Social and Behavioral Sciences Junior Investigator Liaison, and who directs and manages community engagement for the Mosaico Study globally. It was fitting to get Stephaun’s insights on the value and importance of community engagement strategies to help maintain the momentum of a clinical trial in consideration of the impact of COVID-19 and how to keep communities engaged.
Each clinical trial site, via their community engagement plan and Community Advisory Board, are equipped with the tools and strategies to communicate updates or changes in the conduct of clinical trials when the need arises for any reason, including the recent impact of COVID-19.
“There is no one-size fits all approach to the specific activities to educate communities, and recruit and retain study participants”, said Stephaun Wallace, PhD., HVTN Social and Behavioral Sciences Junior Investigator Liaison. “Each clinical trial site develops a unique community engagement plan, which is informed and approved by the local community, so that it represents the voices and social norms of that local community,” Wallace pointed out.
A guiding principle of the HVTN is the need for a strong bi-directional partnership between the clinical trial site and the local community to help facilitate innovation and advances in HIV biomedical research, foster trust and an understanding between the site staff and local community, to ensure that research strategies honor and respect the myriad of differences among study participants. This partnership is underscored by the unique community engagement plan that each site develops.
"Every person is unique, and every geographic location where our sites are working to engage local communities is also unique and diverse. Our strategies to reach those persons must also be unique and diverse”, Wallace concluded.
Source 1: aidsvu.org
Aziel Gangerdine is the Director of Communications for the HVTN.