Supporting Prevention and Treatment for HIV-Affected Teens
HIV prevention and treatment can be uniquely challenging in resource-limited settings in Brazil and Sub-Saharan Africa. Further analyses are critical to determining how best to approach young adult and adolescent populations in these areas. As U.S. health agencies looked to address this problem and its associated gaps in needed data, they leveraged Westat’s years of experience as a contractor to the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Coordinating an Innovative Adolescent Health Initiative
NICHD, the National Institute on Minority Health and Health Disparities, the Office of Behavioral and Social Sciences Research, and the Office of AIDS Research joined forces to sponsor the Prevention and Treatment Through a Comprehensive Care Continuum for HIV-Affected Adolescents in Resource Constrained Settings (PATC³H), an initiative designed specifically to address the challenges of HIV prevention in young adult and adolescent populations. Made up of eight research teams, the program facilitates research of needs and interventions that may help reduce HIV incidence rates among young adults and adolescents. It also helps to maximize the impact of research in HIV prevention and care for youth living in resource-limited geographic areas.
Westat was tapped to serve as coordinator for the program, providing a broad range of support activities including site monitoring, regulatory responsibilities, data harmonization, IT support, and overall project management.
Improving Regulatory Efficiency
Westat developed customized functionality for the PATC³H website that enables clinical study sites to upload study-specific essential documents for Westat’s review and protocol registration. As part of this project, the team also developed an automatic expiration-tracking system, allowing Westat to notify the sites about impending expiries. This tailored web functionality helped to expedite and streamline otherwise time-consuming regulatory administrative processes, allowing research teams to focus on finding comprehensive, synergistic solutions to reducing HIV incidence among young adults and adolescents.
Site Monitoring Solutions
To navigate complex remote site monitoring issues, we seamlessly developed and implemented new procedures. These included surveying the sites to assess remote monitoring capabilities; flexibly adapting current remote monitoring SOPs to various site situations; and exploring new technologies to enhance remote monitoring resources (e.g., sites screen-shared with our clinical research associates and source documents uploaded to a secure Web-based system).
Despite the turbulence of COVID-19, the sponsor remained confident that our clinical trial experience, management prowess, and integrity would ensure compliance to the study protocol, attention to patient safety and confidentiality, and delivery of statistically sound and credible research data. We met that confidence with a commitment to transparency, collaboration, and the highest standards of excellence, accomplishing the sponsor’s project goals on time and on budget during a global pandemic.
Support for Safety Monitoring
Ensuring the safety of participants and validity and integrity of study data is paramount to the success of PATC³H. Westat continues to support these efforts by reviewing and approving Study Progress and Safety Monitoring Plans and Data and Safety Monitoring Board (DSMB) Charters and Rosters; collecting conflict of interest forms; tracking timelines for all DSMB meetings; and offering a menu of additional DSMB support options.
Rolling Out Comprehensive Strategies
The PATC³H program moved from the clinical trial planning phase into an exploratory/developmental cooperative agreement phase in 2020 through the tracking of critical milestones. Moving forward, program sponsors seek to implement piloted strategies for HIV treatment and prevention, including studies designed to prevent new cases. The program is working to link and retain youth living with HIV with continuous care in order to support long-term viral suppression.
PATC3H will publish data designed to inform policies and public health interventions for young people (ages 10-24) affected by HIV living in resource-limited settings.
Featured Project Highlights
Launching an Oncology Trial in the Emerging COVID-19 Pandemic
When a small international company approached Westat in 2020 to conduct a phase I solid tumor study, the World Health Organization had just declared the COVID-19 outbreak as a global pandemic. Aggressive actions to contain the spread of COVID-19 were implemented. People were asked to shelter at home, access to all but the most critical medical procedures was restricted, and hospitals implemented strict policies on entrance and admissions. The challenge was to navigate this environment while simultaneously kicking off a rigorous study protocol.
Expediting an Urgent Sub-study for COVID-19 Treatment
During the global pandemic of 2020, Westat pivoted with urgency to help leverage existing infrastructure from an ongoing influenza study toward a sub-study for a COVID-19 treatment. Despite the challenges posed by the pandemic, our experts successfully implemented remote site monitoring and new safety procedures.
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Westat rescued a Phase I study in progress with flexibility and creativity that enabled our team to see it all the way through to FDA approval. We are proud to have been a part of bringing a treatment to market to help address an inherited condition that can lead to blindness.