How does our support for clinical trials reduce new HIV infections and improve care for young people?

Challenge

Concerned about the growing numbers of U.S. adolescents and young adults (AYA) with HIV, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal and Pediatric Infectious Disease Branch (MPIDB) established the Adolescent Medicine Trials Network for HIV/AIDS Interventions (ATN) in 2000. The initiative was designed to support the research network’s investigators in testing a variety of therapeutic and behavioral interventions to reduce risk factors in AYA for HIV acquisition and to improve health outcomes for AYA living with HIV (LWHIV) and prevent HIV transmission. NICHD has advanced its initiative to identify at-risk communities, engage them in care, and have them participate in research studies to enhance HIV prevention programs and improve access to care and treatment by supporting the current ATN project.

After serving as the ATN Data and Operations Center from 2001-17, Westat was selected to serve as the Operations and Collaboration Center (OCC) for the current ATN iteration. This iteration aims to develop and conduct innovative interventional studies, collaboratively and independently, toward reducing new HIV infections among at-risk youth and improving numbers across the HIV care continuum among AYA LWHIV with a focus on including minors. It also establishes the Scientific Leadership Center (SLC) with which Westat will collaborate. The work demands operational efficiency, protocol development and implementation skills, technological innovativeness, regulatory oversight dexterity, and experience conducting on-site clinical site monitoring.

Solution

Westat has uniquely shaped its operational approach to amplify ATN’s capacity to develop and manage multiple innovative behavioral, community-based, translational, therapeutic, microbicide, and vaccine trials. With our protocol development strategies in place and establishment of our robust, flexible, and responsive regulatory infrastructure, we are ensuring efficient timelines, streamlined communication, clinical site consortium assistance for enrollment and high-quality research, and smooth coordination of scientific collaboration across multiple research projects and institutions in the ATN and with other networks.

Training all clinical site personnel on quality control, quality assurance procedures, and protocol requirements is key to the success of supporting study accrual and retention. So is maximizing our operational efficiencies, and we are doing this with the introduction of several innovative technologies, including the Community Engagement and Recruitment Outcomes Database (CERO DB). CERO DB is a central mechanism that will obtain systematic metrics on the community outreach efforts for engaging and sustaining community partnerships and recruiting and retaining AYA at-risk for HIV or LWHIV at each of the participating site consortiums (SCs). The output from the CERO DB can be used by the SCs to assess whether modifications or additional methods and innovations are needed to achieve the intended outcomes and for identifying best practices across SC community activities.

Westat also developed an automated, user-friendly web-based Query & Notification System (QNS) to facilitate communications between the SCs and protocol teams, and address, track, and archive questions, notifications (e.g., deviations), and responses that arise as SCs conduct ATN clinical studies. The system can send communications to designated individuals based on subject matter (i.e., safety, regulatory) and help ensure that responses are consistent, timely, and documented methodically. The SCs and protocol teams will be able to access the QNS on the ATN website, which we have built and will continue to maintain.

Over the course of this work, we anticipate coordinating ATN participation in other research networks and research supported by pharmaceutical companies.

Further, we will actively support various ATN operational components, such as develop protocol-specific procedures manuals, provide regulatory support and oversight, identify and manage the ATN single Institutional Review Board (IRB), oversee performance of selected SCs, and monitor SC community engagement activities, including coordinate the ATN National Community Advisory Board.

Westat’s staff members will also serve on the leadership units of the ATN, including the Executive Committee and SC Performance Committee.

Results

The results of the ATN studies will be used to inform the nation’s scientific agenda for improving prevention of HIV infection in at-risk AYA and the health outcomes of AYA LWHIV. The effects of this research are intended to substantially contribute to the U.S. Department of Health and Human Services’ (HHS) goal of Ending the HIV Epidemic (EHE) by reducing new HIV infections in the U.S. by 90% by 2030 by scaling up key HIV prevention and treatment strategies.