Challenge

Changes in the HIV epidemic and the emergence of new infectious diseases present ongoing research challenges. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funds research addressing those challenges, including research on the Zika virus, HIV-associated co-infections in children and pregnant women, and more.

Since 1987, Westat has supported NICHD by managing its Coordinating Center, which oversees the NICHD Network of clinical sites in the U.S., South America, Asia, and Africa.

Solution

We develop, monitor, and manage all aspects of Network studies, including:

• Protocol development
• Regulatory management and oversight
• Negotiation and management of subcontracts
• Data management and analysis
• Clinical monitoring
• Acquisition and distribution of investigational products

We also review datasets, write manuscripts and abstracts for publication, and prepare presentations for scientific meetings.

Results

Since its inception, the Network has participated in more than 125 clinical studies, adding 25 protocols in the past 5 years. These protocols have included Phase I to IV trials that evaluate the short- and long-term effects of therapies to:

• Reduce mother-to-infant HIV transmission
• Improve the quality of life and survival of HIV-infected children and adolescents
• Prevent or mitigate the development of the serious outcomes of pediatric and adolescent HIV infection