AIDS/July 2014

Westat supports research and capacity building to prevent, diagnose, and treat HIV infection and AIDS.

HIV: Finding Therapies for Women, Youth, and Babies

For the Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), Westat serves as a coordinating center to provide continuing and recurring support for a clinical trials network that conducts multiple HIV-related clinical trials in collaboration with several other clinical trials networks. The network currently consists of 38 centers in the United States and 19 international centers. It conducts clinical trials related to preventing and treating HIV infection and its infectious and non-infectious complications as well as other high-priority infectious diseases, such as tuberculosis in neonates, infants, children, adolescents, and pregnant women and selected clinical trials of gender-specific manifestations of HIV infection in non-pregnant women.

Clinical trials vary in complexity and duration, ranging from phase I pharmacokinetic studies to phase II/III efficacy trials or observational studies. NICHD Network sites have approximately 1,000 to 1,500 patients enrolled in an average of 20 to 30 clinical trials at any one time.

One trial showed that a combination antiretroviral drug regimen provided to HIV-exposed infants within the first 2 weeks of life can reduce the risk of HIV transmission by approximately 50 percent as opposed to a single drug regimen.

Westat negotiates and manages budgets and subcontracts with all clinical centers, supports protocol and procedures development, trains clinical center staff, and monitors sites. We also assure regulatory compliance, develop and maintain computer systems, process clinical center data, conduct data analysis, and help develop manuscripts.

Providing Clinical Research Support Services for HIV Studies

For the Division of AIDS (DAIDS), National Institute of Allergy and Infectious Diseases (NIAID), Westat is providing a broad range of clinical research support services to DAIDS-supported clinical research entities.

We provide support services in a variety of ways. We conduct site assessment visits and process or for-cause audits at DAIDS-funded clinical centers in the United States as well as centers in Africa, South America, and Asia. We also perform laboratory audits in these regions to determine compliance with Good Clinical Laboratory Practices in virology and immunology at DAIDS-funded laboratories.

We support the development and delivery of training sessions for clinical research staff on a variety of topics through various mechanisms, including web-based e-learning modes.

Westat also provides IT support for the DAIDS Learning Management System and other IT-related tasks, and hosts and supports the clinical research support services web site, which is accessible to the public and DAIDS partners. We host and support a SharePoint site used to share information with DAIDS, and support database development, biostatistical analyses, and development of protocols and manuals of procedures for DAIDS-sponsored clinical research studies and programs.

HIV/AIDS in Adolescents and the Spectrum of Research Needs

Westat is the data and operations center for the Adolescent Medicine Trials Network (ATN) for HIV/AIDS Interventions. ATN conducts studies across the full spectrum of research needs in HIV-infected and at-risk adolescents.

Westat provides support for study design and protocol development, data monitoring, statistical analyses, presentations of results, and manuscript preparation. We develop and maintain Oracle databases for data entry, editing, storage, and retrieval; and maintain a web site for ATN participants.

Westat is also responsible for ensuring regulatory requirements are met, training project staff, and performing site monitoring.

The results of studies conducted in this network are used to inform the nation’s scientific agenda, and to improve the prevention of HIV infection and the medical treatment of HIV-positive adolescents.

Providing Site Monitoring for HIV Studies in Africa

Westat is providing site monitoring services for three projects for the Epidemiology and Strategic Information Services of the Centers for Disease Control and Prevention (CDC). Westat Africa-based clinical research associates travel to the study sites to verify compliance with the protocols, applicable regulations, and Good Clinical Practice guidelines.

Project ORCAS. The CDC and its research partners in Kampala, Uganda, are implementing a trial to evaluate the implementation of cryptococcal antigen (CRAG) screening and pre-emptive antifungal therapy in 300 HIV-infected patients beginning outpatient antiretroviral therapy (ART). For Operational Research for Cryptococcal Antigen Screening to Improve ART Survival, or Project ORCAS, patients who are CRAG positive and asymptomatic are being treated with high-dose fluconazole.

LEEP Study. The CDC and its research partners in Nairobi, Kenya, are studying the recurrence of cervical shedding among HIV-positive women. Approximately 400 HIV-positive women with cervical intraepithelial neoplasia are being randomized to treatment with either cryotherapy or loop electrosurgical excision procedure (LEEP) and will be followed for 2 years.

Project AIM. The HIV Prevention Interventions (Project AIM) on Youth Sexual Intentions, Sexual Behaviors, and HSV-2 Incidence and Prevalence in Junior Secondary Schools in Eastern Botswana is studying if delayed onset of sexual activity reduces risky sexual behaviors. Project AIM is a group-level youth development initiative. The study is being conducted over 3 years and will include two arms: 1) control arm (Standard Life Skills Curriculum); and 2) intervention arm (Standard Life Skills Curriculum coupled with the Project AIM initiative).

Strengthening HIV Lab/Quality Management Programs in Sub-Saharan Africa

Under this cooperative agreement with the Centers for Disease Control and Prevention (CDC), Westat is working with the Laboratory of Bacteriology and Virology at Cheikh Anta Diop University and other partners to develop an HIV-related external quality assurance/proficiency testing program for President’s Emergency Plan for AIDS Relief (PEPFAR) laboratories in sub-Saharan Africa. The partners have also conducted a situational analysis as part of the development of a National Medical Lab Strategic Plan (Situational Analysis/Laboratory Assessments) in Nigeria.

More recently, Cheikh Anta Diop University and Westat have partnered in support of CDC’s HIV Rapid Testing Quality Improvement Initiative (HIV RTQII). HIV RTQII is highly supported through PEPFAR’s Office of the Global AIDS Coordinator in response to the urgent need to improve the quality of HIV testing and rapid tests, in particular within PEPFAR Option B+ countries. The program is intended to be catalytic and build upon existing in-country PEPFAR programs using innovative approaches to address known gaps in the quality management system.

The overall goal of this project is to strengthen laboratory support for surveillance, diagnosis, treatment, disease monitoring, and HIV screening for blood safety in sub-Saharan Africa.

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