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A -- NICHD INTERNATIONAL SITE DEVELOPMENT INITIATIVE (NISDI)

Solicitation Number: WESTAT-7735-0601
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: Westat (NINDS PRIME CONTRACTOR)
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WESTAT-7735-0601
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Combined Synopsis/Solicitation
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Added: November 14, 2006 Modified: November 16, 2006Track Changes
BRIEF BACKGROUND

UNAIDS estimates that there are almost two million adults and children living with HIV infection in Latin America and the Caribbean, of whom almost 700,000 are women of childbearing age and children (numbers that are generally regarded as underestimates). In 2005, fewer that 65,000 adults and children were newly infected with HIV in North America, as compared with almost 180,000 adults and children in Latin American and Caribbean nations. Lastly, while 73% of all people requiring antiretroviral therapy in Latin America are receiving it, only approximately 8% of children are receiving antiretrovirals and almost 3,000 children in these countries died of AIDS in 2005.



The epidemiology of perinatal HIV infection has markedly changed over the years with implementation of interventions to prevent mother-to-child transmission of HIV, i.e., antiretroviral prophylaxis, cesarean delivery before labor and before rupture of membranes, and complete avoidance of breastfeeding. Use of highly active combination antiretroviral regimens to treat HIV disease has significantly decreased morbidity and prolonged the life of infected individuals, and when used by HIV-infected pregnant women, may further decrease the risk of mother-to-child transmission. However, many questions remain. For example, the safety of exposure to combination antiretroviral regimens in pregnant women and their uninfected children, and the long-term effects of potent combination antiretroviral therapy on HIV-infected infants, children, and women, needs to be better defined.



The goals of the National Institute of Child Health and Human Developments (NICHD) research on pediatric HIV infection include development of improved interventions for prevention of mother-to-child transmission of HIV, as well as improved treatment of HIV infection and its sequelae in infants, children, adolescents, pregnant women and mothers. NICHD has funded a NICHD International and Domestic Pediatric and Perinatal HIV Clinical Studies Network Coordinating Center to coordinate clinical studies related to HIV infection in these populations. Westat , a contract research organization located in Rockville, Maryland, U.S.A, has served as this Coordinating Center for over 15 years. The Coordinating Center has funded a network of clinical sites in the U.S. and other countries enrolling subjects in trials related to preventing and treating HIV infection and its complications in neonates, infants, children, adolescents, and pregnant women. The network has included sites in the U.S. and more recently, international sites.



Additionally, over the previous 5 years, NICHD has asked the Coordinating Center to expand its international collaborations in countries in Latin America and the Caribbean through funding of two prospective cohort studies in the NICHD International Site Development Initiative (?NISDI?) project, which began enrollment in 2002. One study enrolled HIV-infected pregnant women and followed these women and their HIV-exposed infants until six months after delivery/birth (the



NISDI Perinatal study). Another study enrolled HIV-exposed and HIV-infected infants, children, and adolescents (the NISDI Pediatric study).



The new NISDI studies will be prospective cohort studies of two different populations:



Protocol I: a perinatal study to collect data regarding HIV-infected pregnant women through 6 months postpartum and HIV-exposed, uninfected children for up to 5 years of follow up.



Protocol II: a pediatric study to collect data on HIV vertically-infected children less than or equal to 5 years of age (up to 5 years and 364 days old) for up to 5 years of follow up.



The conduct of these prospective, multicenter, observational studies of HIV-infected pregnant women and their HIV-exposed but uninfected children (Protocol I) and of HIV-infected children (Protocol II) at sites in Latin America and the Caribbean will provide critical data about the demographic, clinical, immunologic and virologic characteristics of these populations. In addition, such studies will provide information about the safety of antiretroviral drugs or other therapies among HIV-infected pregnant women and children and about the safety of in utero and early postnatal exposure to antiretrovirals by HIV-exposed but uninfected children.



As the NICHD Coordinating Center, Westat's role includes negotiating and managing budgets and subcontracts with clinical centers, participating in protocol and forms development, training clinical center staff, site monitoring, data processing, data analysis, and manuscript preparation. The NICHD Coordinating Center will serve as the coordinating center for the observational studies to be conducted as specified in this RFP.



GOALS/RESEARCH OBJECTIVES



The overall goal of this initiative is to describe HIV-infected pregnant women, HIV-exposed, uninfected children, and HIV-infected children at clinical centers in Latin America and the Caribbean. Please refer to the attached Abstracts I and II for more specific information regarding these two research studies. Sites will have the option of proposing to participate in either one or both of these studies. Sites currently participating in the NISDI protocols must reapply to this RFP in order to be eligible to participate in these studies. If sites choose to propose to participate in both studies, only one proposal needs to be submitted to cover both studies.



NOTICE OF INTENT TO SUBMIT A PROPOSAL

Proposal applicant institutions are requested to complete the Notice of Intent to Submit a Proposal form which is included with this RFP and return it by e-mail or fax to Steven Sokolowski at the address listed on the form by 5:00 p.m. U.S. Eastern Standard Time (USA) on Friday, December 15, 2006. Although the Notice of Intent is not required, is not binding, and is not part of the review of a subsequent proposal, the information that it contains allows Westat staff to estimate the potential review work involved and avoid conflict of interest in the review process.

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Solicitation 1

Type:
Solicitation
Posted Date:
November 16, 2006
Description: All Files
:
Department of Health and Human Services, National Institutes of Health, Westat (NINDS PRIME CONTRACTOR), 1650 Research Blvd., Rockville, MD, 20850, UNITED STATES
:
Russell Walker, Senior Contract Administrator, Phone 240-453-5624, Fax 301-738-3500, Email russellwalker@Westat.com