A -- NICHD INTERNATIONAL HIV SITE DEVELOPMENT INITIATIVE

Notice Date

October 25, 2000

Contracting Office

National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

ZIP Code

20892-7510

Solicitation Number

N01-HD-3-3162

Response Due

January 15, 2000

Point of Contact

Susan Truitt, 301-738-8379

E-Mail Address

Click here to reach the Westat, Inc. contact person (SusanTruitt@westat.com)

Description

Under contract #NO1-HD-3-3162 with the National Institute of Child Health and Human Development (NICHD), Westat is seeking Latin American and Caribbean clinical centers interested in participating in multicenter, prospective, observational perinatal and/or pediatric studies as part of an initiative entitled, "National Institute of Child Health and Human Development International HIV Site Development Initiative." The goal of this initiative is to describe the demographic, clinical, immunologic and virologic characteristics of HIV-infected pregnant women, HIV-exposed infants, and HIV-infected infants, children, and adolescents at clinical centers in Latin America and the Caribbean. Centers will submit one proposal for either one or both of the following two prospective observational studies: 1) a perinatal study to collect data on the characteristics of HIV-infected pregnant women and their HIV-exposed infants through 8-12 weeks after delivery/birth; and, 2) a pediatric study to collect data on HIV-exposed infants as well as HIV-infected infants, children and adolescents until age 24 years. Institutions that apply must have some prior experience in conducting clinical research studies as well as the personnel and laboratory capabilities necessary to conduct observational studies and clinical trials. All proposal applicants must document the ability to enroll a minimum of 30 HIV-infected pregnant women and 20 HIV-exposed infants per year for the perinatal study, and/or 20 HIV-exposed infants and 30 HIV-infected infants, children and adolescents per year for the pediatric study. Proposals submitted must include, but are not limited to, the following information: 1) detailed documentation on the applicant institution's HIV population and on management of HIV-infected women, HIV-exposed infants, and/or HIV-infected infants, children and adolescents; 2) information on the applicant institution's previous research experience, including the research experience of key personnel qualified to conduct a study; 3) a description of the applicant institution's available facilities and laboratories to enroll subjects, including collecting, recording, and storing study data; 4) a description of the applicant institution's communication capabilities; and, 5) a description of the applicant instutition's ability to process required regulatory documentation. Successful offerors will participate as fixed-price subcontractors to Westat. A Request for Proposals (RFP) is being issued by Westat to potential sites on or about November 15, 2000. The deadline for submission of proposals is January 15, 2001, by 5:00 p.m. U.S. Eastern Standard Time. Offerors are also requested to submit a Letter of Intent to Submit a Proposal to Westat by December 15, 2000. Interested parties may request a copy of the entire solicitation packet by faxing or emailing a request to Ms. Susan Truitt, B.A., R.N. at Westat, FAX number 301-738-8379, email SusanTruitt@westat.com. Questions may be directed to Ms. Truitt at 301-738-8346. No collect calls will be accepted.

Record

Loren Data Corp. 20001027/ASOL001.HTM (W-299 SN5051H4)