SOLICITATION NOTICE
A -- Cesarean Section: Herpes/STD Supplement Assessment
- Notice Date
- 7/14/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2006-Q-08797
- Response Due
- 7/21/2006
- Description
- The Centers for Disease Control and Prevention, Epidemiology and Surveillance Branch, Division of Sexually Transmited Disease Prevention intends to award a sole source contract under Simplified Acquisition procedures to Battelle Centers for Public Health Research and Evaluation, University of Washington Center for AIDS and STD, the only source that has access to the population-based sample of pregnant women in the U.S. in whom the incidence of CS versus vaginal delivery will be prospectively determined. This is a firm fixed price award with a period of performance of July 31, 2006 to June 30, 2007. This announcement constitutes a combined solicitation/synopsis; a written solicitation will not be issued. The purpose of this effort is to assess the association of various indicators of herpes-related knowledge and morbidity with CS versus vaginal delivery; to evaluate providers? attitudes and knowledge about genital herpes, perinatal transmission of HSV, and its prevention; to prospectively determine the frequency and predictors of routine STD screening of pregnant women; and to generate preliminary data in preparation for expanded prospective research proposals (e.g., RO-1 other mechanisms) using similar recruitment and survey methodology. Minimum requirements. Contractor must have 10 years plus experience in public health research associated with STDs. Contractor must be covered by a functioning, federally registered institution review board (IRB) and the IRB must approve the research protocol before data collection begins. Contractor must have experience in developing survey questionnaires that include key questions about genital herpes, training interviewers and conducting interviews among pregnant women during their third trimester and postpartum, conduct data entry and management and providing analysis for datasets, and experience working with CDC researchers in generating scientific manuscripts or reports. Contractors must be registered in the Central Contractor Registration (CCR). Contractors may register by calling 1-888-227-2423 or register via the Internet at www.ccr.gov. Registration Notification of any changes shall be made only through FedBizOpps, http://ww.fedbizopps.gov. The NAICS code is 541710. Quotes may be faxed to (404) 639-8095, ATTN: Ms. Johnson or emailed to chj5@cdc.gov. The date specified for receipt of offers is July 21, 2006 9:00 a.m. EST. STATEMENT OF WORK Title of Project: CESAREAN SECTION: HERPES/STD SUPPLEMENT C.1 Background and Need Based on the National Hospital Discharge Survey (NHDS), 27% of live birth deliveries in Genital herpes was recorded as a factor in 4.2 per 1000 CS deliveries (0.4%) in 1979, rising to 15.9 per 1000 (1.6%) in 2003. Among primary CS deliveries (i.e., in women who had not undergone CS in a previous pregnancy) that were undertaken without a trial of labor, the proportion linked to herpes (per 1000 live births) rose from 12.0 in 1979 to 50.5 in 2003. By contrast, for all live births, herpes was linked with only 1.1 and 12.3 per 1000 in 1979 and 2003, respectively. The NHDS herpes data are based on ICD-9 coding, with all the imprecision that implies, and these figures do not speak directly to the indications for CS or the severity or nature of the herpes diagnosis. Accordingly, the direct contribution of herpes simplex virus (HSV) infection as a determinant of CS cannot be computed from these data. However, an opportunity to directly investigate this association presents itself as a supplement to an existing project, soon to begin, wherein 3,000 pregnant women and their obstetrical providers will be enrolled in a prospective survey to study the determinants of CS. The parent study also offers the opportunity to determine the frequency with which pregnant women are screened for STDs in accordance with guidelines of the Centers for Disease Control and Prevention (CDC) and the American College of Obstetricians and Gynecologists (ACOG) and to correlate the findings with providers? understanding of the guidelines. C.2 Project Objective The overall goals of this supplemental pilot study are to assess the association of various indicators of herpes-related knowledge and morbidity with CS versus vaginal delivery; to evaluate providers? attitudes and knowledge about genital herpes, perinatal transmission of HSV, and its prevention; to prospectively determine the frequency and predictors of routine STD screening of pregnant women; and to generate preliminary data in preparation for expanded prospective research proposals (e.g., RO-1 other mechanisms) using similar recruitment and survey methodology. C.3 Scope of Work ? The survey will be undertaken in 3,000 pregnant women in 4 areas of the country (concentric urban, suburban, and rural settings centered on Seattle, St. Louis, Baltimore, and Raleigh-Durham) who will be followed prospectively through their deliveries. Recruitment is designed to approximate a population-based sample of pregnant women in whom the incidence of CS versus vaginal delivery will be prospectively determined. The patients will be recruited and interviewed during the third trimester (TM3), and again post-partum, to evaluate numerous determinants of CS. In addition, all patients? obstetrical providers will be interviewed to assess attitudes and beliefs about CS; and there will be a post-partum medical record review to further assess numerous potential determinants. Finally, the patients? obstetrical and delivery records will be reviewed and standardized data abstracted. The primary study will classify CS as medically determined versus elective, with recognition that these determinants are subject to interpretation. For example, what degree of cephalopelvic disproportion operates as an absolute determinant of CS, compared with lesser degrees that might interact with predictors of ?elective? CS? Is there a correlation between pregnant women?s desire to limit vaginal and perineal trauma, as one possible determinants of elective CS, with clinical indications on the other hand that might justify CS under medical grounds? Are CS or vaginal delivery related to socioeconomic characteristics or insurance status? The primary study was not designed to address genital herpes or other STD issues. However, this project offers a unique and cost-efficient opportunity to prospectively address the associations of various direct and indirect indicators of genital HSV infection with pregnancy outcome. It also offers an opportunity to prospectively assess obstetrical providers? awareness of STD screening recommendations (e.g., CDC, ACOG) in pregnant women and to prospectively evaluate compliance with those recommendations and numerous determinants of STD screening in pregnancy C.4 Technical Requirements Finalize herpes/STD supplement questionnaire and incorporate the inputs from CDC project officers Obtain IRB approval of the herpes/STD supplement at all study sites Interview 3,000 pregnant women during 3rd trimester and again post-partum using the herpes/STD supplement questionnaire Interview the obstetrical providers at the participating sites for the 3,000 pregnant women using the herpes/STD supplement questionnaire. Complete medical review of the 3,000 pregnant women and complete the medical chart abstraction portion of the herpes/STD supplement questionnaire Complete data entry and editing, and share data with CDC project officers to allow for joint analyses by CDC project officers and contractor researchers to address the study objectives C.5 Reporting Schedule The contractor should submit a brief reporting every quarter during the course of the study. The format can either be a paragraph narrative or a table (one page) that summarizes study progresses, including cumulative and the progress made in the preceding 3 months. C.6 Special Considerations CDC IRB will not review the entire research protocol and will rely on Battelle IRB for human subject review. Manuscripts that are authored and co-authored by CDC project officers must obtain CDC clearance before submitting for publication C.7 Government Furnished Property None Deliverables Due date Finalize herpes/STD supplement questionnaire 8/18/2006 IRB approval of the herpes/STD supplement at all sites 9/31/2006 Complete interview of 3,000 pregnant women (during 3rd trimester and post-partum) 4/30/2007 Compete interview of 3000 pregnant women?s OB providers 5/31/2007 Complete 3000 pregnant women?s medical review 5/31/2007 Share data with CDC project officers for analyses 6/30/2007 Instructions to Bidders I. Relevant Experience Please provide a description of each contract/assignment completed in the past 10 years relevant and similar to that in the statement of work contained herein. Please provide the name/address and point of contact for each customer. This section shall not exceed 5 pages. II. Technical Approach Please provide a summary, not more than two pages of proposed approach to completing the proposed work. Please address understanding of requirements, target audience, subject matter and specific considerations/techniques proposed. III. Personnel Please provide a curriculum vitae/resume for each individual expected to provide 20% or more of the labor under order. Please address education, work experience and any relevant training of the individual. Please explain the role each individual is to play in completing the statement of work. IV. Past Performance Please provide a list of references that can validate the quality of performance on prior similar work. Include references for work listed in item I. above, in addition to any others. Please provide the following for each reference, not to exceed a total of five: Name; Employer; Address; Telephone Number/E-mail address; Description of work for which they are provided as a reference; and individual?s role. V. Budget Provide a budget for the proposed work Labor: Include labor rate and number of hours for each individual proposed under the order. Discounts may be offered. Other Direct Costs: List any non-labor costs associated with the work, such as travel, supplies, etc. Total Cost: Labor plus Other Direct Costs
- Place of Performance
- Address: Centers for Disease Control and Prevention, Atlanta, GA
- Zip Code: 30329
- Country: UNITED STATES
- Zip Code: 30329
- Record
- SN01089199-W 20060716/060714220538 (fbodaily.com)
- Source
-
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