B -- HIV OUTPATIENT STUDY (HOPS)

Notice Date

March 28, 2001

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

2001N00046

Point of Contact

Dale Defilipps, Contract Specialist, Phone (770)488-2637, Fax (770)488-2670, Email DDefilipps@CDC.GOV -- Dale Defilipps, Contract Specialist, Phone (770)488-2637, Fax (770)488-2670, Email DDefilipps@CDC.GOV

E-Mail Address

Dale Defilipps (DDefilipps@CDC.GOV)

Description

CDC intends to award a Sole Source contract to Apache Medical Systems, Incorporated (APACHE) to augment complex research activities of a select number of clinical sites currently abstracting data from visits by HIV-infected patients to their clinicians in several U.S. cities. The anticipated performance period is five years. The contractor will be required to continue to collect and assure the quality of data collected from HIV care sites -- notably, of their changing demographics, symptoms, diagnoses (diseases), treatments, and laboratory results -- and to formulate an executive (coordinating) committee (EC) to consider, propose and execute sub-studies within the framework of such data collection. Such sub-studies shall include clinical, epidemiologic, laboratory and social-behavioral issues in HIV infection. Specifically, the Contractor shall perform the following tasks. Task 1: Collect data from physician-patient interactions at 10 study-sites treating many HIV-infected patients (greater than 100 per year at each site). Specifically, the contractor shall collect and assure the quality of data collected from HIV clinics within the data management system. These activities shall include database entry of patient visit information within 30 days of the visit. The data shall be entered into the Clinical Practice Analyst (CPA), and the contractor shall provide technical support for the CPA and modify the software as requested by the Project Officer. The contractor shall also assure the completeness and accuracy of data by, among other things: centralized data-management training for on-site personnel; site visits to assure the timely, complete and accurate addition of data to the overall database; and ongoing quality assurance-driven data management. The contractor shall make 1 to 2 trips per year to each site to conduct training for study staff and monitor the quality of the data. The contractor shall conduct training on methods of data collection and data monitoring. The duration of the training shall be up to 3 days in length; Task 2: The contractor shall develop and finalize complex sub-study protocols for the following topics: Mortality and morbidity of HIV infection in the era of highly active antiretroviral therapy (_HAART'); and sub-studies of HIV infected persons including: a) Prevention and treatment of "Pneumocystis carinii" pneumonia (PCP); b) Factors related to the prevention and treatment of cryptosporidiosis; c) The effect of hepatitis A, B, and C disease, treatment and vaccination on HIV, and vice versa; d) Adherence of HIV-infected patients to physician-prescribed antiretroviral therapy; e) The incidence and vaccination of HIV-participants for influenza A and B, especially during a typical "flu" season (October-to-March in the northern hemisphere). This study requires the contractor to collect and deliver to CDC various lab specimens as specified by the Project Officer; f) Assessment of adherence to therapy to assist in interpreting clinical outcomes of therapy. In addition, the contractor shall evaluate patients' assessments of health and functional status to measure outcomes of clinical therapy; g) Other substudies, engendered by the changing nature of the HIV/AIDS epidemic. As stated in subparagraph e above, these sub-studies require the contractor to collect various lab specimens as determined by the Co-Project Officers; and Task 3: The contractor shall implement the sub-study protocols. All approvals and final clearances (CDC and local IRB's, FWA's and other applicable requirements) must be obtained for the protocol acquired under task 2 above. The contractor shall begin implementation of the sub-study protocols only after all required approvals are obtained. Specifically, the contractor shall perform the following set of core activities based on the individual study protocol(s) developed: data collection via entry at sites in real -time, based on recent physician-patient interaction and recorded notes; data "cleaning" and analysis; specimen collection and shipment; and clinical and social-behavioral interventions. The contractor shall deliver to CDC copies of the study guidelines, substudy protocols, data sets, QA report, lab specimens, and a final report related to the tasks performed. The acquisition will be completed on a sole source basis to APACHE Medical Systems, Incorporated based on the fact that eight years of continuous, ongoing data have already been collected from patients at the study sites participating with the APACHE data collection under the previous 3 (U64/CCU509689-02) and 5-year (U64/CCU513979) CDC cooperative agreements. It is critical to the study to continue to collect longitudinal, ongoing information on the "existing" cohort of patients. The specific cohort of HIV-infected outpatients who provided the clinical and demographic data are not available to anyone other than APACHE Medical Systems, Inc. Since CDC has already invested considerable effort and financial resources in identifying a cohort of HIV-infected outpatients, collecting laboratory and clinical data, and producing publications on the over 5,900 patients already followed over eight years, it would not be feasible to change cohorts for follow up for the following 5 years. Start-up expenses, if another source were able to provide follow-up data from the same patients at the same 8 clinics, would greatly increase the cost of the project. Data from other cohorts could not be combined with the existing follow up data. For equivalent clinical and demographic data to be provided from other cohorts, a full five years of data would have to be provided, at significant increase in cost to the government. APACHE Medical Systems, Inc. is the only organization that can provide the required resources, measure of expertise, data management, and services necessary to meet all of the above requirements including cost constraints. Hence, a sole source procurement is contemplated. See Notes 22 and 26.

Web Link

Visit this URL for the latest information about this (http://www.eps.gov/cgi-bin/WebObjects/EPS.woa/wa/SPF?A=P&P=2001N00046&L=2965)

Record

Loren Data Corp. 20010330/BSOL007.HTM (D-087 SN50H5O0)