SOURCES SOUGHT
A -- Bangkok Tenofovir Study
- Notice Date
- 4/14/2010
- Notice Type
- Sources Sought
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2010-N-12084
- Point of Contact
- Terren J. Grimble, Phone: 770-488-2487, Rafael A. Aviles, Phone: 770-488-2805
- E-Mail Address
-
TGrimble@cdc.gov, raviles@cdc.gov
(TGrimble@cdc.gov, raviles@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent Ref# 2010-N-12084 The Centers for Disease Control and Prevention, the Division of HIV and AIDS Prevention, intents to award a sole source, cost reimbursable contract, in accordance with FAR Part 6.302(1), to Bangkok Tenofovir Study Group (BTSG), Bangkok, Thailand for a base period of six months and six - six month option periods. The Bangkok Tenofovir Study (BTS) is a Phase II/III randomized, double-blind, placebo-controlled study of the safety and efficacy of tenofovir, administered once daily to HIV-1 uninfected injecting drug users (IDUs). The study is designed to determine if daily tenofovir will prevent HIV-1 infection among IDUs and if tenofovir is safe to use among HIV-uninfected IDUs. The purpose of this contract is to complete the Bangkok Tenofovir Study, a research study begun in 2004 via contract with the Bangkok Tenofovir Study Group (BTSG). BTSG provides study activities at 17 Bangkok Metropolitan Authority (BMA) drug treatment clinics. Scope of Work Provide medical and other support (doctors, nurses, clinical research assistants, social workers, laboratory technicians, clerks, advisors and consultants), supervision and follow-up at 17 BMA drug treatment clinics for services to include: enrollment and follow-up of the approximately 2,400 HIV uninfected injecting drug users (IDUs). Screen, consent, enroll and follow-up of the participants according to the approved study protocol over the life of the contract (1-2 years). Collect clinical and behavioral information and obtain blood and other specimens from the study participants according to the time frames established by the approved study protocol, as well as provide medical consultations when appropriate for study participants. Complete monthly and final project reports providing updates on progress to date (e.g., enrollment, specimen collection, behavior risk surveys, etc.). Technical Requirements Base through Option V: Complete enrollment and follow-up of BTS participants. Provide medical support (doctors, nurses, clinical research assistants, social workers, laboratory technicians, clerks, advisors and consultants) and supervision from 17 BMA drug treatment clinics for services to enroll and follow approximately 2,400 total participants including participants enrolled under contracts 200-2004-09965 and 200-2007-21481. This provision of personnel support by the awardee includes payment of their salary and provision of any usual/customary fringe benefits (e.g., payment of government taxes, medical insurance, etc.). Collect clinical research information (medical history, physical examination, medication evaluation, adverse event evaluation) and behavioral data (sexual and drug use risk behavior) and draw blood and other specimens (urine and saliva) from the study participants, as well as conduct medical monitoring and consultation as needed according to the BTS protocol. In addition, schedule reassessments for HIV research purposes according to approved protocol. Provide a report twice a month on enrollment progress containing a brief overview of progress toward meeting objectives, milestones, and schedules; anticipated problems/opportunities and recommended actions. The report shall be submitted and presented two times a month to the Principle Investigator, Project Officer, and the entire clinical trial team. Assure that the trial is conducted according to internationally recognized standards of Good Clinical Practice (GCP) and in compliance with existing federal (including CDC, FDA and the Office of Protection from Research Risks) policies concerning use of investigational agents and protection of human subjects. Report adverse events that occur during the clinical trial as outlined in the Standard Operating Procedures (SOP). Collect, organize, store or transfer data and specimens according to guidelines outlined in the SOP and study protocol. Process, test (HIV-1 antibody, pregnancy, and safety laboratory tests), aliquot, store and transport blood, urine and saliva specimens for HIV/AIDS research purposes (see attached Data Collection Plan). Provide/arrange transportation for staff and participants, including up-country travel as required to comply with follow-up schedules. Provide food supplement and travel and time lost reimbursement to study participants. Conduct training workshop (informed consent process, HIV-1 and risk reduction counseling, completion of clinical research forms, adverse event reporting, data submission) for BMA clinical staff working in the study project (see attached Data Collection Plan). Option VI: Data cleaning, analysis, and presentation Provide support and assist TUC in BTS data cleaning, verification, correction. Provide support and assist TUC in BTS data analysis and presentation. Special Considerations A complete physical exam will be completed at enrollment and exit visits; a focused physical exam for specific participant complaints will be completed at other visits. Government Furnished Property The Government will provide all study products (Tenofovir and placebo) necessary to conduct the clinical drug trial in accordance with the Bangkok Tenofovir Study Protocol. Vendor Qualifications • Expert knowledge and demonstrated capability to conduct large, complex, scientifically- and ethically-sound phase III HIV prevention research among injecting drug users. • Demonstrated history of working closely with the Bangkok Metropolitan Administration (BMA, the city government of Bangkok) Health Department and Medical Services Department • Long term access to injecting drug users in the BMA clinics • Possess logistical framework (trained clinical research staff, skilled medical personnel, communication resources, leadership, management) necessary to conduct and complete a phase III clinical trial. • Ability to recognize and expertly respond to challenges specific to this clinical research study in a timely manner No Request for Proposals (RFP) will be issued based upon this Notice of Intent. Any interested companies are welcome to submit there credentials and ability to provide the services, via e-mail, ibi9@cdc.gov. Include reference number (2010-N-12084). Send responses by Wednesday, April 21, 2010.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2010-N-12084/listing.html)
- Place of Performance
- Address: Bangkok, Thailand
- Record
- SN02121434-W 20100416/100414234757-8040d51fa87d56b4bddfb88e00823f65 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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