SPECIAL NOTICE
A -- Bangkok Tenofovir Open Label follow-up Study
- Notice Date
- 1/8/2013
- Notice Type
- Special Notice
- 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
- 54184
- Archive Date
- 1/29/2013
- Point of Contact
- Pellumbeshe Hoxhaj, Phone: 7704882805
- E-Mail Address
-
kfx2@cdc.gov
(kfx2@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- 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 one 1 year optional phase, total of 18 months. Based on community interest in promising HIV prevention interventions, ongoing high HIV incidence among IDUs, and evidence suggesting pre-exposure prophylaxis with tenofovir would prevent HIV infection, CDC launched the Bangkok Tenofovir Study, a phase-3, randomized, double-blind, placebo-controlled HIV prevention trial to determine if daily oral tenofovir would reduce the risk of HIV infection among IDUs in 2005. This portion of the study concluded in June 2012 and data are currently being evaluated. In the IRB approved protocol, CDC agreed to provide tenofovir to study participants for one year in a follow-on Open Label Study (OLS) if efficacy was demonstrated. BTSG will provide study drug to study participants as described in the IRB approved protocol. The result of the Bangkok Tenofovir Study (BTS) is expected this year. If the results show that tenofovir does not reduce the risk of HIV infection among study participants, then the contractor will notify the participants of the result and organize study documents and materials for retrieval by CDC or CDC contractors (archiving). If the results show that tenofovir does reduce the risk of HIV infection among study participants, then the contractor will offer the participants one year of daily tenofovir. After a year of providing the drug to participants who accept, and conducting laboratory safety testing, the contractor will archive all materials as described. The purpose of this contract is to complete the Open Label Study (OLS) portion of the Bangkok Tenofovir Study / (BTS), 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 The contractor will 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: • Enrolling and following-up of participants (approximately 1,200 (or as many as choose to enroll) HIV-uninfected injecting drug users [IDUs]) according to the approved study protocol; • Collecting clinical and behavioral information and obtaining blood and other specimens from the study participants according to the time frames established by the approved study protocol, as well as providing medical consultations when appropriate for study participants (Note: this at the same frequency of collections as the main BTS project); and • Completing monthly and final project reports providing updates on progress to date (e.g., enrollment, specimen collection, behavior risk surveys, etc.). Performance Requirements The contractor will 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: 1. Phase 1a (three months): Task 1: contacting and offering follow-up to approximately 1,200HIV uninfected BTS participants (or as many as choose to enroll) according to the approved study protocol over the life of the contract (18 months). Task 2: Provide a report twice a month on study 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. Task 3: Archive and store CRFs in secure and locked space. Task 4: Bi-monthly meeting with CDC to review progress and data collection issues 2. Phase 1b (optional phase, one year): Task 2: Provide a report twice a month on study 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. Task 3: Archive and store CRFs in secure and locked space. Task 4: Bi-monthly meeting with CDC to review progress and data collection issues Task 5a, 5b, 5c: 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 (table 1). Table 1. Bangkok Tenofovir Study Procedures Flow Chart Procedures Post-analysis monthly visits Post-analysis 3-monthly visits HIV pre/post-test counseling X X OraQuick HIV testing X X Urine pregnancy test (females) X X Collect blood X Pill Count X X Adherence counseling X X Risk assessment questionnaire (ACASI) X Risk reduction counseling X X 3. Phase 1c (three months): Task 2: Provide a report twice a month on study 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. Task 3: Archive and store CRFs in secure and locked space. Task 4: Bi-monthly meeting with CDC to review progress and data collection issues Task 6: Final report of project to include a summary of study activities; a summary of training activities; an assessment of participant specimen disposition; an assessment of participant document disposition; an assessment of participant data disposition and any additional information regarding participants, data, staff deemed beneficial to CDC. 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, kfx2@cdc.gov. Send responses by Monday, Jannuary 14, 2013.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/54184/listing.html)
- Place of Performance
- Address: Bangkok, Thailand
- Record
- SN02961210-W 20130110/130108234417-47b6e02ae97c00786b5d5f3b13a874f1 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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