Sources Sought - Clinical trial to test the safety and efficacy of intermittent pre-exposure chemoprophylaxis to prevent HIV infection among men who have sex with men (MSM) in Bangkok, Thailand.

THIS IS NOT A SOLICITATION OR A REQUEST FOR PROPOSAL (RFP). IT IS NOT TO BE CONSTRUED AS A COMMITMENT BY THE GOVERNMENT TO ISSUE A SOLICITATION
OR ULTIMATELY AWARD A CONTRACT. ANY COST INCURRED AS A RESULT OF THIS
ANNOUNCEMENT SHALL BE BORNE BY THE OFFEROR AND WILL NOT BE CHARGED TO THE GOVERNMENT FOR REIMBURSEMENT. This is a sources sought notice to determine the availability of interested, capable and qualified businesses and agencies that can conduct a scientific study of the safety and efficacy of pre-exposure to determine if chemoprophylaxis treatment reduces the incidence of HIV-1 infection among uninfected men that have sex with men (MSM) in Thailand.

The Centers for Disease Control and Prevention (CDC) is conducting a market survey to seek potential sources from qualified businesses and agencies. Agencies should be qualified to do business with the United States Government (USG) and they should have the capability to perform scientific services to determine if chemoprophylaxis treatment reduces the incidence of HIV-1 infection among uninfected men that have sex with men (MSM) in Thailand.

The scope of the activities ranges from site preparation and training to provision of clinical facilities, medical personnel and support, study monitoring (including laboratory and pharmacy) and auditing, study drug importation, community liaison and participant recruitment and retention. The contractor shall conduct these activities in four (4) phases (1) Pre-study phase, (2) Enrollment to mid-study phase (3) Mid-study to roll-out phase and (4) Close-out phase. The Truvada Study will be conducted in Bangkok, Thailand.

Phase I - Pre-study

The contractor shall conduct community liaison activities and develop a functional community advisory board to solicit input and support from community members and networks, organize community meetings to inform and interact with the MSM community at large, develop a recruitment plan with strategies, and design and pilot-test recruitment and study materials, develop standard operating procedures and training manuals for study staff; contractor will also oversee and implement site preparation and training.

Phase II - Enrollment to mid-study phase

The contractor shall have full access to hospital space for study activities for up to 2,000 volunteers, provide security for all equipment provided, perform recruitment activities to screen and enroll 2,000 volunteers in the study, provide medical personnel (medical specialists, doctors, nurses, counselors etc) for study conduct as needed, conduct retention activities to increase follow-up rates and accrue at least 2,000 person years of follow-up, conduct study monitoring, auditing and source data verification at the study clinic, evaluate good pharmacy, clinical and laboratory practice, and will import study drug, provide laboratory services to assess drug safety, and medical, diagnostic and pharmaceutical services for study volunteers as needed, reimburse study participants for their costs in relation to study participation, complete a monthly monitoring report with problems encountered and appropriate solutions, updates on study progress to date, and a financial overview.

Phase III - Mid-study to roll-out phase

The contractor shall have full access to hospital space for study activities for up to 2,000 volunteers, monitor and evaluate the roll-out of study volunteers, conduct retention activities to increase follow up rates and accrue 3,800 person years of follow-up, provide medical personnel (doctors, nurses, counselors etc) for study conduct as needed, conduct study monitoring, auditing and source data verification at the study clinic, evaluate good pharmacy, clinical and laboratory practice, and will import study drug, provide laboratory services to assess drug safety, and medical, diagnostic and pharmaceutical services for study volunteers as needed, reimburse study participants for their costs in relation to study participation, complete a monthly monitoring report with problems encountered and appropriate solutions, updates on study progress to date, and a financial overview.

Phase IV - Close-out

The contractor shall complete a Final Project Report providing an overview of community and recruitment activities, participant follow-up and retention, medical and hospital services, study monitoring and auditing, and recommendations for compliance with Thai and US federal regulations, organize a final community meeting to inform and interact with the MSM community at large.

Under this scope of work, the Contractor will be required to provide services in a region where the primary written and spoken language is Thai. The contractor as an independent organization and not as an agent or co-partner of the Government, shall furnish all the necessary medical support, services, qualified personnel, material, equipment, and facilities to conduct the required services.

Businesses having the capability to perform this work are invited to submit a Statement of Capability (SOC) in order for the Government to determine acquisition strategy for this procurement. Capable offerors must clearly demonstrate that they possess expertise, experience and a thorough comprehensive knowledge in the study requirement. The SOC shall contain pertinent and specific information regarding the understanding of the scientific study of the safety and efficacy of pre-exposure to determine if chemoprophylaxis treatment reduces the incidence of HIV-1 infection. In addition, the SOC shall clearly address the offerors capabilities in the following areas:

a) Access to and capability to effectively work with the the MSM community in Bangkok;
b) Capacity to help recruit and retain 2,000 MSM volunteers in the project;
c) Ability to provide training and study monitoring and adherence to good clinical, laboratory and pharmacy practices;
d) Familiarity with Thai and international regulatory requirements regarding drug importation;
e) Capability to provide laboratory services to assess drug safety; and
f) Capability to provide medical personnel, medical services and support.

The SOC shall include the following information: company name, address, point of contact, phone/fax/email, and business size and status (e.g.
small business, 8(a), veteran-owned small business, service-disabled veteran owned business, HUBZone, small disadvantage business and women-owned small business). The NAICS code for this requirement is 541712. Interested parties having the capabilities necessary to perform the stated requirements may submit capability statement via email to Michele Jackson at [email protected]. The SOC is limited to 5 pages, single-spaced, 12 font, Times Roman. The subject line of the email shall be "Clinical trial to test the safety and efficacy of intermittent pre-exposure chemoprophylaxis to prevent HIV infection among men who have sex with men in Bangkok". Responses are due by December 02 , 2008.