SAM #75D30126Q79102

CDC Sole Source Clinical Study Services for CAB-LA (Apretude) PrEP Participants

This opportunity involves the Centers for Disease Control and Prevention (CDC), Division of HIV Prevention, seeking specialized clinical study services related to HIV prevention: - Government Buyer: - Centers for Disease Control and Prevention (CDC), Division of HIV Prevention - OEM Highlight: - ViiV Healthcare is the manufacturer of cabotegravir long-acting (CAB-LA, branded as Apretude), the medication central to this study - Vendors: - Dallas County Health and Human Services Sexual Health Clinic is identified as the only source capable of meeting the requirements - Products/Services Requested: - Clinical study services to procure and deliver lateral flow test results from persons on injectable CAB-LA PrEP - Recruitment and management of at least 50 participants who have been on CAB-LA PrEP for over 6 months - Collection of blood spot specimens and support for CDC-developed assay investigations - Timely reporting and shipping of specimens - Unique/Notable Requirements: - Clinic must be part of a public health network and have a high volume of CAB-LA PrEP clients - Demonstrated expertise in HIV preventative care and experience with IRB-approved protocols - Ability to conduct high-frequency participant interactions and manage complex study logistics - No other provider currently identified with the required capacity and expertise - The procurement is for clinical study services, not for the direct purchase of pharmaceutical products

Description

 The Centers for Disease Control and Prevention (CDC), Division of HIV Prevention requires an HIV care clinic within a public health network with a clientele of at least 50 persons on injectable cabotegravir long-acting (CAB-LA) (Apretude) pre-exposure prophylaxis (PrEP) for over 6 months. CAB-LA uptake is very low in the United States therefore having a sufficient number of participants on CAB-LA in one clinic to be able to successfully recruit at least 50 participants combined with serving a population with high transmission rates is key. The Dallas County Health and Human Services Sexual Health Clinic has a team of care providers and recognized leaders in HIV preventative care who can support investigation of new CDC-developed assays and manage requested blood spot specimen collection during care visits. This public health clinic incorporates the second-highest rate of sexually transmitted infection in the country with a high-frequency interaction with clientele to be able to recruit participant numbers and achieve the multiple-visit series of test evaluations within the contract period. No other provider has the combined capacity of recruiting persons with HIV or at increased risk of acquiring HIV, together with the high level of recognized expertise in long-acting PrEP care, and with experience in running Institutional Review Board (IRB)-approved protocols. The Dallas County Health Principal Investigaor (PI) is embedded in the patient care workflow to be able to effectively oversee recruiting and testing logistics. The Dallas County Health clinicians and care providers interact closely to manage the study aims, and they have available a nurse dedicated to ensuring evaluation testing and results upload for timely reporting and shipping of specimen to CDC. Dallas County health has th capability of successfully performing these clinical studies to satisfy CDC task orders and is currently the only identified source currently able to provide the required services to the CDC.This notice of intent is not a request for competitive quotations; however, all Quotations/ responses received within 15 days of the issuance of this notice shall be considered by the government. A determination by the government not to complete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Any quotation/response should be emailed to the contract specialist at email zvm0@cdc.gov by 07/23/2026.

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