Getting to Zero HIV Transmission Through Enhanced LEN for PrEP (HELP) Study
Contract Overview
Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.
AI Contract Overview
The National Institutes of Health intends to award a sole-source, firm-fixed price purchase order to the University of Maryland Baltimore for additional services during Option Year 4 of Contract 75N90022C00017, under the authority of 41 U.S.C. 253(c)(1), as only one responsible source exists and no other services can meet the agency’s requirements. This action is not a solicitation for competitive bids but a Notice of Intent to negotiate non-competitively for the continuation of the Getting to Zero HIV Transmission Through Enhanced LEN for PrEP (HELP) Study, a five-year multicenter clinical trial designed to evaluate an adaptive intervention to improve long-acting injectable pre-exposure prophylaxis adherence and retention. The study will operate across three geographic nodes in Washington, DC, Baltimore, Maryland, and West Virginia, with potential for adjustments based on consultation with the Contracting Officer’s Representative. The primary objective is to design and implement the adaptive intervention within the first 12 to 18 months of the project using the EPIS implementation science framework, focusing on coalition building and localized strategies to enhance uptake and sustained use of LEN. The performance period is one year, with an anticipated effective date of September 15, 2026. Though this notice does not obligate the government to award a contract or compensate respondents, all responsible parties may submit a capability statement by August 20, 2026, to be considered for potential inclusion in the government’s determination of sole source justification. Responses must be comprehensive enough to assess the respondent’s ability to perform the required work, but the government reserves the right to use any submitted information as it deems necessary and legally appropriate, without obligation to acknowledge receipt or provide feedback. The acquisition is classified under NAICS code 54199, managed by the NIH Office in Bethesda, Maryland, with Susan Nsangou as the point of contact for inquiries.
General Info
Agency
NAICS
Place of Performance
3758, MD, USASet-Aside
Documents
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Full Description
This is a Notice of Intent (NOI). This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 253 (c)(1), Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for quotes. The National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with the University of Maryland Baltimore for additional services during Option Year 4 of the Contract 75N90022C00017.
Only one award will be made as a result of this solicitation. This will be awarded as a firm-fixed price type of contract.
Period of Performance(s) are as follows:
One Year.
An anticipated effective date of September 15, 2026.
Acquisition purpose and objectives:
The scope of activities for this contract shall focus on the “Getting to Zero HIV Transmission Through Enhanced LEN for PrEP (HELP) Study.” The purpose is to understand LEN uptake, adherence, and retention, and assess an adaptive intervention to improve LEN adherence and continuation. HELP will be implemented in Washington, DC, Baltimore, Maryland and West Virginia.
The services are:
Complete all activities necessary to design an adaptive intervention for LEN adherence and retention for the HELP multicenter clinical trial during the first 12-18 months of the project. HELP is a five-year multi-site effectiveness implementation hybrid type 2 randomized controlled trial using the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation science framework.
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- Establish HELP study three geographic locations (nodes) that include Washington, DC, Baltimore and West Virginia. If necessary, node locations may be added or removed in consultation with the COR
- Through coalition building with partners, design intervention focused on LEN adherence and retention.
THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources that could provide the required services may submit a capability statement that will be considered by email by the due date and time on the closure of this posting. All responses received by the closing date of this notice will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.
This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.
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