SAM #75N95026R00007

Pharmacoepidemiological Study Services for GLP-1RAs and DPP-4 Inhibitors in HIV and Substance Use Disorders

The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA) and the National Institute on Alcohol Abuse and Alcoholism (NIAAA), are seeking small business vendors for a pharmacoepidemiological study focused on HIV and substance use disorders: - Government Buyer: - NIH, NIDA, and NIAAA, with the contracting office located at NIH NIAID in Bethesda, MD - Services Requested: - Pharmacoepidemiological study services, including: - Data extraction, management, analysis, and reporting - Use of electronic health record data from the Veterans Aging Cohort Study (VACS) and VA pharmacy records - Focus on the effects of GLP-1 receptor agonists and DPP-4 inhibitors on HIV- and substance use disorder-related outcomes - Requirements: - Vendors must have access to VACS data and an established data analysis pipeline - Demonstrated expertise in pharmacoepidemiology and biomedical data science is required - No specific OEMs or commercial products are named; the emphasis is on service capability and experience - Period of Performance: - 12-month base period with three 12-month option periods - Places of Performance and Delivery: - VA Connect Medical Center in West Haven, CT (study data source) - NIH NIAID office in Bethesda, MD (contracting office)

Description

This is a Small Business Sources Sought notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: The availability and capability of qualified small business sources; Whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; Their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition; Availability of domestic sources manufactured in the United States in sufficient and reasonably available commercial quantities and of a satisfactory quality. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice. It is not to be construed as a commitment by the Government to issue a solicitation or ultimately award a contract. Responses will not be considered as proposals or quotes. No award will be made as a result of this notice. The Government will NOT be responsible for any costs incurred by the respondents to this notice. This notice is strictly for research and information purposes only. Small businesses are encouraged to respond. Background The National Institute on Drug Abuse (NIDA) Clinical Psychoneuroendocrinology (CPN) laboratory, jointly with The National Institute on Alcohol Abuse and Alcoholism (NIAAA), conducts clinical and translational inpatient and outpatient studies to identify possible novel medications for addiction. The CPN uses a combination of state-of-the-art, innovative biobehavioral and pharmacological procedures performed under well-controlled human laboratory conditions. The CPN is particularly interested in the role of neuroendocrine pathways in alcohol- and drug-seeking behaviors and identifying novel effective pharmacotherapies in this regard. Previous literature supports the overall hypothesis that GLP-1RAs may have beneficial effects on HIV-related outcomes in people living with HIV/AIDS (PLWH) and comorbid alcohol and substance use disorders (ASUDs) by decreasing HIV RNA levels, increasing CD4 count, improving retention on antiretroviral therapy (ART), and improving liver function. The co-primary aims will be whether GLP-1RAs, as compared to untreated matched controls and/or matched controls treated with other GLP-1 therapies (i.e., DPP-4 inhibitors) lead to: Improvements in direct HIV-related biomarkers, i.e., decrease in HIV RNA levels and/or increase in CD4 count, Improved retention on ART, Improvement in liver function as measured by clinically relevant biomarkers of liver damage and function (FIB-4, AST, ALT, GGT, bilirubin, alkaline phosphatase, albumin, prothrombin time); Improvement in physical health (details below) and physiological frailty (VAC index); Reduction in pain level. We will also assess relevant secondary aims in each study. The CPN will conduct high-quality pharmacoepidemiological studies using state-of-the-art methods leveraging 20+ years of high-quality, longitudinal electronic health record data from the Veterans Aging Cohort Study (VACS). NIDA is looking to identify capable vendors that can apply approaches consistent with the emerging role of data science in biomedical research and with cutting-edge pharmacoepidemiologic approaches, which have been used in other fields and recently gained traction in the addiction field. Capable vendors must have demonstrated experience in robust pharmacoepidemiology analyses with ASUD and HIV-related outcomes and identifying early efficacy signals with medications that can then be tested in prospective randomized controlled trials. Purpose and Objectives The NIDA, CPN laboratory, is seeking capable vendors that have demonstrated experience in providing data extraction, management, analysis, and report of a propensity-score matched pharmacoepidemiological study of baclofen and spironolactone, prescribed for any indication, on HIV- and ASUD-related outcomes in a general patient population and a naturalistic setting, using the Veterans Aging Cohort Study (VACS). Capable vendors must have experience in managing de-identified data. Project requirements Capable offerors must demonstrate their experience with, and ability to complete the following activities: The objective of the proposed project is to examine GLP-1RAs and their potential health benefits for PLWH, in addition to alcohol and substance use disorders outcomes. Using electronic health record data from the Department of Veterans Affairs (VA), the capable vendor will investigate the association between GLP-1RAs (prescribed for any indication) and HIV- and ASUD-related outcomes in adults, led by targets provided by NIDA staff. Individuals exposed to GLP-1RAs will be propensity-score matched to up to five unexposed individuals. Multivariable linear regression models will estimate changes in HIV- and ASUD-related outcomes before and after exposure. Pharmacy records will be extracted to identify patients who did and did not receive the medication under investigation dispensed at VA pharmacies. The capable vendor, after consulting with NIDA Staff, will identify the first prescription for the medication during the study period and will require a washout period for new episodes of medication exposure. Exposure to the medication is defined as receipt of two or more fills for a minimum number of continuous days (determined as part of the analysis), for any indication, from VA outpatient clinics. For unexposed comparators, the capable vendor will select patients who attended at least one of the same clinics, but never received the medication, ensuring that unexposed patients came from the same source population, were exposed to an overall similar medical care, and had equal opportunities to receive the same medication. The capable vendor, with input from NIDA Staff, will create an “index date” (also referred to as “baseline”), defined as the first fill date for exposed patients and a randomly selected outpatient visit date for unexposed patients. To balance the distribution of all potential confounders across treatment groups, we will perform propensity score approaches (e.g., matching, weighting). This shall be done by first modelling the probability (i.e., propensity) of receiving the medication as a function of measured covariates associated with the exposure and outcome using a multivariable logistic regression model. Variables included in the propensity score model will be guided largely by our previous work. Covariates will be summarized using descriptive statistics, stratified by treatment group. To assess balance, we will calculate absolute standardized mean differences (SMD) between AUDIT-C categories and consider 0.1 or less as balanced. The capable vendor will be responsible for pulling, organizing and cleaning the specific datasets. NIDA IRP will lead the development and preparation of the manuscript. The data are generated via the VA Birth Cohort Study and housed at the VA Connect Medical Center in West Haven, CT. The capable vendor will be completing data management and analysis for this project. Period of Performance: 12 months from date of award with three (3) 12 month option periods. Other important considerations Mandatory Criteria Given timeline restrictions and the importance of research integrity/replication, it is required that the capable vendor possess full access to the VACS data and other sources needed for these analyses, as well as an already built data analysis pipeline. Capability Statement/Information Sought Vendors that believe they possess the capabilities to provide the required products/services should submit documentation of their ability to meet each of the project requirements to the Contracting Officer. The capability statement must specifically address each of the project requirements separately. Additionally, the capability statement should include: The total number of employees, The professional qualifications of personnel as it relates to the requirements outlined, Any contractor GSA Schedule contracts and/or other government-wide acquisition contracts (GWACs) by which all of the requirements may be met, if applicable, Any other information considered relevant to this program. Capability statements must also include the Company Name, Unique Entity ID from SAM.gov, Physical Address, and Point of Contact Information. The response must include the respondents’ technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. For equipment/supply requirements, responses must include the place of manufacturing (i.e., address if supply/equipment is a domestic end product and include country of manufacture). For equipment/supply requirements, small businesses must also address the size status of the manufacturer under the applicable NAICS code (i.e., address Non-Manufacturer Rule). Interested vendors are required to identify their type of business, applicable North American Industry Classification System (NAICS) Code, and size standards in accordance with the Small Business Administration. Capability statements must include the name and telephone number of a point of contact having authority and knowledge to discuss responses with Government representatives. Capability statements in response to this market survey that do not provide sufficient information for evaluation will be considered non-responsive. Number of Copies: Please submit one (1) electronic copy of your response as follows: All capability statements sent in response to this small business sources sought notice must be submitted electronically (via e-mail) to Kim Harris, Contracting Officer, at Kimberly.harris2@nih.gov in MS Word or Adobe Portable Document Format (PDF). The email subject line must specify 75N95026R00007. Facsimile responses will not be accepted. Common Cut-off Date: Electronically submitted tailored capability statements are due no later than 5:00 PM EST on 05/06/2026. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. Disclaimer and Important Notes This notice does not obligate the Government to award a contract or otherwise pay for the 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. After a review of the responses received, a presolicitation synopsis and solicitation may be published in www.sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

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