Life after Mpox (LAMP) Study - Houston

Notice of Intent to Sole Source Product Service Code: AN22 - Health R&D Services; Health research and training; Applied Research NAICS Code: 54171 - Research and Development in the Physical, Engineering, and Life Sciences Notice of intent to award a sole source contract. This is not a solicitation. The Centers for Disease Control and Prevention (CDC) intends to solicit and negotiate a sole source contract with: UT Health Sciences Center at Houston (UTHealth Houston) Sponsored Projects Administration 7000 Fannin St, UCT1006 Houston, Texas, United States, 77030 This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole-source contract pursuant to 10 U.S.C 2304 (C)(1), as implemented by the authority permitting other than full and open competition is FAR § 6.303-1(d) and 6.302-2, Unusual and Compelling Urgency, FAR § 8.405-6(a)(1)(A), Limiting Sources, and FAR § 16.505(b)(2)(i)(A), Exceptions to the Fair Opportunity Process for all contract actions to facilitate the information recovery efforts necessary to address the 2023 MPOX study. This is not a solicitation. The purpose of the project is to implement the Life after Mpox (LAMP) Study research protocol. Per protocol, the research will evaluate and determine factors that influence the ongoing clinical and psychosocial sequelae, morbidity and reduced function outcomes related to MPOX that persist about one year (10-14 months) after the participant’s initial Mpox during the 2022 Mpox outbreak in the U.S.. Additionally, it will identify health and socioeconomic disparities in the Mpox outcomes (e.g., related to race/ethnicity) and the resulting unmet clinical and public health needs to reduce the identified morbidity and disparities. The project will also describe differences between the ongoing psychosocial impact and sexual practices of persons who had Mpox and the current psychosocial status and sexual practices of persons who did not have Mpox during 2022 despite being at comparable risk for infection through intimate contact, the main mode of spread. The Mpox emergency response remains an agency priority. The (LAMP Study was identified as a Response priority during the CDC 2022 Multinational Mpox Response and was assigned to the Response Epidemiology Task Force/Special Studies Team to develop. Implementation of the project has now been transitioned to NCHHSTP/DHP in collaboration with NCEZID. CDC also continues to work closely with the White House Mpox emergency Response Team, including participating in the March 31, 2023, United States Government (USG) virtual gathering to discuss MPOX research. The LAMP study was presented as a CDC priority during that meeting. This contract will afford the CDC the ability to provide information to United States Government on Mpox outcomes, health disparities and the ongoing demand on the health and public health systems. The LAMP Study as described by CDC fills the gap between research agendas that do not identify or report on data about persistent Mpox sequelae, morbidity, and related ongoing Mpox patient needs or further public health response needs. It is still not known how often and what longer-term sequelae of Mpox persist following this outbreak, and what clinical and public health intervention are urgently needed to reduce further morbidity, suffering, and health disparities. The project requires implementation with data collection starting by June 2023 to meet the time sensitive need to rapidly collect data about the frequency and type of ongoing clinical, psychosocial and behavioral sequelae of Mpox that persist at one year after the individual’s original Mpox virus infection, defining disparities in those outcomes and ongoing clinical and public health response needs. The evaluation must include the populations disproportionately affected by the Mpox outbreak in the United States from at least two different areas of the United States to reflect geographic differences in the outbreak. It is critical that data collection occur during June-November 2023, to capture cases at approximately one year (10 – 14 months) after their acute Mpox onset since the majority of cases in the United States occurred during June-September, 2022, after the outbreak began in May 2022. These data are needed to intervene and mitigate chronic outcomes in persons still burdened by the sequelae of their Mpox illness, reduce health disparities and prepare public health programs to mitigate Mpox chronic sequelae and health disparities when future Mpox cases occur. Two sites met all criteria required for successful execution of the project, after extensive examination of and communication with multiple jurisdictions and healthcare sites having potential to meet the following criteria: racial/ethnic diversity; sufficient numbers of Mpox cases during 2022 for the site to enroll at least 100 persons who had Mpox and 100 comparator participants (persons with comparable sexual risk for Mpox acquisition as the Mpox cases but who did not have Mpox in 2022); appropriate clinical expertise and capacity to recruit and implement study activities, including clinical exam of participants who had symptomatic, laboratory-confirmed Mpox virus infection during the illness window; and located in different parts of United States. Many jurisdictions indicated they would not have capacity to conduct the clinical exam part of the study, and multiple jurisdictions contributing large portions of the >30,000 United States Mpox cases occurring during 2022 indicated they anticipated difficulty re-contacting and enrolling both groups of participants and/or challenges sharing some of the critical information to be collected. A number of interested clinical partners determined they would likely not be able to re-contact sufficient numbers of Mpox cases based on challenges already experienced in follow-up attempts. UTHealth Houston plans to assess post-Mpox sequelae and has the ability to re-contact many of the cases. That institution has capacity to meet all the criteria to evaluate the target populations within the required, specified, critical time frame. UTHealth Houston has access to a large number of to a large number of former Mpox cases and other persons at risk for acquitting Mpox in the New York area, as a provider of patient care services, and also has strong relationships with the extended healthcare community and community-based organizations that have frequently referred persons with m or at risk for HIV to UTHealth Houston for care and enrollment into research studies. The authority permitting other than full and open competition is FAR § 6.303-1(d) and 6.302-2, Unusual and Compelling Urgency, FAR § 8.405-6(a)(1)(A), Limiting Sources, and FAR § 16.505(b)(2)(i)(A), Exceptions to the Fair Opportunity Process for all contract actions to facilitate the information recovery efforts necessary to address the 2023 MPOX study. It is prudent to have adequate flexibility to address this public health emergency. This J&A is essential to respond to urgent requests for immediate support to purchase critically needed research information to respond to the Mpox outbreak and any future outbreaks. The Mpox outbreak evolved at a fast pace, resulting in an urgent and compelling need to rapidly procure supplies and services to support the containment and recovery of the outbreak throughout the country. The number of Mpox cases increased from May through August 2022 with a gradual decline in cases through the end of 2022. The bulk of patients who had Mpox will reach one year post infection between June and October 2023. This constitutes an unusual and compelling urgency that demands immediate attention to ensure future actions support public health emergency criteria and responses. Information from the study will help the United States of America remain prepared for and capable of responding to a public health emergency in the necessary and immediate manner that is required. The project aim is to evaluate the clinical and psychosocial sequelae, morbidity and reduced function outcomes related to Mpox that persist at about one year (10-14 months) after the participant’s initial Mpox virus infection and compare psychosocial status and sexual behavior changes of a minimum of 100 post-Mpox patients who had Mpox between May – September 2022 with a comparison group which is a minimum of 100 persons who did not have Mpox during 2022 but were at risk for sexual acquisition of Mpox. UTHealth Houston is uniquely suited to perform the project contemplated by this action. UTHealth Houston has the study protocol and project plan, Institutional Review Board approval, systems, trained personnel, access to and ability to enroll subjects, and databases to immediately implement the project with no transition or startup period. Another entity would require significant start up time and costs that would delay the start of this project and increase the Government’s costs. Additionally, UTHealth Houston has the experience, staff, expertise, equipment, and existing study components to conduct the clinical evaluations as well as psychosocial and behavioral assessments on both persons who had Mpox and persons who did not get Mpox despite comparable risk for infection. Furthermore, UTHealth Houston serves a large population vulnerable to Mpox (ethnic minorities, socioeconomically vulnerable, behavioral risk) and has the academic center support for data and specimen collection and analysis. Interested parties may identify their interest and capability to respond to the requirement. Any response to this notice must show clear and convincing evidence that competition will be advantageous to the Government. Primary expertise should include being a responsible source, with access to the required medical information and the ability to transmit data, to the CDC in the proper format, without requiring a transition or startup period. Due to the sensitivity of the information parties must provide detailed information on how it is you have access to the required data and may submit a capability statement, proposal, or quotation to Kelly Parker, Contract Specialist, at [email protected], which shall be considered by the agency. The Government will review any/all information submitted to determine if any other responsible sources exist that could provide this requirement. The government reserves the right to proceed without response to submissions. Any information received in response to this announcement will be used solely for the purpose of determining whether there is sufficient justification to conduct a competitive procurement. The deadline for submissions is May 31, 2023, at 4:30pm Eastern time. Due to the urgent nature of the required information no extensions or additional time will be granted. The government reserves the right to proceed without response to submissions. This notice will close on June 2, 2023.