National Institutes Of Health Tender

This Is A 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 All Qualified Sources To Perform A Potential Requirement. this Notice Is Issued To Help Determine The Availability Of Qualified Companies Technically Capable Of Meeting The Government Requirement, To Determine The Method Of Acquisition. 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) Intramural Research Program’s (irp) Technology And Translational Research Unit (ttru) Requires The Collection Of Passive Digital Phenotype Data, Self-reports Via Surveys And Daily Diaries; And Biological And Clinical Records Data From Patients Via Health Clinics Or Institutes With Access To The Patient Populations And The Infrastructure To Perform A Research Study Of Digital Phenotyping Gender And Sexual Minority (gsm) Patients Who Use Cannabis, Oversampling Black Gsm. The Primary Goal Is To Determine The Digital Phenotypes Of Sexual Minority Men And Gender Minorities Who Use Cannabis. Additional Goals Include Examining The Associations Between Cannabis Use And Risky Sexual Behaviors And Investigating The Impact Of Cannabis Use On Prep Adherence Among The Men Who Have Sex With Men And Gender Minority Populations. We Require Clinics Or Institutes That Can Provide Participants With Comprehensive Medical Care, Including Prep, In The Maryland Area And That Can Collect Relevant Medical Records, Drug Screens, And Other Clinical Information. The Research Team Will Need To Be Well Versed In Smartphone Studies With The Study Population. purpose And Objectives: Sexualized Cannabis Use, Or The Consumption Of Cannabis Surrounding And During Sexual Encounters, May Significantly Influence Hiv Transmission Rates By Increasing Instances Of Condomless Anal Sex And The Number Of Sexual Partners. While Hiv Pre-exposure Prophylaxis (prep) Has Shown Efficacy Rates Nearing 99% In Adherent Individuals, Adherence, Especially Among Black Sexual Minorities And Gender Minorities, Remains Notably Understudied In The Context Of Cannabis Use. This Project Aims To Understand The Complex Relationship Between Cannabis Consumption, Hiv Transmission Risk, And Prep Outcomes, With A Primary Focus On Black Sexual Minorities And Gender Minorities But Also Encompassing All Individuals Assigned Male At Birth Who Engage In Sex With Men, Regardless Of Their Hiv Status. The Inclusion Of A Broader Demographic Allows For A Comparative Analysis Between Racial Groups, Shedding Light On Potential Disparities And Similarities In Behaviors And Outcomes. Given The Rise In Cannabis Use And The Advent Of Geosocial Networking Apps Catering To Cannabis Users, There's A Speculated Link Between Sexualized Cannabis Use And Increased Hiv Transmission Risks. A Custom Smartphone App Will Be Utilized To Passively Collect Diverse Digital Data, From Gps Locations To Social Media Interactions, Complemented By Smart-context Aware Ecological Momentary Assessments. Artificial Intelligence Will Be Employed To Develop And Validate Prep And Hiv Risk Prediction Algorithms, Drawing From The Rich Digital Phenotype Data That Includes Demographics, Mood, Sexual Behavior, Social Support, Dating Behavior, Substance Use, And Location. Advanced Computational Algorithms Will Be Harnessed To Predict Cannabis Use And Cravings, Emphasizing The Identification Of Pivotal Features That Classify Cannabis Cravings And Use In The Context Of Sexual Behavior. Additionally, This Project Will Probe Into The Associations Between The Systemic Challenges Faced By Black Sexual And Gender Minorities, Such As Stigma, Discrimination, And Mental Health Issues, And Their Connections To Biological Inflammation, High-risk Sexual Behaviors, And Hiv Seroconversion, Utilizing Digital Phenotyping, Event-level Measures, Innovative Cannabis Consumption Metrics, And Objective Biomarker Data. objectives: the National Institute On Drug Abuse (nida) Intramural Research Program’s (irp) Technology And Translational Research Unit (ttru) Requires The Collection Of Passive Digital Phenotype Data, Self-reports Via Surveys And Daily Diaries; And Biological And Clinical Records Data From Patients Via Health Clinics Or Institutes With Access To The Patient Populations And The Infrastructure To Perform A Research Study Of Digital Phenotyping Gender And Sexual Minority (gsm) Patients Who Use Cannabis, Oversampling Black Gsm. The Primary Goal Is To Determine The Digital Phenotypes Of Sexual Minority Men And Gender Minorities Who Use Cannabis. Additional Goals Include Examining The Associations Between Cannabis Use And Risky Sexual Behaviors And Investigating The Impact Of Cannabis Use On Prep Adherence Among The Men Who Have Sex With Men And Gender Minority Populations. We Require Clinics Or Institutes That Can Provide Participants With Comprehensive Medical Care, Including Prep, In The Maryland Area And That Can Collect Relevant Medical Records, Drug Screens, And Other Clinical Information. The Research Team Will Need To Be Well Versed In Smartphone Studies With The Study Population. capability Requirements: Interested Vendors Shall Show Their Capability To Meet The Following Requirements: recruitment And Study Enrollment capable Vendors Must Demonstrate Their Ability To Access And Recruit 200 Participants To Complete This 45-day Study. Participants Populations Must Be A Gsm Who Uses Cannabis; 80% Of The Sample Will Be Black Gsm. capable Vendors Must Demonstrate Direct Experience Conducting Research With Our Target Population To Support Participant Recruitment And Enrollment Objectives. engage With A Capable Vendor That Has Partnerships With Health Clinics In Maryland And Dc Metro Area, That Provide Healthcare To Our Target Populations, So That We Can Leverage Access To These Clinics To Recruit Individuals With A Substance Use Disorder And Sexual Minority Men And Gender Minorities. obtain All Regulatory Approvals Necessary To Conduct The Research. collaborate With A Capable Vendor To Identify Potential Participants Who Meet The Study's Eligibility Criteria. screen And Obtain Informed Consent From Participants In Accordance With The Study Protocol. ensure Completion Of Enrollment Procedures. track Participants Throughout The Study To Ensure Compliance And Conduct Follow-up Outreach To Retain Participants And Encourage Study Completion. 2. Provide Remuneration capable Vendors Must Demonstrate Experience And Ability To Provide A Variety Of Remuneration Support To Participants As Compensation For Time And Effort To Participate In The Study. 3. Collaboration And Communication capable Vendors Must Demonstrate Experience And Ability To Manage Regular Communication And Collaboration Between The Government Through Meetings, Progress Updates, And Consultations Will Be Scheduled As Needed To Ensure Effective Coordination And Exchange Of Information. 4. Medical Care And Prep Provision capable Vendor’s Must Identify Established Partnerships With Clinics And Programs To Provide Necessary Medical Care To The Study Participants. They Must Ensure That Prep Services, Including Prescription And Monitoring, Are Provided To Eligible Participants. Vendors Must Be Able To Coordinate With The Health Clinics To Facilitate The Integration Of Prep Services Into The Participants' Care Plans. Vendors Must Also Be Able To Collaborate With Participating Centers To Obtain Relevant Medical Records, Drug Screens, And Clinical Information Related To Participants' Prep Utilization And Adherence; Drug Treatment Adherence; And Other Related Care. 5. Data Collection And Monitoring capable Vendors Must Demonstrate Experience And Ability To Assist Participants In Installing An Android Smartphone Application For Data Collection, Passive Mobile Data Monitoring, And Ecological Momentary Assessments, As Outlined In Study Protocol. Vendors Must Be Able To Collaborate With Nida-irp To Ensure Seamless Integration Of The Smartphone Application With The Services Provided By Partnering Health Clinics. Ensure Patient Confidentiality In Recordkeeping And Monitor And Promote The Collection Of Passive Data From Participants Using The Smartphone Application For The Duration Of The Study. Capable Vendors Must Be Able To Monitor And Promote The Collection Of Self-report Surveys And Daily Diaries To Collect Additional Data On Cannabis Use And Risky Sexual Behaviors, As Well As Collect And Maintain Clinical Data For Study Duration Including Provide Clinical Data To Nida-irp Researchers. 6. Reporting capable Vendor Must Demonstrate Experience In Preparing All Regulatory Documents To Gain Necessary Approvals. Capable Vendor Must Demonstrate Experience With Providing Regular Updates (e.g. Recruitment Status), Ad Hoc Status Reports, And Managing De-identified Study Data At The End Of The Project. Capable Vendor Must Demonstrate Experience And The Ability To Oversee The Recruitment, Enrollment, And Follow-up Procedures With Participants On Similar Studies. The Capable Vendor Must Demonstrate Their Experience And Ability To Protect All Sensitive Protected Health Information (phi) Or Personally Identifiable Information (pii) Collected While Performing The Required Services. 7. Capable Vendor Site Specifications vendors Must Demonstrate Expertise In Conducting Research Trials Involving Hiv Management And Prevention And Substance Use Disorder Treatment. Capable Vendors Must Possess An Established Infrastructure To Recruit The Required Number Of Research Participants And Provide Hiv Care For People Living With Hiv And Preventing Hiv In Individuals Seeking This Care. capability Statement /information Sought. capable Vendors Shall Demonstrate And Document In The Submitted Capability Statement Its Experience In The Technical Areas, Requirements, And Personnel Listed Above. Furthermore, Vendors Should Include Relevant And Specific Information On Each Of The Following Qualifications: 1) Approach: Vendors Should Prepare A Narrative Describing The Methodologies, Approach, And Techniques Utilized On Similar Relevant Project To Achieve The Requirements Listed Above. 2) Experience: Provide An Outline Describing Experiences On Previous Similar Projects, Specifically The Techniques Employed, The Challenges Encountered, And The Lessons Learned In The Areas Described Above. Additionally, Provide The Name And The Point Of Contact For Any Recent Organizations, Institutions, Or Agencies Where Services Were Provided With A Similar Scope Of Work. 3) Personnel: Provide The Names, Professional Qualifications Of Personnel With Specific Experience In The Work Requested And Knowledge Of, And Experience To Successfully Complete The Requirements Describe Above. the Government Will Assess The Appropriateness Of Professional And Technical Personnel Classifications. The Government Will Consider Any Other Specific And Relevant Information About This Particular Announcement That Would Improve Our Evaluation Of Respondents. Organizations Should Demonstrate Capability To Administer And Coordinate Interrelated Tasks In An Effective And Timely Manner. Documentation May Include, But Is Not Limited To, Contracts In Which The Organization Performed Equivalent Tasks (government And Commercial); References, I.e., Names, Titles, Telephone Numbers And Any Other Information Serving To Document The Organizations Capability; And Awards Or Commendations. companies That Believe They Possess The Capabilities To Provide The Required 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 1) The Total Number Of Employees, 2) The Professional Qualifications Of Personnel As It Relates To The Requirements Outlined, 3) Any Contractor Gsa Schedule Contracts And/or Other Government-wide Acquisition Contracts (gwacs) By Which All Of The Requirements May Be Met, If Applicable, And 4) 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. interested Companies 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. The Government Requests That No Proprietary Or Confidential Business Data Be Submitted In A Response To This Notice. However, Responses That Indicate The Information Therein Is Proprietary Will Be Properly Safeguarded For Government Use Only. 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. When Submitting This Information, Please Reference The Solicitation Notice Number. the Information Submitted Must Be In And Outline Format That Addresses Each Of The Elements Of The Project Requirement And In The Capability Statement /information Sought Paragraphs Stated Herein. A Cover Page And An Executive Summary May Be Included But Is Not Required. the Response Is Limited To Twenty (20) Page Limit. The 20-page Limit Does Not Include The Cover Page, Executive Summary, Or References, If Requested. all Responses To This Notice Must Be Submitted Electronically To The Contract Specialist And Contracting Officer. Facsimile Responses Are Not Accepted. the Response Must Be Submitted To Shaun Rostad, Contract Specialist At E-mail Address Shaun.rostad@nih.gov. the Response Must Be Received On Or Before July 5th, 2024, 1:00 P.m., Eastern Time. 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).”