United States - Participant Recruitment, Screening, and Remuneration at the NIDA IRP Clinical Program

Description

Added: Nov 01, 2019 3:58 pm

INTRODUCTION:
The National Institutes of Health (NIH), through the National Institute on Drug Abuse -Intramural Program (NIDA IRP), is seeking capability statements from BOTH Other than Small Business and Small Business organizations to provide the Government support for participant recruitment, screening, and remuneration at the NIDA IRP Clinical Program.

This is a SOURCES SOUGHT NOTICE to determine the availability of BOTH Other than Small Business and Small Businesses (e.g., 8(a), Veteran-owned small businesses, service-disabled Veteran-owned small businesses, HUBZone small businesses, small disadvantaged businesses, and women-owned small businesses) with the capability to meet the objectives and requirements described below. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible.

BACKGROUND:
The mission of NIDA IRP is to conduct state-of-the-art research on basic mechanisms that underlie substance use disorders (SUDs), and to develop new methods for the treatment of SUDs. Research is supported at the molecular, genetic, cellular, animal, and human clinical levels and is conceptually integrated, highly innovative strategies and techniques. The long-term goal of the research is to better understand the biological and behavioral factors contributing to initiation, maintenance, and elimination of SUDs (and associated diseases), and to translate this knowledge into improved strategies for prevention, treatment, and reduction of negative consequences for the individual and for society caused by substance use disorders. Using volunteer human participants, the IRP clinical program conducts residential and nonresidential research studies that interrelate with pre-clinical laboratory work. In general, these studies include assessment of drug-use patterns, investigation of underlying brain mechanisms, and testing of a variety of SUD behavioral or biomedical treatments.
PURPOSE AND OBJECTIVES:
The purpose of this Sources Sought Notice and market research is to identify vendors with demonstrated experience and capabilities in providing services for the recruitment, screening and remuneration of eligible research participants for inclusion in human research studies conducted by the NIDA IRP as part of their ongoing mission. NIDA IRP seeks to enroll a highly targeted and representative study population of sensitive/unique research participants including those with active SUDs (e.g. nicotine, alcohol, cocaine, marijuana, opioids) who are not seeking treatment, those who are seeking treatment, people who are occasional users of these substances and healthy controls who match the other populations with respect to characteristics such as age, gender, socio-economic status (SES), IQ, etc. The NIDA IRP is also conducting studies requiring HIV-positive populations.
GENERAL REQUIREMENTS:
A Capable Vendor must demonstrate its experience and ability to perform the following key requirements:
I. Recruitment:

1. Develop, implement and manage custom advertising and recruitment strategies.
     a. Most research at the IRP is done on-site at the Biomedical Research Center (BRC) at the Johns Hopkins Bayview Campus located in Baltimore, requiring repeated visits from participants who do not own vehicles. Therefore, capable Vendors must have the experience and ability to recruit large numbers of participants living within five to ten miles of the designated site location.
     b. Each individual research studies will require custom-developed and multi-pronged approaches to recruitment campaigns, therefore a capable Vendor must demonstrate its familiarity with NIDA IRP's target population (or research participants), as well as its ability to develop a tailored recruitment plan based on the specified inclusion/exclusion (I/E) criteria.

2. Establish grassroot community partnerships campaigns aimed at educating the local public on NIDA IRP's mission, building awareness, and establishing trust.
     a. A capable vendor shall demonstrate its expertise in identifying and establishing community relationships with organizations or foundations (e.g. faith-based organizations, community gathering places, and foundations providing support for those with SUDs, etc.) with connections to the various populations NIDA is seeking to identify and recruit.
     b. The overall goal of this effort is to educate the specific populations on who NIDA is, what research NIDA does, and to create a mutually beneficial relationship founded in trust with the local community. Reaching out to the community-based organizations as well as healthcare providers, local physicians and treatment centers will enhance research enrollment.

3. Manage targeted advertising campaigns that include the development and placement of multi-media advertisements.
     a. A capable vendor must demonstrate its experience in customizing targeted messages to a specific population based on varying Inclusion/Exclusion Criteria. For the purpose of this requirement the populations could include but may not be limited to: individuals who are generally healthy but may also have substance use disorders; and/or individuals who do not have a substance use disorder but are otherwise closely matched (e.g. with regard to socioeconomic status (SES), IQ, race, ethnicity, etc.).
     b. A capable vendor should demonstrate its experience in developing and implementing multi-media advertising campaigns in the Baltimore/ Washington metropolitan area. Participants may also come from neighboring states (e.g. northern Virginia, southern Pennsylvania).
     c. Vendors should possess experience in developing creative initiatives and utilizing evidence-based statistics to develop recruitment strategies to target each population identified by NIDA as essential to meet recruitment goals and to overcome challenges to reach these populations. Target populations include but are not limited to individuals who smoke cigarettes (treatment seeking and non-treatment seeking), ex-smokers, and those with marijuana, opioid, cocaine or alcohol use disorders, not necessarily in combination with one another, who may or may not be seeking or are currently in treatment for a SUD. Some studies are also seeking to enroll HIV positive populations. While other studies may involve Magnetic Resonance Imaging (MRI) studies or utilizing non-invasive brain stimulation techniques which require a highly selective I/E criteria. Many studies require participants who do not have dual SUDs, nor other comorbidities such as mental health disorders, or any significant physical illness. Given the diversity of the I/E criteria it is important to the science of the studies and recruitment targets must be reached within reasonable timeframes.

4. Conduct real-time monitoring and continuous optimization of all recruitment strategies as well as establish tracking and performance metrics for each strategy and campaign.
     a. NIDA IRP requires each marketing strategy used (e.g. performance of each ad) to be tracked on an on-going, real time basis. Therefore, a capable vendor must demonstrate is ability to assess the effectiveness of each campaign and continuously monitor the resulting data in order to improve strategies and optimize recruitment goals per protocol.
     b. A capable vendor should have demonstrated experience in managing advertising campaigns through print, internet, community outreach, as well as other media platforms.
II. Screening:

1. Conduct preliminary screening procedure by phone and online that are compliant with a variety of criteria and protocols based on the designated recruitment initiative.
     a. Phone screeners must have experience working with sensitive populations such as those with SUD and/or HIV, etc., and be familiar with empathetic, supportive and non-stigmatizing methods of communication. Screeners must also be familiar with each study and prepared to answer questions about the study such as purpose, timeline, and payment.
     b. A capable vendor should demonstrate its experience in utilizing a structured computer-based screening process designed to capture relevant information from the aforementioned populations to assess basic inclusion/exclusion criteria and the candidate's current research interests. Screening results must be interpreted in the context of the current epidemiology and natural history of drug use, misuse, use disorders and treatment for appropriate referral to research opportunities.
     c. Phone screening must accommodate after-hours callers (i.e. evenings/weekends) and have the flexible ability to handle transient high call volume and include flexible time-frames to accommodate research candidate's availability and call fluctuations based on new campaign launches.

2. Conduct in-person screening procedures that are compliant with a variety of criteria and protocols based on the designated recruitment initiative.
     a. The in-person screening process is a very critical element of this contract and our research operations. All study candidates must undergo a thorough onsite screening process. A small number of the studies permit portions of the screening process to be completed via secure online methods (e.g. Skype, FaceTime) with participants who are offsite. All screening procedures must be streamlined to optimize efficiency and cost-effectiveness of the process.
     b. In person screeners must be familiar with each study and be prepared to answer questions about the study such as purpose, timeline, and payment.
     c. In person screeners are required to conduct basic medical assessments (e.g. obtaining vital signs, drawing blood, performing echocardiograms (ECGs), urine pregnancy testing, CO monitoring, breathalyzer and urine testing for drugs of abuse). Capable vendors will also be required to supply the Clinical Laboratory Improvement Amendments (CLIA) waiver testing kits needed for pregnancy, HIV and urine testing for drugs of abuse.
     d. At least one staff member would be required to be present at all times during onsite screening hours who is qualified to: assess the mental health of potential study participants to determine whether they can give informed consent, assess whether a potential volunteer meets The Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria for mental and substance use disorders, and intervene should psychological distress occur during screening.
     e. The screening process also includes assessment of SUDs via administering medical and psychiatric measures, and psychiatric interviewing. Screeners should be familiar with and qualified to administer psychiatric measures (e.g. Structured Clinical Interview for DSM Disorders (SCID), Substance Use Disorder Evaluation (DSM-5)) and be prepared to obtain measure-specific training as needed.

3. Provide schedule coordination services for those candidates that are accepted through the screening process.
     a. Vendors should have the capability to provide automated options for those respondents who click on digital ads/media and include digital (e.g. text) reminders and confirmations of scheduled appointment times.
     b. Digital (e.g. text) reminders and confirmations of scheduled appointment times must be offered to all candidates.
III. Remuneration:

1. Provide remuneration services to participants as they complete sections of a protocol.
     a. Remuneration may be dispersed as cash, checks, gift cards, online payments or paying bills directly on behalf of the participant, as defined by the protocol.
     b. All expenses must be tracked in the participants' electronic medical record in addition to overall record keeping of all funds distributed.
     c. Coordinate and track participant progress within each study, and account for all remuneration paid to participants through different forms of compensation.
     d. Coordinate travel and subsistence program for participants requiring transportation and lodging, as needed and described in each protocol. This may include but not be limited to taxi, train, bus, or plane, as well as local hotel accommodations when required (in accordance with NIH policies).
IV. Flexible Staffing:

1. Support the effective communication and coordination of all requirements through regular reporting and the implementation of an automated system to track and generate specific performance reports, as well as maintain close communication with study staff to determine and optimize how participants who are interested and eligible for multiple studies will proceed through the recruitment process and into a study.

2. Provide cross-trained staffing solutions with flexible and adaptive hours, (including evenings and weekends) capable of conducting screening services online, over the phone, or in-person.
INSTRUCTIONS:
Interested organizations must demonstrate and document in the submitted capability statement extensive experience in the technical areas and requirements listed above. Furthermore, organizations should include relevant and specific information on each of the following qualifications:
1. Experience: An outline of previous similar projects, specifically the techniques employed in the areas described above.

2. Personnel: Name, professional qualifications of personnel with specific experience in the work requested and knowledge of, and experience in, the field of biomedical research.

3. Facilities: Availability and description of the facilities and equipment required to conduct this type of work.

4. Compliance with Requirements: Vendors must identify and demonstrate specifically how they will meet the requirements listed 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 assessment 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.
The established NAICS code is 541990: Professional, Scientific, and Technical Services/541990 -All Other Professional, Scientific, and Technical Services. The U.S. Small Business Administration establishes a size standard for 541990 as revenue of $16,500,000 or less.
All capability statements also should include the following: 1) company name and address; 2) point of contact, 3) phone/fax/email; 4) NAICS Code(s), 5) business size and status; 6) capability information in response to the requirement and qualifications identified in this notice; and 7) type(s) of business, if applicable (e.g., Other than Small, Small, Veteran-owned, service-disabled Veteran-Owned, women-owned, 8(a), Small Disadvantaged Business (SDB), and Historically Underutilized Business Zone (HUBZone).
THIS IS NOT A REQUEST FOR PROPOSAL: This notice is for information and planning purposes only and does not commit the Government to any contractual agreement. The Government does not intend to award a contract based on responses under this announcement nor otherwise pay for the preparation of any information sent for the Government's use. Any proprietary information should be so marked. 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 to provide feedback to respondents with respect to any information submitted. For additional information on this notice please refer to the www.FBO.gov notice N02DA-20-9001.
The information submitted must be in a clear and concise format that addresses each of the elements of the project requirement listed above. A cover page and an executive summary may be included but is not required. The response is limited to fifteen (15) pages not including a cover page or executive summary. Responses must include your technical and administrative points of contact, including names, titles, addresses, telephone and fax numbers, and e-mail addresses. Additional marketing materials, pamphlets, and information not relevant to the requirements identified above should not be submitted with the capability statement.
Any business concerns that believe they possess the capability necessary to successfully undertake the work described above must SUBMIT CAPABILITY STATEMENTS ELECTRONICALLY to the Contract Specialist, Josh Lazarus at Josh.Lazarus@nih.gov, NO LATER THAN 4:00 p.m. EST on Friday, November 15, 2019. The Subject line for the submission should include this Sources Sought Number. NIDA will not accept paper or faxed capability statements.

Opportunity closing date

15 November 2019

Value of contract

to be confirmed