Services: Research, Analysis, Surveillance and Outreach, Information Technology, and Distribution

The HIV epidemic among men who have sex with men (MSM) in the United States is a public health emergency. MSM, while comprising a small proportion of U.S. men, accounted for at least 61% of new HIV infections in 2009, with particularly concerning increases in HIV incidence among young black MSM. Despite national recommendations for routine HIV screening, many MSM continue to be unaware of their HIV serostatus.

Given the high HIV incidence rates among MSM and known reductions in HIV transmission behaviors after diagnosis and recent results indicating the prevention value of early diagnosis and treatment, increasing the frequency with which MSM are tested for HIV is an important public health goal. However, a barrier to this goal is the high degree of stigma associated with HIV testing. Recent advances in HIV testing and the advent of HIV testing kits that can be self-administered at home may overcome this barrier and increase testing frequency. In order to determine what impact the availability of home HIV-testing kits will have on testing frequency among MSM, CDC contracted with the MANILA Division of Insignia to develop and implement a randomized prevention trial of home-based HIV testing. We partnered with Emory University, Northwestern University, Public Health Solutions of New York, and community-based organizations in Atlanta, Chicago, and New York to conduct this effort. This randomized trial aims to recruit over 1,800 MSM who will be followed for over a 1-year period. Recruitment and data collection for this project commenced in April 2014. Outcomes to be assessed include testing frequency and sexual risk behaviors.

In preparation for the onset of the study, our team and its partners have developed a data collection and test kit ordering website that will be accessed by study participants. We also developed a fulfillment center for HIV kit distribution, obtained OMB clearance for the surveys to be used in the study, and developed a marketing plan targeted at MSM in the U.S. encouraging participation in the study.

Services: Research, Analysis, Surveillance and Outreach, Information Technology, and Web Development

Men who have sex with men (MSM) are disproportionately affected by the US HIV epidemic. HIV incidence has been increasing among MSM since 2000, and in the United States, MSM of color – especially younger men of color – continue to be most severely affected by HIV infection.

CDC currently conducts HIV/AIDS behavioral surveillance to identify populations who are at risk of HIV infection using a surveillance system called the National HIV Behavioral Surveillance System. NHBS data collection occurs in yearly cycles within metropolitan statistical areas with high AIDS prevalence and focuses on three high risk groups: MSM, users of injection drugs, and heterosexuals at increased risk. Each of the groups is the focus of data collection every three years. Consequently, data from MSM are sampled only once every three years, hampering the ability of public health officials to detect trends in MSM risk behavior or measure whether prevention services are effectively reaching the target population. More frequent and geographically comprehensive data collection is needed to establish trends in MSM risk behavior and access to prevention services in order to guide prevention efforts for this group.

One medium by which surveillance efforts aimed at examining MSM sexual risk behavior more frequently is the Internet. To determine this, CDC contracted with the MANILA Division of Insignia to conduct market research to inform the design of a national web-based data collection system among MSM, developing this system according to those best-practices, implementing the system, collecting and managing surveillance data from 29,000 MSM annually for three years, and analyzing these data in order to identify trends in MSM behavior.

Services: Program Modernization, Strategic Planning, Software Development, Integration and Maintenance, Requirements Development and Management

The FDA is the world's “gold standard” for ensuring the safety and efficacy of all products subject to regulation. It is widely acknowledged as the premier, science-based, regulatory Agency and has achieved great success through its rigorous process for safety surveillance and by advancing innovations that speed the progression of regulated products to market. FDA has initiated a number of critical programs and will advance its investment in information management (IM) and information technology (IT) over the coming years. It has also undergone several substantive organizational and infrastructure changes designed to establish a modern and efficient technology platform within which to optimize its business operations. During this important period of change and to ensure initiatives are fully recognized, it is critical to have a common, future-state vision for managing information across the FDA, as recently recognized in Senate Bill S.3187 explicitly noting FDA's need for an IT Strategic Plan and an Enterprise Architecture Program Management Plan, signed by the President.

Recent Commissioner's and the Office of Information Management and Technology (OIMT) Strategic Plans provide clear direction for the FDA, so information management programs, investments, and initiatives can be designed and managed to meet a common end-point. Ongoing FDA business alignment efforts are oriented towards updating relevant governance boards, in keeping with new strategic priorities and cost-based focus.

The Insignia team is responsible for providing the FDA OIMT with comprehensive program modernization services for the development and implementation of FDA's OIMT Intake Process Program which includes: 1) development and/or improvement of processes and procedures; 2) development of program artifacts; 3) upgrade, development and maintenance of an IT Request Tracker and Technology Reference List; 4) development and maintenance of Intake Process workflow automation and development and maintenance of an IT Service Request Catalog site. Our business process and requirements analysts maintain ongoing dialog with internal customers and stakeholder to identify continuous improvement opportunities and to support the effective capturing of business needs. Our software developers have improved, expanded and updated the pilot version of the IT Request Tracker tool. We assist in developing and maintaining a Technology Reference List using standard profile, common vocabulary, and structure for describing information technology pertinent to the development, operation and maintenance of FDA systems and applications. We provide OIMT with an analyses and recommendations of an improved and integrated path forward for tools to enhance the FDA's abilities in Intake Process management.

Services: Research, Analysis, Training, Program and Performance Management, and Information Technology

The Substance Abuse and Mental Health Services Administration awarded the MANILA Division of Insignia, a second 5-year, multimillion-dollar contract to support the National Registry of Evidence-Based Programs and Practices (NREPP). The NREPP is a searchable online registry of mental health and substance abuse interventions that have been reviewed and rated by independent reviewers. The purpose of this registry is to assist the public in identifying approaches to preventing and treating mental and/or substance use disorders that have been scientifically tested and that can be readily disseminated to the field.

Our team supported SAMHSA by reviewing and rating an intervention's quality of research and readiness of dissemination. Under this contract, MANILA delivered the following:

• Recruited, trained, and maintained panels of expert reviewers
• Identified candidate programs and practices
• Conducted program reviews
• Provided feedback to candidate programs
• Developed special topic reports and presentations
• Maintained the NREPP Web site
• Responded to public inquiries via a toll-free line and email systems

Services: Program and Performance Evaluation

In 2002, the President established the New Freedom Commission on Mental Health and charged the group with conducting a comprehensive study of the mental health service system and making recommendations for immediate improvements that the federal and state governments and other stakeholders could implement. In response to the Commission's recommendations, a Federal Action Agenda was developed called Transforming Mental Health Care in America.

As a critical component of this agenda, the Center for Mental Health Services (CMHS) awarded 5-year Mental Health Transformation State Incentive Grants (MHT SIGs) to the Offices of the Governors of seven states (CT, MD, NM, OH, OK, TX, and WA). The MHT SIG program supports an array of infrastructure and service delivery improvement activities to help states build a solid foundation for delivering and sustaining effective mental health and related services based on the six goals of the New Freedom Commission's final report. Through the grant program, states will develop and implement a Comprehensive State Mental Health Plan that builds on a thorough needs assessment and inventory of resources and cuts across state agencies that provide services relevant to mental health.

SAMHSA engaged the MANILA Division of Insignia to design and conduct, in collaboration with the grantees and under the direction of the federal staff, an independent, objective cross-site evaluation. This evaluation satisfied the requirements of the Program Assessment Rating Tool (PART), which was introduced to assess and improve performance of federal programs. Among other tasks, our team worked to evaluate the degree of transformation of systems, identify factors that contribute to successful transformation, and demonstrate the cost-efficiency of the program.

Services: Evaluation, Data Collection, Information Technology

The Safe Schools/Healthy Students Initiative is an unprecedented collaborative grant program supported by three federal departments: the U.S. Departments of Health and Human Services, Education, and Justice. The initiative provides funds for grantees to use—and sometimes develop—state-of-the-art knowledge about what programs and practices work best to promote safe and healthy environments where children can learn and develop.

Local education agencies serve as the primary applicants for SS/HS grants, but they are required to establish formal partnerships with the local mental health system, the local law enforcement agency, and the local juvenile justice agency. Other partners often include public and private social services agencies, businesses, civic organizations, the faith community, and private citizens. As a result of these partnerships, comprehensive plans are developed, implemented, evaluated, and sustained with the goals of promoting the healthy development of children, fostering resilience to adversity, and helping to prevent violence and substance abuse.

SAMHSA engaged the MANILA Division of Insignia to design and implement the 5-year evaluation of the SS/HS program. The work included specifying data collection protocols, creating a resource database, overseeing data collection and analysis, and preparing reports, including the final document for widespread distribution to diverse audiences.

Services: Policy, Evaluation, Data Collection, Information Technology

In December 1998, a program was initiated to implement Section 4007 of the Transportation Equity Act for the 21st Century (TEA-21), giving the Secretary of Transportation authority to grant exemptions to the Federal Motor Carrier Safety Regulations (FMCSRs). The MANILA Division of Insignia operated a project supporting this program, which enables individuals to qualify as commercial motor vehicle drivers without meeting specific standards. The exemption program has two components addressing vision deficiencies and insulin-treated diabetes.

One of our roles was to manage the application process for the exemption program. This involved reviewing driver applications, interacting with applicants to obtain complete information, talking with medical examiners to clarify their reports, and packaging the results with recommendations so that FMCSA can make the final decision. Our staff also wrote the Federal Register notices announcing the intention to issue or deny individual waivers and operate a telephone service to address drivers' concerns.

Our team was also responsible for monitoring the safety record of drivers with exemptions or grandfather rights through earlier waiver programs, performing periodic checks of motor vehicle records and any other available information sources.

We developed an Internet-based tracking system that contains all relevant application information, data describing driving records, and disposition of applications. The tracking system was developed for the Internet so that FMCSA managers can have immediate access to the information on each driver. To support this access, the system has a query function, a series of seminal reports, and the capability to download relevant documents. Our staff also developed other databases that can be used to assess the safety of drivers with exemptions and those who received grandfather rights from earlier waiver programs. These databases are developed with information from the application process and motor vehicle reports to permit analytical risk assessments.

Services: Research, Policy, Evaluation, Data Collection, Information Technology

The MANILA Division of Insignia planned and developed the Federal Motor Carrier Safety Association's National Registry of Medical Examiners for Commercial Motor Vehicle (CMV) Operators. The need for the registry grew from widespread concern that medical examiners may not have a complete understanding of the regulations and guidelines for medical certification of CMV operators. Concern grew following a recent bus accident with multiple fatalities. The driver had certification, but should not have been medically qualified.

The Registry lists medical examiners who become certified through an accredited program. Our planning and development effort focused on two areas: procedures to ensure that the certification process is valid, and development of the National Registry and its associated components. Our formative research examined the multitude of methods and procedures used to certify professionals, including such facets as the role of accrediting agencies, membership groups, and certifying organizations. It also focused on methods for developing the education and training curricula to support certification and how these curricula are accredited. In addition, we explored the procedures for constructing certification examinations, from role delineation studies and item writing to analysis for establishing reliability.

We identified the organizations that develop examinations, looked at how they are administered and how they interacted with other organizations in the certification process. We also looked at how the public and other stakeholders are included in the process, and the standards available for desirable practices. Finally, we determined if there are methods or organizations available to accredit the entire certification process to promote public confidence.

The second area of planning and development is the form that was reached by the National Registry. The Registry is hosted on website that serves multiple populations. The Registry was developed to be a resource for CMV operators who must find a medical examiner to obtain the examination required for operating a CMV by providing a database of certified examiners that drivers can search. The search mechanism was constructed to allow searching by city, state, and zip code with the nearest set of examiners identified using global positioning satellite technology. The Registry is a resource for certified examiners, who can research updated information on relevant federal regulations and guidelines, with an option to download the information to a handheld computer.

Medical examiners interested in being tested for certification and listing in the Registry have been able to use the site to obtain information about the procedures for certification. The site was developed to identify approved training organizations with locations and dates available, as well as places and dates for certification examinations. The site was successfully established to house relevant documents that can be downloaded, including application forms.

Finally, the Registry serves as a public information resource. Since an ongoing concern of the program is to instill public confidence in the process as it relates to highway safety, our staff provided information to document the validity of the certification program. The site describes the roles and responsibilities of certified medical examiners, the training they receive, and the nature of the certification examination. We also documented the accreditation process and the broadly recognized national standards used to ensure training is thorough and appropriate. We achieved the client’s goal to provide a full, succinct portrayal of the program's design to ensure that this segment of FMCSA's program met the need for public safety.

Services: Research, Policy, and Evaluation

The Federal Motor Carrier Safety Administration's (FMCSA) primary mission is to improve truck and bus safety on the nation's highways. As a subcontractor, the MANILA division of Insignia worked with FMCSA to support this mission by establishing panels of medical experts to review the current cardiac standard and guidelines and make recommendations to the FMCSA for amending and/or updating the requirements and guidelines for the CMV drivers. In addition, our team updated the 1988 Federal Highway Administration's conference report on cardiac conditions and commercial drivers.

Our staff managed the panels' processes and their mission to provide recommendations in identifying potential risk factors that might be associated with driving impairment. We also organized discussions on how identified risk factors may affect driving ability and what treatment technology can be used to control risk factors or medical conditions.

Services: Program Management, Research, Policy, and Evaluation

The Federal Motor Carrier Safety Administration's (FMCSA) has the authority to conduct pilot programs to investigate variations in the regulations it is responsible for enforcing. These investigations focus on determining if regulatory variations can provide public benefit without diminishing the current level of commercial motor vehicle safety. “The Home Heating Oil Pilot” program is one of these investigations and is a project for which the MANILA Divison of Insignia provided assistance as a subcontractor. This study aims to investigate an innovation in home heating oil delivery in the winter season.

Our role was to support the collection, analysis, and monitoring of data on the safety history of motor carriers and drivers making home heating oil deliveries. We provided a project manager who was responsible for developing project plans and for management, direction, and execution of the plans. This person oversaw project execution and quality control through multiple daily contacts with the staff.

Finally, our staff was responsible for providing an evaluation and analysis of the results of the program and a final report to Congress. This report documented the findings, conclusions, and recommendations of the program, including recommendations to amend laws and regulations that enhance motor carrier and driver safety while improving compliance with the hours-of-service regulations.

Services: Information Technology, Program Management

The Federal Motor Carrier Safety Administration (FMCSA) published an advance notice of proposal rulemaking (ANPRM) on November 5, 1996, on the hours-of-service rules for interstate commercial motor vehicle (CMV) drivers. As a subcontractor, the MANILA Division of Insignia provided computer programming expertise to develop a website for the collection of data describing the comments to the ANPRM. In addition, MANILA administered public hearings at six locations and analyzed substantive docket comments to the notice of proposal rule making (NPRM).

The web-based system supported review and analysis of the comments to the docket. The system allowed the comment analysts, who were geographically dispersed, to search the docket, submit analytic results and coded data, track the progress of coding, and run numerous reports. In addition, our team was responsible for inspecting the docket for any substantive comments filed up to two weeks, after the official NPRM docket closing date. We analyzed and summarized each substantive comment received in response to the NPRM. Our staff also analyzed each non-substantive comment received and provided a summary of them.

Services: Training, Information Technology

As a major subcontractor under this contract, Insignia works with the prime contractor (GBX Consultants) to deliver instructor-led, military to civilian career transition training and counseling services, specifically delivering Transition Assistance Program (TAP) Employment Workshops. As a team, we have worked side by side with DOL VETS as their global training partner to deliver more than 8,500 TAP workshops for more than 225,000 transitioning service members and spouses worldwide. As subject matter experts in the field of career transition and employment services, Insignia has delivered critical employment information on a variety of topics to include stress management, successful job search strategies, personal appraisal, resume preparation, financial planning, interviewing skills, career exploration, job offer and salary negotiation, and career decision making.

The logistics, scheduling, and tracking of hundreds of classes per month brought challenged our team's ability to react quickly and staff last minute requests. To better manage and fulfill our obligations, we created a web-based system which tracks all of our scheduled classes, the assigned trainer, location of class, and also tracks any changes to the class such as start and end times, location or even cancellations. Any Insignia staff involved with this contract is able to log into the system from any location with internet access and see, in real-time, the status of their assigned classes. We also created an online reporting tool allowing our trainers to submit their class reports online. This system was so successful within Insignia, the prime contractor has adopted the same system which is now used throughout the entire DOL TAP contract.

Insignia has the primary responsibility for delivering TAP workshops in the western region of the United States, including Hawaii and Alaska, as well as the entire Pacific Rim. We have successfully managed this global training program and our skilled management and facilitation team is strategically located worldwide. To support this effort we performed detailed planning, organization and execution of all contract deliverables. We managed every element of this contract including project start up, rapid program expansion, and a very fluid task order management process. We continuously recruited, hired and trained high-quality facilitators to meet all workshop needs. We responded to surge, emergency or last minute workshop requirements. We managed a dynamic TAP workshop schedule with numerous changes to include workshop additions, date changes and cancellations.