SAPR_RTI_Tasks.pdf

Randomized Controlled Trial of

Tailored Tablet-Based Sexual Assault Prevention Interventions

Sample Tasks

Complete Intervention Development and Tablet Programming

Conduct Pilot at BMT Pilot the study procedures and intervention content and delivery in order to trouble shoot and correct any logistical or technological issues prior to the randomized controlled trial. The Contractor shall develop and conduct a small-scale pilot at BMT to ensure all intervention and study methods are feasible within BMT. The pilot shall include testing participant consent procedures and safe guards, ensuring privacy and testing data collection technologies.

Revise materials, methods as needed based on pilot results The Contractor upon approval by the COR shall make any necessary adjustments to the study or intervention methods based on the pilot and finalize all intervention content.

Conduct RCT Conduct a randomized control trial (RCT) with BMT trainees to examine the effectiveness of the interventions for preventing sexual assault victimization and perpetration and related outcomes.

The Contractor shall design a RCT to examine the impact of the tailored interventions. The design shall be sufficiently powered to detect significant differences between control and treatment groups, feasible for execution at BMT, and shall meet institutional requirements and considerations unique to BMT. The final design shall take into account findings from the pilot.

To ensure that participant responses are confidential the Contractor shall develop a data collection, linking, and security plan in which collected data is encrypted, security stored and transferred in accordance with Air Force data security standards. This plan should include at a minimum the method by which trainees develop a unique login for the tablets, the method the Contractor will use to confidentially track individuals over time for survey completion, data and participant safe guards, including assuring participants of their reporting options.

Upon data collection, the Contractor shall provide USAF with a summary of baseline results. For example, the summary should include the number of individuals who consented to participate, the number receiving each intervention, and demographic characteristics of the sample.

The Contractor shall develop a participant survey that assesses several study variables including relevant knowledge, attitudes, and behaviors regarding sexual assault perpetration, victimization, and related outcomes.

The Contractor shall ensure informed consent is obtained from all participants in accordance with the approved institutional review board (IRB) protocols and institutional considerations. Consent procedures shall include the presence of an ombudsperson who is not affiliated with the study or a superior to the study participants. In addition, all other institutional requirements will be met, including obtaining Air Force survey approval. All study methods and materials should be approved by the relevant Institutional Review Board(s) and adhere to human subjects protocols and research ethics and the Contractor shall work with BMT leadership and staff, as appropriate, to prepare the IRB protocols to ensure their feasibility and compliance with USAF and BMT guidelines. For example, trainees must be assured that their survey responses to not constitute making a report of sexual assault and they should be provided a list of reporting options if they wish to make a report. In addition, they should be made aware of all victim advocacy services available in BMT. Given that the study shall take place after January 2018, the study procedures shall comply with the updated Common Rule to be released in January 2018. The Contractor shall also obtain a Certificate of Confidentiality, and the participants shall be notified of the privacy, and confidentiality of their data and that no one in the Air Force will be able to link their responses to their identity.

To ensure that all BMT staff are aware of the study procedures and methods, the Contractor shall communicate with and educate BMT staff on the implementation procedures, data collection procedures, and evaluation procedures to ensure smooth implementation. Although no BMT staff will be involved in data collection or intervention development, it is important that they are aware of the study procedures. At the completion of the training, the Contractor shall provide the USAF with a comprehensive training plan and a list of existing BMT staff members that participated in the study briefings that includes their work phone number and email address information. New staff will be trained as needed to ensure that BMT staff are fully aware of study and intervention procedures.

The Contractor shall conduct the survey baseline, post-test, 6 and 12-month follow-up assessments to determine the effectiveness of the prevention program on several outcomes. The Contractor shall administer the surveys via tablets during BMT and via the web for follow-up assessments taking place after participants complete BMT. The surveys shall measure at baseline, post-test, 6 and 12-month follow-up assessment points several key study variables including behaviors, norms, attitudes, and knowledge regarding sexual assault perpetration, victimization and related outcomes. For 6 and 12 month follow-up assessments, the Contractor shall offer an incentive to participants to complete the survey after their duty hours.

Data collection shall comply with AF Cybersecurity (CS) Programs:

CS programs support the principles of availability, integrity, confidentiality, authentication and non-repudiation of information and information systems for the purpose of protecting and defending the operation and management of Air Force IT and National Security System (NSS) assets and operations.

The contractor shall:

• Register the system with the appropriate Portfolio IAW AFI 17-110, AF IT Portfolio Management and IT Investment Review.

• Provide Cyber Security services in accordance with AFI 17-130 Cybersecurity (CS) Program Management .

• Provide cybersecurity services that promote and encourage the effective management and control of sensitive and classified information, including data and voice communications.

• Be knowledgeable of current security policies, regulations and statutes and shall apply this knowledge in the management and support of all requirements of the PWS.

• Develop and maintain Assessment and Authorization (A&A) packages for Air Force/DoD controlled systems and circuits in accordance with Department of Defense Instruction (DoDI) 8500.01, Cybersecurity; DoDI 8510.01, RMF for DoD IT and AFI 17-101, Air Force Certification and Accreditation (C&A) Program (AFCAP).

• Ensure that all solutions meet the requirements of the DoD Risk Management Framework (RMF) and DoDI 8510.01 – RMF for DoD IT, DoD Instruction (DoDI)

8500.01 – Cyber Security, or the most current standards and guidance that are applicable.

• Ensure personnel are compliant with DoD 8570.01-M, Information Assurance Workforce Improvement Program , Department of Defense Directive (DoDD) 8140.01, Cyberspace Workforce Management, DODD 8570.01, Cyber Security Workforce Training, Certification and Workforce Management and AFMAN 17-1303

- Information Assurance (IA) Workforce Improvement Program

• Ensure that all full- or part-time personnel performing CS duties are identified in the Defense Eligibility Enrollment Reporting System and that their certifications are sent to the DOD CIO in accordance with DOD Directive 8570.01.

As part of the RCT, the Contractor shall design and conduct a process evaluation to document and monitor all intervention activities, including dosage, stability of the program, fidelity, and intervening events or contextual factors that may impact program outcomes.

The Contractor shall conduct the process evaluation as outlined in their plan.

The Contractor shall analyze the process evaluation data and provide the USAF with the data and summary reports following each data collection. In addition, adjustments made based on the evaluation data should be documented in the Monthly Status Report (MSR).

The Contractor shall implement the interventions during BMT and tech training (for re-victimization booster sessions). For the booster intervention delivered during tech training, the Contractor shall ensure that necessary safe guards are in place for intervention delivery, including working with the local SAPR offices. In addition, the Contractor shall develop a plan for ensuring booster completion among eligible participants.

The Contractor shall develop a data analysis plan for the RCT. The plan shall include at a minimum: power analysis, ensuring/addressing data quality and security, ensuring quality control of all documents released, conducting significance testing of results, obtaining IRB oversight and approval, obtaining an AF Survey Control Number, screening the data, exploring missing data patterns, examining psychometric properties of new and existing scales, and producing descriptive statistics for the study outcomes. The Contractor should anticipate and control for attrition and ensure sufficient power exists with nominal attrition. The Contractor shall then test for pretest equivalence of intervention and control participants, and analyze overall attrition and differential attrition across prevention and control conditions. The Contractor shall then test for intervention effects on outcomes before presenting a power analysis demonstrating that there is adequate statistical power to detect intervention effects.

The Contractor shall complete data collection upon approval of the analysis plan by the COR.

The analytic plan shall be updated at least quarterly to incorporate any changes in the plan as the project progresses. At the termination of the contract, a detailed final report will be delivered which will incorporate the content of the fully updated analytic plan and all activities during the performance period.

Throughout the trial, specifically following each data collection, the Contractor shall analyze the data from the RCT as specified in 1.3.3.1 and provide USAF with a report that describes the study methodology, psychometric properties, descriptive statistics, summary of scales and items and relevant significance testing. At the conclusion of the base year, the Contractor shall provide a final report that summaries the study methodology and results of the baseline, post-test, and 6 month follow-up.

Develop female perpetration prevention intervention The Contractor shall develop, implement, and evaluate intervention content that addresses female perpetration prevention.

The Contractor shall develop a pilot plan to for the additional intervention content.

The Contractor shall conduct the pilot and summarize the results in a report. The Contractor shall provide a plan for linking participants to their responses over time and ensure the data collection methods have IRB approval and that informed consent is received, as required by the IRB(s).

Finalize survey and interventions based on results and lessons learned; Transfer all intervention materials and files to AF platform, ensure compatibility Using the data from the RCT, the Contractor shall refine and robust the intervention methods, such as the method by which an individual is assigned to receive a tailored intervention. Refining and robusting the method will include exploring additional risk factors that increase the precision of the intervention assignment without overly relying on factors such as gender and sexual orientation.

The Contractor shall transfer the tailored tablet-delivered interventions to an Air Force platform (e.g., AF net) and ensure that the interventions are compatible with the Air Force platform and system and will make necessary adjustment to ensure the tablet-delivered interventions can be implemented by the Air Force through a platform of its own. The transfer of interventions includes providing the programmed tablets used in the RCT to the Air Force.

Summarize implementation recommendations in report The Contractor shall summarize recommendations and a process for scaling up the tailored tablet-delivered interventions to the young Air Force population. The plan should include key considerations for scaling up, included supported and unsupported populations, considerations for implementation, manpower requirements, comprehensive training plan and materials to train facilitators to administer the interventions, a process for scaling up the technology, the most current, linked data, all applicable software, control of all hardware (tablets and/or other electronic devices), software updates and/or recommendations for modifications and provide any necessary training to identified personnel.

OTHER INFORMATION:

Project Management The Contractor shall provide project management oversight of team and cooperate with Air Force personnel on oversight of project. Project management activities include at a minimum, weekly telecons with AF staff, semi-annual program management reviews, site visits, reverse site visits at the Pentagon, VA, completion of the Monthly Status Report (MSR) and other meetings as needed. The contractor will ensure that individuals participating in the calls and visits are able to provide informative overview of the project’s current status, significant achievements, limitation factors and/or proposed solutions to overcome obstacles are provided and discussed.

Key Personnel The individual leading tasks must have at least 10 years of experience within the past 10 years in the field of violence prevention, have a PhD in the social and behavioral sciences (e.g., psychology, sociology), have experience developing and conducting RCTs, and have experience developing and implementing an evidence-based prevention program. Additionally, 75 percent of all personnel (team leads and team members) must have a minimum of 3 years of experience working on violence prevention and/or evaluation research projects. Fifty percent of team members must have experience working with the Air Force on sexual assault prevention interventions.

Trainee Rights and Confidentiality The Contractor shall ensure at every stage of the study that trainee choice, rights, and confidentiality are prioritized and protected. A data and participant security plan shall be developed that summarizes in one place both the human subjects protections, but also the protections for preserving participant confidentiality and reporting options.

Travel The contractor will be required to perform periodic travel within the Continental United States (CONUS) in performance of this contract. Prior to travel, the contractor shall coordinate with, and receive approval from, the COR at least 10 business days prior to trip unless notification was received by the COR after the 10 day period. The contractor shall be responsible for obtaining all passenger transportation, lodging and subsistence. Reimbursement of CONUS travel costs will be in accordance with the Federal Travel Regulation per FAR 31.205-46. The contractor shall travel using the lower cost mode transportation commensurate with the operational requirements. All costs shall be agreed to in advance and reimbursed on a cost basis upon receipt of the invoice in Wide Area Workflow and copies of receipts turned in to the COR. All air travel shall be booked on American flagged carriers, unless otherwise directed by the Contracting Officer. No General Administrative charges or profit will be paid on these actual costs.

For the base year, it is expected that there will be an extended (approx 45 days) visit to BMT for up to two staff to complete the pilot. For the RCT it is expected there will be an extended visit (approx 180 days) for up to 3 staff to complete the RCT. In addition, it is expected there will be 2 visits to HQ Air Force (Pentagon) and 3 2-day visits to BMT. For Option Years 1 and 2 (each) it is expected there will be 3 visits up to 6 locations (all CONUS), and 2 visits to HQ Air Force (Pentagon).

Data The Government has unlimited rights to all data collected and implementation and training materials that will be developed and tested for this requirement, in addition to any process evaluation data collected, such as training satisfactory surveys or implementation logs.

Tablets Deliver 350 programmed tablets to BMT for the RCT. Tablets of quality to store intervention files, view videos, and have readable font size. Trainees shall only have access to the tablets under the supervision of the Contractor and all tablets shall be returned to the Contractor after each training session, meaning that the Contractor secures all tablets when they are not being used in a classroom setting by the trainees. In addition, the Contractor shall ensure that technical support and troubleshooting is provided 24/7 for tablet users, should issues with tablet functionality arise in the classroom setting. The Contractor shall provide an accountability plan for the computer tablets. The plan should include how tablet use will be monitored and accounted for, how lost tablets will be recovered or replaced.

The Contractor shall ensure that access to purchased equipment is controlled and that the equipment is stored under double lock. The Contractor is responsible for providing technical support for any applications needed to deliver the interventions and screening and the Contractor is responsible for replacing any lost or damaged devices. The Contractor shall deliver the programmed tables to the Government at the end of the RCT intervention implementation.