This project will be co-led by Drs. Bailey (University of California, Los Angeles, UCLA) and Fomby (University of Michigan, UM), who will function as Multiple Principal Investigators for this project. Dr. Fomby will serve as the PI of record with the UM IRB and Dr. Bailey will be responsible for regulatory activities and adverse event reporting.
Project implementation will build on the study?s success with remote management. The clinics where recruitment is taking place are located all over the state of Michigan. Since August 2018, NORC has conducted the fieldwork for this study from its home base in Chicago. NORC conducts field work from Chicago for its operation all over the US and internationally and has extensive experience with remote management of field work. Consequently, all members of the study team have extensive experience working with remote partners. Since the inception of the project, Dr. Bailey?together with the project manager, Vanessa Lang?has successfully managed relationships and coordination of the project from Ann Arbor, although the field team and Planned Parenthood of Michigan (PPMI) partners are located elsewhere. This has been achieved through pre-scheduled, frequent web and telephone meetings, regular email and newsletter updates, and frequent email communication. In addition, Drs. Bailey and Lang have had frequent in-person meetings with clinic staff, field interviewers, and NORC field management: NORC hosts in-person training for new field staff in Ann Arbor as well as quarterly ?booster training? for all field staff and PPMI partners, which Drs. Bailey and Lang attend. Finally, all PIs and collaborators on M-CARES team have successfully worked from home during the COVID-19 stay-at-home order, managing their frequent meetings via Zoom and telephone meetings as well as almost daily email correspondence. This close communication has bridged the geographic distance between M-CARES partners and already facilitated the successful recruitment that formed the basis of the proposed study, as shown in ?preliminary studies? in the grant application.
Drs. Bailey and Fomby will build on this successful foundation to manage all aspects of the project. In order to maintain clear, regular communication from their respective locations, Drs. Bailey and Fomby will meet together with the project manager, Dr. Lang, on frequent telephone or videoconference calls. The project manager will develop the agenda for each week?s meeting and record minutes in a shareable document (e.g., Google Doc). Drs. Bailey and Fomby will each include the other on all email correspondence to study team members, NORC, IRB, PPMI, and administrative agencies. Drs. Bailey and Fomby will also speak by phone/videoconference on an ad hoc basis, seeking to resolve issues requiring shared input within 24 weekday hours.
The UM scope of work involves increased time from Dr. Lang to manage the expanded scope of the project as well as paying for voucher costs awarded to half of study participants recruited under the expansion in project scope.