Notice of Special Interest (NOSI): Promoting implementation research to address HIV-associated comorbidities and risk factors within well-established longitudinal studies (R01 Clinical Trial Optional)

General Questions

1. When is the first receipt date for application submission?
   1. This NOSI will use Standard AIDS receipt dates with the first occurring, January 7, 2024. (Note: When a postmark/submission date falls on a weekend, Federal holiday Link to External Site, or Washington, DC area Federal office closure (NOT-OD-17-041), the application deadline is automatically extended to the next business day.)
   2. Please refer to the PAR 22-105 funding announcement for a comprehensive list of due dates
2. Why is the NOSI only referencing “well-established” longitudinal studies?
   1. Multimodal and multilevel data collected from longitudinal studies can help identify at-risk populations and intervention targets (e.g., biological versus psychosocial versus system-level), thus informing EBI selection for downstream D&I studies.
   2. Leveraging the lessons learned from these studies may offer additional insights regarding critical periods in which interventions are most appropriate for PLWH compared to naïve groups, thus supporting a stronger focus on the implementation science.
   3. Well-established longitudinal studies contain rich phenotype data for participants with unambiguous temporal relationships. These pre-intervention phenotypic data will increase the study rigor, internal validity, and generalizability to other populations (via the possibility of sub-group analyses).
3. What is a “well established” HIV longitudinal study?
   1. An observational cohort study or interventional clinical trial, which longitudinally follows a group of people living with HIV (PLWH) to discern selected outcomes (≥100 persons)
   2. In addition, for interventional clinical trial Recruitment of the parent study must be completed prior to award
   3. For all proposed studies, the investigators must demonstrate that their proposed dissemination and implementation study will NOT confound or disrupt the specific aims of the parent cohort study or clinical trial.
4. Is this NOSI open to international HIV longitudinal studies or are only Domestic HIV longitudinal studies responsive?
   1. Yes. Please refer to the PAR 22-105 Section III. Eligibility Information for further detail.
5. My study is ongoing, can I apply?
   1. Yes. Include a letter of support from the Principal Investigator confirming that the proposed study design does not interfere with ongoing research aims and not duplicative.
   2. If leveraging an ongoing interventional clinical trial: recruitment of the parent study must be completed prior to the new award beginning.
   3. Teams are also encouraged to consult with their Institutional Review Board or Data Safety Monitoring Board for concurrence.
6. Is the funding duration of the submitted application dependent on the length of time remaining on the parent award?
   1. No. As stated in the announcement “ongoing or legacy longitudinal studies” are responsive.
7. The longitudinal study has ended or I do not have an associated study to link to, can I apply?
   1. Yes, investigators are encouraged to utilize lessons learned from ongoing or legacy longitudinal studies alongside other data sources to strengthen D&I research projects targeting PLWH.
8. Will the NIH host Technical Assistance Webinar for this Notice?
   1. Yes, please refer to NOT-HL-23-111. If the meeting has taken place, the recording will be shared on this FAQ page once available.
9. Who do I contact for more information from specific participating Institutes, Centers, and Offices?
   1. Please refer to the Inquires section of the Notice.