NOVA RFP 2022 Program
Novel Research to Advance HIV Prevention
Through the Medical Affairs Investigator-Sponsored Research (ISR) Program, Gilead supports the research efforts of academic institutions, clinical investigators, community-based organizations and research networks to evaluate the best approaches for HIV prevention and implementation strategies in populations that may benefit from PrEP. Gilead supports these research efforts based on the validity of the scientific question proposed to be addressed, and when the results will fill a data gap in clinical research and not duplicate previous studies/data conclusions already available.
F/TDF for PrEP was first approved in 2012 in the United States and was the first option for daily oral PrEP. F/TAF for PrEP was first approved in 2019 in the United States* and provided an option to fill additional unmet needs in those who can benefit from daily oral PrEP. Despite the availability of daily oral PrEP in the United States , uptake and persistence remain low in many areas and barriers persist. Per the CDC, only 25% of the estimated 1.2 million individuals who may benefit from PrEP have been prescribed PrEP, and PrEP use is disproportionately low among priority populations, such as Black and Latino men who have sex with men, Black cisgender women, transgender individuals, and people living in the U.S. South. Innovative strategies to help improve steps in the PrEP continuum, including awareness, uptake, persistence and expansion of PrEP services to novel, non-traditional settings and non-traditional providers, are needed.
*The indication excludes individuals at risk of HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated.
Through the NOVA 2022 RFP process, Gilead will evaluate and potentially support research proposals that address the following areas of interest where additional data is needed:
- Implementation strategies to improve PrEP awareness, uptake, and ongoing access/linkage to prevention care through novel/non-traditional settings and providers
- What is the uptake, feasibility, and acceptability of PrEP delivery in non-traditional settings? Examples include but are not limited to: community-based organizations, STI testing centers, retail pharmacies, community spaces, street fairs, academic institutions/student health centers (including HBCUs/HSIs/TCUs) and mobile clinics.
- Innovative digital approaches to PrEP delivery, including tele-PrEP, to help reduce stigma and improve PrEP awareness and uptake in priority populations
- What are the most effective digital tools or approaches to improve PrEP awareness and uptake in key communities (transgender individuals, Black men who have sex with men in the U.S. South, etc.)? Examples include but are not limited to the following: tele-PrEP, chatbots, AI/AR, gamification and mobile apps.
- F/TAF for PrEP implementation in Black and Latino MSM
- What interventions are most effective to improve utilization and persistence of F/TAF for PrEP among clinically appropriate Black and Latino men who have sex with men who can benefit from PrEP?
Please note: For proposals using F/TAF in the intervention, F/TAF should have regulatory approval for HIV PrEP or have planned regulatory filing for HIV PrEP in the future in the country where the study will be conducted. Note that F/TAF will need to be approved for PrEP in the jurisdiction where the study will take place before study initiation. Additionally, as the study sponsor, the principal investigator will be responsible for compliance with all laws and regulations applicable to research sponsors, including satisfying local requirements and obtaining all necessary regulatory approvals prior to beginning the study.
Consider the following while developing the proposal:
- Incorporation of community and/or user/participant involvement is highly preferred.
- Scientific objectives and endpoints must be clear and based on scientific hypotheses.
- Data collection/evaluation methods must be appropriate, defined and specific.
- The program should be scalable and sustainable after funding completion (when applicable).
- The study should ideally be generalizable to other settings.
- The project must be completed within 18 months, followed by rapid data dissemination and presentation of results.
Key Dates and Program Specifics
Stage 1: Letter of Intent (LOI)
A concise overview of the proposed project and total estimated budget
- Aug. 1: LOI submission window opens
- Aug. 26: LOI submission window closes
LOIs must be submitted via the online Gilead OPTICS portal.
Any questions about the NOVA RFP 2022 program or application process can be submitted to your local Gilead Medical Scientist or NOVA@gilead.com.
Stage 2: Full Application Submission
A complete proposal with detailed budget
All those who have submitted an LOI will be informed of the outcome of the LOI review by Sept. 23. Certain applicants will be invited to submit a full application, including a detailed budget. The timelines for submission and review of full applications are as follows:
- Oct. 28: Deadline for receipt of full application
- Mid-December: Notice of full application outcome
Full applications must be completed in Gilead OPTICS following approval to submit.
Investigators who meet criteria for a standard Gilead ISR program are encouraged to apply.
The program provides awards for proposals completed in up to 18 months. Awards shall be for research purposes only; routine medical care or other costs associated with routine medical care will not be considered for funding.
Gilead plans to award a total of approximately $5 million in funds for research proposals under the NOVA RFP 2022 Program, dependent upon availability of funds and receipt of meritorious applications. Any proposal greater than $500,000 should be discussed with your Gilead Medical Scientist prior to submission.
LOIs will be rigorously reviewed by a Gilead internal committee. Each complete LOI that meets program requirements will be assigned to multiple primary and secondary reviewers. Each reviewer will review and score the LOI and will evaluate how well the proposal addresses the RFP, the potential impact of the study, the strength of the objectives/study design, sustainability/scalability of the methods under study, and the site’s and study team’s ability to recruit the proposed study population. Scoring is based on the modified NIH Scoring Tool. High-scoring LOIs will be discussed by a multidisciplinary committee. Investigators with the top LOI submissions will be offered the opportunity to submit a full application, which will be similarly reviewed.
No Guarantee of Funding
Gilead reserves the right to approve or decline any application at its sole discretion. Submission of an LOI or a full application does not guarantee funding. Applications are reviewed by an internal review committee.
No Inducement or Reward
Gilead approval of awards does not take into account the past, present, or future volume or value of any business or referrals between the parties. Awards are not being given, directly or indirectly, as an inducement or reward with respect to the past or potential future purchase, utilization, recommendation or formulary placement of any Gilead product. Furthermore, except for the use of the Gilead product in an approved award/research, the awardee is not required to purchase, order, recommend or prescribe to any patients any products manufactured by or available through Gilead.