NOVA-21 (Novel Research to Advance HIV Prevention) RFP Program
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 which 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.
Emtricitabine/tenofovir disoproxil fumarate (F/TDF) for PrEP was first approved in 2012 in the United States and was the first option for daily oral PrEP. Emtricitabine/tenofovir alafenamide (F/TAF*) for PrEP was first approved in 2019 in the United States** and provided an option to fill additional unmet needs for those who can benefit from daily oral PrEP. In the DISCOVER study, F/TAF for PrEP was shown to have non-inferior efficacy in preventing acquisition of HIV-1 compared with F/TDF in men who have sex with men (MSM) and transgender women. Compared to F/TDF, F/TAF demonstrated significantly less impact on markers of renal function (including in older individuals who use PrEP, those with baseline renal impairment and those with hypertension), and can be dosed in individuals with a lower minimum CrCl (≥30 mL/min) vs F/TDF (≥60 mL/min). F/TAF also had significantly less impact on BMD vs F/TDF, including significantly less proportions of participants with osteopenia at 48 weeks¹. The long-term significance of these renal and bone safety differences are not known, but these differences between F/TAF and F/TDF may be important in certain demographics or individuals with certain medical histories, and may provide potential advantages in certain PrEP delivery models and settings.
Through the NOVA-21 RFP process, Gilead will evaluate and potentially support research proposals that address the following areas of interest where data gaps exist and seek to answer the following open research questions:
- F/TAF for PrEP implementation in Black and Latinx MSM, transgender people, and gender non-binary individuals*
- What interventions are most effective to improve uptake and persistence of F/TAF for PrEP in clinically appropriate Black and Latinx MSM, and transgender and gender non-binary individuals?
- Long-term impact of F/TAF vs. F/TDF on younger people who use PrEP and have not yet achieved peak BMD
- What is the impact on Z-score for adolescents on F/TAF for PrEP?
- Community-based/led and other non-traditional models to de-medicalize PrEP in key populations (sex workers, people who inject/use drugs, etc.)
- What are the most effective community-based/led models for implementing PrEP?
- Novel implementation strategies and settings to improve awareness and use of PrEP in cisgender women and transgender men**
- What interventions and strategies are most effective to improve PrEP awareness and use among cisgender women and transgender men who may benefit from PrEP?
- HIV testing and linkage to care
- What are the most effective interventions to improve HIV testing and linkage to PrEP services in areas of need?
- Implementation of rapid start/same-day PrEP
- What are the perspectives of healthcare providers and those who use PrEP, clinic feasibility, and efficacy and safety outcomes of implementing same-day start of F/TAF for PrEP for appropriate individuals, prior to kidney function test results?
- PrEP implementation using telehealth and in pharmacies
- What is the feasibility and acceptability of starting individuals who can benefit from PrEP on F/TAF using a telemedicine visit?
- What are the best models for tele-PrEP implementation?
- What is the feasibility of prescribing PrEP in retail pharmacies (in states/jurisdictions that allow retail pharmacists to prescribe PrEP)?
- What are the best models for PrEP implementation in pharmacies?
- What is the comfort level of pharmacists and people who can benefit from PrEP with PrEP delivery and services in retail pharmacies?
- Would PrEP implementation in outpatient/retail pharmacies result in increased linkage to prevention services, higher PrEP uptake, and better persistence?
- Preferences of those who use PrEP in routes of administration and other qualitative research
- What are the profiles/demographics of people who prefer daily oral vs. long-acting injectable PrEP?
- What are the preferences and considerations of those who use PrEP in a long-acting injectable? (e.g. type and frequency of injection, at-home vs. in-office injection, type of injection equipment, etc.)
Please note: For proposals using F/TAF in the intervention, F/TAF should have regulatory approval for HIV PrEP or have plans for a future regulatory filing for HIV PrEP in the country in which 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.
We recommend that submitted proposals:
- Incorporate community and/or user/participant involvement
- Have clear scientific objectives and endpoints based on scientific hypotheses
- Include data collection/evaluation methods that are appropriate, defined and specific
- Note potential scalability and sustainability of the program after funding completion (when applicable)
- Highlight generalizability to other settings
- Discuss feasibility of completion of the project within three years, followed by rapid data dissemination and presentation of results
Submission Deadlines and Application Process
Letter of Intent Submission Window
- July 12, 2021: Submission window opens
- Aug. 20, 2021: Submission window closes
Letters of Intent (LOIs) must be submitted via the Gilead OPTICS online portal.
Questions about the NOVA-21 program or application process can be submitted to your local Gilead Medical Scientist or NOVA@gilead.com.
Full Application Submission
All those who have submitted an LOI will be informed of the outcome of the LOI review by Sept. 27, 2021. 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. 25, 2021: Deadline for receipt of full application
- Mid-December 2021: 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 are encouraged to apply.
The program provides awards for proposals completed in up to three years. 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-21 Program, dependent upon availability of funds and receipt of meritorious applications. Gilead anticipates that approximately 10 awards will be granted. 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 will review and score the LOI and 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. Further, not including 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.
*F/TAF refers to Gilead’s Descovy® (emtricitabine 200 mg / tenofovir alafenamide 25 mg tablets).
**The indication excludes individuals at risk of acquiring HIV-1 from receptive vaginal sex because effectiveness in this population has not been evaluated. Implementation strategies using F/TAF in cisgender women or transgender men at risk of acquiring HIV through receptive vaginal sex are excluded.
1. Mayer K, et al. Lancet 2020; 396: 239-54.