Developmental Core Description
The Developmental Core provides mentoring support for junior investigators who are interested in pursuing an HIV research career. We work collaboratively with other CFAR Cores to identify scientific and career mentors as needed, upon request.
The Developmental Core provides funding (up to $30,000; or $40,000 for proposals from CFAR scientific working groups) for one year for HIV research.
Awards are made for/to one of the following:
-Experienced investigators new to HIV
A senior mentor is required to assist junior Awardees in preparing the application, executing the project, preparing a manuscript, and writing a resulting larger grant proposal to the NIH. Research can be basic, translational, clinical, or social/behavioral, and can address treatment, transmission, or prevention. There are several opportunities during the year for Awardees to present their work.
*Junior investigators are defined as never having served as a PI on an R01 or R01 equivalent grant; holding a terminal degree (e.g. Ph.D., MD); eligible to serve as PI on NIH grant; and employed at UNC, FHI 360, RTI, or a NC HBCU.
Developmental Core News
Congratulations to our 2019 CFAR Administrative Supplement PIs!
Dr. Jess Edwards, Developing novel tools to understand the HIV Epidemic in the United States using Big Data
Dr. Nicholas Brown, Structural studies of HIV-1 hijacking the cullin-RING ligaseCRL4VprBP
Dr. Gauri Rao, The Relationship between Pyrazinamide Pharmacokinetics, Tuberculosis Disease, and Host Immune Responses
Dr. Lisa Hightow-Weidman, An Integrated Technology-Based “Status-Neutral” Approach to Engage YMSM/YTGW in the Prevention and Care Continuum in North and South Carolina
Dr. Tonia Poteat, Transcending Barriers: Preparing to End the Epidemic for Transgender People of Color in the Carolinas
Congratulations to our 2019 CFAR Developmental Awardees!
Dr. Ross Boyce, Feasibility of point-of-care HIV-1 viral load testing in rural western Uganda
Dr. Haitao Guo, Suppress HIV Replication and Potentiate T Cell Response to HIV by Targeting Metabolic
Dr. Stephanie Martin, Engaging Fathers in the Care and Feeding of HIV-Exposed Uninfected Infants in Zambia
Dr. David Van Duin, Antibacterial resistance in people living with HIV
9/19/17 NIH has released a statement about changes to the Certificate of Confidentiality.
8/15/17 Tips on choosing a mentor from NIH: https://www.niaid.nih.gov/grants-contracts/tips-choosing-mentor
NIAID guidance for writing a grant application can also be found on-line.
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you: • select the right NIH funding opportunity announcement First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here. Second, take a moment to answer these four questions about your current or proposed research: If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency. Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying. Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials. NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including: Improving the design, efficiency, and transparency of clinical trials is important because it: We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards. We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations
1) Does the study involve human participants?
2) Are the participants prospectively assigned to an intervention?
3) Is the study designed to evaluate the effect of the intervention on the participants?
4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
• the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:
• select the right NIH funding opportunity announcement
First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.
Second, take a moment to answer these four questions about your current or proposed research:
If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency. Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.
Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials. NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:
Improving the design, efficiency, and transparency of clinical trials is important because it:
We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards. We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.
Kate MacQueen, PhD, MPH
Dr. MacQueen is a Senior Scientist in Social & Behavioral Health Sciences at FHI 360 and Adjunct Associate Professor in in the UNC-CH School of Medicine Department of Social Medicine and in the Gillings School of Global Public Health’s Health Behavior Program. She has conducted research on the social, behavioral and ethical aspects of biomedical HIV prevention trials globally and domestically, including vaccines, microbicides and PrEP. Most recently her work includes leading LinCS 2 Durham, a five year NIH R01 project to help build support for new HIV prevention work with Durham’s black communities; an NIH R21 project on developing a framework for evaluating Good Participatory Practices in TB Drug Trials globally; and USAID funded research on women’s adherence to emerging HIV prevention technologies including tenofovir gel and vaginal rings. She also is a standing member of the NIH Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section [BSPH].
Ada Adimora, MD, MPH
Dr. Adaora Adimora is Professor of Medicine and Epidemiology at the University of North Carolina at Chapel Hill. Board certified in Internal Medicine and Infectious Diseases, she is a physician epidemiologist with more than 20 years of clinical experience in the treatment of patients with HIV disease. She studies the epidemiology of HIV and STIs. Her work has characterized the epidemiology of heterosexual HIV transmission among African Americans, highlighted the role of sexual network patterns in the spread of HIV, and underscored the importance of macroeconomic and social forces in racial disparities in the US HIV epidemic. She was selected by The Root as one 100 African American leaders “who are making extraordinary contributions.” She serves as Chair of the HIV Medical Association, chairs the NIH HIV Prevention Trials Network’s Women at Risk Committee, and is a member of the Women’s Research Initiative on HIV/AIDS, the NIAID Council, and the Presidential Advisory Council on HIV/AIDS.
Cathy Emrick, MPH
Ms. Emrick serves as the Core liaison for Developmental applications and Awardees. Ms. Emrick has an MPH in Health Behavior and Health Education from UNC, and is the Program Coordinator For the UNC Center For AIDS Research (CFAR) Developmental Core. She has focused on the HIV epidemic since 1990, working in community-based organizations, state government, and research at UNC.
Request for Proposals for Developmental Awards
The UNC CFAR Developmental Core provides Developmental Awards and small secondary data analysis awards to emerging HIV investigators for one year of research.
Q: What types of feedback does the CFAR Developmental Review Committee give to applicants?
A: There are definitely themes that we frequently see across applications, disciplines, and years. Common positive feedback includes:
· Project is significant, scientifically interesting
· The proposal includes strong mentors
· The hypothesis is plausible and novel
Common negative feedback includes:
· The proposal and intervention are too ambitious
· PI needs guidance with methods.
· The analysis plan was lacking.
· The sample size is too small
· No power calculations are discussed
· The intervention may be too diffuse
· No clear path to follow up NIH funding
Much of the negative feedback could be avoided by active engagement with the PI’s mentor during the application process. In addition, both the CFAR Biostatistics Core and Sonia Napravnik of the CFAR Clinical Core are willing to assist applicants with their methodology and/or analysis plans. The Social and Behavioral Science Core is also willing to help by looking at intervention ideas and social/behavioral methodology. We strongly recommend applicants utilize these resources before submitting their proposals – applications that have been through these steps prior to final submission tend to be more competitive.
Q: A mentor sounds useful. How do I get one of those?
A: If you have one or more already, feel free to use them. We understand the value of a mentoring team that may include a senior investigator who specializes in the science or methodology utilized by your proposal, another who knows your population or topic area, and perhaps another who has your dream career and can help you plan how to achieve one just like it. If, however, you have not yet found a mentor that is a good fit for you and your research goals, don’t worry – we can help! We could probably make some recommendations based on a conversation with you, but it would be even better if you had some ideas already. We suggest that you go to the NIH RePORTER and search for investigators based on location (ideally UNC, FHI, or RTI), topic area (e.g., HCV and HIV, medication adherence and HIV, or whatever you are interested in), and NIH Institute that you think is the best fit for you. After all, wouldn’t it be great to have a mentor that already knows the project officers, interests, quirks, etc., of your favorite Institute? If they have already figured out how to succeed in your area and Institute, they might be a good person to seek out for advice. Find a few people that fit those criteria if you can, and then email us with those names. We’ll facilitate your interactions with them and see if we can’t help get you one of those useful mentors.
Tips on choosing a mentor from NIH: https://www.niaid.nih.gov/grants-contracts/tips-choosing-mentor
Q: Are overhead/indirect costs or PI salary support allowed in the Developmental proposal budget?
A: It is our policy not to provide indirect costs or PI or faculty salary support at research-based colleges or universities. The UNC SOM similarly donates their share of the indirect costs back into the Award funds to maximize their reach.
While we ask that HBCUs waive indirect costs, HBCU proposal budgets may include up to two semesters of course buy-out.
FHI 360 and RTI PIs are expected to negotiate PI salary support levels and/or indirect charges to maximize the Award reach. For example, this might mean including a support letter saying indirects will be waived or that PI salary support will be partially or fully covered under another mechanism. Basically, we want to see that your institution is as invested in your professional development as we are.
Q: What’s a SWG and why do they get more money than the rest of us?
A: The UNC CFAR is committed to fostering interdisciplinary collaboration among research investigators, and provides the support and resources necessary for investigators to work together in pursuit of unique research topics. UNC CFAR’s Scientific Working Groups (SWGs) are comprised of investigators who share common research interests and goals, and participate in competitively funded research.
One of the CFAR’s missions is to support the work of our SWGs, so we like to see new interdisciplinary research come out of these groups and encourage that by offering them more money. Currently, our CFAR has two SWGs:
· NC HIV Public Health Collaborative (Heidi Swygard, Chair)
· PrEP (Christopher Hurt and David Wohl, C0-Chairs)
If you like the idea of a larger Developmental Award and share their research interests, the SWGs are always open to new members!
Q: I’m a post-doc/fellow and really need some money for a great AIDS-related project. May I apply?
A: We appreciate post-docs/fellows and would love to help you but unfortunately our funds are limited and outcome restraints are tight. Since the CFAR’s continued funding depends in part on how successful our Developmental Awardees are at getting R and K level awards while they are employed at UNC, FHI 360 or RTI Triangle-based offices, or an NC HBCU, federal research funds are becoming harder to come by, and post-docs often move on to other places at the end of their fellowships, we are currently not funding post-docs.
Q: I’m not a junior researcher, but I haven’t worked in HIV before. Don’t you want to help me?
A: Of course we do! In fact, we love to lure in senior investigators from other fields… I mean, help them expand their research interests. The application process is the same as for junior investigators, as are the required documentation and outcomes. If you have already been PI on an R01 for a project in HIV, however, you are already one of us and we cannot lure, ahem, fund you.
Q: My research interests align with NIH’s priorities and will lead to an R01, I’m sure of it. Is that all I need to say about that?
A: No, of course not! Tell us more – we want to hear all about it. To which institute will you be applying? Convince us that you and the NIH are soulmates, destined to come together in the relatively near future. We want a very specific funding path, a plan outlining how the proposed work will lead to NIH funding, a timeline for seeking such funding, the NIH institute or center from which you anticipate seeking funding, and the type of grant you plan to pursue (one page maximum, and not part of four page grant text limit). With which of NIH’s priorities does your project align? Your application must also include a separate document explaining how the proposed work is aligned with the NIH priorities. This document does not count toward the four-page grant text limit either.
Q: Talk to me about CFAR Administrative Supplements.
A: About once a year, NIH announces opportunities for CFAR Administrative Supplements. The RFA targets a short list of specific areas of HIV research that are generally up to about $100,000-$150,000 for one year. Each CFAR may submit one application per topic area to the NIH, so if more than one researcher is interested in a particular topic, we will do an internal review of letters of intent and choose one that can then move forward into a full application.
Q: That’s a lot more money than a CFAR Developmental Award. Can I apply for a CFAR Administrative Supplement?
A: Only if it is in an area of interest for this year’s Administrative Supplement RFA and you get the go-ahead from the CFAR leadership. Eligible applicants should also keep in mind that Supplement proposals must clear two hurdles at NIH – 1) they have to be strong enough in their science and methodology to be selected for funding; and 2) pay attention here – they have to be about HIV/AIDS! NIH will no longer fund non-AIDS projects with AIDS money. So if it is going through the Office of AIDS Research (as CFAR Administrative Supplements must), it had better have HIV or AIDS in its title. There are many STIs and IDs that are important in the world of HIV, but they are no longer going to be funded through the OAR. So if you want a CFAR Administrative Supplement, be sure you state clearly in the application and title that it is going to be HIV/AIDS research.
Q: What are the PI requirements for an Administrative Supplements?
A: They are similar to those of the Developmental Awards, i.e., you must be eligible to serve as a PI on an R level NIH grant, and you must be associated in some way with the CFAR through which you are applying (hence the requirement of the CFAR PI’s approval). The primary desired Supplement outcome is a larger, directly related NIH grant. The gold standard is an R01. We will be closely watching – and reporting on – Administrative Supplement PIs’ success(es), so that the NIH and Congress will see how important it is that they continue to provide CFAR and Supplemental funding.
Q: OK, so let’s say I get funding from a CFAR Developmental Award or a CFAR Administrative Supplement. What do YOU get out of it?
A: Well, if you can cure AIDS, that’d be good. But even if you can’t (yet), what we want is for you to succeed. Our goal is to help junior investigators build their HIV research careers and make a difference in this epidemic. As Charlie always said, we are training our replacements. As Kate says, we can see the light at the end of the tunnel now but the next generation of researchers is going to get to actually walk out into that light.
Of course, to justify our CFAR’s continued funding from NIH, we have to provide evidence that we are on the right track. As mentioned above, the primary desired outcome is always a larger, directly related NIH grant. The gold standard is an NIH R01 (or a less common “R01 equivalent”, i.e., R23, R29, or R37) grant, and that is what all of our Awardees and Administrative Supplement PIs should strive for. However, any post-Award funding that is directly related to your CFAR award is positive achievement and should be reported proudly back to the Developmental Core so that we can effectively brag about it to NIH and anyone else who will listen. An R21, for example, can be an intermediate step toward an R01 and may be easier to attain first. Funding from CDC or other sources is also nice, although less desirable as far as our needed outcomes as funding from NIH. In summary, smaller follow up funding is great, but keep your eye on the R01 as your ultimate goal.
We also need for you to share your CFAR research results with the scientific community. We are all partners in the fight against AIDS and sharing information makes us all stronger. Therefore, our other desired outcome for all CFAR-funded research is dissemination of results. The gold standard in this outcome category is publication in a peer review journal (citing the CFAR, linking it to our grant, and obtaining a PMCID are all required), but as an intermediate step, we accept the presentation of research at national and/or international conferences. Again, keep your eye on the prize – plan to publish.
Your mentor can play a key role in helping you achieve each of these outcomes. We can help as well. You have the support of an incredible HIV research community behind you – utilize us! In fact, even if you are not a Developmental Awardee or Administrative Supplement PI, if you are a junior investigator in the CFAR, we want to help you succeed.
Remember, we will be closely watching – and reporting on – your success(es), so that the NIH and Congress will see how important it is that they continue to provide CFAR and Supplemental funding.
Q: Is there any guidance on-line about writing an NIH grant proposal?
Yes, in fact, there is! NIAID has great detailed information on-line.
The UNC Center For AIDS Research (CFAR) is soliciting proposals for small grants for up to one year (ending by 7/31/21) to support emerging (new and early stage) HIV investigators (basic, behavioral, social, and clinical scientists including Pediatrics, OB-GYN, Internal Medicine, etc.) with terminal degrees who are seeking to fund new ideas in HIV research. Research can be basic, translational, clinical, biostatistical, or social/behavioral, and can address treatment, transmission, or prevention, however, we cannot fund clinical trials as defined by NIH.
The purpose of the CFAR Developmental Awards is to provide seed money for new ideas in HIV research that will lead to applications for independent NIH funding by the Award’s Principal Investigator. The success of the UNC CFAR is measured in large part by the number of subsequent NIH grants that our Developmental Awardees receive while affiliated with the UNC CFAR via employment at UNC-Chapel Hill, FHI 360 or RTI NC Triangle-based offices, or an NC HBCU. See the section on ELIGIBILITY below for more details.
- Contact CFAR Developmental Core during application preparation for a telephone or email conversation to verify eligibility and briefly describe research idea
- Application Due Date: October 14, 2019
- CFAR Scientific Review: November 2019
- Notification of Award: January 2020
- Projected Award Date: August 1, 2020
- Actual start date may be delayed if required approvals are delayed; see below.
- Period of Award: Funding expires on July 31, 2021. There is a possibility of a no cost extension for the research, however, funding cannot be extended beyond July 31
All submissions should be emailed as .pdf attachments to: firstname.lastname@example.org.
Start dates for funded Awards depend on timing of receipt of the following:
- Projects involving vertebrate animals require UNC IACUC
- Projects involving human subjects require UNC IRB approval
- Projects involving clinical research entailing greater than minimal risk to the subjects and/or international research additionally require NIH clearance(s) for the project. The CFAR Developmental Core Manager will provide guidance to Awardees on and facilitate the NIH clearance process.
Up to $30,000 for up to one year; $40,000 if the application is a collaboration coming out of a CFAR Scientific Working Group (include a letter of support from the SWG chair). Because funds release and study implementation is contingent on UNC IRB, international ethics committee (if applicable), and NIH approvals, the funding will only be initiated once all necessary approvals are obtained and all forms are submitted to the CFAR Developmental Core, and can only be guaranteed through July 31, 2021. Awardees will have a deadline of one month from notification of Award to submit applications to their IRB(s) and all non-IRB forms to the Developmental Core. Subsequent NIH approval can take up to four months (worst case scenario).
Funding will likely be available no earlier than August 1, 2020, and may be later, depending on how long the approval processes take for a given application. Regardless of the start date, funding support will end by July 31, 2021.
1) PI must be employed by UNC-Chapel Hill, FHI 360 (Durham office), RTI International (Durham office), or one of the following North Carolina-based historically black colleges or universities (HBCU): NCCU, St. Augustine’s University, NC A&T University, or WSSU. International investigators and other NC Triangle-based investigators with a strong connection to one of the above may also be eligible; investigators should contact the Core Director to determine eligibility before applying.
2)Applicants must meet one of the following criteria:
- NIH-defined new or early stage investigators who have never received an NIH R01 or R01–equivalent (R23, R29, R37, DP1, DP2, DP5, RL1, R35-MIRA, RF1, and U01) award in HIV/AIDS
- Established investigators new to HIV research (i.e., have received at least one non-HIV-related NIH R01 or R01-equivalent award)
3) New or early stage investigator applicants must be actively mentored by an established investigator in the HIV field (i.e., someone with previous HIV-related independent R01-equivalent NIH funding). This must be evident in the application itself, including appropriate letters of support.
4) Established investigators who are new to the HIV field must be collaborating with a senior HIV investigator. This must be evident in the application itself, including appropriate letters of support.
5) International applicants must be actively collaborating with at least one mentor who is faculty at UNC-CH or a UNC CFAR member at an affiliated institution (FHI 360, RTI) in the development of their application. This must be evident in the application itself, including appropriate letters of support.
6) Applicants must have a terminal degree (e.g., PhD, MD, PharmD, etc.).
7) Applicants on T32 grants are not eligible.
8) Applicants with a current K award must have documented NIH pre-approval.
9) Applicants must be eligible to serve as the Principal Investigator (PI) on National Institutes of Health (NIH)-funded grants. Accordingly, university-based applicants must be a faculty member.
10) Post-docs are NOT eligible to apply this year.
11) Former CFAR Developmental Awardees may apply, however, they are unlikely to be funded again. Their applications will be judged in part by the success of their previous Award. Previous Awardees should contact the Developmental Core before submitting a new application.
Proposals will be reviewed by senior investigators on the following criteria:
• Alignment with NIH HIV/AIDS Priority Areas and UNC CFAR funding priorities (defined in Funding Priorities, below)
• Overall scientific merit
• Standard NIH criteria of significance, innovation, approach, environment, and ability of investigator to carry out award (described below)
• Specific and narrowly focused application with realistic goals
• Potential for generating future NIH funding
• Potential for drawing investigators from other fields into AIDS research
• Potential for developing new interactions between or among CFAR investigators
• Priority will be given to collaborative proposals that extend the scope of current CFAR activities across multiple participating laboratories/institutes. Collaborative proposals will be evaluated on the scientific merits of each individual component of the project, as well as the overall integration of the components.
• Proposals from women and minority investigators will be given special consideration in the review process.
Awardees will be notified in writing. All applications are subject to NIH approval and all applicants will receive a written review of their proposals, regardless of funding.
Significance: Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (exclusion) of children, justified in terms of the scientific goals and research strategy proposed?
Environment: Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment, and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Investigator ability: Are the PIs, collaborators, and other researchers well suited to the project? Do they have appropriate experience and training? If the project is collaborative or multi-PI, do the investigators have complementary and integrated expertise; is the leadership approach, governance, and organizational structure appropriate for the project? Is there evidence of strong and appropriate mentorship?
Potential for future related NIH funding: Is there a clear vision for how the proposed work will build toward independent research that is aligned with NIH HIV funding priorities for the investigator?
EXPECTED PROJECT OUTCOMES
• Peer-review publication
• Independent NIH funding (i.e., R21, R01, and R01-equivalent awards).
• Partway through their funding period, Developmental Awardees will be required to present long-term research plans related to their Developmental research at a forum to senior CFAR investigators. Resulting feedback and questions will then inform the implementation of their research, with the goal of stronger preliminary data and analysis in order to ultimately support a successful NIH funding application.
Given that the CFAR will ultimately be judged on the success of its Awardees (defined by NIH as independent NIH funding while associated with the CFAR), Developmental applications will be prioritized based on the alignment of proposals with NIH funding priorities.
We are especially interested in applications that are responsive to or aligned with the UNC CFAR priorities (Pre-Exposure Prophylaxis and NC HIV Public Health Collaborative as well as international HIV research applications. However, applications need not be limited to these areas.
Applications should contain the following components and be submitted in .pdf format.
1. The completed CFAR Small Grant cover page, which includes:
• Applicant information
• A project summary describing why this application is innovative and/or important
2. Project proposal including:
• one page of Specific Aims
• up to four pages of Research Strategy, including sections to address Significance, Innovation and Approach.
3. A separate References section (not included in four-page limit)
4. For new, early stage, and/or international applicants, identification of proposed mentor – an HIV researcher who has been PI on an NIH R01 or R01 equivalent grant – and explanation of the mentor’s role on the project, starting with during the application process. For established investigators new to HIV, an established HIV investigator collaborator must similarly be included and described.
5. If application contains co-PIs, a separate Project Leadership Plan, per NIH guidelines, must be included (not included in four-page limit).
6. A current NIH Biosketch for all key personnel
• NIH biosketch sample, format, and instructions
7. Budget (“Detailed Budget for the Initial Budget Period”) on NIH 398 form page and Budget Justification. Applicants may request up to $30,000 (or $40,000 if applying on behalf of a CFAR SWG) in total direct costs for one year.
• Award funds may not be used to support UNC faculty or post-doc salary, conference travel, or food/drinks.
• See FAQ on the UNC CFAR Developmental Core RFP page for guidance concerning indirect costs.
8. Separate Human Subjects section (not included in four-page limit)
9. Letter of support from the applicant’s proposed mentor, outlining the mentor’s proposed role in the project and connection to the applicant.
10. Additional letters of support are strongly encouraged if applicable (e.g., to verify access to clinic populations, for collaborators, etc.)
11. All applications must include a separate document explaining how the proposed work is aligned with the NIH funding priorities. This document should include a plan outlining how the proposed work will lead to NIH funding, a timeline for seeking such funding, the NIH institute or center from which they anticipate seeking funding, and the type of grant they plan to pursue (maximum of one page, not part of four-page limit).
12. If the application overlaps with or duplicates any aspects of a pending NIH proposal submitted by the PI, include a copy of the Specific Aims page for the proposal(s) and anticipated review dates.
13. A cover letter may be submitted if desired.
14. All applicants should contact the Developmental Core during the application process for a telephone or email conversation to verify eligibility and briefly describe the proposed research idea.
15. NEW AND EARLY STAGE INVESTIGATORS ONLY: Required letters of support resulting from specific consultations are listed below. These consultations should be held in the later stages of application process. Before arranging them, please ensure that your mentor agrees that your proposal is ready for this type of review.
• If you plan to use quantitative methods, the CFAR Biostatistics Core or Sonia Napravnik of the Clinical Core can provide you with a free consultation to review your proposal’s methodology. A letter documenting this pre-submission statistical/informatics review will be required of all applications with quantitative methods. To schedule your free consultation, you must submit a service request (directions at the bottom of the RFA) no later than August 16 (four weeks before the application deadline, September 13).
• If you plan to use qualitative methods, the UNC CFAR Social and Behavioral Sciences Core can provide you with a free Qualitative Methods Consultation to review your proposal. This is highly encouraged, as the consultation and resources the CFAR can provide will strengthen your application. To schedule your free consultation, you must submit a service request (directions at the bottom of the RFA) no later than August 16 (four weeks before the application deadline, September 13).
•Applications involving human subjects will be required to have an accompanying letter from Tania Caravella, CFAR Regulatory Head, documenting a discussion of the project’s ethics and human subject involvement. To schedule a meeting with Tania, you must contact her no later than August 16 (four weeks before the application deadline, September 13).
Projects Involving Clinical Trials: Projects involving clinical research (e.g., observational studies or sub-studies using existing data from an ongoing clinical trial) may be funded by the CFAR.
CFARs are unable to fund clinical trials. The NIH definition of a clinical trial is very broad. Some investigators conducting human subjects research may not be aware that NIH considers their study to be a clinical trial. For guidance, click here. Double-check whether your plan is considered a clinical trial before submitting a proposal.
Applicants considering submission of proposals that might be considered clinical trials are strongly encouraged to seek advice from the Developmental Core Director (email@example.com) before submitting a proposal.
Involvement of other UNC CFAR Cores is strongly encouraged when applicable.
Issues related to Rigor and Reproducibility should be addressed in application.
NIH provides excellent general guidance on grant-writing.
If you would like input or assistance from a CFAR Core Director, Cathy Emrick can facilitate that interaction.
CONDITIONS OF AWARD
• CFAR Developmental Core Awards provide funding for up to a one-year term, ending no later than July 31, 2021. Any funding extension beyond the one-year term must be approved by the CFAR Developmental Core Director and is unlikely this year due to our upcoming competitive renewal. Funds may not be used on other research or activities/resources unrelated to the approved project.
• PIs will be required to submit a yearly progress report. PI will also present research progress and plans for follow up funding to UNC CFAR leadership approximately six months into the Award.
•All publications and manuscripts derived from CFAR funding must:
- Be linked to the UNC CFAR grant by our grant number during the publication process
- Obtain a PMCID (which is different from a PMID) upon publication
- Ideally, acknowledge UNC CFAR support by grant number (P30 AI50410) in the Acknowledgements or Funding section of the text
• Prior to funding, PI must forward a copy of all relevant Institutional Biohazard, Animal Care and IRB approvals to the CFAR Developmental Core. If the pilot involves human subjects and the institutional IRB Committee or NIH has deemed the study “more than minimal risk”, PIs must submit additional documents including an SOP to receive NIH clearance before funding is released, which will be coordinated by the CFAR Developmental Core. Keep these requirements in mind when developing a project timeline – the RFP Schedule outlined above allows extra time for this process to occur before August 2020.
OTHER CFAR SERVICES
Besides direct funding, the UNC CFAR has numerous Cores (HIV/STD Lab Core, Analytical Chemistry/Clinical Pharmacology Core, Clinical Core, Social and Behavioral Science Core, International Core, and Biostatistics Core) that can assist with HIV-related research projects. They have the ability to do assays (HIV/STD Lab, Pharmacology), assist with consultation in developing questionnaires (Clinical, Social and Behavioral), and reviewing any grants you plan to submit to outside agencies. Descriptions of these services can be found on the UNC CFAR website, where you can also submit a request for those services on individual Core pages.
Requesting CFAR Services
How to submit a UNC CFAR service request:
1. Go to the following website: http://unccfar.org/
2. Select the Request a Service button
3. Register for a CFAR account and username (you will use this for all future Core Service Requests)
4. Select the “Social and Behavioral Sciences” option for question 1.
5. Continue to fill out the form with the services requested. Note, please be sure to include your proposed title for your Developmental Award Application.
For additional information, please contact Cathy Emrick (firstname.lastname@example.org). All questions are welcomed.
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Matoga M, Mmodzi P, Massa C, Bula A, Hosseinipour M, Chasela C (2018). Health System Factors Influencing Partner Notification for STIs and HIV in Lilongwe Malawi. A Pre-Intervention Phase Assessment for a Quality Improvement Project. J Infect Dis Med;3(1):125.
Miller WC, Lesko CR, Powers KA (2014). The HIV care cascade: simple concept, complex realization. Sex Transm Dis;41(1):41-2.
Ngongondo M, Miyahara S, Hughes MD, Sun X, Bisson GP, Gupta A, Kumwenda J, Lavenberg JA, Torres TS, Nyirenda M, Kidonge KK, Hosseinipour MC; AIDS Clinical Trials Group A5274 (REMEMBER) Study Team (2018). Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living with HIV with Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. J Acquir Immune Defic Syndr;78(1):54-61.
Ngongondo M, Rosenberg NE, Stanley CC, Lim R, Ongubo D, Broadhurst R, Speight C, Flick R, Tembo P, Hosseinpour MC (2018). Anemia in people on second line antiretroviral treatment in Lilongwe, Malawi: a cross-sectional study. BMC Infect Dis;18(1):39.
Nwaohiri AN, Tang JH, Stanczyk F, Chinula L, Hurst S, Davis NL, Tegha G, Haddad L, Kourtis AP (2018). Discordance between self-reported contraceptive use and detection of exogenous hormones among Malawian women enrolled in a randomized controlled trial. Contraception;97(4):354-6.
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Sellers SA, Chason KD, Fischer WA (2017). Respiratory Mucosal Immune Suppression in HIV-Infected Individuals. Infectious Disease Society of America Meeting, San Diego, CA.
Sellers SA, Dover K, Wohl DA, Miller M, Dittmer D, Fischer WA (2017). The Burden of Respiratory Viral Illness in HIV Infected Patients. American Thoracic Society Meeting, Washington, DC
Sin S-H, Eason B, Kim Y, Kang S, An H, and Dittmer DP (2017). Hyperglobulinemia in KSHV latency mice is prevented by everolimus. 20th International Workshop on KSHV and Related Agents, Berlin, Germany.
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Masa R, Chowa G, and Nyirenda V (2017b). Barriers and facilitators of antiretroviral therapy adherence in rural Eastern Province, Zambia: The role of household economic status. African Journal of AIDS Research, 16(2):91-99.
Firnhaber C, Goeieman B, Faesen M, Levin S, Williams S, Rameotshela S, Swarts A, Michelow P, Omar T, Williamson AL, Allan B, Schnippel K, and Smith JS (2016). Prospective One Year Follow Up of HIV Infected Women Screened for Cervical Cancer Using Visual Inspection with Acetic Acid, Cytology and Human Papillomavirus Testing in Johannesburg South Africa. PLoS One;11(1):e0144905.
Flax VL, Hamela G, Mofolo I, Hosseinipour MC, Hoffman I, Maman S (2016). Infant and young child feeding counseling, decision-making, and practices among HIV-infected women in Malawi’s Option B+ prevention of mother-to-child transmission program: a mixed methods study. AIDS & Behavior;20(11):2612-2623.
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Rosenberg NE, Stanley CC, Rutstein SE, Bonongwe N, Kamanga G, Pettifor A, Mapanje C, Martinson F, Hoffman IF, and Miller WC (2016). Recruiting the Social Contacts of STI Patients for HIV Screening in Lilongwe, Malawi: Process Evaluation and Assessment of Acceptability. Sex Transm Infect;92(8):587-592.
Taboada A, Taggart T, Holloway I, Houpt A, Gordon R, Gere D, Milburn N, Lightfoot AF (2016). A Critical Review of the Characteristics of Theater-Based HIV Prevention Interventions for Adolescents in School Settings. Health Promot Pract. 17(4):537-47.
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Caldwell K and Matthews A (2015). The Role of Relationship Type, Risk Perception, and Condom Use in Middle Socioeconomic Status Black Women’s HIV-prevention Strategies. J of Black Sexuality and Relationships;2(2):91-120.
Grewe ME, Taboada A, Dennis A, Chen E, Stein K, Watson S, Barrington C, Lightfoot AF (2015). ‘I learned to accept every part of myself’: the transformative impact of a theatre-based sexual health and HIV prevention programme. Sex Educ;15(3):303-317.
Herce ME, Mtande T, Chimbwandira F, Mofolo I, Chingondole CK, Rosenberg NE, Lancaster KE, Kamanga E, Chinkonde J, Kumwenda W, Tegha G, Hosseinipour MC, Hoffman IF, Martinson FE, Stein E, van der Horst CM (2015). Supporting Option B+ scale up and strengthening the prevention of mother-to-child transmission cascade in central Malawi: results from a serial cross-sectional study. BMC Infect Dis;15:328.
Juliano JJ, Barnett E, Parobek CM, Taylor SM, Meshnick SR, Stone S, Chang, E, Fong S, and Huang L (2015). Use of Oropharyngeal Washes to Diagnose and Genotype Pneumocystis jirovecii. Open Forum Infect Dis; 2(3):ofv080.
LaCourse SM, Chester FM, Matoga M, et al. (2015). Implementation of routine counselor-initiated opt-out HIV testing on the adult medical ward at Kamuzu Central Hospital, Lilongwe, Malawi. J Acquir Immune Defic Syndr; 69(1):e31-5.
Lesko CR, Sampson LA, Miller WC, Clymore J, Leone PA, Swygard H, Powers KA (2015). Measuring the HIV care continuum using public health surveillance data in the United States. Journal of Acquired Immune Deficiency Syndromes.70(5): 489-494.
Lightfoot AF, Taboada A, Taggart T, Tran T, Burtaine A (2015). “I learned to be okay with talking about sex and safety”: assessing the efficacy of a theatre-based HIV prevention approach for adolescents in North Carolina. Sex Educ;15(4):348-363.
Nunn KL, Wang YY, Harit D, Humphrys MS, Ma B, Cone R, Ravel J, and Lai SK (2015). Enhanced Trapping of HIV-1 by Human Cervicovaginal Mucus Is Associated with Lactobacillus crispatus-Dominant Microbiota. MBio. 6(5): e01084-15.
Onsomu EO, Abuya BA, Okech IN, Rosen DL, Duren-Winfield V, Simmons AC (2015). Association Between Domestic Violence and HIV Serostatus Among Married and Formerly Married Women in Kenya, Health Care Wom Int;36(2):205-28.
Powers KA and Miller WC (2015). Critical Review: Building on the HIV cascade: a complementary “HIV States and Transitions” framework for describing HIV diagnosis, care, and treatment at the population level. JAIDS;69(3):341-7.
Rahangdale L, De Paris K, Kashuba AD, Nelson JA, Cottrell M, Sykes C, Emerson C, Young SL, Stevens T, Patterson KB, Cohen MS (2015). Immunologic, virologic, and pharmacologic characterization of the female upper genital tract in HIV-infected women. J Acquir Immune Defic Syndr;68(4):420-4.
Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng’ambi W, Miller WC, Hoffman I, Hosseinipour M (2015). Recruiting male partners for couple HIV testing and counselling in Malawi’s option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91.
Sin S-H, Kang SA, Kim Y, Eason A, Tan K, An H, and Dittmer DP (2015a). Kaposi’s sarcoma-associated herpesvirus latency locus compensates for interleukin-6 in initial B cell activation. J Virol;90(4):2150-2154.
Vielot N, Hudgens MG, Mugo N, Chitwa M, Kimani J, and Smith J (2015). The Role of Chlamydia trachomatis in High-Risk Human Papillomavirus Persistence Among Female Sex Workers in Nairobi, Kenya. Sex Transm Dis;42(6):305-11.
Yotebieng M, Norris A, Chalachala JL, Matumona Y, Ramadhani HO, Behets F (2015). Fertility desires, unmet need for family planning, and unwanted pregnancies among HIV-infected women in care in Kinshasa, DR Congo. Pan Afr Med J;20:235.
Required Documents from new Developmental Awardees:
Final Developmental application, including budget and budget justification
.pdf copy of IRB approvals from any collaborating institutions as well as UNC
Photo of PI for CFAR website
Documentation of human subjects training for all study personnel
All informed consent forms