Multivalent Antibodies Show Effectiveness for HIV Prevention and Promise for Treatment and Cure

The ability of HIV to mutate has been a major challenge to vaccine development. As the body produces antibodies to target the outer HIV envelope protein, this protein changes, thwarting the circulating antibodies’ ability to neutralize it. Yet recent studies testing multivalent combinations of three broadly neutralizing antibodies, or bnAbs, have yielded promising results in animal models of HIV prevention. Two investigators at the University of North Carolina at Chapel Hill describe the potential of bnAbs to inform HIV prevention, treatment and cure strategies in a recent article in the New Journal of Medicine. 

“BnAbs are thought to be akin to signposts – that they point to a path that might be followed by a future HIV vaccine strategy through induction of bnAbs capable of preventing HIV infection,” said David Margolis, M.D., article co-author and director of the UNC HIV Cure Center.

No single bnAb can protect against all the variants of HIV present in infected individuals. However, combinations of multiple bnAbs provide increased efficacy.  The development of trispecific multivalent antibodies combine the best attributes of each into a single molecule capable of recognizing and neutralizing multiple viruses not recognized by the individual bnAbs.

“Trispecific antibodies engage a broader range of viral particles than do monospecific and bispecific antibodies,” said J. Victor Garcia, Ph.D., article co-author and a professor of medicine at UNC. “Trispecific antibodies may also block infection more efficiently at mucosal surfaces and within deeper tissue as well as neutralize a wider range of viral particles.

The authors also detail how bnAbs could change HIV treatment and cure research. Broadly neutralizing antibodies may contribute to the deployment of long-acting antiretroviral therapy, which would be an attractive alternative for people who currently take daily medication to control their HIV. In the cure arena, bnAbs could be paired with latency reversing agents to target and clear the virus

“Broadly neutralizing antibodies capable of recognizing HIV-infected cells could direct effector cells to clear the latent reservoir,” Margolis said. “In the case of the evasive HIV envelope, three may be the charm.”

Ending Gender Inequalities: Evidence to Impact Conference

You’re invited to join us for the Ending Gender Inequalities: Evidence to Impact Conference

Conference registration opens 28 February 2018
Participating in this meeting will help you:

  • Enhance knowledge of applied gender research, practice, and implementation, including new technology, gender-focused service delivery plans, evidence-based interventions, equalizing gender roles, education and economic empowerment activities
  • Form collaborative networks with skilled global gender scientists to share successes and challenges in implementation and sustainability of evidence-based programs for underserved key populations
  • Strategize solutions and innovative methods to reach key underserved populations, including but not limited to HIV affected populations, women who use substances, refugee women and children, adolescent girls and young women, and survivors of GBV

Conference Poster Abstracts Now Being Accepted

Key areas of interest: gender-based violence, economic empowerment, educating girls and women, health and wellbeing – such as substance use, HIV, family planning, sexual and reproductive health, and other areas focused on addressing gender inequality!

09 February 2018: Submission deadline for those desiring mentorship with abstracts
16 March 2018: Submission deadline for all abstracts
16 March 2018: Travel Award application deadline
30 April 2018: Abstract acceptance notifications and Travel Award notifications

Detailed abstract and submission information provided here:
Abstract Submission Site

For more information
contact us at gender@rti.org
www.rti.org/gender
© 2018 RTI International
Our mailing address is:
3040 E Cornwallis Road – PO Box 12194 – Research Triangle Park, NC 27709-2194

About RTI International

RTI International is an independent, nonprofit research institute dedicated to improving the human condition. Clients rely on us to answer questions that demand an objective and multidisciplinary approach—one that integrates expertise across the social and laboratory sciences, engineering, and international development. We believe in the promise of science, and we are inspired every day to deliver on that promise for the good of people, communities, and businesses around the world.

Student Brings Panel of AIDS Quilt to UNC

Elizabeth Trefney and her father John will see Jeremy Trefney's panel for the first time when it comes to campus in January.

Elizabeth Trefney and her father John will see Jeremy Trefney’s panel for the first time when it comes to campus in January.

As a freshman at UNC, Elizabeth Trefney remembers seeing a flyer publicizing a class about HIV/AIDS. The semester-long course is offered each spring by the UNC Center for AIDS Research (CFAR) and is open to all students. Past classes have focused on how the virus impacts the immune system, currently available treatments and the latest prevention strategies.

For Trefney, the course material felt personal. Her uncle, Jeremy, died of AIDS in 1988. She recently learned her uncle had a panel in the AIDS Memorial Quilt. The quilt began in 1987 as a way of celebrating the lives of those lost to HIV. Trefney’s father, John, says Jeremy’s friends created his panel, which is number 766. There are now more than 48,000 3-by-6-foot panels.

Taking the HIV/AIDS course inspired Elizabeth Trefney to action. She asked UNC’s Executive Vice Provost Ron Strauss, DMD, PhD, who also organizes the HIV/AIDS course, if bringing the quilt to campus was a possibility. Strauss said it was feasible and encouraged Trefney to reach out to the Names Project Foundation in Atlanta, which is the custodian of the AIDS Memorial Quilt.

“At first, I just requested bringing a section of the quilt to campus,” Trefney says. “Then I learned I could request my uncle’s panel. It will be the first time anyone in my family has seen it.”

The panel will be on display in the Carolina Student Union’s West Lounge from Jan. 10-31, 2018. There will be a special presentation where attendees will be asked to shine lights from their cell phones on the quilt in an act of unity on Wednesday, Jan. 24, from 7-8 p.m.

An avid musician, Jeremy Trefney's panel of the AIDS Quilt illustrates his passion for the piano.

An avid musician, Jeremy Trefney’s panel of the AIDS Quilt illustrates his passion for the piano.

Surrounded by Love
Jeremy Trefney worked as a marketing professional by day and played music at night in Cleveland. John Trefney remembers listening to his older brother play the clarinet, saxophone and piano.

“Elizabeth plays the piano and I feel like a piece of him is still with us when she plays,” Trefney says.

John Trefney was a high school sophomore when Jeremy told the family he was gay.

“I had a tough time accepting that. It took me about six months to come to terms with it,” Trefney says. “But the experience brought us closer. And when Jeremy became sick and told us he had AIDS, we embraced him. That was not the case for everyone who was diagnosed at that time. My father would go to the hospital every day. I remember him rubbing my brother’s feet. But some people never had any visitors and they died alone.”

Jeremy Trefney died at the age of 31 in 1988. No treatments for the virus existed at that time. The field has come a long way in the past 30 years with UNC leading major discoveries in treatment, prevention and cure research.

Elizabeth Trefney never met her uncle. She and her father hope bringing his panel to UNC will put a face to the virus that still affects nearly 37 million people worldwide.

“Throughout his fight with AIDS, my brother was always surrounded by love,” John Trefney says. “We hope people will visit his panel while it is on campus, and feel that sense of love and acceptance.”

Apply 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.

Breaking News: The joint UNC-Duke Developmental PrEP RFA has been released! Applications require co-PIs from Duke University and the UNC CFAR and are due February 15, 2018. See below for complete information.

Frequently Asked Questions

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 three SWGs:

·       HIV Cure (David Margolis, Chair)

·       NC HIV Prevention (Heidi Swygard, Chair)

·       PrEP (Christopher Hurt, Chair)

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 all of you but unfortunately our funds are limited.  Since the CFAR’s continued funding depends in part on how successful our Developmental Awardees are at getting R and K level awards, and federal research funds are becoming harder to come by, we have to give preference to applications that will lead to an R or K level award and also ultimately lead to publication of Developmental data.  In other words, while we are not currently completely ruling out post-doc applications at this time, strong preference will be given to junior faculty.

 

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 and linking it to our grant is 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.

2018 Joint UNC-Duke CFAR PrEP RFP

The objective of this RFA is to support emerging research regarding biomedical HIV prevention, particularly PrEP implementation, in North Carolina, by identifying:
1) mechanisms for strengthening the structural and social environment supporting PrEP use among key populations, and 2) innovative methods for engaging key populations in PrEP care.

Examples of responsive research topics include (but are not limited to):

• Exploring innovative approaches that address structural and societal barriers to PrEP service delivery in North Carolina
• Developing and assessing novel or alternative models of PrEP service delivery that promote linkage to and persistence in PrEP care and developing and assessing novel interventions on PrEP adherence
• Among PrEP prescribers and consumers, exploring perceptions of novel biomedical HIV prevention products in the pipeline and how these products might be implemented in practice

Proposals must align with NIH priorities. Applicants are also encouraged to give consideration to studies of populations currently underrepresented in PrEP care, including adolescents; persons who inject drugs; and Black and Latinx cisgender men, cisgender women, and transgender women who have sex with men.

General Information

Two co-PIs required, one each from the UNC CFAR and Duke University
• $100,000 total funds available ($50,000 from each CFAR)
• Each PI will financially manage their CFAR’s half of the Award
• Involvement of CFAR Cores: applicability based on proposed research, across both CFARs as appropriate. A letter of support is required for all applications with a quantitative component from at least one CFAR Biostatistics Core, documenting that they provided a pre-submission statistical/informatics review of the proposal. Applicants with a qualitative application are also required to submit a letter of support documenting a pre-submission consultation with a Social and Behavioral Science Research Core.
Expected Project Outcomes: Peer-review publication and use of findings to support independent NIH funding (i.e., R21, R01, and R01-equivalent awards) for each PI.

RFA Schedule

Application Due Date: February 1, 2018
• Application Review: February 2018
• Projected Award Date: March 15, 2018
Actual start date will be contingent on IRB approvals and the date that the NIH issues clearance for the project, if applicable
• Period of Award: Award period is 12 months or less

Application Submission Process

Applications should contain the following components in order and be submitted as one complete PDF document.

1. The completed UNC-Duke CFAR PrEP Small Grant Coversheet, which includes:
• Applicant information
• Duke applicants only: Duke departmental grants manager’s name, contact number, and signature
• A project summary describing why this application is innovative and/or important

2. A current NIH Biosketch for all key personnel
NIH Notice
NIH biosketch sample, format, and instructions

3. Eligibility requirements
• A faculty level position or equivalent is required to apply
• Applicants on T32 grants are not eligible.
• Applicants with a current K award must have NIH pre-approval.
• Former CFAR Developmental Awardees are eligible; their applications will be judged in part by the success of their previous Award.
• Applicants must be new or early stage investigators who have never received an R01 or R01-equivalent (R01, R23, R29, and R37) award in HIV/AIDS. Established investigators will only be considered if they are new to HIV research.
• UNC CFAR PI must have an affiliation with UNC-Chapel Hill, FHI 360, RTI International, or a North Carolina-based historically black college or university (HBCU). Duke University PI must have an affiliation with Duke University.
• New or early stage investigator applicants must be actively mentored by a senior 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.
• Senior established investigators who are new to the HIV field must be consulting or collaborating with a senior HIV investigator. This must be evident in the application itself, including appropriate letters of support.
• Please contact Developmental Core leaders, Herman Staats (Duke) or Sallie Permar (Duke) or Kate MacQueen (UNC), to discuss your eligibility if you have questions.

4. Budget and Budget Justification on NIH 398 form pages. Applicants may request up to $100,000 in total direct costs for one year.
• Restrictions for Duke University affiliated applicants:
o Travel must be specific to the funded project. Travel to attend a “General Scientific” meeting is NOT allowable. (Travel must be in support of project completion or presenting data from the CFAR project).
o Sub awards for external collaborations are allowable, but must comply with Duke sub-award policies.
o Projects that include an external collaboration, may incur a fee of 59% for the outgoing sub-award.
o Research effort is allowed on the grant (no admin or clerical). Faculty effort must comply with primary department policy.

• Restrictions for UNC CFAR affiliated applicants:
o Award funds may not be used to support UNC faculty or post-doc salary, conference travel, or food/drinks.
o See FAQ on the UNC CFAR Developmental Core RFP page for guidance concerning indirect costs.

5. Research Proposal using the current NIH R03/R21 format (Specific Aims is limited to one page. Research Strategy is limited to six pages. Single-spaced 11 pt Arial font.) The Research Strategy should include sections to address Significance, Innovation and Approach.
• Project Leadership Plan, per NIH guidelines.
• Define roles/areas of responsibility of each PI
• Clearly outline what each institution’s fiscal responsibilities for the project will be, e.g., RA support at each institution, participant incentives, lab costs, etc. Each PI will then be responsible for managing the funds from their institution to meet their deliverables for the project.
• Fiscal management will be according to each institution’s current post-Award management policies.
• Any/all conflict resolution would be brought to the Core Leadership mentoring committees.
• Separate References section (not included in six-page limit)
• Separate Human Subjects section (not included in six-page limit)
• The application must address issues related to Rigor and Reproducibility as described in NIH notice NOT-OD-16-011
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-011.html
http://grants.nih.gov/reproducibility/index.htm#guidance

6. All applications must include a separate document explaining how the proposed work is aligned with the NIH 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 six-page limit). This may include joint and/or separate future funding plans for the two PIs.

• Given that the CFAR will ultimately be judged on the success of its Awardees (defined by NIH as independent NIH funding), applications will be prioritized based on the alignment of proposals with NIH funding priorities.

7. All applicants using quantitative methods must have a letter of support from a CFAR Biostatistics Core documenting that it has provided a pre-submission statistical/informatics review of your proposal. Please email Dr. Cliburn Chan or Dr. Michael Hudgens to schedule a consult. All applicants using qualitative methods must have a letter of support from a CFAR Social and Behavioral Sciences Core documenting that it has provided a pre-submission review of your proposal. Please email Dr. Kathy Sikkema or Dr. Carol Golin.

8. Additional letters of support are strongly encouraged if applicable (e.g., to verify access to clinic populations, for collaborators, etc.), and a cover letter may be submitted if desired.

9. Involvement of Duke CFAR Cores in the proposed research is required when applicable. Use of UNC CFAR Cores is strongly encouraged when applicable.
Duke Immunology Core – Flow Cytometry, Cellular Cytotoxicity, Antibody Binding, etc.
Duke Clinical Core – Regulatory Support, Community Engagement, etc.,
Duke Social and Behavioral Sciences Core – Consultation, Peer Review, etc.

Applications should be prepared as a single PDF file and emailed to: upload.CFAR_Sm.wa5umi9g7e@u.box.com
Simply email your completed Application to the above address. You will receive a confirmation email stating that your upload was successful. If you do not receive a confirmation within a few minutes of submission, your application was not submitted, and you should try again.

Questions concerning the application or submission should be directed to Dr. Staats, Dr. Permar, Dr. MacQueen, or Cathy Emrick.

Funding Pre-Requisites

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.

Applicants considering submission of proposals that might be considered clinical trials are strongly encouraged to seek advice from a CFAR Developmental Core Director (Dr. Herman Staats or Dr. Kate MacQueen) before submitting a proposal.

UNC applicants are also strongly encouraged to consult Tania Caravella, the UNC CFAR Regulatory Head, with any relevant questions during the application preparation process. We have found that such consultation often significantly strengthens proposals.

Start dates for funded awards involving clinical research entailing greater than minimal risk to the subjects will dependent on IRB approvals and the date that the NIH issues clearance for the project. The Duke CFAR Finance Administrator and/or UNC CFAR Developmental Core Manager will provide guidance to Awardees on the NIH clearance process.

Conditions of Award

CFAR Developmental Core Awards provide funding for a one-year term. Any extension to the one-year term must be approved by the CFAR Developmental Cores. Leftover funds may not be used on other research.

PIs will be required to submit a yearly progress report to both CFARs. Duke PI will present a poster presentation at the annual Duke CFAR Fall Scientific Retreat. UNC CFAR PI will present research progress and plans for follow up funding to UNC CFAR leadership approximately six months into the Award.

PIs must acknowledge both UNC and Duke CFAR support (by grant numbers) in all publications and manuscripts derived from CFAR funding.

Prior to funding, you must forward a copy of all Institutional Biohazard, Animal Care and IRB approvals to the appropriate CFAR Developmental Core. If the pilot involves human subjects and the institutional IRB Committee has deemed the study “more than minimal risk”, PIs must submit an SOP plus the project must receive NIH clearance before funding is released, which will be coordinated by the CFAR Developmental Cores.

After being notified of an Award, all new/early stage investigator or junior faculty Awardees (i.e., Instructor or Assistant Professor) and established/senior researchers new to HIV/AIDS will be required to develop a CFAR Mentoring Plan that includes a core leadership person from each CFAR on the mentoring team.

Review Process
Applications will be reviewed by a CFAR Review Committee that will be comprised of highly-qualified scientific leaders with the Duke and UNC CFARs and will be appointed by CFAR leadership. If necessary, the Review Committee may request outside expertise to evaluate the scientific merit of a proposal.

The Committee will review the application based on the following criteria:

* NIH HIV/AIDS Priority Areas
* Overall scientific merit, level of innovation, relevance of the proposal to AIDS research, and ability of investigator
* Duke applicants only: Utilization of Duke CFAR Cores
* Specific and narrowly focused application with realistic goals
* Potential for generating independent 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.

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.

CFAR Funding Institutes
The CFAR program is co-funded by:
 * National Institute of Allergy and Infectious Diseases (NIAID)
 * Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 * National Institute of Aging (NIA)
 * National Institute on Drug Abuse (NIDA)
 * National Cancer Institute (NCI)
 * National Heart, Lung, and Blood Institute (NHLBI)
 * National Institute of Mental Health (NIMH)
 * National Institute of General Medical Sciences (NIGMS)
 * National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 * National Institute on Minority Health and Health Disparities (NIMHD)
 * Fogarty International Center at the National Institutes of Health (FIC)
 * Office of AIDS Research (OAR)

The CFAR program emphasizes the importance of interdisciplinary collaboration, especially between basic and clinical investigators, translational research in which findings from the laboratory are brought to the clinic and vice versa, and an emphasis upon inclusion of minorities and of prevention and behavioral change research.

2018 CFAR Developmental Traditional RFP

The UNC Center for AIDS Research (CFAR) is soliciting proposals for small grants for one year 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.

The purpose of these Awards is to provide seed money for new ideas in HIV research that will lead to applications for independent NIH funding. The success of the UNC CFAR is measured in part by the number of subsequent NIH grants that our Developmental Awardees receive while associated with the CFAR.

RFP Schedule

• Application Due Date: March 1, 2018
• Application Review: March 2018
• PI Notification: April 2018
• Projected Award Date: August 1, 2018 or later
• Actual start date will be contingent on IRB approvals and the date that the NIH issues clearance for the project, if applicable
• Period of Award: Award period is ≤12 months, ending on July 31, 2019

All submissions should be emailed as .pdf attachments to: cfar_rfp@med.unc.edu.

Start dates for funded awards involving clinical research entailing greater than minimal risk to the subjects and/or international research will be dependent on IRB approvals and the date that the NIH issues clearance(s) for the project. The CFAR Developmental Core Manager will provide guidance to Awardees on the NIH clearance process.

AWARD

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, 2019. 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 be available no earlier than August 1, 2018, and may be later, depending on how long the approval processes take for a given application. Regardless of the start date, funding will end by July 31, 2019.

ELIGIBILITY

1) PI must have an affiliation with UNC-Chapel Hill, FHI 360, RTI International, or a North Carolina-based historically black college or university (HBCU). International investigators and other NC Triangle-based investigators with a connection to one of the above are also eligible.
2) Applicants must be new or early stage investigators who have never received an NIH R01 or R01-equivalent (R01, R23, R29, and R37) award in HIV/AIDS. Established investigators will only be considered if they are new to HIV research.
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 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 either a faculty member or a postdoc who has received departmental approval to serve as an NIH PI; post-docs applying for this award must also partner with a faculty co-PI.
10) While post-docs are eligible to apply, faculty members will be given preference in proposal review. The CFAR is judged in part by NIH grants added to our Funded Research Base, i.e., HIV-related grants housed at UNC, FHI 360, and RTI. If a post-doc ends up with a faculty position elsewhere and receives NIH funding there, we cannot count that as a UNC CFAR outcome. Therefore, post-doc applications are significantly strengthened if a clear path to a UNC faculty position or research position at FHI 360 or RTI is detailed in a relevant letter of support.
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.

Please contact Developmental Core Director Kate MacQueen to discuss your eligibility if you have questions. In addition, reach out to us if you need help identifying mentors and collaborators.

REVIEW CRITERIA

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.

FUNDING PRIORITIES

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 HIV Prevention in NC), as well as international HIV research applications. However, applications need not be limited to these areas.

APPLICATIONS

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.

Proposal must be single-spaced and written using 11 point Arial font.

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 and Budget Justification on NIH 398 form pages. 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.

• Restrictions:

• 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. 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 your proposal is ready for this type of review.

• Applications using quantitative methods, from the CFAR Biostatistics Core documenting that it has provided a pre-submission statistical/informatics review of your proposal.
• Applications using qualitative methods, from the CFAR Social and Behavioral Sciences Core documenting that it has provided a pre-submission review of your proposal. Please email Dr. Carol Golin.
• Applications involving human subjects, from Tania Caravella, CFAR Regulatory Head, documenting a discussion of the project’s ethics and human subject involvement

11. Documented eligibility to apply for CFAR Developmental funds as a faculty member/researcher or post-doc working as a co-PI with a faculty member of an eligible institution. This documentation can be part of a letter of support, either from the mentor if appropriate, department chair, etc. Post-docs, please see 9) and 10) in Eligibility section of RFP.

12. Additional letters of support are strongly encouraged if applicable (e.g., to verify access to clinic populations, for collaborators, etc.)

13. 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).

14. A cover letter may be submitted if desired.

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.

Applicants considering submission of proposals that might be considered clinical trials are strongly encouraged to seek advice from the Developmental Core Director (kmacqueen@fhi360.org) before submitting a proposal.

Additional notes:
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.

Here’s more help from NIH in avoiding common grant-writing mistakes and some tips for new investigators.

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, 2019. Any extension to the one-year term must be approved by the CFAR Developmental Core. Leftover funds may not be used on other research.
• 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.
• PI must acknowledge UNC CFAR support by grant number (P30 AI50410) in all publications and manuscripts derived from CFAR funding.
• 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 an SOP plus the project must 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.

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.

CONTACT

For additional information, please contact Cathy Emrick (cathy@unc.edu). All questions are welcomed.

MI Blog: Exploring Goals and Values

When we ask the client what matters most to them, it can be a good way to continue building rapport. This conversation can explore what the client really cares about and how these goals and values may guide their lives. And we also know that goals and values are aspirations, so there may be some discrepancy between where the client is currently (related to these goals and values) and where the client would like to be in the future. In a counseling session, if this exploration is done in a respectful and genuine way, it can lead to the motivation the client needs to move forward in creating change.

Explore these themes further by reading the latest Motivational Interviewing blog post “Evoking Change Talk Through Exploring Goals and Values.”

Testing Antibodies to Prevent HIV

Myron Cohen, MD, co-authored a perspective in Science about broadly neutralizing antibodies.

The journal Science published a perspective on Oct. 6, by two leading HIV investigators highlighting the next frontier of HIV prevention – broadly neutralizing antibodies or bnAbs.

Antibodies to HIV can be found in 25 percent of people living with the virus who are not on treatment, wrote perspective co-author Myron Cohen, MD, associate director of the UNC CFAR. These broadly neutralizing antibodies are now being tested for HIV prevention in the Antibody Mediated Prevention (AMP) study.

The AMP study will test the efficacy of antibody VRC01 in patients. Participants in the study will be given an intravenous infusion of the VRC01 antibody or a placebo 10 times, once every eight weeks.

Men who have sex with men, transgender women, and transgender men who have sex with men are eligible for the study. AMP is being conducted in North America, South America, and Africa. UNC is a site.

To learn more about bnAbs, read the perspective in Science. To watch a presentation Cohen gave about bnAbs on Oct. 13, visit our Friday Morning Conference archives.

Global Health: What’s in It for Us?

Satish Gopal, MD, MPH, center, works with colleagues in Malawi to improve cancer care.

Satish Gopal, MD, MPH, center, works with colleagues in Malawi to improve cancer care.

Satish Gopal, MD, MPH, directs the cancer program at UNC Project-Malawi. He is the only medical oncologist in Malawi, a nation of more than 18 million people. He has received two developmental and two supplemental awards through the UNC CFAR to support his research. Yet, when his daughter became sick with malaria recently, he paused to question his decision to relocate his family to a resource-limited country. In this op-ed in the Journal of the American Medical Association, he explores how this personal sacrifice is leading to important global health contributions.

NIH Increases Funding for iTech Center

Lisa Hightow-Weidman, MD, MPH

Lisa Hightow-Weidman, MD, MPH

The National Institutes of Health (NIH) has awarded the UNC/Emory Center for Innovative Technology (iTech) an additional $13 million to develop interventions for youth at risk for or living with HIV.

“iTech will serve as the first NIH-funded center to use technology in innovative ways to engage HIV infected or at-risk youth,” says Principal Investigator Lisa Hightow-Weidman, MD, MPH, associate professor in the Division of Infectious Diseases at UNC.

Based at UNC, iTech includes seven sites around the US, allowing researchers to collaboratively develop the center’s health interventions. These health interventions will target 15-24-year-olds at risk for or currently living with HIV, specifically young men who have sex with men (YMSM). In 2010, YMSM accounted for 72 percent of new HIV infections among people aged 13-24. Hightow-Weidman said HIV disproportionately impacts African American and Latino YMSM; therefore, these groups will be a major focus of iTech’s interventions.

In September of 2016, the NIH awarded its first round of funding to iTech. This $18 million grant funds six initial studies. This new round of financial support will allow for three more studies.

For youth at risk of becoming infected with HIV, Hightow-Weidman said the team will develop apps that aim to increase HIV testing, and use of and adherence to pre-exposure prophylaxis (PrEP) to prevent HIV. For youth who test positive for the virus, investigators will develop electronic health interventions to engage them in care and improve adherence to antiretroviral therapy.

To learn more about the center’s research, visit https://itechnetwork.org/.