DESCRIPTIONPERSONNELPROJECTSRFPPUBLICATIONSFOR AWARDEES

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:
-Junior investigators*
-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
Pathways
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.

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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.

New information from NIH about clinical 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
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations

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:
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?

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:
• 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.

Improving the design, efficiency, and transparency of clinical trials is important because it:
• 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

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

Core Director

HIVR4P_photo_KateDr. 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].

KMacQueen@fhi360.org

 

Ada Adimora, MD, MPH

Core Co-Director

Adimora

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.

adimora@med.unc.edu

 

Cathy Emrick, MPH

Program Director

Cathy EmrickMs. 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.

cathy@unc.edu

2019 Awardees

Ross Boyce

Dr. Ross Boyce, UNC Infectious Diseases
Traditional CFAR Developmental Awardee

More than a machine: Exploring the ancillary systems and processes required to make point-of-care HIV-1 viral load testing effective in rural western Uganda

Haitao Guo

Dr. Haitao Guo. UNC Lineberger Comprehensive Cancer Center
Traditional CFAR Developmental Awardee

Suppress HIV Replication and Potentiate T Cell Response to HIV by Targeting Metabolic Pathways

Nicholas Brown

Dr. Nicholas Brown, UNC Pharmacology
CFAR Administrative Supplement PI

Structural studies of HIV-1 hijacking the cullin-RING ligase CRL4VprBP

 

 

Current Projects

August 2016 – Present

Past Projects

August 2011 – July 2016

1999 – Spring 2011

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.

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 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.

2020-21 CFAR Developmental Traditional RFP

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.

RFP Schedule

  • 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: cfar_rfp@med.unc.edu.

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.

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, 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.

ELIGIBILITY

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:

  1. NIH-defined new or early stage investigators who have never received an NIH R01 or R01equivalent (R23, R29, R37, DP1, DP2, DP5, RL1, R35-MIRA, RF1, and U01) award in HIV/AIDS
  2. 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.

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 NC HIV Public Health Collaborative 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.

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.

     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. 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 (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, 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.

CONTACT

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

2019

Archin NM, Kirchherr JL, Sung JA, Clutton G, Sholtis K, Xu Y, Allard B, Stuelke E, Kashuba AD, Kuruc JD, Eron J, Gay CL, Goonetilleke N, Margolis DM (2017). Interval dosing with the HDAC inhibitor vorinostat effectively reverses HIV latency. J Clin Invest;127(8):3126-3135.
PMID: 28714868
PMCID: PMC5531421

Billock RM, Samoff E, Cope AB, Sampson LA, Hurt CB, Powers KA (2018). Repeat HIV testing by transmission risk group and rurality of residence in North Carolina. Sex Tran Dis;45(10):684-689.
PMID: 29771865
PMCID: PMC6136956

Bradley T, Ferrari G, Haynes BF, Margolis DM, Browne EP (2018). Single-Cell Analysis of Quiescent HIV Infection Reveals Host Transcriptional Profiles that Regulate Proviral Latency. Cell Rep;25(1):107-117.e3.
PMID: 30282021
PMCID: PMC6258175

Bula A, Kopp DM, Maman S, Chinula L, Tsidya M, Tang JH (2018). Family planning knowledge, experiences and reproductive desires among women who had experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. Contracept Reprod Med;3:22.
PMID: 30349736
PMCID: PMC6192333

Chagomerana MB, Miller WC, Tang JH, Hoffman IF, Harrington BJ, DiPrete B, Wallie S, Jumbe A, Limarzi L, Hosseinipour MC (2018). Prevalence of antiretroviral therapy treatment failure among HIV-infected pregnant women at first antenatal care: PMTCT Option B+ in Malawi. PLoS One;13(12):e0209052.
PMID: 30543685
PMCID: PMC6292583

Chinula L, Nelson JAE, Wiener J, Tang JH, Hurst S, Tegha G, Msika A, Ellington S, Hosseinipour MC, Mataya R, Haddad LB, Kourtis AP (2018). Effect of the depot medroxyprogesterone acetate injectable and levonorgestrel implant on HIV genital shedding: a randomized trial. Contraception;98(3):193-98.
PMID: 29746813
PMCID: PMC6143482

Conserve DF, Alemu D, Yamanis T, Maman S, Kajula L (2018). “He Told Me to Check My Health”: A Qualitative Exploration of Social Network Influence on Men’s HIV

Testing Behavior and HIV Self-Testing Willingness in Tanzania. Am J Mens Health;12(5):1185-1196.
PMID: 29808781
PMCID: PMC6142152

Conserve DF, Muessig K, Maman S, Kajula S (2018). Mate Yako Afya Yako: Formative Research to Develop the Peer-Based HIV Self-Testing Education and Promotion (STEP) Intervention for Networks of Men in Tanzania. Plos One Journal;13(8):e0202521.
PMID: 30148846
PMCID: PMC6110473

Costenbader E, Cislaghi B, Clark CJ, Hinson L, Lenzi R, McCarraher DR, McLarnon-Silk C, Pulerwitz J, Shaw B, Stefanik L (2019). Social Norms Measurement: Catching up with Programs and Moving the Field Forward. J Adol Health;64(4):S4-S6.
PMID: 30914167
PMCID: PMC6426726

Davey DJ, Peters RPH, Kojima N, Mudau M, De Vos L, Olivier D, McIntyre JA, Klausner JD, Medina-Marino A (2018). Sexual behaviors of HIV-infected pregnant women and factors associated with sexual transmitted infection in South Africa. Sex Transm Dis;45(11):754-761.
PMID: 29624560
PMCID: PMC6173658

Eley NT, Namey E, McKenna K, Johnson AC, Guest G (2019). Beyond the Individual: Social and Cultural Influences on the Health-Seeking Behaviors of African American Men. Am J Men’s Health;13(1):1-11.
PMID: 30767594
PMCID: PMC6440067

Ewing AC, Davis NL, Kayira D, Hosseinipour MC, van der Horst C, Jamieson DJ, Kourtis AP; Breastfeeding, Antiretrovirals and Nutrition study team (2019). Prescription of Antibacterial Drugs for HIV-Exposed, Uninfected Infants, Malawi, 2004-2010. Emerg Infect Dis;25(1):103-112.
PMID: 30561313
PMCID: PMC6302572

Francis DB, Noar SM, Fortune DA, Adimora AA (2018). Evaluation of a novel condom distribution and health communication intervention targeting young African American females. 15th Biennial Kentucky Conference on Health Communication, Lexington, KY.

Fray NA, Caldwell KL (2017). Communication Between SES Black Women and Healthcare Providers About HIV Testing. J Natl Med Assoc;109(2):115-125.
PMID: 28599753
PMCID: PMC6324584

Gausi B, Chagomerana MB, Tang JH, Hosseinipour MC, Haddad LB, Hannock T, Phiri S (2018). Human Immunodeficiency Virus Serodiscordance and Dual Contraceptive Method Use Among Human Immunodeficiency Virus-Infected Men and Women in Lilongwe, Malawi. Sex Transm Dis;45(11):747-753.
PMID: 30303948
PMCID: PMC6200388

Herce ME, Miller WM, Bula A, Edwards JK, Sapalalo P, Lancaster KE, Mofolo I, Furtado MLM, Weir SS (2018). Achieving the first 90 for key populations in sub-Saharan Africa through venue-based outreach: challenges and opportunities for HIV prevention based on PLACE study findings from Malawi and Angola. J Int AIDS Soc;21(Suppl 5):e25132.
PMID: 30033589
PMCID: PMC6055127

Hermes DJ, Xu C, Poklis JL, Niphakis MJ, Cravatt BF, Mackie K, Lichtman AH, Ignatowska-Jankowska BM, Fitting S (2018). Neuroprotective effects of fatty acid amide hydrolase catabolic enzyme inhibition in a HIV-1 Tat model of neuroAIDS. Neuropharmacology;141:55-65.
PMID: 30114402
PMCID: PMC6296377

Kayongo A, Gonzalo-Gil E, Gümüşgöz E, Niwaha AJ, Semitala F, Kalyesubula R, Bagaya BS, Joloba ML, Sutton RE (2018). Brief Report: Identification of Elite and Viremic Controllers from a Large Urban HIV Ambulatory Center in Kampala, Uganda. J Acquir Immune Defic Syndr;79(3):394-398.
PMID: 30063647
PMCID: PMC6186412

Ke R, Conway JM, Margolis DM, Perelson AS (2018). Determinants of the efficacy of HIV latency-reversing agents and implications for drug and treatment design. JCI Insight;3(20): e123052.
PMID: 30333308
PMCID: PMC6237475

Knittel AK, Rudolph JE, Shook-Sa BE, Edmonds A, Cohen M, Taylor T, Adedimeji A, Michel K, Milam J, Cohen J, Donohue J, Foster A, Fischl M, Konkle-Parker D, Adimora AA (2019). The effects of incarceration on sexually transmitted infections in women with or at risk for HIV in the United States. International Workshop on HIV and Hepatitis Observational Databases, Athens, Greece.

Knittel AK, Shook-Sa BE, Rudolph JE, Edmonds A, Ramirez C, Adimora AA (2019). Incarceration in women at risk for HIV. American College of Obstetrics and Gynecology Annual Meeting, Nashville, TN.

Kopp DM, Bula A, Maman S, Chinula L, Tsidya M, Mwale M, Tang JH (2018). Influences on birth spacing intentions and desired interventions among women who have experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. BMC Pregnancy Childbirth;18(1):197.
PMID: 29855296
PMCID: PMC5984328

Kovarova M, Benhabbour SR, Massud I, Spagnuolo RA, Skinner B, Baker CE, Sykes C, Mollan KR, Kashuba ADM, García-Lerma JG, Mumper RJ, Garcia JV (2018). Ultra-long-acting removable drug delivery system for HIV treatment and prevention. Nat Commun;9(1):4156.
PMID: 30297889
PMCID: PMC6175887

Lancaster KE, Hetrick A, Jaquet A, Adedimeji A, Atwoli L, Colby DJ, Mayor AM, Parcesepe A, Syvertsen J (2018).  Substance use and universal access to HIV testing and treatment in sub-Saharan Africa: implications and research priorities. J Virus Erad;4(Suppl 2):26-32.
PMID: 30515311
PMCID: PMC6248849

Lancaster KE, Lungu T, Bula A, Shoben A, Hosseinipour MC, Kohler RE, Hoffman IF, Go VF, Golin CE, Wheeler SB, Miller WC (2019). Preferences for PrEP delivery among FSW in Malawi using a discrete choice experiment. Conference on Retroviruses and Opportunistic Infections (CROI), Seattle, WA.

Masa R, Chowa G, and Nyirenda V (2017a). Prevalence and predictors of food insecurity among people living with HIV enrolled in antiretroviral therapy and livelihood programs in two rural Zambian hospitals. Ecology of Food and Nutrition;56(3):256-276.
PMID: 28418728
PMCID: PMC5953554

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.
PMID: 28639469
PMCID: PMC5963730

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.
PMID: 29707699
PMCID: PMC5918274

Miller WC, Lesko CR, Powers KA (2014). The HIV care cascade: simple concept, complex realization. Sex Transm Dis;41(1):41-2.
PMID: 24326580
PMCID: PMC4084671

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.
PMID: 29406428
PMCID: PMC5889344

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.
PMID: 29334932
PMCID: PMC5769314

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.
PMID: 29246819.
PMCID: PMC5840008

Pillay ST, Nag M, Fogle JE, De Paris K (2019). The Epigenetic Profile of CD8+ T Cells During SIV Infection. Immunology 2019 (American Association of Immunologists, Annual Meeting), San Diego, CA.

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.

Sullivan KA, Little M, Rosenberg NE, Mtande T, Zimba C, Jaffe E, Anderson J, Coleman JS, Gilbert S, Gross Wolf MS, Hoffman I, Rahangdale L, Faden R, Lyerly AD (2018). Women’s Views About a Paternal Consent Requirement for Biomedical Research in Pregnancy. J Empir Res Hum Res Ethics;13(4):349-362.
PMID: 29998787
PMCID: PMC6360530

Tang JH, Lemani C, Nkambule J, Talama G, Banda C, Zgambo W, Chagomerana M (2018). Two-year contraceptive continuation rates among immediate postpartum implant users at a district hospital in Malawi: a prospective cohort study. Contraception;98(3):220-222.
PMID: 29750925
PMCID: PMC6143381

Torres TS, Harrison LJ, La Rosa AM, Lavenberg JA, Zheng L, Safren SA, Ngongondo M, Poongulali S, Matoga M, Samaneka W, Collier AC, Hughes MD (2018a). Quality of life among HIV-infected individuals failing first-line antiretroviral therapy in resource-limited settings. AIDS Care;30(8):954-962.
PMID: 29343078
PMCID: PMC6100767

Torres TS, Harrison LJ, La Rosa AM, Cardoso SW, Zheng L, Ngongondo M, Some F, Lalloo UG, Mwelase T, Collier AC, Hughes MD; AIDS Clinical Trials Group (ACTG) A5273 Study Group (2018b). Quality of life improvement in resource-limited settings after one year of second-line antiretroviral therapy use among adult men and women. AIDS;32(5):583-593.
PMID: 29334547
PMCID: PMC5832593

Vogt SL, Moosa P, Omar T, Pather S, Martinson N, Ambinder RF (2017). Molecular diagnostics for AIDS lymphoma diagnosis in South Africa and the potential for other low-and middle-income countries. J Glob Oncol;4:1-6.
PMID: 30241211
PMCID: PMC6180762

Wood D, Lancaster KE, Boily MC, Powers KA, Donnell D, Cohen MS, Dimitrov DT (2018). Recruitment of Female Sex Workers in HIV Prevention Trials: Can Efficacy Endpoints Be Reached More Efficiently? J Acquir Immune Defic Syndr;77(4):350-357.
PMID: 29206720
PMCID: PMC5825250

Wu D, Tang W, Lu H, Zhang TP, Cao B, Ong JJ, Lee A, Liu C, Huang W, Fu R, Li K, Pan SW, Zhang Y, Fu H, Wei C, Tucker JD (2019). Leading by Example: Web-Based Sexual Health Influencers Among Men Who Have Sex With Men Have Higher HIV and Syphilis Testing Rates in China. J Med Internet Res;21(1):e10171.
PMID: 30664490
PMCID: PMC6360381

Yotebieng M, Brazier E, Addison D, Kimmel AD, Cornell M, Keiser O, Parcesepe AM, Onovo A, Lancaster KE, Castelnuovo B, Murnane PM, Cohen CR, Vreeman RC, Davies MA, Duda SN, Yiannoutsos CT, Bono RS, Agler R, Bernard C, Syvertsen JL, Sinayobye JD, Wikramanayake R, Sohn AH, von Groote PM, Wandeler G, Leroy V, Williams CF, Wools-Kaloustian K, Nash D, IeDEA Treat All in sub-Saharan Africa Consensus Statement Working Group (2019). Research priorities to inform “Treat All” policy implementation for people living with HIV in sub-Saharan Africa: a consensus statement from the International epidemiology Databases to Evaluate AIDS (IeDEA). J Int AIDS Soc;22(1):e25218.
PMID: 30657644
PMCID: PMC6338103 

2018

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.
PMID: 29218311
PMCID: PMC5716635

Cameron JE, Rositch AF, Vielot NA±, Mugo NR, Kwatampora JKL, Waweru W, Gilliland AE, Hagensee
ME, Smith JS (2018). Epstein-Barr virus, high-risk human papillomavirus and abnormal cervical cytology
in a prospective cohort of African female sex workers. Sexually Transmitted Diseases. Epub ahead of
print.
PMID: 29664764
PMCID: pending

Chagomerana MB, Miller WC, Tang JH, et al. Optimizing prevention of HIV mother to child transmission:
Duration of antiretroviral therapy and viral suppression at delivery among pregnant Malawian women.
PloS one. 2018;13(4):e0195033.
PMID: 29614083
PMCID: PMC5882113 

Costenbader E, Mangone E, Mueller M, Parker C, MacQueen KM (2017). Rapid organizational network
analysis to assess coordination of services for HIV testing clients: An exploratory study, J HIV/AIDS & Soc
Services. Online 15 Dec 2017. PMID: 30123100 PMCID: PMC6095663 

Dennis AM, Hue S, Learner E, Sebastian J, Miller WC, Eron JJ (2017). Rising prevalence of non-B HIV-1
subtypes in North Carolina and evidence for local onward transmission. Virus Evol;3(1):vex013.
PMID: 28567304
PMCID: PMC5442504

Dennis AM, Pasquale DK, Billock R, Beagle S, Mobley V, Cope A, Kuruc J, Sebastian J, Walworth C,
Peone PA (2018). Integration of Contact Tracing and Phylogenetics in an Investigation of an Acute
Infection. Sex Transm Dis;45(4):222-228.
PMID: 29465708
PMCID: PMC5847418

Denslow SA, Rositch AF, Firnhaber C, Ting J, and Smith JS (2014). Incidence and progression of
cervical lesions in women with HIV: a systematic global review. Int J STD AIDS;25(3):163-77.
PMID: 24216030
PMCID: PMC5524184

Flax VL, Hamela G, Mofolo I, Hosseinipour MC, Hoffman I, and Maman S (2017). Factors influencing
postnatal Option B+ participation and breastfeeding duration among HIV-positive women in Lilongwe
District, Malawi: a qualitative study. PLoS One;12(4):e0175590.
PMID: 28410374
PMCID: PMC5391929

Gausi B, Chagomerana MB, Tang JH, et al. Human Immunodeficiency Virus Serodiscordance and Dual Contraceptive Method Use Among Human Immunodeficiency Virus-infected Men and Women in Lilongwe, Malawi. Sex Transm Dis. 2018;45(11):747-753. PMID: 30303948 PMCID: PMC6200388 

Lockhart A, Psioda M, Ting J, Campbell S, Mugo N, Kwatampora J, Chitwa M, Kimani J, Gakure A, Smith
JS (2018). Prospective evaluation of cervico-vaginal self and cervical physician-collection for the detection
of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium
infections. Sexually Transmitted Diseases. Epub ahead of print.
PMID:29465667 
PMCID: pending

Matoga MM, Rosenberg NE, Stanley CC, LaCourse S, Munthali CK, Nsona DP, Haac B, Hoffman I,
Hosseinipour MC (2018). Inpatient mortality rates during an era of increased access to HIV testing and
ART: A prospective observational study in Lilongwe, Malawi. PLoS One;13(2):e0191944.
PMID: 29415015
PMCID: PMC5802850

Mbichila, T. H., Chagomerana, M., Tang, J. H., Haddad, L. B., Hosseinipour, M. C., Tweya, H., & Phiri, S. (2018). Partnership duration and HIV serodisclosure among people living with HIV/AIDS in Lilongwe, Malawi. International Journal of STD & AIDS29(10), 987–993. PMID: 29743000 

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.
PMID: 29246819
PMCID: PMC5840008 

Rennie S, Perry B, Corneli A, Chilungo A, Umar E (2015). Perceptions of voluntary medical male
circumcision among circumcising and non-circumcising communities in Malawi. Glob Public
Health;10(0):679-691.
PMID: 25630610
PMCID: PMC4433597

Xu C, Hermes DJ, Nwanguma B, Jacobs IR, Mackie K, Mukhopadhyay S, Lichtman AH, Ignatowska-
Jankowska B, Fitting S (2017). Endocannabinoids exert CB1 receptor-mediated neuroprotective effects in
models of neuronal damage induced by HIV-1 Tat protein. Mol Cell Neurosci;83:92-102.
PMID: 28733129
PMCID: PMC5587778.

2017

Croffut SE, Hamela G, Mofolo I, Maman S, Hosseinipour MC, Hoffman IF, Bentley ME, and Flax VL (2017). HIV-positive Malawian women with young children prefer overweight body sizes and link underweight body size with inability to exclusively breastfeed. Matern Child Nutr. [Epub ahead of print].

Flax VL, Hamela G, Mofolo I, Hosseinipour MC, Hoffman I, and Maman S (2017). Factors influencing postnatal Option B+ participation and breastfeeding duration among HIV-positive women in Lilongwe District, Malawi: a qualitative study. PLoS One, 12(4):e0175590.

Fray NA and Caldwell KL (2017). Communication Between SES Black Women and Healthcare Providers About HIV Testing. J Natl Med Assoc. 109(2):115-125.

Goeieman BJ, Firnhaber CS, Jong E, Michelow P, Swarts A, Williamson AL, Allan B, Smith JS, Kegorilwe P, and Wilkin TJ (2017). Prevalence Of Anal HPV And Anal Dysplasia In HIV-Infected Women From Johannesburg, South Africa. J Acquir Immune Defic Syndr, 75(3):e59-e64.

Kourtis AP, Haddad L, Tang J, Chinula L, Hurst S, Wiener J, Ellington S, Nelson JA, Corbett A, De Paris K, King CC, Hosseinipour M, Hoffman IF, and Jamieson DJ (2017). A randomized clinical trial on the effects of progestin contraception in the genital tract of HIV-infected and uninfected women in Lilongwe, Malawi: Addressing evolving research priorities. Contemp Clin Trials;52:27-34. 

Masa R and Chowa G (2017). A multi-level conceptual framework to understand the role of food insecurity on antiretroviral therapy adherence in low-resource settings: From theory to practice. Social Work in Public Health, 32(5):324-338.

Masa R, Chowa G, and Nyirenda V (2017a). Prevalence and predictors of food insecurity among people living with HIV enrolled in antiretroviral therapy and livelihood programs in two rural Zambian hospitals. Ecology of Food and Nutrition 56(3):256-276. 

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.

2016

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. 

Francis DB, Noar SM, Widman L, Willoughby JF, Sanchez DM, and Garrett KP (2016). Perceptions of a campus-wide condom distribution programme: An exploratory study. Health Educ J;75(8):998-1011.

Krubiner CB, Faden RR, Cadigan RJ, Gilbert SZ, Henry LM, Little MO, Mastroianni AC, Namey EE, Sullivan KA, and Lyerly AD (2016). Advancing HIV research with pregnant women: navigating challenges and opportunities. AIDS;30(15):2261-5.

Mouw MS, Taboada A, Steinert S, Willis S, Lightfoot AF (2016). “Because We All Trust and Care about Each Other”: Exploring Tensions Translating a Theater-based HIV Prevention Intervention into a New Context. Prog Community Health Partnersh. 2016;10(2):241-9.

Oramasionwu CU, Kashuba AD, Napravnik S, Wohl DA, Mao L, Adimora AA (2016). Non-initiation of hepatitis C virus antiviral therapy in patients with human immunodeficiency virus/hepatitis C virus co-infection. World J Hepatol. 8:368-75.

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.

Taggart T, Taboada A, Stein JA, Milburn NG, Gere D, Lightfoot AF (2016). AMP!: A Cross-site Analysis of the Effects of a Theater-based Intervention on Adolescent Awareness, Attitudes, and Knowledge about HIV. Prev Sci. 17(5):544-53.

2015

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.

Geng Y, Zhang HH, Lu W (2015). On optimal treatment regimes selection for mean survival time. Stat Med;34(7):1169-84.

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.

Meier BM, Gelpi A, Kavanagh MM, Forman L, Amon JJ. (2015). Employing human rights frameworks to realize access to an HIV cure. J Int AIDS Soc;18(1): 20305.

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. 

Sin S-H, Kim Y, Eason A, and Dittmer DP (2015b).  KSHV Latency Locus Cooperates with Myc to Drive Lymphoma in Mice.  PLoS Pathog. 11(9): e1005135.

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:

2017 PI and Award information

Mentor-Mentee Contract

CFAR Clinical Research Checklist

International Studies Checklist

Cumulative Inclusion Enrollment Report (for progress report)

Planned Inclusion Enrollment Report

SOP (see attached sample)

Final Developmental application, including budget and budget justification

Project abstract

.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