Developmental Core News
11/7/17 Congratulations to our final 2017 (traditional) Developmental Awardees!
Dr. Lauren Brinkley-Rubenstein, Exploring the use of Pre-exposure Prophylaxis (PrEP) among injection drug users in Guilford County, NC
Dr. Jennifer Deese, What’s sex got to do with it? Understanding the potential for confounding and exposure misclassification due to vaginal sex and semen exposure in studies of biological mechanisms associated with HIV acquisition
Dr. Rainier Masa, A Feasibility Study of Umwini, an Asset-Based Intervention to Improve Treatment Outcomes of Adolescents Living with HIV (ALHIV) in Eastern Province, Zambia
9/19/17 NIH has released a statement about changes to the Certificate of Confidentiality.
9/13/17 Congratulations to our 2017 (traditional) Developmental Awardees!
Dr. Nora Franceschini, Pharmacogenomics of anti-retroviral drugs: a pilot study
Dr. Samantha Meltzer-Brody, Perinatal depression and engagement in HIV care among women in Malawi: Formative research to support the development of a culturally appropriate mental health treatment intervention
Dr. Kimberly Powers, Formative Research to Develop a Prospective, Population Based Cohort of Newly HIV-Diagnosed Persons in North Carolina
9/11/17 2017 Small secondary data analysis RFA is now posted!
8/15/17 Tips on choosing a mentor from NIH: https://www.niaid.nih.gov/grants-contracts/tips-choosing-mentor
NIAID guidance for writing a grant application can also be found on-line.
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you: • select the right NIH funding opportunity announcement First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here. Second, take a moment to answer these four questions about your current or proposed research: If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency. Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying. Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials. NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including: Improving the design, efficiency, and transparency of clinical trials is important because it: We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards. We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.
• write the research strategy and human subjects sections of your application
• comply with appropriate policies and regulations
1) Does the study involve human participants?
2) Are the participants prospectively assigned to an intervention?
3) Is the study designed to evaluate the effect of the intervention on the participants?
4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
• the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
• Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
• updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
• new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
• use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
• expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
• respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
• facilitates design of clinical trials while reducing unnecessary duplication
• promotes broad, timely, and responsible dissemination of research information and results
• fosters responsible stewardship of the public’s investment in biomedical research
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:
• select the right NIH funding opportunity announcement
First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form. For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.
Second, take a moment to answer these four questions about your current or proposed research:
If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency. Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.
Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials. NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:
Improving the design, efficiency, and transparency of clinical trials is important because it:
We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards. We will be putting out a series of reminder policy notices, training opportunities, and other resources in the NIH Guide to Grants and Contracts, in the NIH Extramural Nexus, and on this blog. The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.
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. The deadline for 2017 submissions has passed. Please check back for information on 2018 funding opportunities.
Awards are made for/to one of the following:
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.
Kate MacQueen, PhD, MPH
Dr. MacQueen is a Senior Scientist in Social & Behavioral Health Sciences at FHI 360 and Adjunct Associate Professor in in the UNC-CH School of Medicine Department of Social Medicine and in the Gillings School of Global Public Health’s Health Behavior Program. She has conducted research on the social, behavioral and ethical aspects of biomedical HIV prevention trials globally and domestically, including vaccines, microbicides and PrEP. Most recently her work includes leading LinCS 2 Durham, a five year NIH R01 project to help build support for new HIV prevention work with Durham’s black communities; an NIH R21 project on developing a framework for evaluating Good Participatory Practices in TB Drug Trials globally; and USAID funded research on women’s adherence to emerging HIV prevention technologies including tenofovir gel and vaginal rings. She also is a standing member of the NIH Behavioral and Social Science Approaches to Preventing HIV/AIDS Study Section [BSPH].
Ada Adimora, MD, MPH
Dr. Adaora Adimora is Professor of Medicine and Epidemiology at the University of North Carolina at Chapel Hill. Board certified in Internal Medicine and Infectious Diseases, she is a physician epidemiologist with more than 20 years of clinical experience in the treatment of patients with HIV disease. She studies the epidemiology of HIV and STIs. Her work has characterized the epidemiology of heterosexual HIV transmission among African Americans, highlighted the role of sexual network patterns in the spread of HIV, and underscored the importance of macroeconomic and social forces in racial disparities in the US HIV epidemic. She was selected by The Root as one 100 African American leaders “who are making extraordinary contributions.” She serves as Chair of the HIV Medical Association, chairs the NIH HIV Prevention Trials Network’s Women at Risk Committee, and is a member of the Women’s Research Initiative on HIV/AIDS, the NIAID Council, and the Presidential Advisory Council on HIV/AIDS.
Cathy Emrick, MPH
Ms. Emrick serves as the Core liaison for Developmental applications and Awardees. Ms. Emrick has an MPH in Health Behavior and Health Education from UNC, and works in both the UNC Center For AIDS Research (CFAR) Developmental Core as the Program Coordinator and the CFAR International Core as the Core Manager. She has focused on the HIV epidemic since 1990, working in community-based organizations, state government, and research at UNC.
Request for Proposals for Developmental Awards
The UNC CFAR Developmental Core provides Developmental Awards and small secondary data analysis awards to emerging HIV investigators for one year of research.
2017 Small secondary data analysis RFA is now posted!
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.
The UNC Center for AIDS Research (CFAR) is soliciting proposals for small grants of up to $30,000 for one year to support emerging HIV Investigators (clinical, basic, and social 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.
The purpose of these awards is to provide seed money for new ideas in HIV research that will lead to applications for outside independent NIH funding. The success of the UNC CFAR is measured by the number of subsequent NIH grants that our Developmental Awardees receive.
The deadline for 2017 submissions has passed. Please check back for information on 2018 funding opportunities.
Proposals will be reviewed by senior investigators on the basis of:
* Standard NIH criteria of significance, innovation, approach, environment, the ability of investigator to carry out award (defined below)
* Potential for future related NIH funding, including relevance of project to current NIH funding priorities (details below)
Proposals from women and minority investigators will be given special consideration in the review process.
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 and independent NIH funding (i.e., R21, R01, and R01-equivalent awards).
CURRENT NIH PRIORITIES
In Fall 2015, NIH released a list of its funding priorities for the next three to five years at NOT-OD-15-137, along with a related statement from NIMH that describes their impact on grant funding. NIDA has now released its 2017 priorities as well. Given that the CFAR will ultimately be judged on the success of its Awardees (defined by NIH as independent NIH funding), Developmental applications will be prioritized based on the alignment of proposals with NIH funding priorities.
All Developmental applications must 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. If you have any questions or concerns about how your proposed research aligns with the NIH priorities, please contact us and we will work with you and/or identify others who can work with you on this issue.
We are especially interested in applications that are responsive to or aligned with the UNC CFAR priorities (Curing AIDS and NC HIV Prevention), as well as international HIV research applications. However, applications need not be limited to these areas.
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 have a terminal degree (e.g., PhD, MD, PharmD, etc.).
3) 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; postdocs applying for this award must also partner with a faculty co-PI.
4) Applicants must be new or early stage investigators or established investigators in non-HIV fields 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.
5) UNC-CH-affiliated applicants may not use award funds to support faculty or post-doc salary, conference travel, or food/drinks.
6) Investigators who have already received a UNC CFAR Developmental Award are unlikely to be funded a second time. Previous Awardees should contact the Developmental Core before submitting a new application.
7) 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.
8) Junior applicants who are not international applicants must be actively collaborating with a senior investigator in the HIV field (i.e., someone with previous HIV-related independent NIH funding). This must be evident in the application itself, including appropriate letters of support.
9) Senior 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 feel free to reach out to us if you need help identifying mentors and collaborators.
1) Project proposal up to four pages (single-spaced, 11 point Arial font) including Specific Aims, Significance, Innovation, and Approach sections
2) A separate References cited section
3) For junior and international applicants, identification of proposed mentor – a senior faculty member with experience conducing HIV-related research – and explanation of their role on the project, starting with during the application process (this can be a separate page)
4) Separate budget and budget justification section
5) NIH biosketch for all key personnel
6) Statement of how the application fits into an NIH high priority topic of research
7) 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 (one page maximum, not part of four page grant text limit)
8) Letter of support from the applicant’s proposed mentor, outlining the mentor’s proposed role in the project and connection to the applicant.
9) Other 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.
For items 4 and 5, use the forms “Detailed Budget for Initial Budget Period,” and “Biographical Sketch Format Page” which can be found here. An example biosketch can also be found on this NIH website.
Additional notes: Please document 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.
Applicants are strongly encouraged to consult the CFAR Biostatistics Core and/or Tania Caravella, the CFAR Regulatory Head, with any relevant questions during the application preparation process. We have found that such consultations often significantly strengthen proposals.
New this year! Early in 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.
Up to $30,000 for 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, 2018. 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, 2017, and may be later, depending on how long the approval processes take for a given application.
OTHER CFAR SERVICES
Besides direct funding, the UNC CFAR has numerous Cores (Virology/Immunology/Microbiology 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 (Virology, 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.
GRANT WRITING GUIDANCE
Excellent general guidance on grant-writing from NIH can be found here.
For additional information, please contact Cathy Emrick (firstname.lastname@example.org). All questions are welcome.
The University of North Carolina Center For AIDS Research (CFAR) is soliciting proposals for small grants to support junior investigators or experienced investigators new to HIV research interested in evaluating innovative social and behavioral questions in HIV infection using existing data from specific large UNC CFAR-supported cohort studies (WIHS, UCHCC, CNICS).
The purpose of this award is to increase scientific contributions by facilitating secondary data analysis and supporting external grant application submissions to address research questions related to social and behavioral aspects of the HIV/AIDS epidemic. Recipients of this award will be well-positioned to incorporate pilot data from their proposed research question into a larger R21 or R01 NIH grant proposal. In addition to the generation of pilot data to enhance a future NIH grant application, grantees are expected to produce a manuscript for publication from study data.
This award funds a graduate student research assistant (GRA), who will be hired by the UNC CFAR and will work directly with the grantee and with the databases available for analysis. Investigators will be expected to develop the research question of interest and an analytic plan that specifies variables from the dataset to be used, and to write the manuscript.
NIH Priorities: In Fall 2015, NIH released a list of its funding priorities for the next three to five years (please see: NOT-OD-15-137 and the related statement from NIMH that describes their impact on grant funding). NIDA has now released its 2017 priorities as well. Given that the UNC 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.
All applications must include a separate section (at least one paragraph) explaining how the proposed work is aligned with the NIH priorities and will lead to future NIH funding. If you have any questions or concerns about how your proposed research aligns with the NIH priorities, please contact us and we will work with you and/or identify others who can work with you on this issue. We are also especially interested in applications that are responsive to or aligned with the UNC CFAR Scientific Working Groups (SWGs) – Curing HIV/AIDS, NC HIV Prevention, and PrEP – as well as international HIV research applications. However, applications need not be limited to these areas.
Proposed secondary data analysis studies must involve analyses of data from one or more of the following three CFAR projects. Suggested topic ideas, based upon available data are listed for each database:
Women’s Interagency HIV Study (WIHS)
The Women’s Interagency HIV Study (WIHS) is a multi-site interval-cohort funded by the National Institutes of Health (NIH) to investigate the impact and progression of HIV infection among women in the United States. Established in 1993, WIHS has enrolled over 4,000 women with approximately 2,500 in active follow-up (70% HIV+, 30% HIV-). Bi-annual data collection includes: 1) A structured interview: medical and health history, obstetric/gynecological and contraceptive history, health care utilization, engagement in care, sexual behavior, drug and alcohol use, psychosocial factors and lifetime history of abuse; 2) A clinical exam: anthropometric measurements, ankle brachial index, frailty assessments, gynecologic exam and transient liver elastography on a sub-set of participants; 3) Neurocognitive assessment: once every two years; and 4) Specimen collection and laboratory testing: blood and genital-tract specimens. Routine labs include: viral load, CD4, basic chemistries, lipid/metabolic panel (annually) and cervical cytology.
The WIHS scientific aims are incredibly broad (please see here for aims) and the data collection spans a multitude of research domains. Below is a list of characteristics that make the WIHS a unique research platform:
Please see the list of WIHS publications here for a sense of the types of questions that have been answered using this incredibly rich dataset.
For additional information about the WIHS study, please see https://www.med.unc.edu/wihs
The UNC CFAR HIV Clinical Cohort (UCHCC) study
UCHCC includes patients receiving HIV care at UNC since 1996, with >5,000 patients enrolled. Approximately 30% are women, 32% White, 59% Black, and 4% Hispanic; median age at first visit is 37 years, with over 20,000 accrued person-years and 6-year median follow-up. Data includes electronic downloads of demographics, laboratory values, and visit data. Medical record reviews are completed, including HIV risk factors, health maintenance, medications (including antiretrovirals), diagnoses, antiretroviral resistance, hospitalizations, and external records (e.g., vital status). UCHCC patients complete an in-depth, in-person interview, with data on HIV risk behaviors, socio-demographics, HIV testing and access to care, antiretroviral therapy use, social support, and co-morbidities. Additionally, patients complete a patient reported outcomes (PRO) survey, including data on antiretroviral therapy adherence, mental health and substance abuse, and quality of life measures. Specimens (plasma, cell pellets and PBMCs) are collected and stored.
The UCHCC study is well suited to questions related to the HIV Care Cascade in North Carolina, including access to HIV care. In particular, research questions involving social or behavioral factors affecting initiation and/or access to HIV care would be supported by UCHCC data (e.g., the relationship between stable housing and access to HIV care, etc.). Examples of other relevant data/topics from the UCHCC study include:
For the study overview please see https://uchcc.unc.edu/
CFAR Network of Integrated Clinical Systems (CNICS)
The CFAR Network of Integrated Clinical Systems (CNICS) research network is the first electronic medical records-based network to integrate clinical data from the large and diverse population of HIV-infected persons in the modern HAART era. CNICS supports HIV clinical outcomes and comparative effectiveness research using data collected from patients receiving care at one of 8 US-funded Center for AIDS Research (CFAR) sites. As of early 2017, CNICS contained 32,727 patients; 79% male and 20% female. Unlike data collected in structured interviews or retrospective medical record review, CNICS captures a broader range of information associated with the rapidly changing course of HIV disease management. The flexibility of the CNICS consortium enables researchers to address scientific questions that cannot be answered through other collaborative cohorts. Patient data includes validated outcomes, longitudinal resistance data, patient-reported outcomes and readily available biological specimens.
The CNICS study design, data, and data structures are comparable to those of the UCHCC study. Therefore, suggested topics/interest areas supported by the data are also similar but would apply to research questions that apply more broadly than North Carolina; as stated previously, topics relating to social/behavioral factors affecting initiation and/or access to HIV care would be appropriate.
For the study overview please see https://www.uab.edu/cnics/.
STUDY CONTACTS: All applicants are required to meet with the relevant study contact to discuss potential project ideas and research questions. Following this, applicants should include a statement within the cover letter stating with whom they met and ask for a letter of support from the study contact. We also highly recommend meeting with the CFAR Biostatistics Core soon after choosing a research question (CFARbios@bios.unc.edu).
The study contacts are:
WIHS: Catalina Ramirez, email@example.com
UCHCC: Sonia Napravnik at firstname.lastname@example.org.
CNICS: Sonia Napravnik at email@example.com.
APPLICATIONS: Applications are due by 5 pm EDT, Monday, October 16, 2017. Applications should include the following: 1) one page (single-spaced, 11 point Arial font) of Specific Aims; 2) a two page project proposal including Significance, Innovation, and Approach sections; 3) a References section; 4) a proposed mentor – a senior investigator in a related field – and their role on the project; 5) A letter of support from the study contact; and 6) a biosketch. For item 6, use the Biographical Sketch Format Page which can be found here: http://grants.nih.gov/grants/funding/phs398/phs398.html. An example biosketch is also available on the NIH website. If assistance is needed to secure a mentor, contact the Developmental Core.
AWARD: Awards will fund a GRA. Awardees will have a deadline of three weeks from notification of award to submit their IRB applications and proposals to appropriate entities for approval, and the one-year funding period will begin on the date of award notification. As with all UNC CFAR Developmental Awards, funds cannot be used to support faculty time. A small amount of LOE coverage is available for FHI 360 and RTI applicants; please contact Cathy Emrick (firstname.lastname@example.org) to discuss options before applying.
DEADLINES: Applicants are required to meet with database managers before application submission. Final submissions will be due by 5 pm EDT on Monday, October 16, 2017. All submissions should be emailed as an attachment to: email@example.com.
REVIEW PANEL CRITERIA: Originality, scientific merit, ability of investigator to carry out award, and potential for future funding. Â Priority will be given, but not limited, to studies that address topics of health disparities and/or vulnerable populations. Examples of previously funded studies include:
FOR MORE INFORMATION CONTACT: Cathy Emrick, firstname.lastname@example.org
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.
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.
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.
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.
Caldwell K and Matthews A (2015). The Role of Relationship Type, Risk Perception, and Condom Use in Middle Socioeconomic Status Black Women’s HIV-prevention Strategies. J of Black Sexuality and Relationships;2(2):91-120.
Grewe ME, Taboada A, Dennis A, Chen E, Stein K, Watson S, Barrington C, Lightfoot AF (2015). ‘I learned to accept every part of myself’: the transformative impact of a theatre-based sexual health and HIV prevention programme. Sex Educ;15(3):303-317.
Herce ME, Mtande T, Chimbwandira F, Mofolo I, Chingondole CK, Rosenberg NE, Lancaster KE, Kamanga E, Chinkonde J, Kumwenda W, Tegha G, Hosseinipour MC, Hoffman IF, Martinson FE, Stein E, van der Horst CM (2015). Supporting Option B+ scale up and strengthening the prevention of mother-to-child transmission cascade in central Malawi: results from a serial cross-sectional study. BMC Infect Dis;15:328.
Juliano JJ, Barnett E, Parobek CM, Taylor SM, Meshnick SR, Stone S, Chang, E, Fong S, and Huang L (2015). Use of Oropharyngeal Washes to Diagnose and Genotype Pneumocystis jirovecii. Open Forum Infect Dis; 2(3):ofv080.
LaCourse SM, Chester FM, Matoga M, et al. (2015). Implementation of routine counselor-initiated opt-out HIV testing on the adult medical ward at Kamuzu Central Hospital, Lilongwe, Malawi. J Acquir Immune Defic Syndr; 69(1):e31-5.
Lesko CR, Sampson LA, Miller WC, Clymore J, Leone PA, Swygard H, Powers KA (2015). Measuring the HIV care continuum using public health surveillance data in the United States. Journal of Acquired Immune Deficiency Syndromes.70(5): 489-494.
Lightfoot AF, Taboada A, Taggart T, Tran T, Burtaine A (2015). “I learned to be okay with talking about sex and safety”: assessing the efficacy of a theatre-based HIV prevention approach for adolescents in North Carolina. Sex Educ;15(4):348-363.
Nunn KL, Wang YY, Harit D, Humphrys MS, Ma B, Cone R, Ravel J, and Lai SK (2015). Enhanced Trapping of HIV-1 by Human Cervicovaginal Mucus Is Associated with Lactobacillus crispatus-Dominant Microbiota. MBio. 6(5): e01084-15.
Onsomu EO, Abuya BA, Okech IN, Rosen DL, Duren-Winfield V, Simmons AC (2015). Association Between Domestic Violence and HIV Serostatus Among Married and Formerly Married Women in Kenya, Health Care Wom Int;36(2):205-28.
Powers KA and Miller WC (2015). Critical Review: Building on the HIV cascade: a complementary “HIV States and Transitions” framework for describing HIV diagnosis, care, and treatment at the population level. JAIDS;69(3):341-7.
Rahangdale L, De Paris K, Kashuba AD, Nelson JA, Cottrell M, Sykes C, Emerson C, Young SL, Stevens T, Patterson KB, Cohen MS (2015). Immunologic, virologic, and pharmacologic characterization of the female upper genital tract in HIV-infected women. J Acquir Immune Defic Syndr;68(4):420-4.
Rosenberg NE, Mtande TK, Saidi F, Stanley C, Jere E, Paile L, Kumwenda K, Mofolo I, Ng’ambi W, Miller WC, Hoffman I, Hosseinipour M (2015). Recruiting male partners for couple HIV testing and counselling in Malawi’s option B+ programme: an unblinded randomised controlled trial. Lancet HIV. 2015 Nov;2(11):e483-91.
Sin S-H, Kang SA, Kim Y, Eason A, Tan K, An H, and Dittmer DP (2015a). Kaposi’s sarcoma-associated herpesvirus latency locus compensates for interleukin-6 in initial B cell activation. J Virol;90(4):2150-2154.
Vielot N, Hudgens MG, Mugo N, Chitwa M, Kimani J, and Smith J (2015). The Role of Chlamydia trachomatis in High-Risk Human Papillomavirus Persistence Among Female Sex Workers in Nairobi, Kenya. Sex Transm Dis;42(6):305-11.
Yotebieng M, Norris A, Chalachala JL, Matumona Y, Ramadhani HO, Behets F (2015). Fertility desires, unmet need for family planning, and unwanted pregnancies among HIV-infected women in care in Kinshasa, DR Congo. Pan Afr Med J;20:235.
Bayraktar U.D., Diaz L.A., Ashlock B., Toomey N., Cabral L., Bayraktar S., Pereira D., Dittmer D.P., Ramos J.C. (2014). Zidovudine-based lytic-inducing chemotherapy for Epstein-Barr virus-related lymphomas. Leuk Lymphoma;55(4):786-94.
Chasela CS, Kourtis AP, Wall P, Drobeniuc J, King CC, Thai H, et al. (2014). Hepatitis B virus infection among HIV-infected pregnant women in Malawi and transmission to infants. J Hepatol;60(3):508-14.
Choukas-Bradley S, Giletta M, Widman L, Cohen GL, and Prinstein MJ (2014). Experimentally-measured susceptibility to peer influence and adolescent sexual behavior trajectories: A preliminary study. Developmental Psychology; 50(9): 2221-2227.
Flax VL, Bentley ME, Combs GF Jr., Chasela CS, Kayira D, Tegha G, Kamwendo D, Daza EJ, Fokar A, Kourtis AP, Jamieson DJ, van der Horst CM, Adair LS (2014). Plasma and breastmilk selenium in HIV-infected Malawian mothers are positively associated with infant selenium status but are not associated with maternal supplementation: results of the BAN study. Am J Clin Nutr;99:950-6.
Gopal S, Patel MR, Achenbach CJ, Yanik EL, Cole SR, Napravnik S, Burkholder GA, Mathews WC, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. (2014a) Lymphoma Immune Reconstitution Inflammatory Syndrome in the Center for AIDS Research Network of Integrated Clinical Systems Cohort. Clin Infect Dis;59(2):279-286.
Kendig CE, Samuel JC, Varela C, Msiska N, Kiser MM, McLean SE, Cairns BA, Charles AG (2014). Pediatric surgical care in Lilongwe, Malawi: outcomes and opportunities for improvement. J Trop Pediatr;60(5):352-7.
Maliwichi M, Rosenberg NE, Macfie R, Olson D, Hoffman I, van der Horst CM, Kazembe PN, Hosseinipour MC, McCollum ED. (2014) CD4 count outperforms World Health Organization clinical algorithm for point-of-care HIV diagnosis among hospitalised HIV-exposed Malawian infants. Trop Med Int Health. Epub ahead of print.
McCollum ED, Preidis GA, Maliwichi M, Olson D, McCrary LM, Kazembe PN, Horst Cv, Hoffman I, Hosseinipour MC. (2014) Clinical versus rapid molecular HIV diagnosis in hospitalized African infants: a randomized controlled trial simulating point-of-care infant testing. J Acquir Immune Defic Syndr;66(1):e23-30.
McKinley SA, Chen A, Shi F, Wang S, Mucha PJ, Forest MG, Lai SK (2014). Modeling neutralization kinetics of HIV by broadly neutralizing monoclonal antibodies in genital secretions coating the cervicovaginal mucosa. PLoS One;9(6):e100598.
Mphonda SM, Rosenberg NE, Kamanga E, Mofolo I, Mwale G, Boa E, Mwale M, Martinson F, Hoffman I, Hosseinipour MC (2014). Assessment of peer-based and structural strategies for increasing male participation in an antenatal setting in Lilongwe, Malawi. Afr J Reprod Health;18(2):97-104.
Parobek CM, Jiang LY, Patel JC, Alvarez-Martínez MJ, Miro JM, Worodria W, Andama A, Fong S, Huang L, Meshnick SR, Taylor SM, Juliano JJ (2014). A Multilocus Microsatellite Genotyping Array to Investigate the Genetic Epidemiology of Pneumocystis jirovecii. J Clin Microbiol.[Epub ahead of print]
Rahangdale L, Stewart A, Stewart RD, Badell M, Levison J, Ellis P, Cohn SE, Kempf MC, Lazenby GB, Tandon R, Rana A, Nguyen ML, Sturdevant MS, Cohan D; HOPES (HIV and OB Pregnancy Education Study) (2014). Pregnancy intentions among women living with HIV in the United States.Â J Acquir Immune Defic Syndr;65(3):306-11.
Rosenberg NE, Kamanga G, Pettifor AE, Bonongwe N, Mapanje C, Rutstein SE, Ward M, Hoffman IF, Martinson F, Miller WC (2014). STI Patients Are Effective Recruiters of Undiagnosed Cases of HIV: Results of a Social Contact Recruitment Study in Malawi. J Acquir Immune Defic Syndr;65(5):e162-9.
Rutstein SE, Brown LB, Biddle AK, Wheeler SB, Kamanga G, Mmodzi P, Nyirenda N, Mofolo I, Rosenberg NE, Hoffman IF, Miller WC (2014). Cost-effectiveness of provider-based HIV partner notification in urban Malawi. Health Policy Plan;29(1):115-26.
Soriano-Sarabia N, Bateson RE, Dahl NP, Crooks AM, Kuruc JD, Margolis DM, and Archin NM (2014). Quantitation of replication-competent HIV-1 in populations of resting CD4+ T cells. J Virol;88(24):14070-7.
Dennis AM, Wheeler JB, Valera E, Hightow-Weidman L, Napravnik S, Swygard H, Barrington C, Eron JJ (2013). HIV risk behaviors and sociodemographic features of HIV-infected Latinos residing in a new Latino settlement area in the Southeastern United States. AIDS Care, 25(10), 1298-307.
Firnhaber C, Mayisela N, Mao L, Williams S, Swarts A, Faesen M, Levin S, Michelow P, Omar T, Hudgens MG, Williamson AL, Allan B, Lewis DA, and Smith JS (2013). Validation of cervical cancer screening methods in HIV positive women from Johannesburg South Africa. PLoS One;8(1):e53494.
Flax VL, Bentley ME, Chasela CS, Kayira D, Hudgens MG, Kacheche KZ, Chavula C, Jamieson DJ, van der Horst CM & Adair LS. Lipid-based nutrient supplements are feasible as a breastmilk replacement for HIV-exposed infants from 24-48 weeks of age. J Nutr, 2013;143:701-7. PMC3738238.
Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Eron JJ, Richards KL. (2013a) Temporal trends in presentation and survival for HIV-associated lymphoma in the antiretroviral therapy era. J Natl Cancer Inst. 105(16):1221-9. PMID: 23892362
Gopal S, Patel MR, Yanik EL, Cole SR, Achenbach CJ, Napravnik S, Burkholder GA, Reid EG, Rodriguez B, Deeks SG, Mayer KH, Moore RD, Kitahata MM, Richards KL, Eron JJ. (2013b) Association of early HIV viremia with mortality after HIV-associated lymphoma. AIDS. 27(15):2365-73. PMID:23736149
Henley C, Forgwei G, Welty T, Golden M, Adimora A, Shields R, Muffih PT (2013). Scale-up and case-finding effectiveness of an HIV partner services program in Cameroon: an innovative HIV prevention intervention for developing countries. Sex Transm Dis. 40(12), 909-14.
Kendig CE, McCulloch DJ, Rosenberg NE, Samuel JC, Mabedi C, Shores CG, Hosseinipour MC, Matoga M, Charles AG (2013). Prevalence of HIV and Disease Outcomes on the Medical and Surgical Wards at Kamuzu Central Hospital, Lilongwe, Malawi. Trop Med Health, 41(4), 163-70.
Patel SJ, Mugo NR, Cohen C, Ting J, Nguti R, Kwantampora J, Waweru W, Patnaik P, Donders GG, Kenney DL, Kimani J, Kiviat NB, and Smith JS (2013). Multiple human papillomavirus infections and HIV seropositivity as risk factors for abnormal cervical cytology among female sex workers in Nairobi. Int J STDs AIDS. 24(3):221-5.
Paz-Bailey G., Miller W., Shiraishi R.W., Jacobson J.O., Abimbola T.O., & Chen S.Y. (2013) Reaching Men Who Have Sex with Men: A Comparison of Respondent-Driven Sampling and Time-Location Sampling in Guatemala City. AIDS Behav, 17:3081–3090. PMCID in process.
Wang XB, Tucker JD, Yang L, Zheng H, Zhang F, Cohen MS, Yang B, Cai W (2013). Unsafe Sex and STI Prevalence Among HIV-Infected Adults in Guangzhou, China: Opportunities to Deamplify Sexual HIV Transmission. AIDS Behav;17(3):1137-43.
Atashili J, Adimora AA, Ndumbe PM, Ikomey GM, Rinas AC, Myers E, Eron J, Smith JS, and Miller WC (2012a). High prevalence of cervical squamous intraepithelial lesions in women on antiretroviral therapy in Cameroon: Is targeted screening feasible? Cancer Epidemiol;36(3):263-9.
Atashili J, Miller WC, Smith JS, Ndumbe PM, Ikomey GM, Eron J, Rinas AC, Myers E, and Adimora AA (2012b). Age trends in the prevalence of cervical squamous intraepithelial lesions among HIV-positive women in Cameroon: a cross-sectional study. BMC Res Notes;5:590.
Brown LB, Miller WC, Kamanga G, Kaufman JS, Pettifor A, Dominik RC, Nyirenda N, Mmodzi P, Mapanje C, Martinson F, Cohen MS, Hoffman IF (2012).Â Predicting partner HIV testing and counseling following a partner notification intervention. AIDS Behav;16(5):1148-55.
Chasela, C.S., Wall, P., Drobeniuc, J., King, C.C., Teshale, E., Hosseinipour, M.C., Ellington, S.R., Codd, M., Jamieson, D.J., Knight, R.J., Fitzpatrick, P., Kourtis, A.P., Hoffman, I.F., Kayira, D., Mumba, N., Kamwendo, D.D., Martinson, F., Powderly, W., van der Horst, C., Kamili, S.; the BAN team. (2012). Prevalence of hepatitis C virus infection among human immunodeficiency virus-1-infected pregnant women in Malawi: The BAN study. J Clin Virol, 54, 318-20. PMC3652577
Hammond WP (2012). Taking It Like a Man: Masculine Role Norms as Moderators of the Racial Discrimination – Depressive Symptoms Association Among African American Men. Am J Public Health;102 Suppl 2:S232-4.
Hernandez, A.M., Zule, W.A., Karg, R.S., Browne, F.A., Wechsberg, W.M (2012). Factors That Influence HIV Risk among Hispanic Female Immigrants and Their Implications for HIV Prevention Interventions. Int J Family Med. 2012:876381. Epub. PMC3296155
Kincaid, C., Jones, D.J., Sterrett, E., McKee, L. (2012). A review of parenting and adolescent sexual behavior: the moderating role of gender. Clin Psychol Rev, 32, 177-88. doi: 10.1016/j.cpr.2012.01.002
McCollum, E.D., Johnson, D.C., Chasela, C.S., Siwande, L.D., Kazembe, P.N., Olson, D., Hoffman, I., van der Horst, C., Hosseinipour, M.C. (2012). Superior Uptake and Outcomes of Early Infant Diagnosis of HIV Services at an Immunization Clinic Versus an “Under-Five” General Pediatric Clinic in Malawi. J Acquir Immune Defic Syndr, 60, e107-10.
Meier BM, Pardue C, London L. (2012) Implementing Community Participation Through Legislative Reform: A Study of the Policy Framework for Community Participation in the Western Cape Province of South Africa. BMC Int Health Hum Rights. 12:15.
Pettifor A, MacPhail C, Anderson AD, and Maman S. ‘If I buy the Kellogg’s then he should [buy] the milk’: young women’s perspectives on relationship dynamics, gender power and HIV risk in Johannesburg, South Africa. Cult Health Sex. 2012;14(5):477-90.
Tucker, J.D., Walensky, R.P., Yang, L.G., Yang, B., Bangsberg, D.R., Chen, X.S., Cohen, M.S. (2012a). Expanding provider-initiated HIV testing at STI clinics in China. AIDS Care. [Epub ahead of print] PMC3400702
Tucker JD, Yang LG, Yang B, Young D, Henderson GE, Huang SJ, Lu HK, Chen XS, Cohen MS (2012b). Prior HIV testing among STD patients in Guangdong Province, China: opportunities for expanding detection of sexually transmitted HIV infection. Sex Transm Dis. 39, 182-7.
Vorkas C, Kayira D, van der Horst C, Hoffman I, Hosseinipour M, Kanyemba C, Nguluwe N, Chikaonda T, Kalikhoka M, Kalaundi D, Namarika D, Gilligan P, Krysiak R (2012). Tuberculosis Drug Resistance and Outcomes among Tuberculosis Inpatients in Lilongwe, Malawi. Malawi Med J;24(2): 21-24.
Braun M, Kabue MM, McCollum ED, Ahmed S, Kim M, Aertker L, Chirwa M, Eliya M, Mofolo I, Hoffman I, Kazembe PN, van der Horst C, Kline MW, Hosseinipour MC (2011). Inadequate coordination of maternal and infant HIV services detrimentally affects early infant diagnosis outcomes in Lilongwe, Malawi. J Acquir Immune Defic Syndr, 56, e122-8. PMC3112277
Brown LB, Miller WC, Kamanga G, Nyirenda N, Mmodzi P, Pettifor A, Dominik RC, Kaufman JS, Mapanje C, Martinson F, Cohen MS, Hoffman IF (2011). HIV partner notification is effective and feasible in sub-Saharan Africa: opportunities for HIV treatment and prevention. J Acquir Immune Defic Syndr;56(5):437-42.
Cené, C.W., Akers, A.Y., Lloyd, S.W., Albritton, T., Powell Hammond, W., & Corbie-Smith, G. (2011). Understanding social capital and HIV risk in rural African American communities. J Gen Intern Med, 26, 737-744.
Gay, C., Dibben, O., Anderson, J.A., Stacey, A., Mayo, A.J., Norris, P.J., Kuruc, J.D., Salazar-Gonzalez, J.F., Li, H., Keele, B.F., Hicks, C., Margolis, D., Ferrari, G., Haynes, B., Swanstrom, R., Shaw, G.M., Hahn, B.H., Eron, J.J., Borrow, P., Cohen, M.S. (2011). Cross-Sectional Detection of Acute HIV Infection: Timing of Transmission, Inflammation and Antiretroviral Therapy. PLoS One, 6, e19617.
Kincaid, C.Y., Jones, D.J., Gonzalez, M., Payne, B.K., DeVellis, R. (2011). The Role of Implicit Measurement in the Assessment of Risky Behavior: A Pilot Study with African American Girls. Journal of Child and Family Studies. J Child Fam Studies, 21, 799-806.
McCollum, E.D., Preidis, G.A., Golitko, C.L., Siwande, L.D., Mwansambo, C., Kazembe, P.N., Hoffman, I., Hosseinipour, M.C., Schutze, G.E., Kline, M.W. (2011). Routine inpatient human immunodeficiency virus testing system increases access to pediatric human immunodeficiency virus care in sub-Saharan Africa. Pediatr Infect Dis J, 30, e75-81.
Qureshi JS, Samuel J, Lee C, Cairns B, Shores C, Charles AG (2011). Surgery and global public health: the UNC-Malawi surgical initiative as a model for sustainable collaboration. World J Surg;35(1):17-21.
Ramos JC, Sin SH, Staudt MR, Roy D, Vahrson W, Dezube BJ, Harrington W Jr, Dittmer DP. Nuclear factor kappa B (NFkB) pathway associated biomarkers in AIDS defining malignancies (2011). Int J Cancer. doi: 10.1002/ijc.26302. [Epub ahead of print]
Samuel JC, Campbell EL, Mjuweni S, Muyco AP, Cairns BA, Charles AG (2011). The Epidemiology, Management, Outcomes and Areas for Improvement of Burn Care in Central Malawi: an Observational Study; J Int Med Res. 2011;39(3):873-9.
Brown, L.B., Krysiak, R., Kamanga, G., Mapanje, C., Kanyamula, H., Banda, B., et al. (2010). Neisseria gonorrhoeae antimicrobial susceptibility in Lilongwe, Malawi, 2007. Sex Transm Dis, 37, 169-172. doi: 10.1097/OLQ.0b013e3181bf575c
Chasela, C.S., Hudgens, M.G., Jamieson, D.J., Kayira, D., Hosseinipour, M.C., Kourtis, A.P., et al. (2010). Maternal or Infant Antiretroviral Drugs to Reduce HIV-1 Transmission. New Engl J Med, 362, 2271-2281.
Corbett, A.H., Hosseinipour, M.C., Nyirenda, J., Kanyama, C., Rezk, N.L., Mkupani, P., et al. (2010). Pharmacokinetics of generic and trade formulations of lamivudine, stavudine and nevirapine in HIV-infected Malawian children. Antivir Ther, 15, 83-90. PMC2867092
Corbie-Smith, G., Akers, A., Blumenthal, C., Council, B., Wynn, M., Muhammad, M., et al. (2010). Intervention mapping as a participatory approach to developing an HIV prevention intervention in rural African American communities. AIDS Educ Prev, 22, 184-202. PMC3037273
Firnhaber, C., Van Le, H., Pettifor, A., Schulze, D., Michelow, P., Sanne, I.M., et al. (2010). Association between cervical dysplasia and human papillomavirus in HIV seropositive women from Johannesburg South Africa. Cancer Causes Control, 21, 433-443. PMC2835728
Gherghe C, Lomob T, Leonard CW, Datta SAK, Bess JW, Gorelick RJ, Rein A and Weeks KM. (2010) Definition of a high-affinity Gag recognition structure mediating packaging of a retroviral RNA genome. Proc Natl Acad Sci USA. 107:19248-19253.
Hobbs, M.M., Steiner, M.J., Rich, K.D., Gallo, M.F., Warner, L., & Macaluso, M. (2010). Vaginal swab specimen processing methods influence performance of rapid semen detection tests: A cautionary tale. Contraception, 82(3), 291-295. PMC2921540
Masharsky AE, Dukhovlinova EN, Verevochkin SV, Toussova OV, Skochilov RV, Anderson JA, Hoffman I, Cohen MS, Swanstrom R, and Kozlov AP. (2010). A significant transmission bottleneck among newly and recently HIV-1 infected injection drug users in St. Petersburg, Russia. J Infect Dis 20:1697-1702.
Meyer, W., Costenbader, E.C., Zule, W.A., Otiashvili, D., & Kirtadze, I. (2010). ‘We are ordinary men’: MSM identity categories in Tbilisi, Georgia. Cult Health Sex, 12, 955-971. doi: 10.1080/13691058.2010.516370.
Rhodes, S.D., Hergenrather, K.C., Duncan, J., Vissman, A.T., Miller, C., Wilkin, A.M., et al. (2010). A pilot intervention utilizing Internet chat rooms to prevent HIV risk behaviors among men who have sex with men. Public Health Rep, 125 (Supp), 129-137. PMC2788406
Samuel JC, Akinkuotu A, Baloyi P, Villaveces A, Charles A, Lee CN, Miller W, Hoffman IF, Muyco AP (2010). Â Hospital-based injury data in Malawi: strategies for data collection and feasibility of trauma scoring tools. Trop Doct;40(2):98-9.
Scheyett, A., Parker, S., Golin, C., White, B., Davis, C.P., & Wohl, D. (2010). HIV-infected prison inmates: depression and implications for release back to communities. AIDS Behav, 14, 300-307. PMC2888156
Sena, A.C., Hammer, J.P., Wilson, K., Zeveloff, A., & Gamble, J. (2010). Feasibility and acceptability of door-to-door rapid HIV testing among Latino immigrants and their HIV risk factors in North Carolina. AIDS Patient Care STDS, 24, 165-173. PMC2864055
Required Documents from new Developmental Awardees:
Final Developmental application, including budget and budget justification
.pdf copy of IRB approvals from any collaborating institutions as well as UNC
Photo of PI for CFAR website
Documentation of human subjects training for all study personnel
All informed consent forms