Request for Proposals for Small Collaborative Clinical-Social Science Analyses Awards

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.

ELIGIBILITY:

1) These awards are limited to persons affiliated with UNC Chapel Hill, FHI 360, RTI International, and North Carolina-based historically black colleges and universities (HBCUs).

2) Applicants must have a terminal degree.

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;” postdocs must be on path to becoming UNC faculty.

4) Experienced researchers will only be considered if they are new to HIV research.

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)

Description:

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.

Suggested Topics:

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:

  • The WIHS is the largest and longest study of women with and at-risk for HIV in the world. It is unique in its racial/ethnic diversity and inclusion of large numbers of women of color and women of lower socioeconomic status who mirror the HIV epidemic among US women.
  • WIHS has a control group (HIV-seronegative women) that is matched to women with HIV with respect to demographic, behavioral, and other risk characteristics.
  • Rich clinical, behavioral, and laboratory data/specimens are uniformly collected at 6-month intervals, which provides data that is more robust and complete than is typically afforded by clinic cohorts.
  • It includes a biospecimen repository that spans more than 20 years.

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.

Additional Information:

For additional information about the WIHS study, please see https://www.med.unc.edu/wihs

The UNC HIV Clinical Cohort (UCHCC) study

Description:

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.

Suggested Topics:

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:

  • Mental health
  • Substance abuse
  • Social support
  • Housing

Additional Information:

For the study overview please see https://uchcc.unc.edu/

CFAR Network of Integrated Clinical Systems (CNICS)

Description:

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.

Suggested Topics:

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.

Additional Information:

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 ().

The study contacts are:

WIHS: Catalina Ramirez,

UCHCC: Sonia Napravnik at .

CNICS: Sonia Napravnik at .

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 (see below “For more information contact”).

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 () 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: .

REVIEW PANEL CRITERIA: Originality, scientific merit, ability of investigator to carry out award, and potential for future funding. 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:

  • “Understanding barriers to timely presentation to HIV care in North Carolina”
  • “Intimate partner violence, health behaviors and outcomes in a cohort of HIV-infected women”

FOR MORE INFORMATION CONTACT:
Cathy Emrick,