Clinical Core

If you would like to request a service from the Clinical Core, please fill out this Service Request Form and email it to cfar-clinical-core@duke.edu

The Clinical Core services fall into 5 broad categories:
Consultation on study design, implementation, analysis and manuscript preparation 
Drs. Bartlett, Dow and Le are highly experienced clinical investigators, and their experience offers a great service to laboratory-based investigators and junior investigators who need human subjects for their research. They average 20 consultations on studies per year. These consultations may provide input on study design, study interventions, study outcome measures, appropriate subject populations, project implementation, adverse events, study analysis, interpretation of results, and publication of manuscripts.  

Clinical Research Support
The Clinical Core can assist with a number of issues related to the conduct of specific research studies. This may include consultations on study design, study feasibility and recruitment and retention issues. In addition, study coordinator assistance may be available for some studies. Salary support is requested for study coordinator assistance whenever possible. Stuart Carr has been working with various study teams on these issues for a number of years.
           
Regulatory Support    
Regulatory compliance is essential by all Duke CFAR investigators, and the Clinical Core provides expertise and assistance in ensuring compliance.  Regulatory support is the service most commonly requested by Clinical Core Users, and approximately 100 users access this service annually.  Given the number of international studies and the number of countries in which CFAR investigators are engaged in research, the management of regulatory compliance has become enormously complex. The CFAR Clinical Core can assist international partners with requirements for DUHS IRB submissions, human subject protection training, and other specific requirements related to their research. Stuart Carr and Kathy Link have many years of regulatory experience working with various types of studies in the United States and internationally. 
                    
Database and Biorepository Access  
The Clinical Core has established a database and biorepository. This Database includes nearly 1900 HIV-infected persons receiving care in the Duke University Adult Infectious Diseases Clinic and will soon include approximately 100 HIV-infected children and adolescents receiving care in the Pediatric Infectious Diseases Clinic.  The demographics of these patient populations mirror the reported demographics for North Carolina (57% African American and 28% women). There are currently over 70,000 plasma samples in this biorepository.

For more detailed information, please click here.
 
Community Engagement
The Clinical Core supports Community Advisory Boards (CABs) in Durham, North Carolina and in Moshi, Tanzania.  The CABs provide CFAR investigators with an important opportunity to interact with the community and receive feedback on study proposals and to disseminate research results back to the community.  The Durham CAB meets every two months.  The Moshi CAB meets monthly, and it has separate meetings for a Youth CAB.  These CABs have been active within the National CFAR CAB Coalition, attending meetings in Philadelphia, Seattle and Boston and participate on conference calls.  Julieta Giner is the Durham CAB liaison. Bona Shirima is the Moshi CAB liaison. Both have many years of experience working with the HIV- infected and HIV-affected communities.

Center for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS)

The Hemophilia Growth and Development Study (HGDS) data and specimens

NIH HIV Clinical Trials Networks Specimen Repository

Duke HIV Database and Biorepository

NIAID HIV/AIDS Specimen Repository Programs - Includes data and/or specimens from Multicenter AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS)

HIV and Heart Disease
Contextualizing Factors Associated with Non-adherence to Cardiovascular Disease Prevention Strategies for People Living with HIV who have Achieved Viral Suppression
Purposes: Visit 1 is being conducted to assess the rate of and factors associated with hypertension and hypercholesterolemia medication non-adherence among people living with HIV who have achieved HIV viral suppression (<200 copies/ml) at Duke Clinic 1K. Visit 2 is being conducted to describe the social-ecological context surrounding factors associated with hypertension and hypercholesterolemia medication non-adherence among people living with HIV who have achieved HIV viral suppression (<200 copies/ml) at Duke Clinic 1K.
Protocol Summary: A total of 60 people living with HIV who are seen in Duke Clinic 1K who take drugs for both hypertension and hypercholesterolemia will be enrolled. Enrollment/Visit 1 will consist of the informed consent process followed by the completion of an online survey related to how they take their hypertension and hypercholesterolemia drugs. This visit will be conducted by telephone. The visit should take about 25 minutes to complete. Some of these people will be contacted for an optional Visit 2 which will consist of a virtual or an in-person interview related to how they take their hypertension and hypercholesterolemia drugs. This visit may take 45 minutes to complete.
Eligibility: People living with HIV, 18 or older, fluent in English, competent to give informed consent who have achieved HIV viral suppression (<200 copies/ml) and are taking medications for hypertension and hypercholesterolemia.
Location: Enrollment/Visit 1 is virtual over the telephone. Optional Visit 2 is either virtual or at Duke Clinic 1K.
Contact: Stuart Carr, 919-668-4849

A Nurse-Led Intervention to Extend the HIV Treatment Cascade for Cardiovascular Disease Prevention (EXTRA-CVD)
Purpose: The purpose of this study is to find out how we can improve blood pressure and cholesterol treatment for people living with HIV who are on HIV medication.
Protocol Summary: If you decide to participate in this study, you will be asked to come to your HIV clinic for research visits every 4 months for one year (4 total visits). You will be randomly assigned to one of two groups- the nurse intervention group or the education control group. If you are assigned to the nurse intervention group, you’ll meet with the nurse on the day you enroll to complete a health risk assessment, review your medications, and discuss adherence treatments recommended by your doctor. Similar in-person visits will occur every 4 months for a year. You’ll also receive a home blood pressure monitor and work with your nurse
over the next year to get better control of your blood pressure and cholesterol. If you are assigned to the education control group, you’ll meet with the nurse in person every 4 months over the next year. You’ll discuss topics such as diet, exercise, sexually transmitted infections, etc.
Eligibility: Persons living with HIV who have both high blood pressure and high cholesterol
Location: Duke Clinic 1K
Contact: Kiran Grover 919-668-1095

HIV and Kidney Disease
Long-term Consequences of HIV in the Kidney: Core C
Purpose: The purpose of this study is to collect blood and stool specimens and clinical data on people living with HIV with Stage 1, 2 or 3 chronic kidney disease and people living with HIV who don't have kidney disease. These specimens will support research into the long-term consequences of chronic HIV infection in the kidney, including the role of HIV infection in promoting kidney disease and the potential for the kidney to serve as a reservoir for the virus.
Protocol Summary: After the consent process, participants will have one blood draw. There will be one survey to complete. They will be given a prepaid shipping box with supplies and instructions for stool collection. The collection will occur at home. They will be able to mail the box directly to the processing lab.
Eligibility: People living with HIV, 18 or older, non-diabetic with or without stage 1, 2 or 3 chronic kidney disease who are in active follow up at Duke for their HIV infection.
Location: Visit 1 is virtual.  Visit 2 is a short visit (15 to 20 minutes) at Duke Clinic 1K
Contact: Stuart Carr, 919-668-4849

HIV and Cognitive Function
IMMUNE Study
Purpose: HIV infection and marijuana use can each affect the immune system and the brain, which in turn may affect cognitive functioning (for example, memory, attention, reasoning). The purpose of this study is to determine the impact of marijuana use on these processes and the immune system in youth with HIV.
Protocol Summary: Most participants will have 1 visit. Visit 1 includes a screening, questionnaires, neuropsychological tests, and a blood draw. A subset of participants who complete Visit 1 will be asked to participate in Part 2, Immune Profiling and PET MR Scan at UNC.
Eligibility: 18-29 years old, HIV-positive, Suppressed viral load and on ART for at least 6 months, last CD4 count above 350, willing to have blood draw
Location: Duke Clinic 1K
Contact: Dominick Bresson, 336-404-8180

HIV Treatment Study for Minors
Merck MK-8591A-028
Purpose:  This is a Phase 2 study to evaluate the pharmacokinetics, safety, and efficacy of Doravirine/Islatravir in children with HIV-1 Infection who are virologically suppressed are less than 18 years of age, and weigh greater than or equal to 35 kg (77 pounds).
Protocol Summary:  Potential participants may be screened and if eligible may enroll in the study within 45 days after screening. After the enrollment visit, there will be visits at Day 14 (by phone), Day 28 and then at Weeks 8, 16, 24, 36, 48, 60, 72, 84, 96 and an end of treatment follow up visits. There is optional pharmacokinetic (PK) testing at the Day 28 visit. Study visits will generally consist of a physical exam, vital signs, review of other medications with blood and urine collection. The study drug contains 100 mg Doravirine and .75 mg Islatravir combined in a tablet and is taken once per day. Doravirine has been FDA approved. Islatravir is an experimental drug meaning the U.S. Food and Drug Administration (FDA) has not approved it yet.
Eligibility:  To be eligible, a child must meet the following (not the full list):

• HIV-1 positive.
• Be virologically suppressed (<50 copies/mL of HIV) for at least 3 months prior to the screening visit.
• Taking antiretroviral medications for at least 3 months prior to the screening visit.
• Able to swallow the study drug.
• <18 years of age.
• Weigh at least 35 kg (77 pounds)
• Not pregnant and willing to use birth control during the study.

Location:  Duke Children’s Health Center
Contact:  Stuart Carr, 919-668-484

Gilead GS-US-380-1474
Purpose: The main purpose is to evaluate the pharmacokinetics (PK) for GS-9883 and confirm dose in this age population/weight band, and to evaluate its safety and tolerability.
Protocol Summary: This is a Phase 2 open label PK, safety, and antiviral activity of GS-9883/Emtricibine (F)/Tenofovir Alafenamide (TAF) fixed dose combination in HIV-1 infected virologically suppressed adolescents and children. There are two parts and four different age/weight groups (cohorts) to the study. Part A is 2 or 4 week intensive PK to evaluate the GS-9883 after which study participants will receive the GS-9883/F/TAF through a minimum of 48 weeks or until commercially available. Part B is treatment only phase. Subjects will receive GS-9883/F-TAF for a minimum of 48 weeks or until commercially available. Age cohort 1 (12 to less than 18 years of age will enroll into Part A and B. Age cohort 2 (6 to less than 12 years of age) will enroll into Part A and B. Age cohort 3 (2 to less than 12 and less than 25 kilograms) will be enrolled into Part A. Cohorts 1 and 2 Parts A and B have closed to accrual. Cohort 3 Parts A  and B have closed to accrual. Cohort 4, Groups 1-4, will enroll into Part A and B.
Eligibility: HIV positive, >/= 1 month of age to less than 18 years of age, with an HIV viral load less than 50 copies/ml on a stable HIV treatment regimen for at least 6 months prior to screening, or ARV treatment naïve for Cohort 4, Group 2-4. Cohort 4, Group 1:  >/=14 to <25 kg and >/= 2 years of age, virologically suppressed and unable to swallow tablets; Group 2:  >/= 10 kg to < 14 kg and >/= 1 month of age, on ARV treatment or ARV naive; Group 3:  >/= 6 to 10 kg and >/= 1 month of age, on treatment or ARV naive ; and, Group 4: >/= 3 to 6 kg and  >/= 1 month of age, on ARV treatment or ARV naive. 
Location: Duke Children’s Health Center
Contact: Stuart Carr, 919-668-4849
Enrollment: Currently on temporary hold.

Advanced Stage at Diagnosis and Elevated Mortality among HIV-infected US Cancer Patients in the National Cancer Database

Anna E. Coghill, Xuesong Han, Gita Suneja, Chun Chieh Lin, Ahmedin Jemal, Meredith S. Shiels
Cancer. Author manuscript; available in PMC 2020 Aug 15.
Published in final edited form as: Cancer. 2019 Aug 15; 125(16): 2868–2876. Published online 2019 May 3. doi: 10.1002/cncr.32158
PMID: 31050361    PMCID: PMC6663596
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6663596/

A group-based mental health intervention for young people living with HIV in Tanzania: results of a pilot individually randomized group treatment trial

Dorothy E. Dow, Blandina T. Mmbaga, John A. Gallis, Elizabeth L. Turner, Monica Gandhi, Coleen K. Cunningham, Karen E. O’Donnell
BMC Public Health. 2020; 20: 1358. Published online 2020 Sep 4. doi: 10.1186/s12889-020-09380-3
PMID: 32887558    PMCID: PMC7487650        
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7487650/

Why Do People Living with HIV Adhere to Antiretroviral Therapy and Not Comorbid Cardiovascular Disease Medications? A Qualitative Inquiry

Charles Muiruri, Isabelle P Sico, Julie Schexnayder, Allison R Webel, Nwora Lance Okeke, Christopher T Longenecker, Juan Marcos Gonzalez, Kelley A Jones, Sarah E Gonzales, Hayden B Bosworth
Patient Prefer Adherence. 2020; 14: 985–994. Published online 2020 Jun 16. doi: 10.2147/PPA.S254882
PMID: 32669837    PMCID: PMC7337208
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7337208/

Opportunities to leverage telehealth approaches along the hypertension control cascade in sub-Saharan Africa

Charles Muiruri, Preeti Manavalan, Shelley A. Jazowski, Brandon A. Knettel, Helene Vilme, Leah L. Zullig
Curr Hypertens Rep. Author manuscript; available in PMC 2020 Mar 2.
Published in final edited form as: Curr Hypertens Rep. 2019 Aug 26; 21(10): 75. Published online 2019 Aug 26. doi: 10.1007/s11906-019-0983-2
PMID: 31451940     PMCID: PMC7050852 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7050852/

Testing for HIV infection in the emergency departments of 2 hospitals in the Southeastern United States

Rachel Safeek, Tamsey Hill, Arthur Hendricks, David Underwood, Mary Washington, Jessica Guidici, Tammy Wong, Charles Gerardo, Charles Hicks, Mehri McKellar
J Am Coll Emerg Physicians Open. 2020 Aug; 1(4): 487–493. Published online 2020 May 26. doi: 10.1002/emp2.12102
PMID: 33000075      PMCID: PMC7493519  
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7493519/

John Bartlett, M.D.
Clinical Core Director
jab5@duke.edu
(919) 681-8043

Dorothy Dow, M.D.
Clinical Core Associate Director
dorothy.dow@duke.edu

Thuy Le, M.D., Ph.D.
Clinical Core Associate Director
thuy.le@duke.edu
(919) 668-5053

Stuart Carr
Clinical Core Study Coordinator
stuart.carr@dm.duke.edu
(919) 668-4849

Katherine Link, RN
Clinical Core Regulatory Coordinator
katherine.link@duke.edu
(919) 668-0161

Clinical Core group email: cfar-clinical-core@duke.edu