The Clinical Core is integral to Duke CFAR activities by providing access for investigators to specified and carefully characterized populations of people with HIV (PWH); providing expert assistance in study design, implementation, and regulatory support; identifying new scientific opportunities based upon novel clinical observations; promoting interdisciplinary team science; and engaging investigators new to HIV/AIDS research. We emphasize bidirectional communication and engagement with communities of researchers and PWH in North Carolina and Tanzania through our Community Advisory Boards (CABs).
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 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.
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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
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
Addressing Barriers to Achieving Cardiometabolic Disorders Prevention and Treatment Goals for Persons Living with HIV in the Southeastern United States
Aim 1: To identify social determinants of cardiometabolic health and determine facilitators and modifiable barriers in achieving treatment goals utilizing in-depth interviews prompted by photo elicitation.
Aim 2: To assess knowledge, skills, and confidence for self-management of cardiometabolic disorders utilizing a Patient Activation Measure survey.
Aim 3: Guided by the Behavior Change Wheel model and using the human-centered design approach to tailor a self-management support and education intervention with stakeholder input to address barriers to achieving treatment goals for cardiometabolic disorders at the study sites.
Protocol Summary: A total of 140 people living with HIV who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes and are seen in Duke Clinic 1K, or Amity Medical Group and Eastowne Family Physicians in Charlotte will be enrolled. AIM1: (20 participants) Enrollment/Visit 1 will consist of the informed consent process followed by the completion of an online demographic survey. This visit will be conducted in clinic. Participants will be trained in the use of the camera, the specific photo missions to be completed, and the ethics of photo elicitation. The visit should take about 45 minutes to complete. Visit 2: Participant will return the camera, select and caption photographs per specific photo missions that will be uploaded to secure server. This visit will be conducted in clinic and take approximately 30 minutes to complete. Visit 3: Virtual in-depth interview to discuss the content of the photographs and explore the facilitators and barriers to achieving heart health that are identified by the participant. AIM2: (120 participants) Enrollment/Visit 1: informed consent process followed by completion of Patient Activation Measure online survey. AIM3: (10 key stakeholders: HIV providers, CAB representatives, nurses, etc.) Enrollment/Visit 1-3: Informed consent process followed by 3 virtual meetings over 3 months. Each virtual meeting will last 3 hours, engaging participants in tailoring self-management support and education interventions at the study sites.
Eligibility: People living with HIV, 35 or older, fluent in English, competent to give informed consent who have one or more of the following conditions: hypertension, dyslipidemia, or type 2 diabetes.
Location: Duke Clinic 1K, and Amity Medical Group and Eastowne Family Physicians in Charlotte, NC
Contact: Duke: Laura Farrow, 919-668-0176 / Charlotte: Lalia Victoria 919-613-5430
Addressing barriers to anti-hypertensive medication adherence among persons living with HIV who have achieved viral suppression
Purpose: To determine key barriers and facilitators of antihypertensive medications adherence for people living with HIV who have achieved viral suppression
Protocol Summary: Study will enroll up to 20 PLWH to participate in interviews on barriers and facilitators of antihypertensive medication and up to 70 PLWH will be enrolled to complete a survey to determine salient barriers that an intervention must address in order to increase antihypertensive medications adherence for people living with HIV who have achieved viral suppression. Aim 1A enrollment will consist of the informed consent process followed by the completion of an interview related to understanding the barriers and facilitators to taking anti-hypertensive medication. Aim 1A visits will occur virtually over the phone or in person if preferred. This visit should take around 45 minutes to complete. Aim 1B enrollment will consist of the informed consent process followed by the completion of a Best/Worst Survey. The visit should take about 30 minutes to complete. Aim 1B will occur virtually and participants will receive a link to complete the survey.
Eligibility: People Living with HIV who have a suppressed HIV viral load (<200 copies/ml), hypertension (SBP >130mmHg on two occasions in the EMR within the last year and/or on anti-hypertensive medication), and on anti-hypertensive medication.
Location: Interviews will be conducted virtually over the phone on in a private room in 1K Clinic. Survey links will be sent virtually for the participant to complete.
Contact: Mersedes Brown, 919-668-7364
HIV and Cognitive Function
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: 18-30 years old, living with HIV for at least one year, 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: Ethan Bott, 919-684-2285
HIV Treatment Study for Minors
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: Cohorts 1, 2 and 3 are closed. Cohort 4 only: Group 1: ≥ 2 years of age, weigh ≥ 14 to < 25 kg (≥ 31 to < 55 lbs.) and, taking a stable HIV treatment regimen and virologically suppressed (<50 copies/mL) for ≥ 6 months before screening, and unable to swallow tablets; Group 2: ≥ 1 month of age, ≥ 10 to < 14 kg (≥ 22 to < 31 lbs.), ARV treatment naive or on ARV treatment for ≥ 1 month, Group 3: ≥ 1 month of age, ≥ 6 to < 10 kg (≥ 13 to < 22 lbs.), ARV treatment naive or on ARV treatment for ≥ 1 month and, Group 4: ≥ 1 month of age, ≥ 3 to < 6 kg (≥ 6.6 to < 13 lbs.), ARV treatment naive or on ARV treatment for ≥ 1 month. All 4 groups will initially receive the study drug in a “tablet for suspension” form which is easier to swallow than the regular study drug tablets.
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
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
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
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
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
John Bartlett, M.D.
Clinical Core Director
Dorothy Dow, M.D.
Clinical Core Associate Director
Thuy Le, M.D., Ph.D.
Clinical Core Associate Director
Clinical Core Research Program Leader
Katherine Link, RN
Clinical Core Regulatory Coordinator
Clinical Core group email: email@example.com