The BASE Lab partners with investigators who are conducting research related to clinical trials and engaging key collaborators in clinical research. Listed below are The BASE Lab’s current and past research partnerships as well as research projects led by The BASE Lab.
Status: On-going
The BASE Lab team serves as the Social Science Team for the Clinical Trials Transformation Initiative (CTTI). CTTI is a public-private partnership co-founded by Duke University and the U.S. Food and Drug Administration (FDA) that develops and promotes practices that enhance the quality and efficiency of clinical trials. The BASE Lab leads the development and implementation of social science research protocols for CTTI, gathering evidence used to develop CTTI recommendations.
Assessing Digital Elements in Electronic Informed Consent (eIC)
Status: Completed
Serving as the principal investigator, The BASE Lab faculty (Corneli) and staff partnered with Medable to conduct a pilot, randomized, cross-over design study to evaluate text-only versus enhanced electronic informed consent (eIC) in a mock hypertension trial, assessing participant comprehension and acceptability.
The BASE Lab faculty member designed the study and led the development of the study instruments. Interviewers conducted the interviews. Analysts led the thematic analysis of the qualitative study data, used descriptive statistics to summarize the quantitative data, and wrote analytical summaries. The BASE Lab faculty led manuscript preparation.
Developing an Evaluation Framework for NIH’s Single IRB Policy
Status: Completed
The BASE Lab faculty and staff serve as the Social Science Team for the Clinical Trials Transformation Initiative (CTTI). In this capacity, The BASE Lab faculty collaborated with a multi-stakeholder CTTI project team and the National Institutes of Health (NIH) to design and conduct qualitative research to gather key stakeholders’ experiences with implementing the single IRB (sIRB) process. Data informed the development of a framework CTTI developed to evaluate the implementation of the new NIH sIRB policy.
A BASE Lab faculty member contributed to developing the grant proposal, led study protocol and question guide development, and wrote up the study findings. Interviewers conducted in-depth interviews with key stakeholders. Analysts thematically analyzed the data and prepared analytical summaries. The BASE Lab faculty and interviewers/analysts led manuscript preparation.
Adolescent HIV Vaccine Clinical Trial Acceptability and Feasibility in North Carolina
Status: Completed
The BASE Lab is partnered with principal investigator Amelia Thompson, MD, MPH, Assistant Professor of Pediatrics and member of the Duke Human Vaccine Institute (at the time of study implementation), to identify the acceptability of and barriers and facilitators to adolescent participation in HIV vaccine clinical trials. Interviews were conducted with cisgender and transgender adolescents, and with parents/caregivers of cisgender and transgender adolescents.
A BASE Lab faculty member provided mentorship in developing the grant proposal, study protocol, and question guides, and in writing the study findings. Interviewers and analysts conducted in-depth interviews with adolescents and caregivers, led the thematic data analysis, and provided tailored training for Dr. Thompson’s team to build capacity in qualitative interviewing and thematic analysis of interview data. Collectively, the team prepared a manuscript for publication.
Gathering Evidence to Develop and Assess Caregiver and Participant Communications
Status: Completed
The BASE Lab partnered with the Pediatric Trials Network (PTN) and Duke Clinical Research Institute’s communications team to conduct interviews with caregivers and adolescent participants to:
- Assess the attractiveness, comprehension, relevance, acceptability, persuasiveness, and credibility of draft PTN thank you notes and lay summaries of study results
- Identify engagement preferences during and after PTN studies, and expected feelings and responses to receiving thank you notes and lay summaries of study results
A faculty member led study protocol and question guide development. The interviewers identified and recruited PTN trial participants and caregivers with partner PTN sites and conducted in-depth interviews. Analysts led the thematic analysis of interview data and prepared analytical summaries. Collectively, the team prepared manuscripts for publication.
HOP-STEP: Healthy Outcomes in Pregnancy with SLE Through Education of Providers
Status: On-going
The BASE Lab is partnering with Megan Clowse, MD and Cuoghi Edens, MD to prepare for a multi-center trial of the HOP-STEP intervention. This intervention is designed for rheumatologists to initiate conversations about pregnancy intention and contraception use with women of reproductive age with lupus (SLE) in the rheumatology clinic. The goal is to improve maternal health in women with lupus through implementing simple and routine patient-centered, factually accurate conversations about pregnancy prevention and planning, thus increasing the frequency of women with SLE receiving ACR-aligned reproductive health care.
During intervention development, The BASE Lab facilitates quarterly meetings of two Community Collaborator Teams, which help to guide intervention design by ensuring that it aligns with the needs and lives of women with SLE and their providers. The patient collaborators are a diverse group of women of reproductive age living with SLE, and provider collaborators are rheumatologists, OB/GYN, MFM providers, and experts in complex contraception. After implementation of the intervention, The BASE Lab designs, conducts, and analyzes in-depth interviews with intervention participants and providers.
Quality of Life and Medical Information Needs and Comprehension of Patients with Psoriasis and with Systemic Lupus Erythematosus
Status: Completed
The BASE Lab partnered with UCB Pharmaceuticals, a global immunology and neurology biopharma company, to lead the development and implementation of a mixed-methods study to identify, describe, and quantify quality of life experiences and medical information needs among patients with either psoriasis or systemic lupus erythematosus.
A BASE Lab faculty member developed the grant proposal, study protocol, question guides, and surveys. Interviewers screened potential participants and conducted in-depth interviews and surveys; analysts thematically analyzed the qualitative data and used descriptive statistics and tests of association to describe the survey data. The team collectively prepared a final report for the study sponsor.
Acceptability of a Gonorrhea Vaccine
Status: On-going
As part of a U19 study in partnership Cynthia Cornelissen, PhD at Georgia State University, The BASE Lab faculty (Corneli) serves as the lead investigator of the mixed-method sub-study to assess the acceptability of a future gonorrhea vaccine among key informants and future vaccine recipients in the U.S. and Kenya.
The BASE Lab faculty leads the design of the study, the qualitative question guides, and the surveys. Interviewers and analysts conduct interviews and surveys. The BASE Lab partners with DataShare in the Department of Population Health Sciences for survey analysis. All research activities in Kenya are conducted in partnership with late Kawango Agot, PhD, MPH, MPhil, FAAS and Impact Research and Development Organization (IRDO). The team collectively prepares manuscripts.