Participant comprehension and acceptability of enhanced versus text-only electronic informed consent: an innovative qualitative pilot study.

BACKGROUND: The use of electronic informed consent (eIC) in decentralized trials offers a pragmatic approach to enrolling participants across multiple geographic areas. METHODS: Using a randomized, cross-over study design, we conducted a qualitative descriptive evaluation of two eIC approaches-text-only eIC and enhanced eIC-in a mock hypertension Phase III clinical trial. We assessed participant comprehension and acceptability (usability, satisfaction, and eIC preference). RESULTS: A total of 24 individuals with hypertension participated in the study: 12 reviewed the text-only eIC first, followed by the enhanced eIC, and 12 reviewed the enhanced eIC first, followed by the text-only eIC. The study population was diverse in gender, age, race, and geographic location. We found no descriptive differences in participant comprehension and satisfaction between the two eIC approaches. However, more participants preferred the enhanced eIC, and participants indicated that the digital elements were personable and made them feel more informed, engaged, comfortable, and prepared to participate in clinical research. CONCLUSIONS: Our findings suggest that enhancing the eIC process with digital elements may have beneficial outcomes among potential participants beyond comprehension and satisfaction.

Patient and Physician Perspectives of Systemic Lupus Erythematosus Flare: A Qualitative Study.

OBJECTIVE: Systemic lupus erythematosus (SLE) flares are associated with increased damage and decreased health-related quality of life. We hypothesized that there is discordance between physicians' and patients' views of SLE flare. In this study, we aimed to explore patient and physician descriptions of SLE flares. METHODS: We conducted a qualitative descriptive study using in-depth interviews with a purposeful sample of patients with SLE (who met 1997 American College of Rheumatology or Systemic Lupus International Collaborating Clinics criteria) and practicing rheumatologists. Interviews were audio-recorded, transcribed, and analyzed using applied thematic analysis. RESULTS: Forty-two patient participants with SLE, representing a range of SLE activity, completed interviews. The majority described flare symptoms as joint pain, fatigue, and skin issues lasting several days. Few included objective signs or laboratory measures, when available, as features of flare. We interviewed 13 rheumatologists from 10 academic and 3 community settings. The majority defined flare as increased or worsening SLE disease activity, with slightly more than half requiring objective findings. Around half of the rheumatologists included fatigue, pain, or other patient-reported symptoms. CONCLUSION: Patients and physicians described flare differently. Participants with SLE perceived flares as several days of fatigue, pain, and skin issues. Providers defined flares as periods of increased clinical SLE activity. Our findings suggest the current definition of flare may be insufficient to integrate both perceptions. Further study is needed to understand the pathophysiology of patient flares and the best way to incorporate patients' perspectives into clinical assessments.

Identification of Determinants and Implementation Strategies to Increase PrEP Uptake Among Black Same Gender-Loving Men in Mecklenburg County, North Carolina: The PrEP-MECK Study.

BACKGROUND: Pre-exposure prophylaxis (PrEP) use is low among Black same gender-loving men (BSGLM) in Mecklenburg County, NC, an Ending the HIV Epidemic priority jurisdiction. We created PrEP-MECK-an investigator partnership among a community-based organization representative, a PrEP provider, and researchers-and conducted iterative preparation research to identify determinants of PrEP uptake and implementation strategies to address them. METHODS: We first established the PrEP-MECK Coalition of community stakeholders. Next, informed by PrEP-MECK Coalition input and PRECEDE-PROCEED's educational/ecological assessment phase, we conducted focus group discussions with BSGLM not using PrEP and in-depth interviews with BSGLM who were currently or had previously taken PrEP to describe determinants and suggest implementation strategies. Based on interim findings, we partnered with clinics participating in the Mecklenburg County PrEP Initiative, which offers free PrEP services to uninsured individuals. We also conducted Consolidated Framework for Implementation Research-informed organizational assessments with community-based organizations and clinics to assess readiness to pilot the implementation strategies. RESULTS: We conducted 4 focus group discussions, 17 in-depth interviews, and 6 assessments. BSGLM were aware of PrEP yet perceived that costs made it unattainable. Awareness of how to access PrEP and the Mecklenburg County PrEP Initiative was lacking, and clinic scheduling barriers and provider mistrust limited access. We identified client-level implementation strategies, primarily focusing on engaging the consumer, to increase comfort with and awareness of how to access PrEP, and clinic-level implementation strategies focusing on changing clinic infrastructure, to make PrEP access easier. CONCLUSION: We plan to evaluate implementation of these strategies once fully developed to determine their acceptability and other outcomes in future research.

A taxonomy of the scope and organization of local sexually transmitted disease services for policy and practice.

Local health departments (LHDs) and their organizational partners play a critical role in controlling sexually transmitted diseases (STDs) in the United States. We examine variation in the differentiation, integration, and concentration (DIC) of STD services and develop a taxonomy describing the scope and organization of local STD services. LHD STD programs (n = 115) in Alabama (AL) and California (CA) responded to surveys assessing STD services available in 2014. K-means cluster analysis identified LHD groupings based on DIC variation. Discriminant analysis validated cluster solutions. Differences in organizational partnerships and scope of STD services were compared by taxonomy category. Multivariable regression models estimated the association of the STD services organization taxonomy and five-year (2010­2014) gonorrhea incidence rates, controlling for county-level sociodemographics and resources. A three-cluster solution was identified: (1) low DIC (n = 74), (2) moderate DIC (n = 31), and (3) high DIC (n = 10). In discriminant analysis, 95% of jurisdictions were classified into the same types as originally assigned through K-means cluster analysis. High DIC jurisdictions were more likely (p < 0.001) to partner with most organizations than moderate and low DIC jurisdictions, and more likely (p < 0.001) to conduct STD needs assessment, comprehensive sex education, and targeted screening. In contrast, contact tracing, case management, and investigations were conducted similarly across jurisdictions. In adjusted analyses, there were no differences in gonorrhea incidence rates by category. Jurisdictions in CA and AL can be characterized into three distinct clusters based on the DIC of STD services. Taxonomic analyses may aid in improving the reach and effectiveness of STD services.