Barriers to HIV Pre-Exposure Prophylaxis Use Among Women in the US: A Systematic Literature Review.

Introduction: The high acquisition rate of HIV infection among women in the United States is concerning. Despite the FDA approving the first pre-exposure prophylaxis (PrEP) drug in 2012, PrEP utilization remains significantly lower among women. This literature review aims to analyze the current body of research concerning HIV PrEP usage among women in the US. Methods: A search of three medical databases was conducted. After the screening, 19 studies were selected for analysis. A risk of bias assessment was performed. Results: A final set of records meeting the inclusion criteria (n=19) was included in the review for data collection and analysis. The study methodology for these research articles included interview-based designs (semi-structured and brief formats) in 1-on-1 meetings, focus groups, surveys, and retrospective data analysis. Participants' HIV risk characteristics were reported by way of sexual behavior, drug use, combined sexual behavior and drug use, and living in a high HIV rate neighborhood. Nineteen themes were identified and organized into three categories: (1) Common medication administration barriers, (2) PrEP-specific barriers, and (3) Situational barriers. The three most common themes reported by participants included a concern about side effects, low perceived risks of HIV, and lack of PrEP information. The CASP Qualitative Checklist and risk assessment summary showed acceptable validity among studies. Discussion: This review identifies significant barriers hindering women's PrEP utilization, which would benefit from more prevalent stakeholder communication and education directed to at-risk populations. Inconsistently reported descriptive data on participants and the low patient populations make it difficult to generalize outcomes.

Safety outcomes of low versus high dose imatinib mesylate in patients with advanced, metastatic, or nonresectable gastrointestinal stromal tumors: A systematic review.

Background and Objectives: Gastrointestinal stromal tumors (GIST) are a rare cancer where tumors grow along the gastrointestinal tract. While treatment options aim towards surgical resection, some patients present with advanced metastatic and/or nonresectable diseases. The tyrosine kinase inhibitor imatinib mesylate is approved for this indication. However, dose escalation from 400 to 600 mg/d or 800 mg/d is allowed. The present study systematically evaluates the safety outcomes, particularly the incidence of grade ⩾ 3 adverse events (AEs) with low dose compared with high dose imatinib in these patients. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020 guidelines were utilized to identify relevant studies through the PubMed, Cochrane Library, and Ovid databases and included randomized and non-randomized clinical trials comparing a low dose intervention of imatinib 400 mg/d with a high dose comparator of 600 or 800 mg/d in patients with histologically confirmed advanced metastatic and/or nonresectable GIST. Four studies were reviewed regarding study summaries and patient characteristics, patient demographics, and risk of bias, with a main emphasis on the evaluation of both efficacy outcomes and safety outcomes. Results: Three of the four studies did not provide significant differences in response outcomes; however, all four studies reported a higher incidence of grade ⩾ 3 AEs in the high dose imatinib groups. Individual study reports of more high dose patients experiencing a grade ⩾ 3 event ranged from 0.6% to 19.8%, while combined low and high dose patient arms revealed a 17.1% difference favoring a high dose patient event. A sub-analysis of the three most frequently occurring categories, blood and lymphatic system disorders, gastrointestinal disorders, and general disorders and administration site conditions each revealed more high dose patients experiencing said category events compared to those low dose counterparts. Conclusion: Low dose imatinib provides clinically meaningful response and demonstrated better tolerability with less frequently reported reactions. This evidence supports further research into the maintenance of 400 mg/d for this patient population compared to a dose escalation.

Digital badges in academia: An educational tool for the clinical research coordinator.

Digital badges can provide condensed competency-based knowledge enabling individuals a chance to explore specialized careers in clinical research. A digital badge can be an efficient pathway to introduce clinical research job roles and educate a larger diverse workforce for clinical research coordinator positions at AMCs. The New Jersey Alliance for Clinical and Translational Science (NJ ACTS) developed a digital badge with potential to broaden exposure to training opportunities for CRCs and improve their prospects for a career at Rutgers. This paper describes the development of a digital badge introducing individuals to the clinical research profession, especially for those who aspire to become a CRC. The badge was designed to include five domains (Scientific Concepts and Research Design, Ethical and Participant Safety Considerations, Clinical Study Operations and Site Management, and Data Management and Informatics). Participants assessed the badge for accuracy and presentation level. The results demonstrated that the competencies were met, and content was appropriate for someone with limited knowledge of clinical research. Survey results along with the Difficulty Index and Discrimination Index calculated for quiz questions supported the badge rank as foundational. Research is ongoing to evaluate the value of the badge to job acquisition, performance, and career growth.

Methods and perceptions of success for patient recruitment in decentralized clinical studies.

Patient recruitment, diversity, and retention continue to impede successful and representative clinical studies. This systematic review aims to assess the impact of decentralized methods on recruitment, retention, and diversity in recent clinical studies. A systematic search of literature reporting on recruitment in decentralized clinical studies was performed. Studies were reviewed for those reporting the primary outcome of recruitment in decentralized clinical trials, observational studies, or those covering the topic of clinical trials. Secondary outcomes included retention, participant diversity, and participant satisfaction. This systematic search returned 13 studies highlighting the role of decentralized methods impacting participant recruitment, retention, and diversity in clinical studies. Eleven reported improved recruitment using decentralized methods. Seven of these reported improvements directly compared to traditional methods. Seven studies reported positive retention outcomes, with four directly comparing decentralized methods with traditional methods. Six studies were reported to have trended toward increased diversity in the demographics of the sample population, including race or geographic location. Related reviews have stated a lack of published comparable data to determine if decentralized clinical methods improved recruitment and retention. Results suggest this review addresses such a gap, providing data on how decentralized methods such as virtual visits can positively impact recruitment and retention.

Real-world effectiveness of mRNA COVID-19 vaccines in the elderly during the Delta and Omicron variants: Systematic review.

BACKGROUND: As of 31 December 2022, there were over 6.6 million coronavirus disease 2019 (COVID-19) deaths and over 651 million cases across 200 countries worldwide. Despite the increase in vaccinations and booster shots, COVID-19 cases and deaths continue to remain high. While the effectiveness of these vaccines has already been established by different manufacturers, the fact remains that these vaccines were created quickly for global emergency use, tested under controlled clinical conditions from voluntary subjects and age groups whose general characteristics may differ from the actual general population. AIM: To conduct a systematic review to determine the real-world effectiveness of mRNA COVID-19 vaccines in the elderly during the predominance of Delta and Omicron variants in preventing COVID-19 related infection, hospital, intensive care unit (ICU) admission and intubation, and death. METHODS: A combination of Medical Subject Headings and non-Medical Subject Headings was carried out to identify all relevant research articles that meets the inclusion and exclusion criteria from PubMed, Cochrane, CINAHL, Scopus, ProQuest, Embase, Web of Science, and Google Scholar databases, as well as qualified research studies from pre-print servers using medRxiv and Research Square, published from January 1, 2021 - December 31, 2022. RESULTS: As per the inclusion and exclusion criteria, the effectiveness of Pfizer-BioNTech and Moderna vaccines were evaluated from an estimated total study population of 26,535,692 using infection, hospital, ICU admission and intubation, and death as outcome measures from studies published between 2021 and 2022, conducted in New York, Finland, Canada, Costa Rica, Qatar, Greece, and Brazil. The risk of bias was evaluated using risk of bias in nonrandomized studies of interventions (ROBINS-I) tool for cohort, case-control, and cross-sectional studies. While clinical trial data on Pfizer-BioNTech and Moderna vaccines demonstrated 94% vaccine effectiveness in the elderly, the results in this study showed that vaccine effectiveness in real-world settings is marginally lower against infection (40%-89%), hospitalization (92%), ICU admission and intubation (98%-85%), and death (77%-87%) with an indication of diminished effectiveness of vaccine over time. Furthermore, 2 doses of mRNA vaccines are inadequate and only provides interim protection. CONCLUSION: Because of the natural diminishing effectiveness of the vaccine, the need for booster dose to restore its efficacy is vital. From a research perspective, the use of highly heterogeneous outcome measures inhibits the comparison, contrast, and integration of the results which makes data pooling across different studies problematic. While pharmaceutical intervention like vaccination is important to fight an epidemic, utilizing common outcome measurements or carrying out studies with minimal heterogeneity in outcome measurements, is equally crucial to better understand and respond to an international health crisis.

The NJ Alliance for Clinical and Translational Science (NJ ACTS) experience: Responding at "warp speed" to COVID-19.

Introduction: The COVID-19 pandemic's need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health's Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS's research mobilization efforts during COVID-19. Methods: Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020. Results: Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies. Conclusion: This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic.

CTSA Search Solutions: A novel approach to searching CTSA hub website content.

Clinical and Translational Science Award (CTSA) hub websites are a critical communication gateway to assist the clinical and translational science community and promote CTSA hub offerings. The objective of this funded pilot project was to create a website and online database for the CTSA consortium that allows users to conduct structured searches among the 50 + CTSA hub websites. The result is CTSA Search Solutions, an online, searchable database that includes access to 50 + CTSA hub websites with 80+ structured search term options and over 800 links collected, organized, and published. Hubs can be searched by name and filtered by a specific CTSA topic, state, region, or even number of years funded to make detailed comparisons with the data identified. The home page for each hub can be accessed directly from the search page. The CTSA Search Solutions online database will allow for a wide breadth of CTSA personnel (core leads, researchers, administrators, communicators, and evaluators) to find consolidated information to learn about specific CTSA hub program highlights, as well as conduct research into program hub outputs and best practices across the nationwide CTSA consortium.

Effect of transplant status in CD19-targeted CAR T-cell therapy: a systematic review and meta-analysis.

Chimeric antigen receptor (CAR) T-cell therapy has shown promise for relapsed/refractory malignancies. Many patients have undergone prior hematopoietic stem cell transplant (HSCT), yet effects of transplant status on CAR T-cell therapy efficacy and safety have not been reported. The purpose of the study is to systematically evaluate the likelihood of achieving optimum response, severe cytokine release syndrome (sCRS), and neurotoxicity in the context of CAR T-cell therapy for HSCT-naïve patients versus those with prior HSCT. Trials were identified in ClinicalTrials.gov, Cochrane Library, and PubMed, and through reference pearl growing. Included studies used CD19-directed CAR T-cells for relapsed/refractory B-lineage Acute Lymphoblastic Leukemia and B cell Chronic Lymphocytic Leukemia, enrolled both HSCT-naïve and prior-HSCT patients, and denoted transplant status with outcomes. Six studies were included for optimum response, five for sCRS incidence, and four for neurotoxicity incidence. The pooled odds ratio for optimum response was 1.57 favoring HSCT-naïve patients (95% CI 0.54-4.61), whereas the pooled odds ratios for sCRS and neurotoxicity were 1.41 (95% CI 0.51-3.94) and 1.37 (95% CI 0.28-6.77), respectively, toward HSCT-naïve patients. Odds ratios were non-statistically significant. Overall risk of bias was moderate. While pooled estimates showed an advantage among HSCT-naïve patients for achieving optimum response and increased likelihood for sCRS and neurotoxicity, findings were not statistically significant. Any differences in efficacy and safety of CAR T-cell therapy cannot be verifiably attributed to transplant status, and additional controlled trials with increased sample sizes are needed to determine whether suggestive patterns favoring HSCT-naïve patients are validated.

Integration of Massage Therapy in Outpatient Cancer Care.

BACKGROUND: Massage therapy can be helpful in alleviating cancer-related symptoms and cancer treatment-related symptoms. While surveys have noted that cancer patients seek out massage as a nonpharmacologic approach during cancer treatment, little is known about the integration of massage in outpatient cancer care. PURPOSE: The purpose of this study was to examine the extent to which massage is being integrated into outpatient cancer care at NCI-designated Cancer Centers. SETTING: This study used descriptive methods to analyze the integration of massage in NCI-designated Cancer Centers providing clinical services to patients (n = 62). DESIGN: Data were collected from 91.1% of the centers (n = 59) using content analysis and a telephone survey. A dataset was developed and coded for analysis. MAIN OUTCOME MEASURE: The integration of massage was assessed by an algorithm that was developed from a set of five variables: 1) acceptance of treatment as therapeutic, 2) institution offers treatment to patients, 3) clinical practice guidelines in place, 4) use of evidence-based resources to inform treatment, and 5) shared knowledge about treatment among health care team. All centers were scored against all five variables using a six-point scale, with all variables rated equally. RESULTS: The integration of massage ranged from not at all (0) to very high (5) with all five levels of integration evident. Only 11 centers (17.7% of total) rated a very high level of integration; nearly one-third of the centers (n = 22) were found to have no integration of massage at all-not even provision of information about massage to patients through the center website. CONCLUSIONS: The findings of this analysis suggest that research on massage is not being leveraged to integrate massage into outpatient cancer care.