4 results
140 Feasibility of Implementing Community Engaged Recruitment Approaches into a Multisite Trial with an Accelerated Timeline
- Megan Pressley, Florencia Gonzalez, Jane Otado, Priscilla Adler, Siham Mahgoub
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue s1 / April 2022
- Published online by Cambridge University Press:
- 19 April 2022, p. 12
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OBJECTIVES/GOALS: The objective of this project was to recruit racially and ethnically diverse participants with an accelerated timeline into a COVID-19 vaccine trial. METHODS/STUDY POPULATION: Recruitment of diverse populations was a priority. Culturally appropriate strategies were implemented to increase enrollment of African Americans and Hispanics from the DC Metropolitan area. These strategies included the use of the Community Advisory Board for consultation, faith-based community events, town halls, radio advertisements which targeted the African American community, and the NIAID COVID-19 registry. Meaningful patient engagement by the study recruiter/coordinator throughout the study was key to recruitment and retention of participants (i.e. listening attentively, sharing personal experiences with vaccination, providing participants with enough information to make an informed decision). Education on the importance of research and vaccines was a component throughout the process. RESULTS/ANTICIPATED RESULTS: The Howard University site screened 188 participants. Of those, 150 were recruited into the vaccine trial from diverse racial and ethnic backgrounds (30% AA, 21% Hispanic, 5% Asian, 1% mixed race), a total of 57% over seven weeks. Of the 150 participants 64% were male and 36% females. The study involved a 2:1 randomization with vaccine vs. placebo. All of the 150participants received the first and second COVID-19 vaccine/placebo doses administered 21 days apart. DISCUSSION/SIGNIFICANCE: Culturally-relevant recruitment strategies allowed for meaningful community and patient interactions and were important determinants for effectively recruiting a racially and ethnically diverse group of participants within a short amount of time. Strategies employed could be applied effectively in other trials.
190 Enhancing Research Ethics, Equity and Protections for Uninsured Study Participants
- Assya Pascalev, Jane Otado, Priscilla N. Adler, Marc R. Blackman, Sarah Vittone
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- Journal:
- Journal of Clinical and Translational Science / Volume 6 / Issue s1 / April 2022
- Published online by Cambridge University Press:
- 19 April 2022, p. 26
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OBJECTIVES/GOALS: To increase diversity in clinical and translational research (CTR), to strengthen protections for uninsured and under-insured study participants from vulnerable groups by addressing their medical, ancillary care and psycho-social needs and to develop a systematic ethically sound approach to addressing such needs in the study protocol and budget. METHODS/STUDY POPULATION: We conducted) ethical analyses of: (1) the regulatory and ethics scholarship concerning protections and duty of care to research participants from vulnerable groups, and 2) arguments concerning the nature and scope of ancillary care obligations of researchers, as well as 3) a review of the applicable local, federal, and international regulations and practices concerning the duty of care to CTR participants and potential participants who are uninsured, under-insured and/or undocumented members of vulnerable groups. RESULTS/ANTICIPATED RESULTS: Uninsured and underinsured study participants pose major ethical challenges for CTR as medical needs arising during a study are usually covered by the participants own insurance. Lack of health insurance increases vulnerability and creates (1) a barrier to research participation for members of socially disenfranchised groups, (2) risk of discriminatory exclusion of such participants from clinical studies, and (3) inter-institutional inconsistencies in meeting their medical needs; thus limiting diversity in CTR. To address the challenges, we propose an inclusive, systematic, ethically sound approach, which deliberately plans for and provides resources within a study protocol to address the medical and psycho-social needs of uninsured participants during and beyond the study. DISCUSSION/SIGNIFICANCE: Including diverse participants in CTR ensures data quality and social justice. PIs and IRBs should adopt an inclusive approach to the medical needs of vulnerable uninsured participants, plan for their medical and ancillary care needs in the protocol and budget, list community resources, provide follow-up support and note assistance in their files.
Satisfaction and perceptions of research participants in clinical and translational studies: An urban multi-institution with CTSA
- Priscilla Adler, Jane Otado, John Kwagyan
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- Journal:
- Journal of Clinical and Translational Science / Volume 4 / Issue 4 / August 2020
- Published online by Cambridge University Press:
- 06 March 2020, pp. 317-322
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Purpose:
To examine research participants’ levels of satisfaction and perceptions and aid researchers to better engage research volunteers from all racial and ethnic populations in clinical trials. A participant satisfaction survey was developed that focused on three domains to reflect satisfaction with delivery of care, environment, and center operations. In addition, the survey contained open-ended questions to reflect overall experiences and perceptions. Two hundred and seventy-eight participants (55% African American and 29% non-Hispanic Whites) with an average age of 52 years completed the survey.
Results:The results indicated that the majority of the participants rated their satisfaction very highly across all domains. Ninety percent stated they were very satisfied/satisfied or very strongly agreed/agreed in the three domains. Obtaining high-quality care/access to health care professionals (60%), learning more about their illness/disease (60%), and helping others (57%) were noted as important factors in choosing to participate in a trial. Regarding overall experience, majority of respondents stated that friendliness, expertise of staff, learning more about their disease, and contributing to science were important. Further, financial compensation was not a primary motivation for participation. A majority of participants stated that they would participate in future studies and would recommend a friend or a family member to participate in clinical trials.
Conclusions:The findings indicate that the degree of satisfaction with the research staff and with the specific trial itself are important determinants for enrolling, completing a study, and for participating in future trials.
2171: Satisfaction and perceptions of research participants in Clinical and Translational Studies
- Jane A. Otado, John kwagyan, Debra Ordor, Sarah Vittone, Priscilla Adler
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- Journal:
- Journal of Clinical and Translational Science / Volume 1 / Issue S1 / September 2017
- Published online by Cambridge University Press:
- 10 May 2018, pp. 53-54
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OBJECTIVES/SPECIFIC AIMS: The objectives of this study were (1) to examine research participant levels of satisfaction, experiences, and perceptions; and (2) to determine best practices for researchers for engaging research volunteers in clinical trials, and thereby reducing barriers to participation. METHODS/STUDY POPULATION: A self-administered IRB approved survey on satisfaction and perceptions of research participants in clinical and translational studies was developed. The study questions were validated by 5 key informants from each of the 3 research centers who were asked to provide constructive feedback on the clarity and relevance of the questions. The final survey was a 25-item questionnaire that used a Likert scale and focused on 5 domains to reflect satisfaction with “Staff delivery of care,” “Environment,” “Center Operations,” “Study specific questions,” and “overall experiences.” Questions to reflect participant perceptions were open ended. A convenience sample of all participants currently enrolled in research studies at CTSA institutions (GU, HU, and MHRI) was obtained. In total, 131 participants completed the survey. Of these, 15 were “surrogate” partners. RESULTS/ANTICIPATED RESULTS: Eighty-two (60%) of the participants were African Americans, 40 (29%) were Whites; 94 (67%) were first time study participants. Over 90% of those surveyed strongly agreed that they were “treated well,” that their “privacy was respected,” and that they “felt comfortable asking questions of the staff.” Eighty-four percent indicated they would participate in future studies while over 91% indicated they would recommend a family member or a friend. Only 46% of participants coming for their first research visit strongly agreed that the “compensation received was satisfactory.” However, 74% of participants returning for follow-up or who had been enrolled in a previous study felt the compensation was appropriate. Seventy-four percent of those enrolled for the first time indicated “knowing the duration of this study” as compared with only 38% of repeat visitors. When asked what they liked most about participating in a research study their primary responses were “contribution to science” and “knowledge about their diseases.” Conversely, when asked what they liked least about the study they responded that the blood draws were uncomfortable and there were often barriers to transportation and parking. DISCUSSION/SIGNIFICANCE OF IMPACT: The results of this survey demonstrated that the majority of research participants rate their experience as highly favorable even among those who had never participated in clinical research previously. In some existing literature, it has been reported that financial compensation was a major motivation to participation in studies involving healthy volunteers. In this current study, however, financial compensation did not appear to be the primary motivation for participation. The participants’ at all 3 sites stated that the main reason for their participation was the increased knowledge about their disease and the contribution to science. Negative experiences cited were primarily discomfort with blood draw, transportation, and parking logistics. Most importantly, a majority of the participants stated they would participate in future studies and would recommend a family member or a friend for a clinical study. In our sample, there was no difference in the favorable ratings as determined by race/ethnicity. In conclusion, the findings of this study inform the community with regard to how the research participants rate their experiences, and thus motivate others to participate in clinical research. Reasons for participants to withdraw from trials may be associated to their dissatisfaction with a trial or with the study staff. Thus, the degree of satisfaction with the research staff and the trial itself is crucial to reducing drop-out rates and increasing compliance with study procedures. Hence participant satisfaction is key to increasing participation in clinical trials, particularly among African Americans and other racial and ethnic minorities.
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