The FINANCIAL –After taking part in the study, 96 percent of survey responders would recommend participation in a clinical trial to others, according to a survey of a segment of clinical trial participants from the GRACE (Gender, Race And Clinical Experience) trial, the study of treatment-experienced adult women with HIV to examine gender differences in response to HIV therapy.
The GRACE participant survey assessed the characteristics of patients, and reported on their experiences with and opinions about that study. The results from 151 patients showed that access to treatment and support from study site staff were important factors in enrollment and completion of the GRACE trial, according to Johnson & Johnson Services.
The GRACE study was a Phase 3b trial that evaluated sex- and race-based differences in outcomes associated with PREZISTA (darunavir)/ritonavir-based therapy in 429 treatment-experienced HIV-infected adults. The study included 65 sites throughout the United States, Puerto Rico and Canada. By using specific recruitment and retention strategies, the trial achieved enrollment of 67 percent women (and 33 percent men), successfully demonstrating that it is possible to recruit large numbers of women into U.S.-based HIV treatment studies, according to Johnson & Johnson Services.
Survey respondents (n=151) reported that the best part of the GRACE study was access to treatment (41 percent), with most becoming more focused on their health (82 percent) and continuing treatment after the trial (87 percent). Additionally, 47 percent of survey participants cited support from study staff as the most important factor in completing the trial, describing the “professional, supportive, comforting, nonjudgmental, confidential, [and] caring” staff as willing to take extra time to help the participants. Survey respondents also reported feeling more confident about themselves and their future as a result of participating in the GRACE study. Negative experiences as reported by the participants included too many blood draws (26 percent), travel to the study site (13 percent) and the opinion that medicines were hard to take (12 percent). Factors associated with nonadherence, study discontinuation and poor virologic response cited by respondents included being the primary caregiver for children, unemployment, and difficulties with transportation, respectively.
“As researchers, we spend much time analyzing the data points pulled from a clinical trial. The results of the GRACE participant survey provide us with the unique opportunity to view the clinical trial experience through the eyes of a patient,” sai d Kathleen Squires, MD, Director, Division of Infectious Diseases, Thomas Jefferson University, who was a primary investigator in the GRACE study and is the lead author for the patient survey manuscript. “The survey has the potential to help shape how future studies are conducted, as it further addresses some of those barriers that may prevent individuals from participating in clinical research. We now can begin to understand how to better anticipate the barriers and help patients in overcoming them,” Squires added.
“When GRACE was completed, the study investigators and HIV community encouraged Janssen to conduct a survey of participants. The positive patient feedback on their experience participating in the study speaks to the design and the care provided by the sites,” said Bryan Baugh, M.D., Medical Director at Janssen Therapeutics. “We want to commend everyone who helped us develop the study and the investigators who helped to make being in the study a positive experience for many participants,” Baugh added.
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