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Treatment Access Biggest Trial Plus in Survey of Women/Minority GRACE Study
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2nd International Workshop on HIV & Women. January 9-10, 2012, Bethesda, Maryland
Mark Mascolini
Access to antiretroviral therapy was the most frequently cited "best part of GRACE" in a survey following this trial of darunavir/ritonavir in treatment-experienced people, most of them women and minorities [1]. But study participants also regularly cited altruistic reasons for joining and completing the trial.
Conducted from October 2006 through December 2008, GRACE enrolled 429 treatment-experienced people at 65 sites in the United States, Puerto Rico, and Canada, including 287 women (67%) and 373 blacks or Hispanics (84%) [2]. A higher proportion of women than men dropped out of the study (33% versus 23%, P = 0.042), but 48-week virologic response rates were similar for women and men (51% versus 58.5%). Adverse event rates were also similar for women and men.
From June 2010 through June 2011, GRACE investigators conducted a cross-sectional study at 22 of 65 GRACE sites involving 243 trial participants representative of the entire GRACE population [1]. A 40-item questionnaire included both multiple-choice and open-ended questions about patient characteristics, experiences, and opinions about participating in GRACE.
Of the 243 participants, 151 (62%) completed the survey. Nearly two thirds of respondents and nonrespondents (64% and 65%) were women, and median ages were 44 and 43. A lower proportion of respondents than nonrespondents were black (55% versus 62%), a higher proportion of respondents had used illicit drugs (17% versus 10%), and lower proportion had CDC class C HIV infection (34% versus 40%). Respondents had a higher GRACE-entry CD4 count than nonrespondents (221 versus 187).
A lower proportion of respondents than nonrespondents discontinued GRACE (27% versus 40%). Although 88% of respondents reported completing GRACE, only 73% actually did so. Survey respondents had a higher sub-50-copy time-to-loss-of-virologic-response (TLOVR) rate at 48 weeks than did nonrespondents (61% versus 46%). In a 48-week response analysis that excluded nonvirologic failure, survey respondents had a marginally higher virologic response rate than nonrespondents (77% versus 70%).
Only 27% of survey participants had private health insurance, while 53% relied on Medicaid or Medicare, and 20% had no insurance. Three quarters of respondents (73%) had at least a high-school education, but only 42% were working when they signed up for GRACE. Fewer than 5% of respondents were homeless, lived in a shelter, or spent nights in jail while participating in GRACE. Three quarters of survey respondents (77%) reported no difficulty in arranging transportation to study sites.
While 39% of respondents cited access to medications as their main reason for entering GRACE, 38% listed the need to help others, and 22% thought a study involving women and people of color was important. A large majority, 79%, said it was important to get both the main study drugs (darunavir and ritonavir) and other study drugs for free. Access to antiretroviral therapy was the most frequently reported benefit of the trial, cited by 41%, followed by "being part of something bigger" (18%) and feeling better (18%).
Almost half of study participants listed "too many blood draws" as the worst part of their trial experience, while 23% listed getting to the study site, and 22% listed difficulty in taking study drugs. Nearly half of respondents (47%) reported support from the trial site as the most important factor in completing the trial, while 16% cited feeling better, 15% listed family support, 13% pointed to access to treatment, and 9% named "wanting to contribute to something bigger."
Univariate analysis identified a long list of factors associated with not having a viral load below 50 copies at week 48: not working, being a primary caregiver for children, pre-GRACE history of clinic visit or medication nonadherence, not traveling to study site in one's own car, obtaining most HIV information from one's own health care provider, feeling it is important for one's health care provider to be the same sex, using Medicare or Medicaid, and feeling it is not important to be provided with study drugs other than darunavir.
In a previous GRACE report, quality of life measured by the Functional Assessment of HIV Infection (FAHI) questionnaire determined that the FAHI score for the total GRACE population improved significantly by study week 4 [3]. Near-maximum FAHI levels reached at week 12 were maintained through week 48, with larger improvements in women than men and in blacks than in Hispanics or whites.
References
1. Squires K, Feinberg J, Averitt Bridge D, et al. Additional insights on GRACE (Gender, Race And Clinical Experience) from the patient's perspective: GRACE participant survey. 2nd International Workshop on HIV & Women. January 9-10, 2012, Bethesda, Maryland. Abstract O_20.
2. Currier J, Averitt Bridge D, Hagins D, et al, GRACE (Gender, Race, And Clinical Experience) Study Group. Sex-based outcomes of darunavir-ritonavir therapy: a single-group trial. Ann Intern Med. 2010;153:349-357. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3056066/?tool=pubmed.
3. Feinberg J, Saag M, Squires K, Currier J, Ryan R, Coate B, Mrus J. Health-related quality of life in the gender, race, and clinical experience trial. AIDS Res Treat. Epub 2011 Aug 28. Doi 10.1155/2011/349165. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3166720/?tool=pubmed
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