Original Article

Regional Variation in HIV Clinical Trials Participation in the United States

Authors: Christine Heumann, MD, Susan E. Cohn, MD, MPH, Supriya Krishnan, DSc, Jose R. Castillo-Mancilla, MD, Michelle Cespedes, MD, MS, Michelle Floris-Moore, MD, MS, Kimberly Y. Smith, MD, the ACTG Underrepresented Populations Survey Group

Abstract

Objectives: To ensure generalizability of clinical research results, it is important to enroll a heterogeneous population that is representative of the target clinical population. Earlier studies have found regional variation in participation in human immunodeficiency virus (HIV) clinical trials, with the lowest rates seen in the southern United States. Rates of new HIV diagnoses are highest in the South, highlighting the need for in-depth understanding of disparities in clinical trial participation. We evaluated whether regional variation in study participation remains, and describe factors that facilitate or prevent HIV clinical trial participation by region.

Methods: A one-time, anonymous, bilingual, self-administered survey was conducted among HIV-infected adults receiving HIV care at all 47 domestic AIDS Clinical Trials Group clinical research sites, with a goal of completing 50 surveys per site. W2 tests were used to evaluate differences in knowledge of and participation in HIV clinical trials by region, including Northeast, Midwest, South, and West regions. Multivariable logistic regression was used to estimate odds ratios and 95% confidence intervals (CIs) for the effect of region on knowledge of and participation in HIV clinical trials.

Results: Of 2263 completed surveys, 2125 were included in this analysis. The proportion of respondents in the South who reported knowledge of studies (66%) was significantly lower than in the Northeast (76%), Midwest (77%), and West (73%) (P = 0.001). Respondents in the South also were the least likely group to report ever having tried to or having participated in a research study (51%) compared with respondents in the Northeast (60%), Midwest (57%), and West (69%; P < 0.001). After adjusting for age, sex, education, race/ethnicity, tobacco use, and alcohol use, the odds ratio for knowledge of and participation in clinical trials for the Northeast (1.36; 95% CI 1.07-1.72) and West (1.85; 95% CI 1.39-2.45) remained significant compared with the South. African American respondents in the South were the most likely population group to report not understanding research studies (15%) as a reason for not participating, compared with the Northeast (9%), Midwest (8%), andWest (6%; P < 0.001).

Conclusions: Significant regional variations in knowledge of and participation in HIV clinical trials exist. Our results suggest that increasing awareness and understanding of research studies, particularly among African Americans in the South, may facilitate HIV clinical trial participation that is more representative of the HIVinfected population across the United States.

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References

1. Diaz T, Chu SY, Sorvillo F, et al. Differences in participation in experimental drug trials among persons with AIDS. J Acquir Immune Defic Syndr Hum Retrovirol 1995;10:562-568.
 
2. Stone VE, Mauch MY, Steger K, et al. Race, gender, drug use, and participation in AIDS clinical trials. Lessons from a municipal hospital cohort. J Gen Intern Med 1997;12:150-157.
 
3. Lake JE, Friedman RK, Cunha CB, et al. Participation of women in HIV clinical trials: the IPEC-FIOCRUZ experience. HIV AIDS (Auckl) 2011;3:61-68.
 
4. Gifford AL, Cunningham WE, Heslin KC, et al. Participation in research and access to experimental treatments by HIV-infected patients. N Engl J Med 2002;346:1373-1382.
 
5. Madge S, Mocroft A, Wilson D, et al. Participation in clinical studies among patients infected with HIV-1 in a single treatment centre over 12 years. HIV Med 2000;1:212-218.
 
6. Freedberg KA, Sullivan L, Georgakis A, et al. Improving participation in HIV clinical trials: impact of a brief intervention. HIV Clin Trials 2001;2:205-212.
 
7. Corbie-Smith G, Odeneye E, Banks B, et al. Development of a multilevel intervention to increase HIV clinical trial participation among rural minorities. Health Educ Behav 2013;40:274-285.
 
8. Sullivan PS, McNaghten AD, Begley E, et al. Enrollment of racial/ethnic minorities and women with HIV in clinical research studies of HIV medicines. J Natl Med Assoc 2007;99:242-250.
 
9. Shapiro MF, Morton SC, McCaffrey DF, et al. Variations in the care of HIV-infected adults in the United States: results from the HIV Cost and Services Utilization Study. JAMA 1999;281:2305-231.
 
10. Sateren WB, Trimble EL, Abrams J, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 2002;20:2109-2117.
 
11. Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC), US Department of Health and Human Services. HIV surveillance report. Rates of diagnoses of HIV infection among adults and adolescents, by area of residence, 2011-United States and 6 dependent areas. http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf. Published February 2013. Accessed October 31, 2013.
 
12. Whetten K, Reif S. Overview: HIV/AIDS in the deep south region of the United States. AIDS Care 2006;18(Suppl 1): S1-S5.
 
13. Ford JG, Howerton MW, Lai GY, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer 2008;112:228-242.
 
14. Corbie-Smith G, Thomas SB, Williams MV, et al. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med 1999;14:537-546.
 
15. Sengupta S, Strauss RP, DeVellis R, et al. Factors affecting African-American participation in AIDS research. J Acquir Immune Defic Syndr 2000;24:275-284.
 
16. Gamble VN. Under the shadow of Tuskegee: African Americans and health care. Am J Public Health 1997;87:1773-1778.
 
17. Freimuth VS, Quinn SC, Thomas SB, et al. African Americans’ views on research and the Tuskegee Syphilis Study. Soc Sci Med 2001;52:797-808.
 
18. Stone VE, Mauch MY, Steger KA. Provider attitudes regarding participation of women and persons of color in AIDS clinical trials. J Acquir Immune Defic Syndr Hum Retrovirol 1998;19:245-253.
 
19. Gwadz MV, Colon P, Ritchie AS, et al. Increasing and supporting the participation of persons of color living with HIV/AIDS in AIDS clinical trials. Curr HIV/AIDS Rep 2010;7:194-200.
 
20. King WD, Defreitas D, Smith K, et al. Attitudes and perceptions of AIDS clinical trials group site coordinators on HIV clinical trial recruitment and retention: a descriptive study. AIDS Patient Care STDS 2007;21:551-563.