Skip to main content

Advertisement

Log in

Increasing and Supporting the Participation of Persons of Color Living with HIV/AIDS in AIDS Clinical Trials

  • Published:
Current HIV/AIDS Reports Aims and scope Submit manuscript

Abstract

Persons living with HIV/AIDS (PLHA) of color are under-represented in AIDS clinical trials (ACTs), which may limit the generalizability of research findings and denies many individuals access to high levels of care and new treatments available through ACTs. Disproportionately low rates of recruitment in health care settings and by providers are a major barrier to ACTs for this group. Moreover, PLHA of color are more likely than their white peers to decline to participate, mainly due to fear and mistrust (although willingness is also high), negative social norms about ACTs, and difficulty navigating the unfamiliar ACT system. We describe a small number of successful behavioral and structural interventions to increase the participation of PLHA of color in screening for and enrollment into ACTs. HIV care settings, clinical trials sites, and trial sponsors are uniquely positioned to develop procedures, supports, and trials to increase the proportion of PLHA of color in ACTs.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Similar content being viewed by others

References

Papers of particular interest, published recently, have been highlighted as: • Of importance

  1. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report, 2008, Vol. 20. Available at http://www.cdc.gov/hiv/topics/surveillance/resources/reports/. Accessed June 23, 2010.

  2. Centers for Disease Control and Prevention. HIV/AIDS among African-Americans. Available at http://www.cdc.gov/hiv/pubs/Facts/afam.htm. Accessed March 28, 2005.

  3. Rubin MS, Colen CG, Link BG: Examination of inequalities in HIV/AIDS mortality in the United States from a fundamental cause perspective. Am J Public Health 2010, 100:1053–1059.

    Article  PubMed  Google Scholar 

  4. National Institute of Allergy and Infectious Diseases (NIAID). HIV Infection in Minority Populations. Available at http://www.niaid.nih.gov/topics/HIVAIDS/Understanding/Population%20Specific%20Information/Pages/minorityPopulations.aspx. Accessed February 28, 2010.

  5. 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.

    Article  PubMed  Google Scholar 

  6. • 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. AIDS clinical trials site coordinators and research nurses were surveyed for this study that evaluated their attitudes about and recruitment practices for HIV-positive people of color, women, and injection drug users.

    Article  PubMed  Google Scholar 

  7. National Institute of Allergy and Infectious Diseases (NIAID). Strategic plan for addressing health disparities: Fiscal years 2002–2006. Available at http://www.niaid.nih.gov/healthdisparities/NIAID_HD_Plan_Final.pdf. Accessed April 26, 2006.

  8. Cargill VA, Stone VE: HIV/AIDS: A minority health issue. Med Clin North Am 2005, 89:895–912.

    Article  PubMed  Google Scholar 

  9. Parada J: The changing face of AIDS. Minority Health Today 2000, 1:9–17.

    Google Scholar 

  10. El-Sadr W, Capps L: The challenge of minority recruitment in clinical trials for AIDS. JAMA 1992, 267:954–957.

    Article  CAS  PubMed  Google Scholar 

  11. Gandhi M, Ameli N, Bacchetti P, et al.: Eligibility criteria for HIV clinical trials and generalizability of results: The gap between published reports and study protocols. AIDS 2005, 19:1885–1896.

    Article  PubMed  Google Scholar 

  12. King WD, Wong MD, Shapiro MF, et al.: Does racial concordance between HIV-positive patients and their physicians affect the time to receipt of protease inhibitors? J Gen Intern Med 2004, 19:1146–1153.

    Article  PubMed  Google Scholar 

  13. Stone V, Mauch M, 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.

    CAS  PubMed  Google Scholar 

  14. Hussain-Gambles M: Ethnic minority under-representation in clinical trials. Whose responsibility is it anyway? J Health Organ Manag 2003, 17:138–143.

    Article  PubMed  Google Scholar 

  15. Stolberg SG: Racial disparity is found in AIDS clinical studies. New York Times. 2002:A24, May 2.

  16. Marshak A, Costantini G, Middleton S, et al.: Screening for AIDS clinical trials in the project ACT cohort of racial/ethnic minorities and women in New York City: substantial interest but low eligibility. Presented at the 4th International AIDS Society Conference. Sydney, Australia; July 22–27, 2007.

  17. DeFreitas D: Race and HIV clinical trial participation. J Natl Med Assoc 2010, 102:493–499.

    PubMed  Google Scholar 

  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.

    CAS  PubMed  Google Scholar 

  19. • 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. This article describes participation in clinical research studies of HIV medicines among women and people of color from 15 states.

    PubMed  Google Scholar 

  20. van Ryn M: Research on the provider contribution to race/ethnicity disparities in medical care. Med Care 2002, 40:I140–I151.

    PubMed  Google Scholar 

  21. Cotton DJ, Finkelstein DM, He W, Feinberg J: Determinants of accrual of women to a large, multicenter clinical trials program of human immunodeficiency virus infection. The AIDS Clinical Trials Group. J Acquir Immune Defic Syndr 1993, 6:1322–1328.

    CAS  PubMed  Google Scholar 

  22. Murphy TF: Women and drug users: the changing faces of HIV clinical drug trials. QRB Qual Rev Bull 1991, 17:26–32.

    CAS  PubMed  Google Scholar 

  23. Stone VE: Strategies for optimizing adherence to highly active antiretroviral therapy: lessons from research and clinical practice. Clin Infect Dis 2001, 33:865–872.

    Article  CAS  PubMed  Google Scholar 

  24. Bangsberg DR, Hecht FM, Clague H, et al.: Provider assessment of adherence to HIV antiretroviral therapy. J Acquir Immune Defic Syndr 2001, 26:435–442.

    CAS  PubMed  Google Scholar 

  25. van Dijk L, Heerdink ER, Somai D, et al.: Patient risk profiles and practice variation in nonadherence to antidepressants, antihypertensives and oral hypoglycemics. BMC Health Serv Res 2007, 7:51.

    Article  PubMed  Google Scholar 

  26. National Commission on Acquired Immune Deficiency Syndrome: The Twin Epidemics of Substance Use and HIV. Available at http://www.dogwoodcenter.org/references/studies91F.html. Accessed June 24, 2010.

  27. Wood E, Montaner JS, Bangsberg DR, et al.: Expanding access to HIV antiretroviral therapy among marginalized populations in the developed world. AIDS 2003, 17:2419–2427.

    Article  PubMed  Google Scholar 

  28. Abrams Weintraub T, Saitz R, Samet JH: Education of preventive medicine residents: alcohol, tobacco, and other drug abuse. Am J Prev Med 2003, 24:101–105.

    Article  PubMed  Google Scholar 

  29. Gwadz M, Leonard N, Riedel M, et al.: Project ACT: A pilot intervention to increase screening for AIDS clinical trials among racial/ethnic minorities and women in New York City. Presented at the XVI International AIDS Conference. Toronto, Canada; August 13–18, 2006.

  30. Gamble VN: A legacy of distrust: African Americans and medical research. Am J Prev Med 1993, 9:35–38.

    CAS  PubMed  Google Scholar 

  31. Shavers-Hornaday VL, Lynch CF, Burmeister LF, Torner JC: Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health 1997, 2:31–45.

    Article  CAS  PubMed  Google Scholar 

  32. Gwadz MV, Leonard NR, Nakagawa A, et al.: Gender differences in attitudes toward AIDS clinical trials among urban HIV-infected individuals from racial and ethnic minority backgrounds. AIDS Care 2006, 18:786–794.

    Article  CAS  PubMed  Google Scholar 

  33. Wendler D, Kington R, Madans J, et al.: Are racial and ethnic minorities less willing to participate in health research? PLoS Med 2006, 3:e19.

    Article  PubMed  Google Scholar 

  34. • Adeyemi OF, Evans AT, Bahk M: HIV-infected adults from minority ethnic groups are willing to participate in research if asked. AIDS Patient Care STDS 2009, 23:859–865. This article describes factors influencing participation in HIV research among people of color.

    PubMed  Google Scholar 

  35. • Volkmann ER, Claiborne D, Currier JS: Determinants of participation in HIV clinical trials: The importance of patients’ trust in their provider. HIV Clin Trials 2009, 10:104–109. This study explores factors that increase people’s willingness to participate in AIDS clinical trials and preferred means of conveying information about trials.

    Article  PubMed  Google Scholar 

  36. Mills E, Wilson K, Rachlis B, et al.: Barriers to participation in HIV drug trials: A systematic review. Lancet Infect Dis 2006, 6:32–38.

    Article  PubMed  Google Scholar 

  37. Brown-Peterside P, Chiasson MA, Ren L, Koblin BA: Involving women in HIV vaccine efficacy trials: Lessons learned from a vaccine preparedness study in New York City. J Urban Health 2000, 77:425–437.

    Article  CAS  PubMed  Google Scholar 

  38. Flay B, Petraitis J: The theory of triadic influence. In Advances in Medical Sociology, vol IV. Edited by Albrecht G. Greenwich, CT: JAI Press; 1994:19–44.

    Google Scholar 

  39. Latkin C: Outreach in natural settings: the use of peer leaders for HIV prevention among injecting drug users’ networks. Public Health Rep 1998, 113(Suppl 1):151–159.

    PubMed  Google Scholar 

  40. Andersen JW, Fass R, van der Horst C: Factors associated with early study discontinuation in AACTG studies, DACS 200. Contemp Clin Trials 2007, 28:583–592.

    Article  PubMed  Google Scholar 

  41. Gorelick PB, Harris Y, Burnett B, Bonecutter FJ: The recruitment triangle: reasons why African Americans enroll, refuse to enroll, or voluntarily withdraw from a clinical trial. An interim report from the African-American Antiplatelet Stroke Prevention Study (AAASPS). J Natl Med Assoc 1998, 90:141–145.

    CAS  PubMed  Google Scholar 

  42. 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.

    Article  CAS  PubMed  Google Scholar 

  43. • Gwadz MV, Cylar K, Leonard NR, et al.: An exploratory behavioral intervention trial to improve rates of screening for AIDS clinical trials among racial/ethnic minority and female persons living with HIV/AIDS. AIDS Behav 2010, 14:639–648. This article describes a pilot behavioral intervention that was efficacious at increasing rates of ACT screening among people of color and women living with HIV/AIDS.

    Article  PubMed  Google Scholar 

  44. Broadhead RS, Heckathorn DD, Weakliem DL, et al.: Harnessing peer education networks as an instrument for AIDS prevention. Public Health Rep 1998, 113(Suppl 1):42–57.

    PubMed  Google Scholar 

  45. Heckathorn DD, Broadhead RS, Anthony DL, Weakliem DL: AIDS and social networks: HIV prevention through network mobilization. Sociol Focus 1999, 32:159–179.

    Google Scholar 

  46. Broadhead RS, Heckathorn DD, Altice FL, et al.: Increasing drug users’ adherence to HIV treatment: Results of a peer-driven intervention feasibility study. Soc Sci Med 2002, 55:235–246.

    Article  PubMed  Google Scholar 

  47. Heckathorn D: Respondent-driven sampling: A new approach to the study of hidden population. Soc Probl 1997, 44:174–199.

    Article  Google Scholar 

  48. Miller W, Rollnick S: Motivational Interviewing: Preparing People for Change, edn 2. New York: Guilford; 2002.

    Google Scholar 

  49. Bandura A: Social Foundations of Thought and Action. Englewood Cliffs, NJ: Prentice Hall; 1986.

    Google Scholar 

  50. Ethier KA, Rodriguez MR, Fox-Tierney RA, et al.: Recruitment in AIDS clinical trials: Investigation of sociodemographic and psychosocial factors affecting participation in clinical research. AIDS Behav 1999, 3:219–230.

    Article  Google Scholar 

Download references

Acknowledgments

Funding for this study was provided by the National Institute of Allergy and Infectious Diseases, National Institutes of Health (1 R01 AI070005) and the Center for Drug Use and HIV Research (P30DA011041), funded by the National Institute on Drug Abuse at the National Institutes of Health. We would like to acknowledge the men and women who participated in the ACT1 and ACT2 Projects, and Dr. Usha Sharma (Program Officer) and Dr. Vanessa Elharrar (Medical Officer), Division of AIDS, National Institute of Allergy and Infectious Diseases. The project is dedicated to the memory of Keith Cylar, Co-founder and Co-CEO of Housing Works (1958–2004), and former Housing Works PI, The ACT1 Project.

Disclosure

No potential conflicts of interest relevant to this article were reported.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Marya Viorst Gwadz.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Gwadz, M.V., Colon, P., Ritchie, A.S. et al. Increasing and Supporting the Participation of Persons of Color Living with HIV/AIDS in AIDS Clinical Trials. Curr HIV/AIDS Rep 7, 194–200 (2010). https://doi.org/10.1007/s11904-010-0055-3

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s11904-010-0055-3

Keywords

Navigation