Improving Participation in HIV Clinical Trials: Impact of a Brief Intervention

REFERENCES

• Update: Trends in AIDS incidence-United States, 1996. MMWR Morb Mortal Wkly Rep. 1997;46:861–867.
   PubMedGoogle Scholar
• Karon JM, Rosenberg PS, McQuillan G, Khare M, Gwinn M, Petersen LR. Prevalence of HIV infection in the United States, 1984 to 1992. JAMA. 1996;276:126–131.
   PubMed Web of Science ®Google Scholar
• Rosenberg PS. Scope of the AIDS epidemic in the United States. Science. 1995;270:1372–1375.
   PubMed Web of Science ®Google Scholar
• Hammer SM, Squires KE, Hughes MD, et al. A controlled trial of two nucleoside analogues plus indinavir in persons with human immunodeficiency virus infection and CD4 cell counts of 200 per cubic millimeter or less. AIDS Clinical Trials Group 320 Study Team. N Engl J Med. 1997;337:725–733.
   PubMed Web of Science ®Google Scholar
• Hogg RS, Heath KV, Yip B, et al. Improved survival among HIV-infected individuals following initiation of antiretroviral therapy. JAMA. 1998;279:450–454.
   PubMed Web of Science ®Google Scholar
• Palella FJ, Jr, Delaney KM, Moorman AC, et al. Declining morbidity and mortality among patients with advanced human immunodeficiency virus infection. HIV Outpatient Study Investigators. N Engl J Med. 1998;338:853–860.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMedGoogle Scholar
• Levin C. Women and HIV/AIDS research. Eval Rev. 1990;14:447–463.
   Web of Science ®Google Scholar
• Vlahov D, Astemborski J, Solomon L, Galai N, Basarab L, Nelson KE. Interest in HIV vaccines among injection drug users in Baltimore, Maryland. AIDS Res Hum Retro viruses. 1994;10:S265–S268.
   PubMed Web of Science ®Google Scholar
• Svensson CK. Representation of American blacks in clini-cal trials of new drugs. JAMA. 1989;261:263–265.
   PubMed Web of Science ®Google Scholar
• Gorelick PB, Richardson D, Hudson E, et al. Establishing a community network for recruitment of African Americans into a clinical trial. The African-American antiplatelet stroke Prevention Study (AAASPS) experience. J Nati Med Assoc. 1996;88:701–704.
   PubMed Web of Science ®Google Scholar
• Gorelick PB, Harris Y, Burnett B, Bonecutter FJ. The re-cruitment 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.
   PubMed Web of Science ®Google Scholar
• Ubel PA, Merz JF, Shea J, Asch DA. How preliminary data affect people's stated willingness to enter a hypothetical randomized controlled trial. J Investig Med. 1997;45:561–566.
   PubMed Web of Science ®Google Scholar
• Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S. Attitudes and beliefs of African Americans toward par-ticipation in medical research. J Gen Intern Med. 1999;14:537–546.
   PubMed Web of Science ®Google Scholar
• Loannidis JP, Bassett R, Hughes MD, Volberding PA, Sacks HS, Lau J. Predictors and impact of patients lost to follow-up in a long-term randomized trial of immediate versus deferred antiretroviral treatment. J Acquir Immune Defic Syndr Hum Retrovirol. 1997;16:22–30.
   PubMedGoogle Scholar
• Samet JH, Libman H, Steger KA, et al. Compliance with zidovudine therapy in patients infected with human immu-nodeficiency virus, type 1: A cross-sectional study in a municipal hospital clinic. Am J Med. 1992;92:495–502.
   PubMed Web of Science ®Google Scholar
• Sherer R. Adherence and antiretroviral therapy in injection drug users. JAMA. 1998;280:567–568.
   PubMed Web of Science ®Google Scholar
• Craven DE, Liebman HA, Fuller J, et al. AIDS in intravenous drug users: Issues related to enrollment in clinical trials. J Acquir Immune Defic Syndr. 1990;3:S45–S50.
   PubMed Web of Science ®Google Scholar
• Stone VE, Mauch MY, Steger K, Janas SF, Craven DE. Race, gender, drug use, and participation in AIDS clinical trials. Lessons from a municipal hospital cohort. J Gen Intern Med. 1997;12:150–157.
   PubMed Web of Science ®Google Scholar
• Samet JH, Libman H, LaBelle C, et al. A model clinic for the initial evaluation and establishment of primary care for persons infected with human immunodeficiency virus. Arch Intern Med. 1995;155:1629–1633.
   PubMed Web of Science ®Google Scholar
• Cotton DJ, Finkelstein DM, He W, Feinberg J. Determi-nants 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.
   PubMed Web of Science ®Google Scholar
• El-Sadr W, Capps L. The challenge of minority recruitment in clinical trials for AIDS. JAMA. 1992;267:954–957.
   PubMed Web of Science ®Google Scholar
• Brown LS, Jr. Enrollment of drug abusers in HIV clinical trials: A public health imperative for communities of color. J Psychoactive Drugs. 1993;25:45–52.
   PubMed Web of Science ®Google Scholar
• Schain WS. Barriers to clinical trials. Part II: Knowledge and attitudes of potential participants. Cancer. 1994;74:2666–2671.
   PubMed Web of Science ®Google Scholar
• Frayne SM, Burns RB, Hardt EJ, Rosen AK, Moskowitz MA. The exclusion of non-English-speaking persons from research. J Gen Intern Med. 1996;11:39–43.
   PubMed Web of Science ®Google Scholar
• Levin C, Neveloff Dubler N, Levine R. Building a new con-sensus: Ethical principal and policies for clinical research on HIV/AIDS. IRB: Rev Hum Subjects Res. 199113: 1–22.
   Google Scholar
• Thomas SB, Quinn SC. The Tuskegee Syphilis Study, 1932 to 1972: Implications for HIV education and AIDS risk education programs in the black community. Am J Public Health. 199181: 1498–1505.
   Google Scholar
• Gamble VN. A legacy of distrust: African Americans and medical research. Am J Prey Med. 1993;9:35–38.
   PubMed Web of Science ®Google Scholar
• United States Food and Drug Administration. General con-siderations for the clinical evaluation of drugs. Washington, DC: Government Printing Office; 1997.
   Google Scholar
• Kessler DA. The regulation of investigational drugs. N Engl J Med. 1989;320:281–288.
   PubMed Web of Science ®Google Scholar
• McCarthy CR. Historical background of clinical trials in-volving women and minorities. Acad Med. 1994;69:695–698.
   PubMed Web of Science ®Google Scholar
• Merkatz RB, Temple R, Subel S, Feiden K, Kessler DA. Women in clinical trials of new drugs. A change in Food and Drug Administration policy. The Working Group on Women in Clinical Trials. N Engl J Med. 1993;329:292–296.
   PubMed Web of Science ®Google Scholar