Understanding differences in enrollment outcomes among high-risk populations recruited to a phase IIb HIV vaccine trial

Journal of Acquired Immune Deficiency Syndromes

Volumn 50, Issue 3, 2009, Pages 314-319

  Frew, Paula M ^a,b,c,d   Rio, Carlos Del ^a,b,c   Lu, Lu ^a,d   Clifton, Sarah ^a,c,d   Mulligan, Mark J ^a,b,c  

^a EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b EMORY CENTER FOR AIDS RESEARCH   (United States)

^c EMORY UNIVERSITY   (United States)

^d EMORY UNIVERSITY   (United States)

Author keywords

HIV vaccine; Minorities; Recruitment; Retention; Willingness to participate; Women

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

ALTRUISM; ARTICLE; COMPENSATION; DEMOGRAPHY; DRUG EFFICACY; EDUCATIONAL STATUS; FEMALE; GRADUATE; HIGH RISK POPULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MALE; MASS MEDIUM; MINORITY GROUP; PATIENT SELECTION; POSTGRADUATE EDUCATION; PRIORITY JOURNAL; PROSPECTIVE STUDY; RACE; RESEARCH SUBJECT; SEXUAL ORIENTATION; SOCIAL ASPECT; ADULT; CLINICAL TRIAL; OUTCOME ASSESSMENT; PHASE 2 CLINICAL TRIAL;

ADULT; AIDS VACCINES; DEMOGRAPHY; FEMALE; HIV INFECTIONS; HUMANS; MALE; OUTCOME ASSESSMENT (HEALTH CARE); PATIENT SELECTION;

EID: 63149087404     PISSN: 15254135     EISSN: None     Source Type: Journal    
DOI: 10.1097/QAI.0b013e3181945eec     Document Type: Article

References (62)

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7. Newman PA, Duan N, Roberts KJ, et al. HIV vaccine trial participation among ethnic minority communities. J Acquir Immune Defic Syndr. 2006; 41:210-217.
8. Mills E, Nixon S, Singh S, et al. Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge. PLoS Med. 2006;3:e94.
9. Tello J, Soong SJ, Hunter B, et al. HIV vaccine acceptance among heterosexual clients of a sexually transmitted diseases clinic. Am J Med Sci. 1998;315:11-16.
10. Ness RB, Nelson DB, Kumanyika SK, et al. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol. 1997;7:472-478.
11. Koblin B, Heagerty P, Sheon A, et al. Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS. 1998;12:785-793.
12. Newman P, Duan N, Rudy E, et al. Challenges for HIV vaccine dissemination and clinical trial recruitment: if we build it, will they come? AIDS Patient Care and STDS. 2004;18:691-701.
13. Koblin BA, Holte S, Lenderking B, et al. Readiness for HIV vaccine trials: changes in willingness and knowledge among high-risk populations in the HIV network for prevention trials. J Acquir Immune Defic Syndr. 2000;24: 451-457.
14. de Bruyn G, Hudgens MG, Sullivan PS, et al. Participant retention in clinical trials of candidate HIV vaccines. J Acquir Immune Defic Syndr. 2005;39:499-501.
15. Halpern SD, Metzger DS, Berlin JA, et al. Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J Acquir Immune Defic Syndr. 2001;27:281-288.
16. O'Connell JM, Hogg RS, Chan K, et al. Willingness to participate and enroll in a Phase 3 preventive HIV-1 vaccine trial. J Acquir Immune Defic Syndr. 2002;21:521-528.
17. Jenkins RA, Chinaworapong S, Morgan PA, et al. Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;18:171-177.
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20. Buchbinder S, Mehrotra D, Duerr A, et al. The step study: a test-of-concept HIV vaccine efficacy trial. Lancet. 2008;372:1881-1893.
21. Shavers-Hornaday VL, Lynch CF, Burmeister LF, et al. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health. 1997;2:31-45.
22. Allen M, Israel H, Rybczyk KR, et al. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses. 2001;17: 667-674.
23. Moutsiakis DL, Chin NP. Why blacks do not take part in HIV vaccine trials. J Natl Med Assoc. 2007;99:254-257.
24. Fuchs J, Durham M, McLellan-Lemal E, et al. Negative social impacts among volunteers in an HIV vaccine efficacy trial. J Acquir Immune Defic Syndr. 2007;47:1-7.
25. Shavers VL, Lynch CF, Burmeister LF. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol. 2002;12:248-256.
26. Salazar LF, Holtgrave DR, Crosby RA, et al. Issues related to gay and bisexual men's acceptance of a future AIDS vaccine. Int J STD AIDS. 2005;16:546-548.
27. Priddy FH, Cheng AC, Salazar LF, et al. Racial and ethnic differences in knowledge and willingness to participate in HIV vaccine trials in an urban population in the Southeastern US. Int J STD AIDS. 2006;17: 99-102.
28. Brown-Peterside P, Chiasson MA, Ren L, et al. 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.
29. Brown-Peterside P, Rivera E, Lucy D, et al. Retaining hard-to-reach women in HIV prevention and vaccine trials: Project ACHIEVE. Am J Public Health. 2001;91:1377-1379.
30. Murphy DA, O'Keefe ZH, Kaufman AH. Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev. 1999;11:389-399.
31. Newman PA, Duan N, Lee SJ, et al. Willingness to participate in HIV vaccine trials: the impact of trial attributes. Prev Med. 2007;44:554-557.
32. UNAIDS/WHO. AIDS Epidemic Update. Geneva, Switzerland: UNAIDS/World Health Organization; December 2007.
33. Hall HI, Song R, Rhodes P, et al. Estimation of HIV incidence in the United States. JAMA. 2008;300:520-529.
34. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Supplemental Report: cases of HIV infection and AIDS in the United States and dependent areas, by race/ethnicity, 2002-2006. Available at: http://www.cdc.gov/hiv/topics/surveillance/resources/reports/2008supp-voll3nol/ pdf/HIVAIDS-SSR-Voll3-Nol.pdf Accessed September 25, 2008.
35. Centers for Disease Control and Prevention. Update to racial/ethnic disparities in diagnoses of HIV/AIDS-33 States, 2001-2005. MMWR Morb Mortal Wkly Rep. 2008;56:189-193.
36. Kaiser Family Foundation. HIV/AIDS Policy Fact Sheet: Black Americans and HIV/AIDS. HIV Policy Program: Washington, DC; July 2007.
37. Djomand G, Katzman J, di Tommaso D, et al. Enrollment of racial/ethnic minorities in NIAID-funded networks of HIV vaccine trials in the United States, 1988 to 2002. Public Health Rep. 2005;120:543-548.
38. Newman PA, Duan N, Roberts KJ, et al. HIV vaccine trial participation among ethnic minority communities. J Acquir Immune Defic Syndr. 2006; 41:210-217.
39. Mills E, Nixon S, Singh S, et al. Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge. PLoS Med. 2006;3:e94.
40. Tello J, Soong SJ, Hunter B, et al. HIV vaccine acceptance among heterosexual clients of a sexually transmitted diseases clinic. Am J Med Sci. 1998;315:11-16.
41. Ness RB, Nelson DB, Kumanyika SK, et al. Evaluating minority recruitment into clinical studies: how good are the data? Ann Epidemiol. 1997;7:472-478.
42. Koblin B, Heagerty P, Sheon A, et al. Readiness of high-risk populations in the HIV Network for Prevention Trials to participate in HIV vaccine efficacy trials in the United States. AIDS. 1998;12:785-793.
43. Newman P, Duan N, Rudy E, et al. Challenges for HIV vaccine dissemination and clinical trial recruitment: if we build it, will they come? AIDS Patient Care and STDS. 2004;18:691-701.
44. Koblin BA, Holte S, Lenderking B, et al. Readiness for HIV vaccine trials: changes in willingness and knowledge among high-risk populations in the HIV network for prevention trials. J Acquir Immune Defic Syndr. 2000;24: 451-457.
45. de Bruyn G, Hudgens MG, Sullivan PS, et al. Participant retention in clinical trials of candidate HIV vaccines. J Acquir Immune Defic Syndr. 2005;39:499-501.
46. Halpern SD, Metzger DS, Berlin JA, et al. Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J Acquir Immune Defic Syndr. 2001;27:281-288.
47. O'Connell JM, Hogg RS, Chan K, et al. Willingness to participate and enroll in a Phase 3 preventive HIV-1 vaccine trial. J Acquir Immune Defic Syndr. 2002;21:521-528.
48. Jenkins RA, Chinaworapong S, Morgan PA, et al. Motivation, recruitment, and screening of volunteers for a phase I/II HIV preventive vaccine trial in Thailand. J Acquir Immune Defic Syndr Hum Retrovirol. 1998;18:171-177.
49. Percy L, Elliott R. Strategic Advertising Management. 2nd ed. Oxford, England: Oxford University Press; 2005.
50. Frew PM, Macias W, Harding AC. In "Step" with HIV vaccines?: A content analysis of recruitment campaigns for an international HIV vaccine study. J. Health Mass Commun. 2008;1:11-39.
51. Buchbinder S, Mehrotra D, Duerr A, et al. The step study: a test-of-concept HIV vaccine efficacy trial. Lancet. 2008;372:1881-1893.
52. Shavers-Hornaday VL, Lynch CF, Burmeister LF, et al. Why are African Americans under-represented in medical research studies? Impediments to participation. Ethn Health. 1997;2:31-45.
53. Allen M, Israel H, Rybczyk KR, et al. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses. 2001;17: 667-674.
54. Moutsiakis DL, Chin NP. Why blacks do not take part in HIV vaccine trials. J Natl Med Assoc. 2007;99:254-257.
55. Fuchs J, Durham M, McLellan-Lemal E, et al. Negative social impacts among volunteers in an HIV vaccine efficacy trial. J Acquir Immune Defic Syndr. 2007;47:1-7.
56. Shavers VL, Lynch CF, Burmeister LF. Racial differences in factors that influence the willingness to participate in medical research studies. Ann Epidemiol. 2002;12:248-256.
57. Salazar LF, Holtgrave DR, Crosby RA, et al. Issues related to gay and bisexual men's acceptance of a future AIDS vaccine. Int J STD AIDS. 2005;16:546-548.
58. Priddy FH, Cheng AC, Salazar LF, et al. Racial and ethnic differences in knowledge and willingness to participate in HIV vaccine trials in an urban population in the Southeastern US. Int J STD AIDS. 2006;17: 99-102.
59. Brown-Peterside P, Chiasson MA, Ren L, et al. 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.
60. Brown-Peterside P, Rivera E, Lucy D, et al. Retaining hard-to-reach women in HIV prevention and vaccine trials: Project ACHIEVE. Am J Public Health. 2001;91:1377-1379.
61. Murphy DA, O'Keefe ZH, Kaufman AH. Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts. AIDS Educ Prev. 1999;11:389-399.
62. Newman PA, Duan N, Lee SJ, et al. Willingness to participate in HIV vaccine trials: the impact of trial attributes. Prev Med. 2007;44:554-557.