Barriers of enrolment in HIV vaccine trials: A review of HIV vaccine preparedness studies

Vaccine

Volumn 29, Issue 35, 2011, Pages 5850-5859

  Dhalla, Shayesta ^a   Poole, Gary ^a  

^a UNIVERSITY OF BRITISH COLUMBIA   (Canada)

Author keywords

Barriers; Health belief model; HIV vaccine preparedness; Non OECD; OECD; Personal social; Risk cost

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

CLINICAL TRIAL (TOPIC); COST; DECISION MAKING; FAMILY; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFORMATION; MALE HOMOSEXUAL; PATIENT PARTICIPATION; PRIORITY JOURNAL; REVIEW; RISK; SAMPLE SIZE; SOCIAL ASPECT; SYSTEMATIC REVIEW; TIME; UNSAFE SEX;

ADOLESCENT; ADULT; AIDS VACCINES; CLINICAL TRIALS AS TOPIC; DEVELOPED COUNTRIES; DEVELOPING COUNTRIES; FEMALE; HEALTH KNOWLEDGE, ATTITUDES, PRACTICE; HIV INFECTIONS; HUMANS; MALE; PATIENT PARTICIPATION; RISK FACTORS;

EID: 79960745138     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.06.055     Document Type: Review

References (77)

1. Lindegger G., Richter L.M. HIV vaccine trials: critical issues in informed consent. S Afr J Sci 2000, 96(June):313-317.
2. Jackson D.J., Martin H.L., Bwayo J.J., Nyange P.M., Rakwar J.P., Kashonga F., et al. Acceptability of HIV vaccine trials in high-risk heterosexual cohorts in Mombasa, Kenya. AIDS 1995, 9(November (11)):1279-1283.
3. Kegeles S.M., Johnson M.O., Strauss R.P., Ralston B., Hays R.B., Metzger D.S., et al. How should HIV vaccine efficacy trials be conducted? Diverse U.S. communities speak out. AIDS Educ Prev 2006, 18(December (6)):560-572.
4. Becker M.H. The health belief model and sick role behavior. Health Educ Monogr 1974, 2:409-419.
5. Mills E., Cooper C., Guyatt G., Gilchrist A., Rachlis B., Sulway C., et al. Barriers to participating in an HIV vaccine trial: a systematic review. AIDS 2004, 18(November (17)):2235-2242.
6. Aliyu G., Mohammad M., Saidu A., Mondal P., Charurat M., Abimiku A., et al. HIV infection awareness and willingness to participate in future HIV vaccine trials across different risk groups in Abuja, Nigeria. AIDS Care 2010, 22(10):1277-1284.
7. Mills E., Nixon S., Singh S., Dolma S., Nayyar A., Kapoor S. Enrolling women into HIV preventive vaccine trials: an ethical imperative but a logistical challenge. PLoS Med 2006, (March (3)):e94.
8. O'Connell J.M., Hogg R.S., Chan K., Strathdee S.A., McLean N., Martindale S.L., et al. Willingness to participate and enroll in a phase 3 preventive HIV-1 vaccine trial. J Acquir Immune Defic Syndr 2002, 31(December (5)):521-528.
9. Newman P.A., Daley A., Halpenny R., Loutfy M. Community heroes or " high-risk" pariahs? Reasons for declining to enroll in an HIV vaccine trial. Vaccine 2008, 26(February (8)):1091-1097.
10. OECD members and partners [Internet]. cited March 7, 2011]. Available from: http://www.oecd.org/pages/0,3417,en_36734052_36761800_1_1_1_1_1,00.html.
11. Périssé A.R., Schechter M., Moreira R.I., do Lago R.F., Santoro-Lopes G., Harrison L.H. Willingness to participate in HIV vaccine trials among men who have sex with men in Rio de Janeiro, Brazil. Projeto Praca Onze study group. J Acquir Immune Defic Syndr 2000, 25(December (5)):459-463.
12. Jenkins R.A., Temoshok L.R., Virochsiri K. Incentives and disincentives to participate in prophylactic HIV vaccine research. J Acquir Immune Defic Syndr Hum Retrovirol 1995, 9(May (1)):36-42.
13. Crumbo C.L., Rybczyk K., Wagner L.J. Characteristics of volunteer participants in phase I HIV vaccine trials. J Assoc Nurses AIDS Care 1997, 8(September-October 5):59-65.
14. Chesney M.A., Chambers D.B., Kahn J.O. Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note. J Acquir Immune Defic Syndr Hum Retrovirol 1997, 16(December (4)):266-271.
15. Sheon A.R., Wagner L., McElrath M.J., Keefer M.C., Zimmerman E., Israel H., et al. Preventing discrimination against volunteers in prophylactic HIV vaccine trials: lessons from a phase II trial. J Acquir Immun Defic Syn Retrovirol 1998, 19(December (5)):519-526.
16. Thapinta D., Jenkins R.A., Celentano D.D., Nitayaphan S., Buapunth P., Triampon A., et al. Evaluation of behavioral and social issues among Thai vaccine trial volunteers. J Acquir Immune Defic Syndr Hum Retrovirol 1999, 20(March (3)):308-314.
17. Allen M., Israel H., Rybczyk K., Pugliese M.A., Loughran K., Wagner L., et al. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses 2001, 17(May (8)):667-674.
18. Maek-A-Nantawat W., Phonrat B., Naksrisook S., Thantamnu N., Pitisuttithum P., Bussaratid V., et al. Evaluation of attitude, risk behavior and expectations among Thai participants in phase I/II HIV/AIDS vaccine trials. J Med Assoc Thai 2003, 86(April (4)):299-307.
19. Jenkins R.A., Thapinta D., Morgan P.A., Wongkamhaeng S., Sornsathapornkul P., Bussaratid V., et al. Behavioral and social issues among volunteers in a preventive HIV vaccine trial in Thailand. J Acquir Immune Defic Syndr 2005, 40(December (5)):592-599.
20. Tarimo E.A.M., Thorson A., Kohi T.W., Mwami J., Bakari M., Sandström E., et al. BMC Public Health 2010, 10:292.
21. Tarimo E.A.M., Thorson A., Kohi T.W., Bakari M., Mhalu F., et al. Reasons for declining to enroll in a phase I and II HIV vaccine trial after randomization among eligible volunteers in Dar es Salaam, Tanzania. PLoS One 2011, 6(2):e14619.
22. MacQueen K.M., Buchbinder S., Douglas J.M., Judson F.N., McKirnan D.J., Bartholow B. The decision to enroll in HIV vaccine efficacy trials: concerns elicited from gay men at increased risk for HIV infection. AIDS Res Hum Retroviruses 1994, 2(10 Suppl.):S261.
23. Gross M., Seage G.R., Mayer K.H., Goldstein R.S., Losina E., Wold C. Interest among gay/bisexual men in greater Boston in participating in clinical trials of preventive HIV vaccines. J Acquir Immune Defic Syndr Hum Retrovirol 1996, 12(August (4)):406-412.
24. Koblin B.A., Avrett S., Taylor P.E., Stevens C.E. Willingness to participate in HIV-1 vaccine efficacy trials and the effect of media events among gay and bisexual men in New York City: Project ACHIEVE. J Acquir Immune Defic Syndr Hum Retrovirol 1997, 15(June (2)):165-171.
25. Hays R.B., Kegeles S.M. Factors related to the willingness of young gay men to participate in preventive HIV vaccine trials. J Acquir Immune Defic Syndr Hum Retrovirol 1999, 20(February (2)):164-171.
26. Strauss R.P., Sengupta S., Kegeles S., McLellan E., Metzger D., Eyre S., et al. Willingness to volunteer in future preventive HIV vaccine trials: issues and perspectives from three U.S. communities. J Acquir Immune Defic Syndr 2001, 26(January (1)):63-71.
27. Sherr L., Bolding G., Elford J. Recruiting London gay men into an HIV vaccine trial: Is it feasible?. AIDS Care 2004, 16(July (5)):565-571.
28. Priddy F.H., Cheng A.C., Salazar L.F., Frew P.M. 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(February (2)):99-102.
29. Starace F., Wagner T.M., Luzi A.M., Cafaro L., Gallo P., Rezza G. Knowledge and attitudes regarding preventative HIV vaccine clinical trials in Italy: results of a national survey. AIDS Care 2006, 18(January (1)):66-72.
30. Vlahov D., Astemborski J., Solomon L., Galai N., Basarab L., Nelson K.E. Interest in HIV vaccines among injection drug users in Baltimore, Maryland. AIDS Res Hum Retroviruses 1994, 2(10 Suppl.):S265-S268.
31. Serpelloni G., Vlahov D., Mazzi M., Rezza G. Interest in HIV vaccines among Italian injection drug users. J Acquir Immune Defic Syndr Hum Retrovirol 1995, 10(October (2)):206-207.
32. Nyamathi A.M., Suhadev M., Swaminathan S., Fahey J.L. Perceptions of a community sample about participation in future HIV vaccine trials in south India. AIDS Behav 2007, 11(July (4)):619-627.
33. Tello J., Soong S.J., Hunter B., Meriwether R., Hook E.W.3rd, Mulligan M.J. HIV vaccine acceptance among heterosexual clients of a sexually transmitted diseases clinic. Am J Med Sci 1998, 315(January (1)):11-16.
34. Celentano D.D., Beyrer C., Natpratan C., Eiumtrakul S., Sussman L., Renzullo P.O., et al. Willingness to participate in AIDS vaccine trials among high-risk populations in northern Thailand. AIDS 1995, 9(September (9)):1079-1083.
35. MacQueen K.M., Vanichseni S., Kitayaporn D., Lin L.S., Buavirat A., Naiwatanakul T., et al. Willingness of injection drug users to participate in an HIV vaccine efficacy trial in Bangkok, Thailand. J Acquir Immune Defic Syndr 1999, 21(July (3)):243-251.
36. Jenkins R.A., Torugsa K., Markowitz L.E., Mason C.J., Jamroentana V., Brown A.E., et al. Willingness to participate in HIV-1 vaccine trials among young Thai men. Sex Transm Infect 2000, 76(October (5)):386-392.
37. de Souza C.T., Lowndes C.M., Szwarcwald C.L., Sutmoller F., Bastos F.I. Willingness to participate in HIV vaccine trials among a sample of men who have sex with men, with and without a history of commercial sex, Rio de Janeiro, Brazil. AIDS Care 2003, 15(August (4)):539-548.
38. Sahay S., Mehendale S., Sane S., Brahme R., Brown A., Charron K., et al. Correlates of HIV vaccine trial participation: an Indian perspective. Vaccine 2005, 23(Febraury (11)):1351-1358.
39. Jaspan H.B., Berwick J.R., Myer L., Mathews C., Flisher A.J., Wood R., et al. Adolescent HIV prevalence, sexual risk, and willingness to participate in HIV vaccine trials. J Adolesc Health 2006, 39(November (5)):642-648.
40. Smit J., Middelkoop K., Myer L., Seedat S., Wood R., Stein D.J., et al. Sexual risk factors associated with volunteering for HIV vaccine research in South Africa. AIDS Care 2006, 18(August (6)):569-573.
41. Lindegger G., Quayle M., Ndlovu M. Local knowledge and experiences of vaccination: implications for HIV-preventive vaccine trials in South Africa. Health Educ Behav 2007, 34(February (1)):108-123.
42. Djomand G., Metch B., Zorrilla C.D., Donastorg Y., Casapia M., Villafana T., et al. The HVTN protocol 903 vaccine preparedness study: lessons learned in preparation for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr 2008, 48(May (1)):82-89.
43. Suhadev M., Nyamathi A.M., Swaminathan S., Suresh A., Venkatesan P. Factors associated with willingness to participate in HIV vaccine trials among high-risk populations in South India. AIDS Res Hum Retroviruses 2009, 25(February (2)):217-224.
44. Fincham D., Kagee A., Swartz L. Inhibitors and facilitators of willingness to participate (WTP) in an HIV vaccine trial: construction and initial validation of the inhibitors and facilitators of willingness to participate scale (WPS) among women at risk for HIV infection. AIDS Care 2010, 22(April (4)):452-461.
45. Moodley K., Barnes J., van Rensburg E.J., Myer L. Willingness to participate in South African HIV vaccine trials-concerns of medical professionals in the Western Cape. S Afr Med J 2002, 92(November (11)):904-906.
46. Olin J., Kokolamami J., Lepira F.B., Mwandagalirwa K., Mupenda B., Ndongala M.L., et al. Community preparedness for HIV vaccine trials in the Democratic Republic of Congo. Cult Health Sex 2006, 8(November-December 6):529-544.
47. Barrington C., Moreno L., Kerrigan D. Local understanding of an HIV vaccine and its relationship with HIV-related stigma in the Dominican Republic. AIDS Care 2007, 19(August (7)):871-877.
48. Koblin B.A., Heagerty P., Sheon A., Buchbinder S., Celum C., Douglas J.M., 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(May (7)):785-793.
49. Ruzagira E., Wandiembe S., Bufumbo L., Levin J., Price M.A., Grosskurth H., et al. Willingness to participate in preventive HIV vaccine trials in a community-based cohort in Southwestern Uganda. Trop Med Int Health 2009, 14(February (2)):196-203.
50. Douglas J.M., Judson F.N., Parks J.P., Buchbinder S., McKirnan D. Participation of homosexual/bisexual men in preventive HIV vaccine trials: baseline attitudes and concerns and predicted behaviors during trials. AIDS Res Hum Retroviruses 1994, 2(10 Suppl.):S257-S260.
51. McGrath J.W., George K., Svilar G., Ihler E., Mafigiri D., Kabugo M., et al. Knowledge about vaccine trials and willingness to participate in an HIV/AIDS vaccine study in the Ugandan military. J Acquir Immune Defic Syndr 2001, 27(August (4)):381-388.
52. Suhadev M., Nyamathi A.M., Swaminathan S., Venkatesan P., Raja Sakthivel M., Shenbagavalli R., et al. A pilot study on willingness to participate in future preventive HIV vaccine trials. Indian J Med Res 2006, 124(December (6)):631-640.
53. Sengupta S., Strauss R.P., DeVellis R., Quinn S.C., DeVellis B., Ware W.B. Factors affecting African-American participation in AIDS research. J Acquir Immune Defic Syndr 2000, 24(July (3)):275-284.
54. Meyers K., Metzger D.S., Navaline H., Woody G.E., McLellan AT HIV vaccine trials: Will intravenous drug users enroll?. Am J Public Health 1994, 84(May (5)):761-766.
55. Meyers K., Metzger D.S., McLellan A.T., Navaline H., Sheon A.R., Woody G.E. Will preventive HIV vaccine efficacy trials be possible with female injection drug users?. J Acquir Immune Defic Syndr Hum Retrovirol 1995, 10(December (5)):577-585.
56. Van De Ven P., Bartholow B., Rawstorne P., Crawford J., Kippax S., Grulich A., et al. Scaling HIV vaccine attitudes among gay men in Sydney, Australia. AIDS Res Hum Retroviruses 2002, 18(December (18)):1333-1337.
57. Buchbinder S.P., Metch B., Holte S.E., Scheer S., Coletti A., Vittinghoff E. Determinants of enrollment in a preventive HIV vaccine trial: hypothetical versus actual willingness and barriers to participation. J Acquir Immune Defic Syndr 2004, 36(May (1)):604-612.
58. Li Q., Luo F., Zhou Z., Li S., Liu Y., Li D., et al. Willingness to participate in HIV vaccine clinical trials among Chinese men who have sex with men. Vaccine 2010, 28(June (29)):4638-4643.
59. Yin L., Zhang Y., Qian H.Z., Rui B., Zhang L., Zhu J., et al. Willingness of Chinese injection drug users to participate in HIV vaccine trials. Vaccine 2008, 26(February (6)):762-768.
60. Bartholow B.N., MacQueen K.M., Douglas J.M., Buchbinder S., McKirnan D., Judson F.N. Assessment of the changing willingness to participate in phase III HIV vaccine trials among men who have sex with men. J Acquir Immune Defic Syndr Hum Retrovirol 1997, 16(October (2)):108-115.
61. Newman P.A., Duan N., Lee S.J., Rudy E., Seiden D., Kakinami L., et al. Willingness to participate in HIV vaccine trials: the impact of trial attributes. Prev Med 2007, 44:554-557.
62. Ritvo P., Willms D., Meisner R., Brown L., Goldman A., Sevankambo N. Vaccine preparedness: lessons from Lyantone, Uganda. Afr J AIDS Res 2006, 5(1):11-16.
63. Cooper C.J., Metch B., Dragavon J., Coombs R.W., Baden MD NIAID HIV Vaccine Trials Network (HVTN) Vaccine-Induced Seropositivity (VISP) Task Force. Vaccine-induced HIV seropositivity/reactivity in noninfected HIV vaccine recipients. JAMA 2010, 304(July (3)):275-283.
64. Pitisuttithum P., Choopanya K., Bussaratid V., Vanichseni S., van Griensven F., Phonrat B., et al. Social harms in injecting drug users participating in the first phase III HIV vaccine trial in Thailand. J Med Assoc Thai 2007, 90(November (11)):2442-2448.
65. Poole G., Matheson D.H., Cox D.N. The psychology of health and health care: a Canadian perspective 2011, Pearson Prentice Hall, Toronto. 4th ed.
66. Etcheverry M.F., de Lazzari E., Fuchs J.D., Meroño M., Sierra E., Del Romero J., et al. Pilot study assessing HIV vaccine trial readiness among female sex workers, injection and non-injection drug users, and men who have sex with men in Spain. AIDS Behav 2010, 14(June 3):607-617.
67. Allen M.A., Liang T.S., La Salvia T., Tjgum B., Gulakowski R.J., Murguia M. Assessing the attitudes, knowledge, and awareness of HIV vaccine research among adults in the United States. JAIDS 2005, 40(5):617-624.
68. Koblin B.A., Holte S., Lenderking B., Heagerty P. Readiness for HIV vaccine trials: changes in willingness and knowledge among high-risk populations in the HIV network for prevention trials. The HIVNET Vaccine Preparedness Study Protocol Team. J Acquir Immune Defic Syndr 2000, 24(August (5)):451-457.
69. Hennessy M., MacQueen K., McKirnan D.J., Buchbinder S., Judson F., Douglas J.M., et al. A factorial survey study to assess the acceptability of HIV vaccine trial designs. Control Clin Trials 1996, 17(June (3)):209-220.
70. Newman P.A., Duan N., Roberts K.J., Seiden D., Rudy E.T., Swendeman D., et al. HIV vaccine trial participation among ethnic minority communities: barriers, motivators, and implications for recruitment. J Acquir Immune Defic Syndr 2006, 41(February (2)):210-217.
71. Brooks R.A., Newman P.A., Duan N., Ortiz D.J. HIV vaccine trial preparedness among Spanish-speaking Latinos in the US. AIDS Care 2007, 19(January (1)):52-58.
72. Newman P.A., Duan N., Kakinami L., Roberts K. What can HIV vaccine trials teach us about future HIV vaccine dissemination?. Vaccine 2008, 26(May (20)):2528-2536.
73. Carneiro M., de Figueiredo Antunes C.M., Greco M., Oliveira E., Andrade J., Lignani L., et al. Design, implementation, and evaluation at entry of a prospective cohort study of homosexual and bisexual HIV-1-negative men in Belo Horizonte, Brazil: Project Horizonte. J Acquir Immune Defic Syndr 2000, 25(October (2)):182-187.
74. Kiwanuka N., Robb M., Kigozi G., Birx D., Philips J., Wabwire-Mangen F. Knowledge About Vaccines and Willingness to Participate in Preventive HIV Vaccine Trials: A Population-Based Study, Rakai Uganda. J Acquir Immune Defic Syndr 2004, 36(June (1)):721-725.
75. Nyamathi A., Koniak-Griffin D., Tallen L., González-Figueroa E., Levson L., Mosley Y., et al. Use of community-based participatory research in preparing low income and homeless minority populations for future HIV vaccines. J Interprof Care 2004, 18(November (4)):369-380.
76. Lesch A., Kafaar Z., Kagee A., Swartz L. Community members' perceptions of enablers and inhibitors to participation in HIV vaccine trial. S Afr J Psychol 2006, 36(4):734-761.
77. de Bruyn G., Skhosana N., Robertson G., McIntyre J.A., Gray G.E. Knowledge and attitudes towards HIV vaccines among Soweto adolescents. BMC Res Notes 2008, August (1):76.