Socio-behaviour challenges to phase III HIV vaccine trials in sub-Saharan Africa

African Health Sciences

Volumn 5, Issue 3, 2005, Pages 198-206

  Smit, Joalida ^a,b   Middelkoop, Keren ^b   Myer, Landon ^b   Lindegger, Graham ^c   Swartz, Leslie ^a   Seedat, Soraya ^a   Tucker, Tim ^d   Wood, Robin ^b   Bekker, Linda Gail ^b   Stein, Dan J ^a  

^a STELLENBOSCH UNIVERSITY   (South Africa)

^b UNIVERSITY OF CAPE TOWN   (South Africa)

^c UNIVERSITY OF KWAZULU NATAL   (South Africa)

^d SOUTH AFRICAN MEDICAL RESEARCH COUNCIL   (South Africa)

Author keywords

Africa; Behaviour; Clinical trials; HIV; Preparation; Review; Vaccines

Indexed keywords

HUMAN IMMUNODEFICIENCY VIRUS VACCINE;

AFRICA; BEHAVIORAL RESEARCH; CLINICAL RESEARCH; CLINICAL TRIAL; CULTURAL FACTOR; DATA ANALYSIS; DATA BASE; DECISION MAKING; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; EVIDENCE BASED MEDICINE; HEALTH BEHAVIOR; HEALTH PROMOTION; HEALTH STATUS; HETEROSEXUALITY; HIGH RISK POPULATION; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; INFECTION PREVENTION; INTERMETHOD COMPARISON; MEDLINE; PATIENT ATTITUDE; PATIENT PARTICIPATION; PSYCINFO; REVIEW; RISK ASSESSMENT; RISK REDUCTION; SEXUAL BEHAVIOR; SOCIAL ASPECT; SYSTEMATIC REVIEW;

AFRICA SOUTH OF THE SAHARA; AIDS VACCINES; BEHAVIORAL RESEARCH; CLINICAL TRIALS, PHASE III AS TOPIC; HIV INFECTIONS; HUMANS; SOCIAL BEHAVIOR;

EID: 33747287677     PISSN: 16806905     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (104)

1. Esparza J, Bhamarapravati N. Accelerating the development and future availability of HIV-1 vaccines: why, when, where, and how? Lancet 2000; 355: 2061-6.
2. UNAIDS. Fourth global report on the AIDS epidemic. Geneva, Switzerland: UNAIDS, 2004.
3. Parker R. The global HIV/AIDS pandemic, structural inequalities and the politics of international health. Am J Public Health 2002; 92: 343-6.
4. Myer L, Morroni C, Susser ES. The social pathology of the HIV/AIDS pandemic. Int J Epidemiol 2003; 32: 189-192.
5. Dunkle KL, Jewkes RK, Brown HC, Gray GE, McIntyre JA, Harlow SD. Gender-based violence, relationship power, and risk of HIV infection in women attending antenatal clinics in South Africa. Lancet 2004; 363: 1415-21.
6. MacPhail C, Campbell C. 'I think condoms are good but, aai, I hate those things': condom use among adolescents and young people in a Southern African township. Soc Sci Med 2001; 52: 1613-27.
7. Little F, Myer L, Mathews C. Barriers to accessing free condoms at public health facilities across South Africa. S Afr Med J 2002; 92: 218-20.
8. Stoneburner RL, Low-Beer D. Sexual partner reductions explain human immunodeficiency virus declines in Uganda: comparative analyses of HIV and behavioural data in Uganda, Kenya, Malawi, and Zambia. Int J Epidemiol 2004; 33: 624.
9. Cohen DA, Scribner R. An STD/HIV prevention intervention framework. AIDS Patient Care STD 2000; 14: 37-45.
10. Gupta GR. Gender and HIV / AIDS: transforming prevention programs. AidsCaptions. 1995; 2: 8-10.
11. Tucker TJ, Mazithulela G. Development of an AIDS vaccine: perspective from the South African AIDS Vaccine Initiative. BMJ 2004; 329: 454-6.
12. Francis DP, Heyward WL, Popovic V, Orozco-Cronin P, Oreland K, Gee C. Candidate HIV/AIDS vaccines: lessons learned from the world's first phase III efficacy trials. AIDS 2003; 17: 147-56.
13. Weidle PJ, Mastro T D, Grant AD, Nkengasong J, Macharia D. HIV/AIDS treatment and HIV vaccines for Africa. Lancet 2002; 359: 2261-2267.
14. Burton DR, Desrosiers RC, Doms RW, Feinberg MB, Gallo RC, Hahn B. A Sound Rationale Needed for Phase III HIV-1 Vaccine Trials. Science 2004; 303: 316.
15. Vermund SH. Vaccine Efficacy Trials for Human Immunodeficiency Virus/ Acquired Immunodeficiency Syndrome Are Feasible in the United States: A Commentary on the HIVNET Vaccine Preparedness Study. Am J Epidemiol 2001; 153: 628-31.
16. Cohen J. No Consensus on Rules for AIDS Vaccine Trials. Science 1998; 281: 22-3.
17. Temoshok LR. Behavioral research contributions to planning and conducting HIV vaccine efficacy studies. AIDS Res Hum Retroviruses 1994; 10: s277-s280.
18. World Health Organisation. Future access to HIV vaccines. Report from a WHO-UNAIDS Consultation, Geneva, 2-3 October 2000. AIDS 2001; 15: w27-w44.
19. Lurie, M. Migration and AIDS in southern Africa: A review. S A J Sci 2000; 96: 343-346.
20. Awotona A. Approaches to post-war reconstruction and development: Lessons from Africa. Habitat International 1992; 16: 79-98.
21. Alubo SO. Debt crisis, health and health services in Africa. Soc Sci Med 1990; 31: 639-48.
22. Benedicta E. Femanomics, women literacy and economics in Sub Saharan Africa. Equal Opportunities International 2000; 19: 8-16.
23. Chesney MA, Lurie P, Coates TJ. Strategies for addressing the social and behavioral challenges of prophylactic HIV vaccine trials. J Acquir Imune Defic Syndr Hum Retrovirol 1995; 9: 30-5.
24. Grinstead OA. Social and behavioral issues in phase III HIV preventive vaccine trials. AIDS 1995; 9: s245-s250.
25. Lindegger G, Slack C, Vardas E. HIV vaccine trials in South Africa - some ethical considerations. S Afr Med J 2000; 90: 769-72.
26. Lurie P, Bishaw M, Chesney MA, Cooke M, Fernandes ME, Hearst N. Ethical, behavioral, and social aspects of HIV vaccine trials in developing countries. JAMA 1994; 271: 295-301.
27. Moodley K. HIV Vaccine Trial participation in South Africa: An ethical assessment. J Med Philos 2002; 27: 197-215.
28. Mugenyi PN. HIV vaccines: the Uganda experience. Vaccine 2002; 20: 1905-8.
29. Bass E. VaxGen trial yields trove of behavioural and social science findings. IAVI Report 2003; 7: 1.
30. Van Griensvan F, Keawkungwal J, Tappero JW, Sangkum U, Pitisuttithum P, Vanichseni S. Lack of increased HIV risk behavior among injection drug users participating in the AIDSVAX B/E HIV vaccine trial in Bangkok, Thailand. AIDS 2004; 18: 295-301.
31. Koblin BA, Taylor PE, Avrett S, Stevens CE. The feasibility of HIV-1 vaccine efficacy trials among gay/bisexual men in New York City: Project ACHIEVE. AIDS Community Health Initiative Enroute to the Vaccine Effort. AIDS 1996; 10: 1555-61.
32. Sheon AR. Overview: HIV vaccine feasibility studies. AIDS Res Hum Retroviruses 1994; 10: s195-s196.
33. Vermund SH. The role of prevention research in HIV vaccine trials. AIDS Res Hum Retroviruses 1994; 10: s303-s305.
34. Seage GR, Holte S, Metzger D, Koblin BA, Gross M, Celum C. Are US populations appropriate for trials of human immunodeficiency virus vaccine? Am J Epidemiol 2001; 153: 619-627.
35. Blower SM, McLean AR. Prophylactic vaccines, risk behaviour change, and the probability of eradicating HIV in San Francisco. Science 1994; 265: 1451-1454.
36. Chesney MA, Chambers DB, Kahn JO. Risk behavior for HIV infection in participants in preventive HIV vaccine trials: a cautionary note. J Acquir Immune Defic Syndr Hum Retrovirol 1997; 16: 266-71.
37. Piot, P. Report by the executive director. Joint United Nations Programme on AIDS. Presented in Rio de Janeiro, 15-16 December. 2002.
38. UNAIDS. An overview of HIV/AIDS related stigma. Geneva: UNAIDS, 2004.
39. UNAIDS. HIV/AIDS related stigma and discrimination. A review and suggested ways forward for South Asia. Geneva: UNAIDS, 2002.
40. Baleta A. South African faces an AIDS crisis as government health campaigns fail. Lancet 1999; 353: 653.
41. Maduna-Butshe AC. Women sex workers and the HIV pandemic: stigma and blame in context. SAfAIDS News 1997; 5: 8-11.
42. Muyinda H, Seeley J, Pickering H, Barton T. Social aspects of AIDS-related stigma in rural Uganda. Health Place 1997; 3: 143-7.
43. Allen M, Israel H, Rybczyk K, Pugliese MA, Loughran K, Wagner L. Trial-related discrimination in HIV vaccine clinical trials. AIDS Res Hum Retroviruses 2001; 17: 667-74.
44. Thapinta D, Jenkins RA, Celentano DD, Nitayaphan S, Buapunth P, Triampon A. Evaluation of behavioral and social issues among Thai HIV vaccine trial volunteers. J Acquir Immune Defic Syndr Hum Retrovirol 1999; 20: 308-14.
45. Esparza J, Osmanov S. HIV vaccines: A global perspective. Curr Mol Med 2003; 3: 183-93.
46. Garber DA, Silvestri G, Feinberg MB. Prospects for an AIDS vaccine: three big questions, no easy answers. Lancet Infect Dis 2004; 4: 397-413.
47. Hoth DF, Bolognesi DP, Corey L, Vermund SH. HIV Vaccine Development: A Progress Report. Ann Intern Med 1994; 121: 603-11.
48. Johnson AM, Laga M. Heterosexual transmission of HIV. AIDS 1988; 2: S49-S56.
49. Mann JM. Heterosexual transmission of HIV: a global view a decade later. Int J STD AIDS 1993; 4: 353-6.
50. N'Galy B, Ryder RW. Epidemiology of HIV infection in Africa. J Acquir Immune Defic Syndr 1988; 1: 551-8.
51. Heyward WL, Osmanov S, Esparza J. Establishment of WHO-sponsored sites for HIV vaccine evaluation in developing countries. In: Giraldo G, Bolognesi DP, Salvatore M, Beth-Giraldo E, eds. Development and application of vaccines and gene therapy for AIDS. Vol 48 of Antibiotics and Chemotherapy, Basel, Switzerland, Karger AG Press, 1996;139-44.
52. O'Connell JM, Hogg RS, Chan K, Strathdee SA, McLean N, Martindale SL. Willingness to participate and enroll in a phase 3 preventive HIV-1 vaccine trial. J Acquir Immune Defic Syndr 2002; 31: 521-8.
53. Hays RB, Kegeles SM. 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: 164-71.
54. Koblin BA, Heagerty P, Sheon A, Buchbinder S, Celum C, Douglas JM. 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: 785-93.
55. Celentano DD, Beyrer C, Natpratan C, Eiumtrakul S, Sussman I, Renzullo PO. Willingness to participate in AIDS vaccine trials among high-risk populations in northern Thailand. AIDS 1995; 9: 1079-83.
56. Jenkins RA, Temoshok LR and Virochsiri K. Incentives and h. J Acquir Immune Defic Syndr Hum Retrovirol 1995; 9: 36-42.
57. Jenkins RA, Torugsa K, Markowitz LE, Mason CJ, Jamroentana V, Brown AE. Willingness to participate in HIV-1 vaccine trials among young Thai men. Sex Transm Infect 2000; 76: 386-92.
58. McGrath JW, George K, Svilar G, Ihler E, Mafigiri D, Kabugo M. 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: 381-8.
59. Halpern SD, Metzger DS, Berlin JA, Ubel PA. Who will enroll? Predicting participation in a phase II AIDS vaccine trial. J Acquir Immune Defic Syndr 2001; 27: 281-8.
60. Maek-A-Nantawat, Pitisuttithum P, Phonrat B, Bussaratid V, Naksrisook S, Peonim W. Evaluation of attitude, risk behavior and expectations among Thai participants in Phase I/II HIV/AIDS vaccine trials. J Med Assoc Thai 2003; 86: 299-307.
61. Koblin BA, Avrett S, Taylor PE, Stevens CE. 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: 165-171.
62. Bartholow BN, MacQueen KM, Douglas JM, Buchbinder S, McKirnan D and Judson FN. 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: 108-15.
63. Koblin BA, 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: 451-7.
64. Moodley K, Barnes J, van Rensburg EJ, 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: 904-6.
65. MacQueen KM, Buchbinder S, Douglas JM, Judson FN, McKirnan DJ, 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; 10: s261-s264.
66. Strauss RP, Sengupta S, Kegeles S, McLellan E, Metzger D, Eyre S. Willingness to volunteer in future preventive HIV vaccine trials: issues and perspectives from three U.S. communities. J Acquir Immune Defic Syndr 2001; 26: 63-71.
67. McGrath JW, Mafigiri D, Kamya M, George K, Senvewo R, Svilar G. Developing AIDS vaccine trials educational programs in Uganda. J Acquir Immune Defic Syndr 2001; 26: 176-81.
68. Scheer S, Douglas JM, Jr., Vittinghoff E, Bartholow BN, McKirnan D, Judson FN. Feasibility and suitability of targeting young gay men for HIV vaccine efficacy trials. J Acquir Immune Defic Syndr Hum Retrovirol 1999; 20: 172-8.
69. Perisse AR, Schechter M, Moreira RI, do Lago RF, Santoro-Lopes G, Harrison LH. 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: 459-63.
70. Grady C. HIV preventive vaccine research: selected ethical issues. J Med Philos 1994; 19: 595-612.
71. Gagnon MP, Godin G. Young adults and HIV vaccine: determinants of the intention of getting immunized. Can J Public Health 2000; 91: 432-4.
72. Ijsselmuiden CB, Faden RR. Research and informed consent in Africa - another look. N Eng J Med 1992; 326: 830-833.
73. Mariner KW. Taking informed consent seriously in global HIV vaccine research. J Acquir Immune Defic Syndr 2003; 32: 117-122.
74. Oliver S. Informed consent and transcultural research. SAMJ 1995; 85: 984-985.
75. Woody GE, Metzger D, Mulvaney F. Preparations for AIDS vaccine trials. Recruitment and retention of in- and out-of-treatment injection drug users. AIDS Res Hum Retroviruses 1994; 10: s197-s199.
76. Nelson KE, Beyrer C, Natpratan C, Eiumtrakul S, Celentano DD, Khamboonruang C. Preparatory studies for possible HIV vaccine trials in northern Thailand. AIDS Res Hum Retroviruses 1994; 10: s243-s246.
77. Jackson JB, Musoke P, Fleming T, Guay LA, Bagenda D, Allen M, Nakabiito C, Sherman J, et al. Intrapartum and neonatal single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: 18-month follow-up of the HIVNET 012 randomised trial. Lancet 2003; 362: 859-68.
78. Baeten JM, Richardson BA, Martin HL, Jr., Nyange PM, Lavreys L, Ngugi EN. Trends in HIV-1 incidence in a cohort of prostitutes in Kenya: implications for HIV-1 vaccine efficacy trials. J Acquir Immune Defic Syndr 2000; 24: 458-64.
79. Brown-Peterside P, Rivera E, Lucy D, Slaughter I, Ren L, Chiasson MA. Retaining hard-to-reach women in HIV prevention and vaccine trials: Project ACHIEVE. Am J Public Health 2001; 91: 1377-9.
80. Marmor M, Titus S, Wolfe H, Krasinski K, Maslansky R, Simberkoff M. Preparations for AIDS vaccine trials. Retention, behavior change, and HIV-seroconversion among injecting drug users (IDUs) and sexual partners of IDUs. AIDS Res Hum Retroviruses 1994; 10: s207-s213.
81. Bakari M, Lyamuya E, Mugusi F, Aris E, Chale S, Magao P. The prevalence and incidence of HIV-1 infection and syphilis in a cohort of police officers in Dar es Salaam, Tanzania: a potential population for HIV vaccine trials. AIDS 2000; 14: 313-20.
82. Deschamps MM, Johnson WD, Jr and Pape JW. Feasibility and cohort development for HIV vaccine trials in Haiti. AIDS Res Hum Retroviruses 1994; 10: s231-s233.
83. Douglas JM, Judson FN, Parks JP, Buchbinder S and 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; 10: s257-s260.
84. Jackson DJ, Martin HL, Bwayo JJ, Nyange PM, Rakwar JP, Kashonga F. Acceptability of HIV vaccine trials in high-risk heterosexual cohorts in Mombasa, Kenya. AIDS 1995; 9: 1279-83.
85. Myer L, Mathews C, Little F. Condom use and sexual behaviors among individuals procuring free male condoms in South Africa: a prospective study. Sex Transm Dis 2002; 29: 239-41.
86. Weinhardt LS, Forsyth AD, Cary MP, Jaworski BC, Durant LE. Reliability and validity of self-report measures of HIV-related sexual behaviour: Progress since 1990 and recommendations for research and practice. Arc Sex Beh 1998; 27: 155-181.
87. McKirnan DJ, Doetsch J, Vanable P, Buchbinder S, Douglas JM and Judson F. Preparations for AIDS vaccine trials. Developing brief valid screening instruments for HIV-related sexual risk behavior among gay and bisexual men. AIDS Res Hum Retroviruses 1994; 10: s285-s288.
88. Aquilino WS. Privacy effects on self-reported drug-use: interactions with survey mode and respondents characteristics. NIDA research monograph 1997; 167: 383-415.
89. Bloom DE. Technology, experimentation, and the quality of survey data. Science 1998; 98: 867-73.
90. Catania JA. A framework for conceptualising reporting bias and its antecendents in interviews assessing human sexuality. J Sex Res 1999; 36: 25-38.
91. Des Jarlais DC, Paone D, Milliken J, Turner CF, Miller H, Gribble J. Audio-computer interviewing to measure risk behaviour for HIV among injecting drug users: a quasi-randomised trial. Lancet 1999; 353: 1657-61.
92. Gribble JN, Miller HG, Rogers SM and Turner CF. Interview mode and measurement of sexual behaviours: Methodological issues. J Sex Res 1990; 26: 16-23.
93. Catania JA, Gibson DR, Chitwood DD, Coates TJ. Methodological problems in AIDS behavioural research: influences on measurement error and participation bias in studies of sexual behaviour. Psych Bull 1990; 108: 339-362.
94. Turner CF, Ku L, Rogers SM, Lindberg LD, Pleck JH, Sonenstein FL. Adolescent Sexual Behavior, Drug Use, and Violence: Increased Reporting with Computer Survey Technology. Science 1998; 280: 867-73.
95. Cooley PC, Rogers SM, Turner CF, Al Tayyib AA, Willis G, Ganapathi L. Using touch screen audio-CASI to obtain data on sensitive topics. Computers in Human Behavior 2001; 17: 285-93.
96. Van de Wijgert J, Padian N, Shiboski S, Turner C. Is audio computer-assisted self-interviewing a feasible method of surveying in Zimbabwe? Int J Epidemiol 2000; 29: 885-90.
97. Johnson AM, Copas AJ, Erens B, Mandalia S, Fenton K, Korovessis C. Effect of computer-assisted self-interviews on reporting of sexual HIV risk behaviours in a general population sample: a methodological experiment. AIDS 2001; 15: 111-5.
98. Des Jarlais DC, Paone D, Milliken J, Turner CF, Miller H, Gribble J. Audio-computer interviewing to measure risk behaviour for HIV among injecting drug users: a quasi-randomised trial. Lancet 1999; 353: 1657-61.
99. Williams ML, Freeman RC, Bowen AM, Zhao Z, Elwood WN, Gordon C. A comparison of the reliability of self-reported drug use and sexual behaviors using computer-assisted versus face-to-face interviewing. AIDS Educ Prev 2000; 12: 199-213.
100. Jennings TE, Lucenko BA, Malow RM, Devieux JG. Audio-CASI vs interview method of administration of an HIV/STD risk of exposure screening instrument for teenagers. Int J STD AIDS 2002; 13: 781-4.
101. Gallant M, Maticka-Tyndale E. School-based HIV prevention programmes for African youth. Soc Sci Med 2004; 58: 1337-51.
102. Jegede AS, Odumosu O. Gender and health analysis of sexual behaviour in south-western Nigeria. Afr J Reprod Health 2003; 7:63-70.
103. Musoke D. Another condom uproar in Uganda. New Afr 1991; 37.
104. Dare OO, Cleland JG. Reliability and validity of survey data on sexual behaviour. Health Transit Rev 1994; 4: 93-110.