Conceptual framework for behavioral and social science in HIV vaccine clinical research

Vaccine

Volumn 29, Issue 44, 2011, Pages 7794-7800

  Lau, Chuen Yen ^a   Swann, Edith M ^a   Singh, Sagri ^b   Kafaar, Zuhayr ^c   Meissner, Helen I ^d   Stansbury, James P ^e  

^a NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES   (United States)

^b INTERNATIONAL AIDS VACCINE INITIATIVE   (United States)

^c STELLENBOSCH UNIVERSITY   (South Africa)

^d NATIONAL INSTITUTES OF HEALTH   (United States)

^e CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Behavioral social science; Clinical trial; Conceptual framework; HIV vaccine

Indexed keywords

ANTIRETROVIRUS AGENT; HUMAN IMMUNODEFICIENCY VIRUS VACCINE; MICROBICIDE;

ARTICLE; BEHAVIORAL SCIENCE; CLINICAL RESEARCH; COMMUNITY; CONCEPTUAL FRAMEWORK; CONDOM; EPIDEMIC; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; PRIORITY JOURNAL; SOCIAL BEHAVIOR; SOCIOLOGY;

AIDS VACCINES; BEHAVIOR; BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; HUMANS; PATIENT COMPLIANCE; PATIENT PARTICIPATION; SOCIAL SCIENCES;

EID: 80053602998     PISSN: 0264410X     EISSN: 18732518     Source Type: Journal    
DOI: 10.1016/j.vaccine.2011.07.108     Document Type: Article

References (81)

1. Coates T., Richter L., Caceres C. Behavioral strategies to reduce HIV transmission: how to make them work better. Lancet 2008, 372:669-684.
2. Glanz K., Rimer B.K. Theory at a glance. A guide for health promotion practice 2005, National Cancer Institute, National Institutes of Health, U.S. Department of Health and Human Services, Washington, DC. 2nd ed.
3. Auerbach J. The role of behavioral research in HIV/AIDS prevention. Curr Opin Infect Dis 1998, 11:3-7.
4. Blankenship K., Bray S., Merson M. Structural interventions in public health. AIDS 2000, 14(Suppl. 1). S 11-21.
5. Rhodes F., Stein J., Fishbein M., Goldstein R., Rotheram-Borus M. Using theory to understand how interventions work: project RESPECT, condom use, and the integrative model. AIDS Behav 2007, 11:393-407.
6. Galea S., Ahern J., Vlahov D. Contextual determinants of drug use risk rehavior: a theoretical framework. J Urban Health Bull NY Acad Med 2003, 80(Suppl. 4 (4)). iii50-iii58.
7. Kafaar Z., Kagee S.A., Lesch A., Swartz L. Is participation in HIV vaccine trials a health promoting behaviour?. AIDS Care 2007, 19(10):1307-1309.
8. Swartz L., Kagee A., Lesch A., Kafaar Z., Fincham D., Ntlemeza B. Community members' perceptions of enablers and inhibitors to participation in HIV/AIDS vaccine trials 2006, South African AIDS Vaccine Initiative, Stellenbosch, South Africa.
9. International AIDS Vaccine Initiative University of Nairobi, international center for research on women. Gender related barriers and social impact of women's participation in AIDS vaccine research 2008, International Center for Research on Women, Washington, DC.
10. International Center for Research on Women International AIDS vaccine initiative. University of Nairobi. Clinical science meets social science: gender and AIDS vaccine research 2008, International Center for Research on Women, Washington, DC.
11. AVAC Good participatory practice guidelines for biomedical HIV prevention trials 2010, UNAIDS, AVAC, Switzerland.
12. Auerbach J. Sociological AIDS research needs an intervention. Footnotes: a publication of the American sociological association September/October 2008, vol. 36 (7). Available at: http://www.asanet.org/footnotes/septoct08/aids.html.
13. Friedman S., Kippax S., Phaswana-Mafuya N., Rossi D., Newman C. Emerging future issues in HIV/AIDS social research. AIDS 2006, 20:959-965.
14. Berkman L.F., Kawachi I. A historical framework for social epidemiology. Social epidemiology 2000, Oxford, New York, p. 3-12.
15. Link B., Phelan J. Social conditions as fundamental causes of disease. J Health Soc Behav 1995, (Extra issue):80-94.
16. Hargreaves J., Bonell C., Boler T., Boccia D., Birdthistle I., Fletcher A., et al. Systematic review exploring time trends in the association between educational attainment and risk of HIV in sub-Saharan Africa. AIDS 2008, 22:403-414.
17. Johnson L., Dorrington R., Bradshaw D., du Plessis H., Makubalo L. The effect of educational attainment and other factors on HIV risk in South African women: results from antenatal surveillance, 2000-2005. AIDS 2009, 23:1583-1588.
18. UNAIDS ITToE A strategic approach: HIV and AIDS in education May 2009, UNAIDS, Paris.
19. Mavedzenge S.N., Weiss H.A., Montgomery E.T., Blanchard K., de Bruyn G., Ramjee G., et al. Determinants of differential HIV incidence among women in three southern African locations. J AIDS 2011, June 7 [Epub ahead of print]. 10.1097/QAI.0b013e3182254038.
20. Mah T.L., Halperin D.T. Concurrent sexual partnership and the HIV epidemics in Africa: evidence to move forward. AIDS Behav 2010, 14:11-16.
21. Epstein H. The invisible cure. Africa, the west, and the fight against AIDS 2007, Farrar, Straus, Giroux, New York.
22. Green E.C. Rethinking AIDS prevention: learning from successes in developing countries 2003, Preager, Westport, CT.
23. Fisher H.H., Patel-Larson A., Green K., Shapatava E., Uhl G., Kalayil E.J., et al. Evaluation of an HIV prevention intervention for African Americans and Hispanics: findings from the VOICES/VOCES community-based organization behavioral outcomes project. AIDS Behav 2011, May 14 [Epub ahead of print: PMID: 21573724].
24. Johnson W.D., Diaz R.M., Flanders W.D., Goodman M., Hill A.N., Holtgrave D., et al. Behavioral interventions to reduce risk for sexual transmission of HIV among men who have sex with men. Cochrane Database Syst Rev 2008, (July (3)). CD001230.
25. CDC hiv testing among men who have sex with men - 21 cities, United States, 2008. MMWR 2011, 60(June (21)):694-6999.
26. Car L.T., van-Velthoven M.H., Brusamento S., Elmoniry H., Car J., Majeed A., et al. Integrating prevention of mother-to-child HIV transmission (PMTCT) programs with other health services for preventing HIV infection and improving HIV outcomes in developing countries. Cochrane Database Syst Rev June 2011, 6. CD008741.
27. El-Sadr W., Affrunti M., Gamble T., Zerbe A. Antiretroviral therapy: a promising HIV prevention strategy?. J AIDS 2010, 55(Suppl. 2):s116-s121.
28. Nachega J.B., Marconi V.C., van Zyl G.U., Gardner E.M., Preiser W., Hong S.Y., et al. HIV treatment adherence, drug resistance, virologic failure: evolving concepts. Infect Disord Drug Targets 2011, 11(April (2)):167-174.
29. McCoy C.B., De Gruttola V., Metsch L., Comerford M. A comparison of the efficacy of two interventions to reduce HIV risk behaviors among drug users. AIDS Behav 2011, 9975-9981. [Epub ahead of print]. 10.1007/s10461-011-9975-1.
30. Semple S.J., Strathdee S.A., Zians J., McQuaid J.R., Patterson T.L. Drug assertiveness and sexual risk-taking behavior in a sample of HIV-positive, methamphetamine-using men who have sex with men. J Subst Abuse Treat 2011, May 6 [Epub ahead of print: PMID: 21550758].
31. CDC Syringe exchange programs - United States, 2008. MMWR 2010, 59(45):1488-98509.
32. Kalichman S.C., Cherry C., Kalichman M.O., Amaral C.M., White D., Pope H., et al. Integrated behavioral intervention to improve HIV/AIDS treatment adherence and reduce HIV transmission. Am J Public Health 2011, 101(March (3)):531-538. [Epub 2011 January 13].
33. Simbayi L.C., Kalichman S.C., Skinner D., Jooste S., Cain D., Cherry C., et al. Theory-based HIV risk reduction counseling for sexually transmitted infection clinic patients in Cape Town. South Africa Sex Transm Dis 2004, 31(December (12)):727-733.
34. Cowan F.M., Pascoe S.J., Langhaug L.F., Mavhu W., Chidiya S., Jaffar S., et al. The Regai Dzive Shiri project: results of a randomized trial of an HIV prevention intervention for youth. AIDS 2010, 24(October (16)):2541-2552.
35. Ross D.A. Behavioural interventions to reduce HIV risk: what works?. AIDS 2010, 24(October (Suppl. 4)):S4-S14.
36. Schaalma H., Aarø L.E., Flisher A.J., Mathews C., Kaaya S., Onya H., et al. Correlates of intention to use condoms among Sub-Saharan African youth: the applicability of the theory of planned behaviour. Scand J Public Health 2009, 37(June (Suppl. 2)):87-91.
37. Cowan F.M., Pascoe S.J., Langhaug L.F., Dirawo J., Chidiya S., Jaffar S., et al. The Regai Dzive Shiri Project: a cluster randomised controlled trial to determine the effectiveness of a multi-component community-based HIV prevention intervention for rural youth in Zimbabwe - study design and baseline results. Trop Med Int Health 2008, 13(October (10)):1235-1244.
38. Jewkes R., Nduna M., Levin J., Jama N., Dunkle K., Puren A., et al. Impact of stepping stones on incidence of HIV and HSV-2 and sexual behavior in rural South Africa: cluster randomized controlled trial. BMJ 2008, 337(August):a506.
39. Ross D.A., Changalucha J., Obasi A.I., Todd J., Plummer M.L., Cleophas-Mazige B., et al. Biological and behavioral impact of an adolescent sexual health intervention in Tanzania: a community-randomized trial. AIDS 2007, 21(September (14)):1943-1955.
40. Obasi A.I., Cleophas B., Ross D.A., Chima K.L., Mmassy G., Gavyole A., et al. Rationale and design of the MEMA kwa Vijana adolescent sexual and reproductive health intervention in Mwanza Region, Tanzania. AIDS Care 2006, 18(May (4)):311-322.
41. Aarø L.E., Flisher A.J., Kaaya S., Onya H., Fuglesang M., Klepp K.I., et al. Promoting sexual and reproductive health in early adolescence in South Africa and Tanzania: development of a theory- and evidence-based intervention program. Scand J Public Health 2006, 34(2):150-158.
42. Jewkes R., Nduna M., Levin J., Jama N., Dunkle K., Khuzwayo N., et al. A cluster randomized-controlled trial to determine the effectiveness of Stepping Stones in preventing HIV infections and promoting safer sexual behavior amongst youth in the rural Eastern Cape, South Africa: trial design, methods and baseline findings. Trop Med Int Health 2006, 11(January (1)):3-16.
43. Adimora A.A., Auerbach J.D. Structural interventions for HIV prevention in the United States. J AIDS 2010, 55(Suppl. 2):s132-s135.
44. Parker R., Aggleton P. HIV and AIDS-related stigma and discrimination: a conceptual framework and implications for action. Soc Sci Med 2003, 57:13-24.
45. Allen M., Lau C.Y. Social impact of preventive HIV vaccine clinical trial participation: a model of prevention, assessment and intervention. Soc Sci Med 2008, 66:945-951.
46. Lau C., Stansbury J.P., Gust D.A., Kafaar Z. Social and behavioral science in HIV vaccine trials: a gap assessment of the literature. Expert Rev Vaccines 2009, 8(2):179-190.
47. Muthuswamy V. Ethical issues in HIV/AIDS research. Indian J Med Res 2005, 121:601-610.
48. 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.
49. Tarimo E.A., Thorson A., Kohi T.W., Bakari M., Mhalu F., Kulane A. Reasons fordeclining to enroll in a phase I and II HIV vaccine trial after randomizationamong eligible volunteers in Dar es Salaam, Tanzania. PLoS One 2011, 6(February (2)):e14619.
50. Tarimo E.A., Thorson A., Kohi T.W., Mwami J., Bakari M., Sandström E., et al. Balancing collective responsibility, individual opportunities and risks: a qualitative study on how police officers reason around volunteering in an HIV vaccine trial in Dar es Salaam, Tanzania. BMC Public Health 2010, 10(May):292.
51. Dhalla S., Woods R., Strathdee S.A., Patrick D.M., Hogg R.S. HIV vaccine preparedness studies in the organization for economic co-operation and development (OECD) countries. AIDS Care 2007, 19(October (9)):1118-1127. [Epub 2007 June 13. Review. Erratum in: AIDS Care 2008 Feb;20(2):3 p following 262].
52. Dhalla S., Nelson K.E., Singer J., Poole G. HIV vaccine preparedness studies in the non-organization for economic co-operation and development (non-OECD) countries. AIDS Care 2009, 21(March (3)):335-348.
53. Jenkins R., Thapinta D., Morgan P., Wongkamhaeng S., Sornsathapornkul P., Bussaratid V., et al. Behavioral and social issues among volunteers in a preventative HIV vaccine trial in Thailand. J Acquir Immune Defic Syndr 2005, 40(5):592-599.
54. Lesch A., Kafaar Z., Kagee S.A., Swartz L. Community members' perceptions of enablers and inhibitors to participation in HIV vaccine trials. S Afr J Psychol 2006, 36(4):734-761.
55. 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(1):108-123.
56. 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. [review].
57. Socio-behavioural Working Group South African AIDS Vaccine Initiative (SAAVI) and International AIDS Vaccine Initiative (IAVI). Meeting Report on Facilitating Meaningful Community Participation in HIV Vaccine Research 2007, SAAVI and IAVI, Stellenbosch, South Africa.
58. Lindegger G., Milford C., Slack C., Quayle M., Xaba X., Vardas E. Beyond the checklist: assessing understanding for HIV vaccine trial participation in South Africa. J Acquir Immune Defic Syndr 2006, 43(December (5)):560-566.
59. Colfax G., Buchbinder S., Vamshidar G., Celum C., McKirnan D., Neidig J., et al. Motivations for Participating in an HIV vaccine efficacy trial. J Acquir Immune Defic Syndr 2005, 39(3):359-364.
60. Newman P., Duan N., Lee S., 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.
61. Newman P., Duan N., Roberts K., Seiden D., Rudy E., Swendeman D., et al. HIV vaccine trial participation among ethnic minority communities, barriers, motivators, and implications for recruitment. J AIDS 2006, 41(2):210-217.
62. Strauss R., Sengupta S., Kegeles S., McLellan E., Metzger D., Eyre S., et al. Willingness to volunteer in future prevention HIV vaccine trials: issues and perspectives from three U. S. communities. J AIDS 2001, 26:63-71.
63. Campbell C. Letting them die: why HIV/AIDS intervention programmes fail 2003, James Currey, Oxford.
64. Swartz L., Singh S., Giocos G., Martin L., Louw L., Kagee A., et al. Facilitating meaningful community participation in HIV vaccine research. Poster presented at the AIDS Vaccine International Conference 2007.
65. Zimet G.D., Liau A., Fortenberry V.D. Health beliefs and intention to get immunized for HIV. J Adolesc Health 1997, 20(May (5)):354-359.
66. Newman P.A., Logie C. HIV vaccine acceptability: a systematic review and meta-analysis. AIDS 2010, 24(July (11)):1749-1756.
67. 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. [Epub 2008 March 28].
68. Sayles J., Macphail C., Newman P., Cunningham W., Future HIV Vaccine acceptability among young adults in South Africa. Health Educ Behav 2010, 37(2):193-210.
69. Kakinami L., Newman P., Lee S., Duan N. Differences in HIV vaccine acceptability between genders. AIDS Care 2008, 20(5):542-546.
70. Sengupta S., Strauss P., Miles M., Roman-Isler M., Banks B., Corbie-Smith G.A. Conceptual model exploring the relationship between HIV stigma and implementing HIV clinical trials in rural communities of North Carolina. N C Med J 2010, 71(2):113-122.
71. Newman P., Seiden D., Roberts K., Kakinami L., Duan N. A small dose of HIV? HIV vaccine mental models and risk communication. Health Educ Behav 2009, 36(2):321-333.
72. 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, 3(3):308-311.
73. Roberts K., Newman P., Duan N., Rudy E. HIV vaccine knowledge and beliefs among communities at elevated risk: conspiracies, questions and confusion. J Natl Med Assoc 2005, 97(December (12)):1662-1671.
74. Frew P., Macias W., Chan K., Harding A. In " Step" with HIV vaccines?. a content analysis of local recruitment campaigns for an international HIV vaccine study. J Health Mass Commun 2009, 1(1):11-39.
75. Djomand G., Metch B., Zorrilla C., Donastrog Y., Casapia M., Villafana T., et al. The HVTN protocol 903 vaccine preparedness study. J AIDS 2008, 48(1):82-89.
76. Russell F., Carapetis J., Liddle T., Edwards T., Ruff T., Devitt J. A pilot study of the quality of informed consent materials for Aboriginal participants in clinical trials. J Med Ethics 2011, 31:490-494.
77. de Bruyn G., Skhosana N., Robertson G., McIntyre J., Gray G. Knowledge and attitudes towards HIV vaccines among Soweto adolescents. BMC Res Notes August 2008, 1:76.
78. Gray K., Legg K., Sharp A., Mackie O., De Souza C., Weber J., et al. Participation in two phase II prophylactic HIV vaccine trials in the UK. Vaccine 2008, 26:2919-2924.
79. Newman P., Yim S., Daley A., Walisser R., Halpenny R., Cunningham W., et al. " Once Bitten, Twice Shy" ; Participant perspectives in the aftermath of an early HIV vaccine trial termination. Vaccine 2010, 29:451-458.
80. Frew P., del Rio C., Lu L., Clifton S., Mulligan M. Understanding differences in enrollment outcomes among high-risk populations recruited to a phase IIb HIV vaccine trial. JAIDS 2009, 50(3):314-319.
81. Smit J., Middlekoop K., Myer L., Lindegger G., Swartz L., Seedat S., et al. Socio-behavior challenges to phase III HIV vaccine trials in sub-Saharan Africa. Afr Health Sci 2005, 5(3):198-206.