Barriers to participating in an HIV vaccine trial

Mills, Edward J.; Cooper, Curtis; Guyatt, Gordon; Gilchrist, Amy; Rachlis, Beth; Sulway, Chris; Wilson, Kumanan

doi:10.1097/00002030-200411190-00003

Cited by 93 publications

(104 citation statements)

References 29 publications

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“…Concerns about false positives have been associated with lower WTP (Mills et al, 2004); yet this is a likely consequence of HIV vaccine trial participation. Trial participation might be facilitated by: provision of Polymerase Chain Reaction testing; identification cards indicating participation in a trial (e.g., HVTN 042; HVTN, 2004); testing algorithms that distinguish false positives from actual infection; and engagement of local communities in trial planning and implementation (Newman et al, 2006b).…”

Section: Discussionmentioning

confidence: 99%

“…HIV vaccine preparedness studies indicate that concerns about vaccine-induced infection, side effects, false HIV-positives, and trial-related discrimination are associated with lower WTP (Mills et al, 2004). Most studies used a compositional approach, administering a series of disparate questions to assess the impact of discrete trial attributes on WTP.…”

Section: Introductionmentioning

confidence: 99%

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Willingness to participate in HIV vaccine trials: The impact of trial attributes

Newman

Duan

Lee

et al. 2007

Preventive Medicine

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Objectives-To assess willingness to participate (WTP) in hypothetical Phase III preventive HIV vaccine trials, and the impact of trial attributes on WTP, among low socioeconomic, ethnically diverse adults from communities at elevated risk for HIV infection.Method-Participants (n=123; median age=38; 69% male; 37% Latino; 14% African-American) were recruited in Los Angeles in 2003 using multi-site, venue-based sampling. WTP was assessed for eight hypothetical HIV vaccine trials that varied across seven dichotomous attributes, using a 2 7-4 fractional factorial experimental design. Individual-specific impact of vaccine trial attributes on WTP was estimated using within-individual ANOVA and then meta-analyzed across individuals.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Willingness to participate in HIV vaccine trials: The impact of trial attributes

Newman

Duan

Lee

et al. 2007

Preventive Medicine

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“…These may include, among others, level of access to health coverage and financial resources; minority-held attitudes, beliefs, and perceptions about clini- 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 (n=76) (n=19) (n=67) (n=242) (n=243) (n=364) (n=259) (n=226) (n=312) (n=155) (n=281) (n=177) (n=55) (n=22) (n=172) cal research; or level of knowledge regarding clinical research. [13][14][15] Further assessment on the effectiveness of strategies to increase minority participation in clinical research in the U.S. is needed. 16 There are important reasons why further efforts to sustain and increase minority enrollment in HIV vaccine trials are needed.…”

Section: Enrollment Trends Of Racial/ethnic Minoritiesmentioning

confidence: 99%

Enrollment of Racial/Ethnic Minorities in NIAID-Funded Networks of HIV Vaccine Trials in the United States, 1988 to 2002

et al. 2005

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Objective. The purpose of this study was to analyze enrollment of racial/ethnic minorities in Phase I and Phase II HIV vaccine trials in the U.S. conducted by National Institute of Allergy and Infectious Diseases (NIAID)-funded networks from 1988 to 2002. Methods. A centralized database was searched for all NIAID-funded networks of HIV vaccine trial enrollment data in the U.S. from 1988 through 2002. The authors reviewed data from Phase I or Phase II preventive HIV vaccine trials that included HIV-1 uninfected participants at low to moderate or high risk for HIV infection based on self-reported risk behaviors. Of 66 identified trials, 55 (52 Phase I, 3 Phase II) met selection criteria and were used for analyses. Investigators extracted data on participant demographics using statistical software. Results. A total of 3,731 volunteers enrolled in U.S. NIAID-funded network HIV vaccine trials from 1988 to 2002. Racial/ethnic minority participants represented 17% of the overall enrollment. By pooling data across all NIAID-funded networks from 1988 to 2002, the proportion of racial/ethnic minority participants was significantly greater (Fisher's exact test p-value <0.001) in Phase II trials (278/1,061 or 26%) than in Phase I trials (347/2,670 or 13%). By generalized estimating equations, the proportion of minorities in Phase I trials increased over time ( p=0.017), indicating a significant increase in racial/ethnic minority participants from 1988 to 2002. Conclusions. There has been a gradual increase in racial/ethnic minority participation in NIAID-funded network HIV vaccine trials in the U.S. since 1988. In the light of recent efficacy trial results, it is essential to continue to increase the enrollment of diverse populations in HIV vaccine research.

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“…Several limitations of this study should be mentioned. First, the survey did not include issues related to vaccine trial attributes, such as vaccine-induced infection, side effects, or false-positives on HIV tests, which are associated with lower WTP (Mills, 2004). Thus, the results of this study may overestimate WTP.…”

Section: Resultsmentioning

confidence: 99%

Acceptability of HIV Vaccine - Efficacy Trials in Drug Users and Sexual Partners of HIV Infected Patients in Barcelona, Spain

Sanvisens¹,

Rivas²,

Guerola³

et al. 2011

HIV-infection - Impact, Awareness and Social Implications of Living With HIV/AIDS

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Barriers to participating in an HIV vaccine trial

Cited by 93 publications

References 29 publications

Willingness to participate in HIV vaccine trials: The impact of trial attributes

Willingness to participate in HIV vaccine trials: The impact of trial attributes

Enrollment of Racial/Ethnic Minorities in NIAID-Funded Networks of HIV Vaccine Trials in the United States, 1988 to 2002

Acceptability of HIV Vaccine - Efficacy Trials in Drug Users and Sexual Partners of HIV Infected Patients in Barcelona, Spain

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