Readiness of High-Risk Populations in the HIV Network for Prevention Trials to Participated in HIV Vaccine Efficacy Trials in the United States

Boston University, Boston, Massachusetts, United States
AIDS (Impact Factor: 5.55). 06/1998; 12(7):785-93. DOI: 10.1097/00002030-199807000-00015
Source: PubMed


To determine the willingness of populations at high risk of HIV-1 infection to participate in HIV vaccine efficacy trials, determine factors influencing decision-making, and evaluate knowledge levels of vaccine trial concepts.
Cross-sectional study.
HIV-1-negative homosexual men, male and female injecting drug users and non-injecting women at heterosexual risk were recruited in eight cities in the United States (n=4892).
A substantial proportion of the study population (77%) would definitely (27%) or probably (50%) be willing to participate in a randomized vaccine efficacy trial. Increased willingness was associated with high-risk behaviors, lower education level, being uninsured or covered by public insurance, and not having been in a previous vaccine preparedness study. Altruism and a desire for protection from the vaccine were major motivators for participation. Major concerns included positive HIV-1 antibody test due to vaccine, safety of the vaccine, and possible problems with insurance or foreign travel. Baseline knowledge of vaccine trial concepts was low.
It is likely that high-risk volunteers will be willing to enroll in HIV vaccine efficacy trials. A variety of participant and community educational strategies are needed to address participant concerns, and to ensure understanding of key concepts prior to giving consent for participation.

Download full-text


Available from: Kenneth Mayer
  • Source
    • "Several studies reported no difference in willingness to participate by race/ethnicity [15] [21] [24] but others have found variation between groups [16–18,20]. These findings were predominately derived from studies which assessed willingness to participate in HIV vaccine trials or other HIV vaccine related activities without examining actual trial enrollment. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Introduction: In the United States, Latinos and Blacks are disproportionately affected by HIV/AIDS, but have been underrepresented in HIV vaccine trials. We assessed screening and enrollment of Blacks and Latinos for preventive HIV vaccine trials conducted in New York City, 2009-2012. Methods: A retrospective analysis was conducted among 18-50 year old men and transgender women screening for four preventive phase 1 and 2 HIV vaccine trials. Demographic, recruitment, and behavioral/medical eligibility data and outcome of screening were examined. To determine factors associated with enrollment, a multivariable logistic regression analysis was performed. Results: Among 6077 individuals who provided contact information, 2536 completed a phone pre-screen. 96 (1.6% of recruitment contacts) enrolled. Latinos were 35.7% of recruitment contacts, but 17.7% of those enrolled, whereas Blacks were 22.5% and 32.3%, respectively. Among all Latinos, nearly one third were excluded for being uncircumcised, an eligibility criterion for several studies. In multivariable analysis among potentially eligible potential participants, controlling for age and recruitment method, Latinos were less likely than Whites to enroll in a preventive HIV vaccine trial (aOR 0.52, 95% CI 0.28-0.95) whereas Blacks were as likely as Whites (aOR 0.99, 95% CI 0.59-1.67). Individuals recruited through print advertisements, social media/internet, referral, and other modes were more likely to enroll compared to those recruited through in-person outreach, controlling for age and race/ethnicity. Conclusions: Targeted outreach has led to substantial inclusion of Latinos and Blacks, with Blacks comprising almost a third of those enrolled in these preventive HIV vaccine trials. Latinos, however, were less likely to enroll compared to Whites. Circumcision status as an eligibility criterion partly accounts for this, but further studies are warranted to address the reasons Latinos decide not to participate in preventive HIV vaccine trials.
    Preview · Article · Oct 2015 · Vaccine
  • Source
    • "identifier: NCT01436357 and NCT01296451) aims to elicit a Tcell response associated with spontaneous clearance and therefore viral persistence estimates (progression to chronic HCV infection ) are necessary for sample size projections for Phase III assessment. While HIV VPS have included PWID, this population has typically comprised only a minority of study participants [19] [20] [21]. As part of the first HCV VPS, this paper reports key outcomes impacting HCV vaccine trial feasibility in PWID based on a community-based prospective observational study of HCV antibody negative PWID – the Hepatitis C Incidence and Transmission Study-community (HITS-c). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise challenging scientific and ethical issues. Based on data from the first 3years of a community-based prospective observational study - the Hepatitis C Incidence and Transmission Study-community (HITS-c) - this paper examines the feasibility of conducting trials of candidate HCV vaccines with people who inject drugs (PWID) in Sydney, Australia. Of the 166 PWID confirmed HCV antibody negative and eligible for enrolment, 156 (94%) completed baseline procedures. Retention was high, with 89% of participants retained at 48weeks and 76% of participants completing at least 75% of study visits within 2weeks of schedule. The rate of primary HCV infection was 7.9/100py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment and 12 (75%) had evidence of chronic viraemia with progression to chronic HCV infection estimated to be 6/100py. Power calculations suggest a chronic HCV infection rate of at least 12/100py (primary HCV infection rate 16/100py) will be required for stand-alone trials of highly efficacious candidates designed to prevent chronic infection. However, elevated primary HCV infection was observed among participants not receiving opioid substitution therapy who reported heroin as the main drug injected (26.9/100py, 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100py, 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100py, 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100py, 95% CI 9.8, 56.7) in the 6months prior to baseline. These data suggest that it is possible to recruit and retain at-risk PWID who adhere to study protocols and that modification of eligibility criteria may identify populations with sufficiently high HCV incidence. Results support the feasibility of large multi-centre HCV vaccine trials, including in the Australian setting.
    Full-text · Article · Aug 2014 · Vaccine
  • Source
    • "Protection against HCV infection through trial enrolment was identified as a motivator for participation by several participants. As observed in previous studies (Koblin et al., 1998; Meyers et al., 1995), this expectation is of concern, given that in any trial, half the participants will be randomised to placebo and, even among those who receive the vaccine, initial vaccine efficacy is expected to be low to moderate (Houghton and Abrignani, 2005). Several participants who held contingent WTP also expressed concerns about low vaccine efficacy suggesting that this issue warrants further investigation. "
    [Show abstract] [Hide abstract]
    ABSTRACT: A safe and efficacious vaccine may be the most efficient and cost-effective strategy for controlling the hepatitis C virus (HCV) epidemic among people who inject drugs (PWID) and several candidates are in development. However, little is known about the factors that influence willingness to participate (WTP) in candidate HCV vaccine trials among this group. HCV seronegative PWID recruited between 2008 and 2010 as part of a prospective observational cohort study in Sydney, Australia were asked whether they would be willing to participate in a future candidate hepatitis C vaccine trial and to provide reasons to explain their decision. Of 113 participants, 74% indicated WTP, 15% were unwilling to participate and 11% reported WTP that was contingent on vaccine characteristics and trial design issues. The most commonly reported motivator for hypothetical trial participation was altruism, followed by potential health benefits, financial remuneration, and knowledge gain. Barriers to hypothetical participation included fears about possible harms to health, such as concerns about vaccine safety, side effects, and acquiring HCV from the vaccine; other barriers included mistrust of biomedical research and time constraints. These results may be useful in designing strategies to enhance HCV vaccine trial recruitment and retention and have ethical implications for developing informed consent processes and standards of care.
    Full-text · Article · Nov 2011 · Drug and alcohol dependence
Show more

We use cookies to give you the best possible experience on ResearchGate. Read our cookies policy to learn more.