Motivators and barriers influencing willingness to participate in candidate HCV vaccine trials: Perspectives of people who inject drugs

Park, Ju Nyeong; White, Bethany; Bates, Anna; Enriquez, Jarliene; Liao, Len; Maher, Lisa

doi:10.1016/j.drugalcdep.2011.10.009

Cited by 19 publications

(26 citation statements)

References 39 publications

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“…However, as previously reported, our participants indicated a strong desire to participate in future HCV vaccine trials with 88% expressing WTP [44]. Further, CTL increased significantly following a brief intervention designed to improve understanding of key HCV vaccine trial concepts [22], suggesting this group has the capacity to provide truly informed consent and that the ethical implementation of HCV vaccine trials will be possible in Australia.…”

Section: Discussionsupporting

confidence: 58%

Assessing the feasibility of hepatitis C virus vaccine trials: Results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study

White¹,

Madden²,

Prins³

et al. 2014

Vaccine

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Efficacy trials of preventive hepatitis C virus (HCV) vaccine candidates raise complex and challenging scientific and ethical issues. Based on data from the first three years 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). 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 48 weeks and 76% of participants completing at least 75% of study visits within two weeks of schedule. The rate of primary HCV infection was 7.9/100 py (95% CI 4.9, 12.7). Of the 17 incident cases, 16 completed at least one follow-up assessment by 24 weeks and 12 (75%) had evidence of chronic viremia with progression to chronic HCV infection estimated to be 6/100 py. Power calculations suggest a chronic HCV infection rate of at least 12/100 py (primary HCV infection rate 16/100 py) 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 (26.9/100 py 95% CI 14.5, 50.0) and those who reported unstable housing (23.5/100 py 95% CI 7.6, 72.8), daily or more frequent injecting (22.7/100 py 95% CI 12.2, 42.2) and receptive syringe sharing (23.6/100 py 95% CI 9.8, 56.7) in the six months 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.

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Section: Discussionsupporting

confidence: 58%

Assessing the feasibility of hepatitis C virus vaccine trials: Results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study

White¹,

Madden²,

Prins³

et al. 2014

Vaccine

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“…In a study of young HCV-negative PWID from San Francisco, 88% of participants reported on a 4-point Likert scale item that they would be definitely (44%) or probably (44%) willing to participate in an HCV vaccine trial (21). In a study of 113 Australian PWID, 74% indicated in response to an open-ended question that were willing to participate in an HCV vaccine trial (22). …”

Section: Discussionmentioning

confidence: 99%

“…Speculatively, unemployment may have emerged as having a stronger association with WTP than related socioeconomic indicators due to its relationship with other relevant factors, such as time availability and lack of access to private insurance; however, further research is needed to explore these possibilities. Previous research has indicated that financial incentives are likely to be key motivators of HCV vaccine trial participation among PWID (22–24). Thus, as similar research has suggested (58), socioeconomic status of prospective participants must be taken into account when considering the use of monetary incentives during a clinical trial, as large incentives may induce coercion.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C vaccine clinical trials among people who use drugs: potential for participation and involvement in recruitment

Young

Stephens

Khaleel

et al. 2015

Contemporary Clinical Trials

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Candidate prophylactic HCV vaccines are approaching phase III clinical trial readiness, yet little is known about the potential for participation among target groups or innovative ways to promote enrollment within ‘hard-to-reach’ populations. This study describes HCV vaccine trial participation willingness among a high-risk sample of people who use drugs and their willingness to assist researchers by promoting the trial among peers. Willingness to participate in and encourage peers’ participation in an HCV vaccine trial was assessed among injection and non-injection drug users enrolled in a cohort study in Kentucky using interviewer-administered questionnaires (n=165 and 415, respectively, with willingness to participate assessed among HCV-seronegative participants only). Generalized linear mixed models were used to determine correlates to being "very likely" to participate or encourage participation in a trial. Most reported being likely to participate or encourage participation in a vaccine trial (63% and 87%, respectively). Men were significantly less likely to report willingness to encourage others’ participation, while willingness to encourage was higher among HCV-seropositive participants. Unemployment, lesser education, receipt of financial support from more peers, and nonmedical prescription drug use were positively associated with willingness to participate, as were heroin and methamphetamine use. Differential enrollment in HCV vaccine clinical trials by socioeconomic status may occur, underscoring ethical considerations and need for avoiding coercion. Notably, the data suggest that a peer-driven approach to promoting trial participation among people who use drugs could be feasible in this population and that HCV-seropositive individuals and women could be especially instrumental in these efforts.

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“…Incentives have been shown to be effective in motivating PWID to participate in medical interventions (Perlman et al, 2003) and experimental studies (Park et al, 2012). Interestingly, we found that the majority of respondents who were unwilling to participate in HCV-related educational activities would not be swayed to do so by provision of incentives.…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C Virus–Related Knowledge and Willingness to Receive Treatment Among Patients on Methadone Maintenance

Zeremski

Dimova

Zavala

et al. 2014

Journal of Addiction Medicine

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Objectives Although persons who inject drugs have high prevalence of hepatitis C virus (HCV) infection, few receive treatment mostly because of lack of knowledge about the infection and its treatment. We assessed the level of HCV-related knowledge and willingness to participate in HCV treatment among methadone-maintained patients. Methods A 30-item survey covering HCV-related knowledge and willingness to engage in HCV-related education and treatment was developed and completed by 320 methadone-maintained patients. Results Respondents’ mean age was 53 ± 8.7 years, 59.5% were male, 55.1% were African American, and 38.3% were Hispanic. The mean duration of methadone maintenance was 7 ± 6.7 years. In the preceding 6 months, 6.9% of patients reported injection drug use, whereas 37.3% used noninjection drugs. Hepatitis C virus seropositivity was self-reported by 46.3% of patients. The majority of patients (78%) expressed willingness to participate in HCV-related education and to receive HCV treatment. Most patients (54.7%) correctly answered 5 or more of 7 questions assessing HCV knowledge. Hepatitis C virus–seropositive individuals and prior attendees at HCV-related educational activities demonstrated a higher level of HCV-related knowledge (P < 0.001 and P = 0.002, respectively). Younger patients (P = 0.014), those willing to attend an HCV-related educational activity (P < 0.001), and those with higher–HCV-related knowledge (P = 0.029) were more accepting of HCV treatment. Fear of medication-related side effects was the most common reason for treatment avoidance. Conclusions The majority of patients reported willingness to receive HCV-related education and treatment. Treatment willingness was significantly associated with previous attendance at an HCV educational activity and a higher level of HCV-related knowledge.

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Motivators and barriers influencing willingness to participate in candidate HCV vaccine trials: Perspectives of people who inject drugs

Cited by 19 publications

References 39 publications

Assessing the feasibility of hepatitis C virus vaccine trials: Results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study

Assessing the feasibility of hepatitis C virus vaccine trials: Results from the Hepatitis C Incidence and Transmission Study-community (HITS-c) vaccine preparedness study

Hepatitis C vaccine clinical trials among people who use drugs: potential for participation and involvement in recruitment

Hepatitis C Virus–Related Knowledge and Willingness to Receive Treatment Among Patients on Methadone Maintenance

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