Using ethnographic fieldwork to inform hepatitis C vaccine preparedness studies with people who inject drugs

Maher, Lisa; White, Bethany; Donald, Aylza; Bates, Anna; Enriquez, Jarliene; Pham, Steve; Liao, Len

doi:10.1016/j.drugpo.2009.04.004

Cited by 22 publications

(24 citation statements)

References 46 publications

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“…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%

“…Extant research indicates that trial-related characteristics (e.g., safety, privacy, efficacy, trial duration, compensation, vaccine administration method), as well as altruism, peer support, mistrust, confidentiality concerns, and comprehension of the concept of clinical trials, vaccines, and/or HCV may affect WTP (21–25). In addition, two qualitative studies reported financial compensation as a key motivator for trial participation, along with altruistic motives and positive peer communication and support (23, 24). Despite evidence that peer communication and support can play a role in promoting participation in HCV and HIV clinical trial research (20, 23, 26), no study to date has explored feasibility of involving peer-promotion in HCV trial recruitment among drug users.…”

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confidence: 99%

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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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Section: Discussionmentioning

confidence: 99%

mentioning

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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“…27,28 Behavioural data and sera were collected by research assistants with experience working with the target population and trained in venepuncture and pre-and post-test counselling. Participants were not remunerated for the screening process.…”

Section: Participants and Recruitmentmentioning

confidence: 99%

Ongoing susceptibility to hepatitis B virus infection among people who inject drugs in Sydney

White

Dore

Lloyd

et al. 2012

Australian and New Zealand Journal of Public Health

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“…Briefly, recruitment sites in three Sydney regions (South West, Inner and Western Sydney) were selected following ten months of ethnographic fieldwork [24]. Potentially eligible PWID were identified via targeted outreaching sampling [25] or incentivised peer referral.…”

Section: Methodsmentioning

confidence: 99%

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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Using ethnographic fieldwork to inform hepatitis C vaccine preparedness studies with people who inject drugs

Cited by 22 publications

References 46 publications

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

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

Ongoing susceptibility to hepatitis B virus infection among people who inject drugs in Sydney

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

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