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

Abstract

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.

A Descriptive Cross-Sectional Analysis Of Potential Factors, Motivations, And Barriers Influencing Research Participation And Retention Among People Who Use Drugs In The Rural United States

“…A lack of assistance programs in areas where rural PWUD reside further exacerbate the economic needs of this population [48,49]. The weight of nancial compensation in our ndings is consistent with studies of rural Kentucky PWUD populations and others that note receipt of nancial compensation as positively associated with research participation and retention [24,50,51]. Lower economic status is also associated with poorer study retention; once enrolled in a longitudinal research study, PWUD who live below the federal poverty line are more likely to be lost to follow-up [52].…”

“…We adapted survey questions from a study that assessed willingness to participate in an HCV vaccine clinical trial among rural PWUD in Appalachia [24]. The Community Advisory Board of the Kentucky CARE2HOPE study and peer recovery support specialists of the Oregon OR-HOPE study reviewed and approved the survey's nal version to con rm the appropriateness of the survey.…”

“…Individual level differences between genders in research recruitment and participation among rural PWUD have been mixed. The National Institute on Drug Abuse (NIDA) Treatment Clinical Trials Network (CTN) did not identify gender differences in research recruitment and retention among PWUD, and willingness to participate in an HCV vaccine trial among PWUD did not differ by gender [24,25]. However, women are still underrepresented in HCV and HIV clinical research [26], and gender differences in utilization of harm reduction services exist among rural PWUD [27].…”

Protocol for a mixed-methods feasibility study for the surviving opioid overdose with naloxone education and resuscitation (SOONER) randomised control trial

“…Recruitment and retention for this study might be further strengthened by engaging peer workers directly in participant recruitment and retention. Although this approach has been successful in other studies with similar populations, in the context of a study designed to test the effectiveness of OEND in a broad variety of clinical settings, we felt that the introduction of peer workers would act as a cointervention and reduce the scalability of the intervention 18 43–45…”

Silence Surrounding Hepatitis C Status in Risk Relationships Among Rural People Who Use Drugs

“…These findings suggest that supportive family, friends, and partners of people living with HCV could have a pivotal role in encouraging the uptake of newer, efficacious direct acting antiviral treatments for HCV. Of note, in recent research among PWUD in Appalachian Kentucky, 87% expressed willingness to encourage their peers’ enrollment in HCV vaccine clinical trial research (Young, Stephens, Khaleel, & Havens, 2015). Although the promotion of HCV clinical trial research is different from that of HCV treatment, the study provides promising, preliminary evidence that peer-promotion of HCV treatment may be feasible.…”