Of the 860 individuals who screened susceptible to HBV infection, 595 (69.2%) returned for the Dose 1 visit and were enrolled in the vaccine study. A total of 460 participants (77.3% of those receiving Dose 1) returned for their second dose. Of the 271 randomized to the standard group, 141 (52.0% of Dose 1 recipients) returned for Dose 3, and 120 (44.4% of Dose 1 recipients) returned for the follow-up visit. Among the 324 randomized to the accelerated arm, 206 (63.6% of Dose 1 recipients) returned for Dose 3, and 116 (35.8% of Dose 1 recipients) returned for the follow-up visit.
Table
1 presents the results of the bivariate analyses. As hypothesized, completion of the vaccine series was significantly higher for participants in the accelerated arm versus the standard arm, for those receiving most of their syringes directly from the SEP where they were enrolled in the study as opposed to another source, and for direct SEP customers than for people whose main source of syringes in the past 30 days had been secondary exchange (i.e., a direct SEP customer provided the participant with SEP syringes). In addition, completion rates were higher among those offered vaccination at the Chicago SEP, among non-Hispanic Blacks versus Hispanics, among women versus men, among those unemployed versus employed, and among those of older age, and poorer self-rated health status. The results did not support the hypotheses that greater HBV knowledge or self-efficacy to be vaccinated would be significantly associated with completion. In addition, perceived motivations for participating were not significantly associated with completion of the vaccination series. Further analysis revealed no interactions between city and main source of syringes over the past three months, between income and most recent medical visit within the past year, or between income and SEP utilization (data not shown).
Table 1
Unadjusted correlates of dose 3 completion
Accelerated treatment group | 595 | 1.61 | 1.16 | 2.24 | 0.01 |
City | 595 | | | | |
Chicago | | Reference | | | |
Hartford | | 0.75 | 0.46 | 1.22 | 0.25 |
Bridgeport | 0.48 | 0.24 | 0.93 | 0.03 |
Race | 588 | | | | |
Non-Hispanic Black/African American | | Reference | | | |
White | | 0.74 | 0.49 | 1.13 | 0.15 |
Hispanic | | 0.63 | 0.43 | 0.94 | 0.02 |
Excluded Native American/Alaskan Native, Other, Refused (n = 7)
| | |
Women | 594 | 1.45 | 1.00 | 2.11 | 0.05 |
Age (continuous, range 18–68) | 595 | 1.05 | 1.03 | 1.07 | <.01 |
Education | 581 | | | | |
Less Than high school | Reference | | | |
High school or graduate equivalency degree | | 0.94 | 0.63 | 1.39 | 0.74 |
Some College or College graduate | 1.15 | 0.76 | 1.75 | 0.51 |
Excluded missing other (14) and vocation schools (11)
| | | |
Employment (Full- or part-time) | 578 | 0.66 | 0.44 | 1.01 | 0.05 |
Average monthly income | | | | |
$0-300 | | Reference | | | |
$301-556 | | 0.87 | 0.52 | 1.45 | 0.58 |
$557-1,000 | 1.10 | 0.70 | 1.73 | 0.68 |
$1,001-9,000 | 0.76 | 0.47 | 1.23 | 0.26 |
Not homeless | 577 | 0.93 | 0.66 | 1.31 | 0.68 |
Excluded missing (n = 14), and don’t know (n = 4)
| | | | |
Pay for housing | 582 | 1.43 | 1.03 | 1.99 | 0.04 |
Self-reported health status (Likert 1 = excellent, 5 = poor) | 578 | 1.21 | 1.02 | 1.42 | 0.03 |
Excluded missing (13) and don’t know (4)
| | | | | |
Told by health care worker HCV pos | 576 | 0.97 | 0.59 | 1.60 | 0.90 |
Excluded missing (15) and don’t know/unsure (4)
| | | | | |
Doctors visit during past year | 582 | 1.06 | 0.74 | 1.51 | 0.80 |
Customer of local syringe exchange | 539 | 0.98 | 0.64 | 1.49 | 0.91 |
Main source of syringes, prior 30 days | 558 | | | | |
SEP direct | | Reference | | | |
Pharmacy | | 0.45 | 0.19 | 1.05 | 0.06 |
SEP customer | | 0.37 | 0.22 | 0.64 | <0.01 |
Diabetic, someone else, at place you shoot | | 0.79 | 0.47 | 1.34 | 0.38 |
Excluded missing (37)
| | | | | |
Most syringes from this exchange, past 3 months | 462 | 1.59 | 1.07 | 2.37 | 0.02 |
EVER referred by SEP to healthcare/drug tx/social service | 575 | 1.29 | 0.28 | 2.00 | 0.26 |
Excluded missing (17) don’t know (3)
| | | | | |
Average # of shots from a syringe (range 1–75) | 557 | 0.98 | 0.93 | 1.02 | 0.31 |
Total injections, prior 30 days (range 1–540) | 521 | 1.00 | 0.99 | 1.00 | 0.84 |
Excluded does not apply (n = 25)
| | | | | |
Used a needle someone else had used at least, prior 30 days | 553 | 1.73 | 0.90 | 3.33 | 0.10 |
Someone paid you w/ drugs or money for sex | 580 | 1.21 | 0.81 | 1.80 | 0.36 |
You paid someone with drugs or money for sex | 575 | 0.83 | 0.55 | 1.25 | 0.38 |
Language of interview | 582 | | | | |
English | | Reference | | | |
Spanish | | 0.57 | 0.30 | 1.10 | 0.09 |
Language spoken most often | 578 | | | | |
English | | Reference | | | |
Spanish | | 0.76 | 0.45 | 1.27 | 0.30 |
Excluded missing and other (n = 3)
| | | | | |
Hepatitis Knowledge | 585 | 2.78 | 0.45 | 17.10 | 0.27 |
Vulnerability | 581 | 1.01 | 0.85 | 1.19 | 0.94 |
Severity | 581 | 1.10 | 0.93 | 1.30 | 0.25 |
Response efficacy | 580 | 1.01 | 0.85 | 1.19 | 0.94 |
Self-efficacy | 581 | 0.93 | 0.79 | 1.10 | 0.39 |
Social outcome expectancy | 580 | 1.04 | 0.88 | 1.23 | 0.64 |
Social outcome value | 581 | 1.05 | 0.89 | 1.24 | 0.57 |
All covariates that were significant at the p ≤ 0.10 level in the bivariate analyses were entered into a multivariate model (Table
2). Four variables remained significantly associated with completion of the vaccine series such that those who completed the series were more likely: (1) to have been randomized to the accelerated treatment group, (2) to be direct SEP customers rather than to report using secondary exchange as their main source of syringes in the past thirty days, (3) to be older, and (4) having poorer self-rated health status.
Table 2
Multivariate logistic regression of correlates associated with dose 3 completion (N = 430*)
Accelerated Treatment Group | 1.92 | 1.34 | 2.58 | <0.001 |
Age (continuous) | 1.05 | 1.03 | 1.07 | <0.001 |
Less healthy (Likert Scale 1–5) | 1.26 | 1.05 | 1.5 | 0.01 |
Main source of syringes past 3 months | | |
Direct from SEP | Reference | | | |
Direct from pharmacy | 0.43 | 0.179 | 1.04 | 0.60 |
From SEP customer | 0.33 | 0.19 | 0.58 | <0.001 |
Other | 0.68 | 0.39 | 1.18 | 0.17 |
Methods
This analysis, designed to compare completion rates between two dosing schedules, was constructed on the hypothesis that completion rates would be higher among the accelerated group. A second manuscript comparing efficacy between those randomized to the accelerated versus the standard schedule is in preparation. As anticipated, vaccination completion was significantly more likely among participants in the accelerated treatment group, suggesting that shortening the vaccine schedule reduces the risk of encountering barriers to participation common among IDUs, which can include incarceration or competing health care and personal needs.
Low rates of completion of the three-dose HBV vaccine series have previously been documented among IDUs especially in, but not limited to, the United States [
9,
23‐
25]. Accelerated HBV vaccine dosing schedules that have been implemented among hard-to-reach populations including active IDUs have been shown to increase completion rates [
8,
26‐
29]. However, none of these prior studies has used SEPs as the access point for identifying and vaccinating active injectors. In our present study, despite offering financial incentives for vaccination at SEPs, only 58% of Dose 1 recipients completed the vaccine series. However, several studies have established a consensus that paying individuals do increase vaccination completion rates in drug injecting populations [
10,
30,
31].
There has been discussion regarding whether or not a booster dose is necessary for the accelerated HBV vaccine series. Although benefits of a booster dose for the accelerated HBV vaccine schedule have been suggested, several studies have concluded that booster doses are neither necessary nor is maintenance of an antibody level ≥10 mIU/mL essential for protection because an anamnestic response has been detected up to 22 years post-vaccination [
32‐
34]. Further research would be necessary to evaluate the feasibility of offering a 12-month booster dose at SEPs. Although this might not seem a priority in light of the above findings, the lower success rate for vaccination among people who inject drugs suggests that a booster might be appropriate in this population [
24,
35‐
39].
Completion was slightly more likely among older participants, consistent with earlier findings of low vaccination rates among young injectors and among younger people in general [
8,
11,
40]. Thus, special attention should be paid to recruiting and retaining younger participants, especially since they are less likely to have already been exposed to and infected with HBV (albeit increasingly more likely in the future to have been vaccinated against HBV infection in early childhood). Multifaceted interventions, targeting youth within their community deserve further consideration. A review of the literature on services and interventions for runaway and homeless youth concluded that interventions addressing the varied and interconnected needs of youth are more successful than those targeting one problem at a time [
41,
42]. Further research is needed to specifically understand barriers to vaccine program completion among young injectors.
Participants with a poorer self-rated health score were more likely to complete the vaccine series. This runs counter to expectations from previous work that found competing needs served as a barrier to health care acquisition and preventive health care, particularly among vulnerable populations including homeless adults and IDUs [
43‐
45]. This may, instead, be one example of the potential for collinearity in the variables in our dataset. Older individuals were more likely to report poorer health (data not shown) and were also more likely to complete the vaccine series.
Compared to direct SEP customers, a significantly lower completion rate was observed among people who engaged in secondary exchange. The benefit of providing health services at SEPs has been repeatedly demonstrated [
3,
9,
12,
23,
46,
47], but this advantage may be of limited benefit to non-customers. Our findings suggest that recruitment of non-SEP customers should draw on peer networks in addition to more traditional recruitment strategies (e.g., outreach, posted fliers). SEP customers who distribute SEP syringes to non-customers should be encouraged to promote participation through their own social networks, word of mouth, or easy-to-distribute promotional cards. The underlying reasons that some IDUs do not go directly to SEPs were not assessed within the current study. Further research is needed to identify barriers to SEP utilization and alternative methods for targeting this hidden population of IDUs.
This study has a number of limitations. First, participants were predominantly direct or indirect SEP customers, so the findings have limited generalizability to the full IDU population in these communities. Second, as with any study that relies on self-reported behavioral data, this evaluation may be influenced by self-report and recall bias. Third, recruitment methods were intended to simulate what would be realistic and feasible for a typical SEP with limited resources and staffing to implement a vaccination intervention; the recruitment strategy may have resulted in a non-random sampling that may have introduced unmeasured bias into the study population. Fourth, lack of adequate specificity in some of the variables collected such as sources of income, a full medical history, and the precise nature of social relationships limited a full assessment of competing subsistence or health needs. Finally, enrolment was slow. It took three years to recruit sufficient participants to power the analysis. We have previously reported that an improved study design would have involved getting rid of the two-week waiting period for test result to identify those eligible for vaccination and giving the first dose of vaccine at enrolment [
15]. This approach was also found to be most cost-effective.