Understanding and enhancing compliance with the second dose of hepatitis B vaccine: a cohort analysis and a randomized controlled trial.

OBJECTIVE: To determine the predictors and extent of noncompliance with a second dose of hepatitis B vaccine and the effectiveness of a compliance enhancement strategy. DESIGN: Cohort analysis and randomized clinical trial. SUBJECTS: A total of 256 consecutive adults attending a sexually transmitted diseases clinic from October 1992 to July 1993 who were seronegative for hepatitis B virus and agreed to receive hepatitis B vaccination. SETTING: Hamilton, Ont. INTERVENTION: Subjects were followed up for 4 months. Those who did not return for the second dose of vaccine by 6 weeks after the first (2 weeks overdue) were randomly assigned to the enhanced intervention group (telephone and mail reminders) or the regular intervention group (mail reminder only). Subjects were considered noncompliant if they did not return for the second dose by 4 months after the first. RESULTS: The risk of not returning for the second dose of vaccine within 4 months after the first was strongly and linearly associated with level of education (p = 0.004). The noncompliance rate among those with less than a grade 10 education was 50%, grade 10-13 education 34%, some college education 15% and some university education 9%. In the randomized controlled trial the enhanced intervention group had twice the compliance rate of the regular intervention group (48% v. 25%; p = 0.008). Subjects with no postsecondary education were highly responsive to the enhanced intervention (relative risk 2.1; p = 0.02) compared with those with a higher level of education (relative risk 1.0; p = 1.0). CONCLUSION: Hepatitis B vaccine recipients with lower educational levels are at increased risk of noncompliance with the second dose of vaccine but are highly responsive to telephone reminders.