Intervention to improve follow-up for abnormal Papanicolaou tests: a randomized clinical trial

Abstract

Objective: To evaluate the effect of a theory-based, culturally targeted intervention on adherence to follow-up among low-income and minority women who experience an abnormal Pap test.

Method: 5,049 women were enrolled and underwent Pap testing. Of these, 378 had an abnormal result and 341 (90%) were randomized to one of three groups to receive their results: Intervention (I): culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; Active Control (AC): nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling; or Standard Care Only (SCO). The primary outcome was attendance at the initial follow-up appointment. Secondary outcomes included delay in care, completion of care at 18 months, state anxiety (STAI Y-6), depressive symptoms (CES-D), and distress (CDDQ). Anxiety was assessed at enrollment, notification of results, and 7-14 days later with the CDDQ and CES-D.

Results: 299 women were included in intent-to-treat analyses. Adherence rates were 60% (I), 54% (AC), and 58% (SCO), p = .73. Completion rates were 39% (I) and 35% in the AC and SCO groups, p = .77. Delay in care (in days) was (M ± SD): 58 ± 75 (I), 69 ± 72 (AC), and 54 ± 75 (SCO), p = .75. Adherence was associated with higher anxiety at notification, p < .01 and delay < 90 days (vs. 90+) was associated with greater perceived personal responsibility, p < .05. Women not completing their care (vs. those who did) had higher CES-D scores at enrollment, p < .05.

Conclusions: A theory-based, culturally targeted message was not more effective than a nontargeted message or standard care in improving behavior.

Figure 1

Flow of Patients through the Study