Background: Researchers have been conducting efficacy and effectiveness studies on interventions that address medication-taking behavior in patients with HIV infection. However, they also must examine the fidelity to the research protocol for the delivery of the intervention.
Objectives: The aims of this study were to determine the level of fidelity to each of the specified end points (number of intervention sessions, session duration, number of telephone calls per session, the length of time between sessions, sessions with multiple interventions, and attrition from the intervention protocol) in the delivery of the 12-week, nurse-delivered, structured telephone intervention designed to improve medication adherence and to determine the factors (race, gender, and socioeconomic status) related to participation in the intervention.
Methods: This descriptive correlational study was a substudy of a larger randomized clinical trial (N = 200) testing the effectiveness of a 12-week nurse-delivered intervention designed to improve medication adherence to antiretroviral medications in persons with HIV infection. The Intervention Tracking Form was used to collect data on all intervention delivery end points during the delivery of the structured intervention. A sociodemographic questionnaire was used to collect the sociodemographic characteristics of the sample.
Results: Two thirds of the sample (n = 66) were male, and slightly more than half were White. The average age was 39.68 (SD = 7.98) years. The average number of intervention sessions delivered was 8.1 (SD = 4.07). Participants were more likely to receive the first five intervention sessions (n = 77, 77.8%), and 21 (21.2%) dropped out of treatment before it was completed. Nearly one quarter (n = 24, 24.2%) of the sample had doubled-up interventions. Intervention sessions lasted, on average, 11.3 min. Typically, more than one telephone call was needed before the participant was reached (M = 2.2). The mean number of days between sessions was 11.5 days. Women were more likely to have doubled-up interventions (p = .036). There was a marginally significant difference (p = .075) in the number of sessions received between the Whites and non-Whites: Whites (M = 8.8, SD = 3.9) received slightly more sessions compared with non-Whites (M = 7.24, SD = 4.2). When examining the interaction effects between the demographic factors considered, a race-by-income effect was observed for the mean number of attempts to contact the participant (p = .044).
Discussion: These results demonstrate a lack of fidelity to the research intervention protocol. Factors beyond the researchers' control may have influenced fidelity to the intervention protocol.
Judith A. Erlen, PhD, RN, FAAN, is Professor, Doctoral Program Coordinator, Associate Director, Center for Research in Chronic Disorders; and Susan M. Sereika, PhD, is Associate Professor, Director, Center for Research and Evaluation, and Director, Data Management and Analysis Core, Center for Research in Chronic Disorders, University of Pittsburgh, Pennsylvania.
Accepted for publication October 20, 2005.
This study was partially supported by grants from the National Institute of Nursing Research (R01 NR04749 and P30 NR03924). The authors would also like to acknowledge the support of the other research team members: Jacqueline Dunbar-Jacob, PhD, RN, FAAN; Susan Hunt, MD; Christopher Ryan, PhD; John W. Mellors, MD; Mary Pat Lewis, PhD, RN; and the staff who implemented this project. In addition, without the help of the study participants, this study would not have been possible.
Corresponding author: Judith A. Erlen, PhD, RN, FAAN, Professor, Doctoral Program Coordinator, Associate Director, Center for Research in Chronic Disorders, School of Nursing, University of Pittsburgh, 440 Victoria Building, Pittsburgh, PA 15261 (e-mail: firstname.lastname@example.org).