Assessing fidelity to an intervention in a randomized controlled trial to improve medication adherence.

BACKGROUND: Behavioral intervention effectiveness in randomized controlled trials requires fidelity to the protocol. Fidelity assessment tools tailored to the intervention may strengthen intervention research. OBJECTIVE: The aim of this study was to describe the assessment of fidelity to the structured intervention protocol in an examination of a nurse-delivered telephone intervention designed to improve medication adherence. METHODS: Fidelity assessment included random selection and review of approximately 10% of the audiorecorded intervention sessions, stratified by interventionist and intervention session. Audiotapes were reviewed along with field notes for percentage of agreement, addressing whether key components were covered during the sessions. Visual analog scales were used to provide summary scores (0 = low to 5 = high) of interaction characteristics of the interventionists and participants with respect to engagement, demeanor, listening skills, attentiveness, and openness. RESULTS: Four nurse interventionists delivered 871 structured intervention sessions to 113 participants. Three trained graduate student researchers assessed 131 intervention sessions. The mean percentage of agreement was 92.0% (±10.5%), meeting the criteria of 90% congruence with the intervention protocol. The mean interventionist interaction summary score was 4.5 ± 0.4, and the mean participant interaction summary score was 4.5 ± 0.4. DISCUSSION: Overall, the interventionists successfully delivered the structured intervention content, with some variability in both the percentage of agreement and quality of interaction scores. Ongoing assessment aids in ensuring fidelity to study protocol and having reliable study results.

The HIV Medication Taking Self-efficacy Scale: psychometric evaluation.

AIM: This paper is a report of an examination of the psychometric properties of the HIV Medication Taking Self-efficacy Scale. BACKGROUND: Self-efficacy is a critically important component of strategies to improve HIV medication-taking; however, valid and reliable tools for assessing HIV medication-taking self-efficacy are limited. METHOD: We used a cross-sectional, correlational design. Between 2003 and 2007, 326 participants were recruited from sites in Pennsylvania and Ohio in the United States of America. Six self-report questionnaires administered at baseline and 12 weeks later during 'Improving Adherence to Antiretroviral Therapy' were used to examine the variables of interest. Means and variances, reliability, criterion, and construct validity of the HIV Medication Taking Self-efficacy Scale were assessed. FINDINGS: Participants reported high self-confidence in their ability to carry out specific medication-related tasks (mean = 8·31) and in the medication's ability to effect good outcomes (mean = 8·56). The HIV Medication Taking Self-efficacy Scale and subscales showed excellent reliability (α = 0·93∼0·94). Criterion validity was well-established by examining the relationships between the HIV Medication Taking Self-efficacy Scale and selected physiological and psychological factors, and self-reported medication adherence (r = -0·20∼0·58). A two-factor model with a correlation between self-efficacy belief and outcome expectancy fitted the data well (model χ(2) = 3871·95, d.f. = 325, P < 001; CFA = 0·96; RMSEA = 0·046). CONCLUSION: The HIV Medication Taking Self-efficacy Scale is a psychometrically sound measure of medication-taking self-efficacy for use by researchers and clinicians with people with HIV. The findings offer insight into the development of interventions to promote self-efficacy and medication adherence in persons with HIV.

Mediating roles of medication-taking self-efficacy and depressive symptoms on self-reported medication adherence in persons with HIV: a questionnaire survey.

BACKGROUND: To date, only a few studies have examined the mediating role of self-efficacy on the relationship between depressive symptoms or perceived social support and medication adherence in persons with HIV. OBJECTIVES: The purpose of this study was to examine the impact of perceived social support, depressive symptoms and medication-taking self-efficacy on self-reported medication adherence in persons with HIV. A proposed comprehensive model included three mediation hypotheses in order to examine the mediating roles of medication-taking self-efficacy and depressive symptoms. METHOD: Baseline data from "Adherence to Protease Inhibitors" were used. The 215 persons with HIV aged 19-61 (mean=40.7, S.D.=7.58) were recruited from multiple sites in Pittsburgh, PA (USA) and through self-referral. The participants were assessed using the Beck Depression Inventory, Interpersonal Support Evaluation List, the Medication Taking Self-Efficacy Scale, and the modified Morisky Self-report Medication Taking Scale. Structural equation modeling (EQS version 6.1) was used. The Satorra-Bentler Scaled chi(2) test statistics (S-B chi(2)), Comparative Fit Index (CFI), and the Standardized Root Mean Squared Residual (SRMR) were used to assess the fit of a comprehensive model including three mediation hypotheses. RESULTS: A comprehensive model with the three hypotheses showed a good model fit (S-B chi(2) (24, N=215)=69.06, p<.001; CFI=.95; SRMR=.057). Medication adherence self-efficacy fully mediated the prediction of self-reported medication adherence by perceived social support and depressive symptoms. Depressive symptoms partially mediated the prediction of medication-taking self-efficacy by perceived social support. CONCLUSIONS: The findings of this study provide researchers with increased understanding of the mediating role of medication-taking self-efficacy beliefs between selected psychological variables and self-reported medication adherence in persons with HIV. Future studies need to test the moderating effect of gender, ethnicity and risk factors for HIV on this model and the intervention effect of self-efficacy beliefs using longitudinal data.

A randomized controlled trial of a smoking cessation intervention for pregnant adolescents.

BACKGROUND: The smoking prevalence rate among pregnant adolescents has been estimated at 59-62%, and 60-80% of these adolescents continue to smoke throughout their pregnancies. OBJECTIVES: The aim of this study was to evaluate the short- and long-term effects of smoking cessation strategies tailored to the pregnant adolescent to attain and maintain abstinence. The specific aim was to examine differences in short- and long-term smoking behaviors among three groups: Teen FreshStart (TFS), Teen FreshStart Plus Buddy (TFS-B), and Usual Care (UC) control. METHODS: In this randomized controlled intervention study, a 3-group (TFS, TFS-B, and UC) by 3-occasion (baseline, 8 weeks postrandomization, and 1-year following study entry) design was used. The study included 142 pregnant adolescents who were aged 14 to 19 years. Both self-reported smoking status collected on the Smoking History Questionnaire and saliva cotinine levels were used to identify smoking behaviors. RESULTS: There were no significant differences among the three treatment groups at baseline in terms of the racial distribution, age, gestational age, age of menses initiation, number in family household, number of family members who smoked, or tobacco use. A significant difference between the UC group and the TFS-B group (p = .010) was seen in smoking behaviors measured 8 weeks following treatment initiation. At 1 year following study entry, however, there were no differences between the groups in smoking behaviors. DISCUSSION: The TFS-B intervention was more effective in attaining short-term smoking cessation in the pregnant adolescent than TFS or UC. Findings suggest that the peer-enhanced programming had a limited effect but could not sustain the participant beyond postpartum (1 year following study entry). Future studies should include relapse prevention to sustain smoking abstinence into the postpartum period.

Characteristics of inner-city pregnant smoking teenagers.

OBJECTIVE: To describe baseline characteristics of inner-city pregnant adolescent smokers and examine these variables as potential predictors of long-term tobacco abstinence. STUDY DESIGN: Descriptive study design of the characteristics of pregnant adolescent smokers, with conceptual underpinnings from the Problem-Behavior Theory. SETTING: Recruitment and data collection were completed in inner-city outpatient clinics and public schools. PARTICIPANTS: The study enrolled 142 pregnant smoking adolescents. MAIN OUTCOME MEASURES: Self-reported smoking behavior (abstinence vs. smoking) assessed at 12 months from study enrollment was the criterion outcome variable. Variables from Problem-Behavior Theory, tobacco use, and demographics variables were selected as predictors of interest. RESULTS: Twelve months following study enrollment, 123 (87%) participants were smoking, with 19 (13%) reporting abstinence. Pregnant adolescents received messages of encouragement from parents and peers to quit smoking but complicated their pregnancies and smoking cessation efforts by concurrently consuming alcohol during the pregnancy. CONCLUSION: Findings from this study support previous research on adolescent smokers and extend our knowledge to the inner-city pregnant adolescent smoker. These pregnant teenagers present many needs and challenges for the nurses responsible for their care.