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ObjectiveThe purpose of the study is to describe allocation of responsibility for illness management in families of children and adolescents perinatally infected with HIV.MethodsA total of 123 youth (ages 8–18) and caregivers completed family responsibility and medication adherence questionnaires as part of a substudy of Pediatric AIDS Clinical Trials Group protocol 219c.ResultsApproximately one-fourth of the youth reported being fully responsible for taking medications. A smaller percentage of caregivers reported full youth responsibility. Older youth and caregivers of older youth reported higher degree of youth responsibility for medication-related tasks, though age was unrelated to adherence. Caregiver report of greater responsibility for medications was associated with better adherence.ConclusionsCaregivers are likely to transition responsibility for HIV care to older youth but this transition was not always successful as evidenced by poor medication adherence. Interventions supporting successful transition may improve adherence and subsequently health outcomes in pediatric HIV.
Protease inhibitor therapy and aggressive multidrug regimens have increased the likelihood that children perinatally infected with HIV will survive into adolescence and young adulthood. Improved understanding of the pathogenesis of HIV and viral activity has suggested that medication adherence must be nearly perfect to minimize viral load and prevent drug resistance (Paterson et al., 1999). Unfortunately, treatment for HIV presents special challenges for adherence. Antiretroviral (ART) medications often involve demanding dosing schedules and have significant adverse effects. Because pediatric HIV most often affects disadvantaged families through maternal–child transmission, illness management may be affected by family and caregiver issues such as parental illness and stress, substance abuse, lack of adequate support networks, loss and change of caregivers, and poor access to healthcare resources. Additional adherence challenges related to HIV infection include potential cognitive and learning limitations and the stigma of the disease.
Studies of youth with other pediatric chronic medical conditions suggest adherence to treatment regimens deteriorates in adolescence (Drotar & Ievers, 1994), and medication adherence in pediatric HIV has been found to decline as children grow older (Mellins, Brackis-Cott, Dolezal, & Abrams, 2004; Williams et al., 2006). Parents tend to decrease their involvement and supervision of their children's daily activities as they move into adolescence (Laird, Pettit, Bates, & Dodge, 2003; Wysocki et al., 1996). While this facilitates the process of adolescent separation and individuation necessary for transition to adulthood, multiple studies have shown that low levels of parental involvement in illness management result in poorer management and health outcomes among youth with chronic illness (Allen, Tennen, McGrade, Affleck, & Ratzan, 1983; Boland, Grey, & Mezger, 1999; Ellis et al., 2007; LaGreca & Schuman, 1995).
Transitions in responsibility for illness management from parent to adolescent are ultimately necessary for appropriate self-management to become established when the adolescent becomes a young adult. These transitions, however, also allow possible ambiguity about family members’ responsibilities for completion of illness-management tasks. In a study demonstrating the potential for disagreement during the adolescent developmental period, Dashiff (2003) examined perceptions of responsibility for diabetes management tasks. Mothers and adolescents agreed the adolescent was primarily responsible for diabetes care tasks, but fathers believed mothers to be primarily responsible. Such ambiguity can create problematic adherence behavior and health outcomes. Agreement between maternal and adolescent perceptions of the allocation of responsibility for diabetes management tasks significantly predicted better metabolic control within a sample of middle-class White adolescents (Anderson, Auslander, Jung, Miller, & Santiago, 1990).
Walders and colleagues (2000) assessed disagreement between adolescents and their caregivers regarding the allocation of responsibility for illness-management tasks in a sample of inner-city African-American adolescents with chronic asthma. Parental overestimation was defined as tasks for which the parent maintained the adolescent took responsibility, but the adolescent reported he or she did not. Parental overestimation of adolescent responsibility was found to be related to decreased adherence to asthma treatment. One study (Naar-King, Ellis, Idalski, Frey, & Cunningham, 2007) found that an intervention that improved adherence and health outcomes for adolescents with type 1 diabetes also reduced parental overestimation of adolescent responsibility in an urban sample. Wysocki et al. (1996; 2006) found that high child responsibility for management of type I diabetes was related to poorer health outcomes.
The research literature on allocation of responsibility for management of pediatric HIV is limited. Only two studies to date have addressed the issue of delineation of responsibility for illness management in this population. Mellins et al. (2004) found a trend for greater child responsibility for medications to be related to poorer adherence, while increased parental involvement was associated with improved adherence. However, the study did not include adolescents older than 13 years, and responsibility was measured with a single likert-type item. Martin et al. (2007) assessed responsibility with a nine-item scale adapted from responsibility scales used in the studies of asthma and diabetes described earlier. They found that children perceived themselves to have more responsibility than caregivers described, and this discrepancy was associated with nonadherence. However, the relatively small sample of 24 families was not representative of the families typically receiving health care in urban HIV clinics. As noted earlier, studies of other pediatric chronic conditions in urban settings show the opposite pattern, that parents rate their children as more responsible than children report themselves to be (Walders et al., 2000).
The current study is the first large multisite study of allocation of responsibility in the management of pediatric HIV. This report provides descriptive data on allocation of responsibility in older children and adolescents (heretofore referred to as youth) with perinatally acquired HIV in 36 urban clinics. We hypothesized that parent and youth report of increased child responsibility would be associated with parent and youth report of lower levels of adherence to anti-HIV medications.
This cross-sectional study was based on data from the Pediatric AIDS Clinical Trials Group (PACTG) Protocol 1042S, an adherence and neuropsychological sub-study of a longitudinal, observational follow-up protocol PACTG 219c. The methods of PACTG 219C have been previously described (Williams et al., 2006). For 1042S, perinatally infected youth (N = 420) age 8 to <19 years were randomly selected from 219c and stratified by age (<12 years and ≥12 years). Eligibility criteria included: ART regimen during study duration with no planned treatment interruption, primary language of English or Spanish, and actively enrolled in PACTG 219c with an age appropriate Wechsler test for PACTG219C within 3 months of P1042s study entry so that this assessment would not have to be repeated. The study was approved by institutional review boards at all participating sites. Assent or written informed consent was obtained from youth participants. Written informed consent was obtained from the parents or legal guardians of all youth younger than the age of consent. From the 420 potential caregiver–youth dyads, 261 were not enrolled (99 declined to enroll, 91 were deemed ineligible, 62 were never approached due to closure of the study to accrual, and no information was available for 9). Among the 159 participants who were enrolled in the study, 151 were considered evaluable. The other eight participants were considered nonevaluable and their data excluded from analyses because they were found to be ineligible between screening and enrollment, they withdrew consent prior to study completion, they were unable to comply with study requirements, or there was a randomization error. Sites completed a form requesting reasons for refusal for 72 of the 99 who declined to enroll. Of these 72, 25 caregivers did not volunteer a reason. For the remaining 47, reasons included lack of time (n = 19), lack of interest in research trials (n = 18), and travel difficulties (n = 10). Participants were recruited from 36 sites across the US and Puerto Rico (1–10 participants per site).
Demographic variables collected were child's age and ethnicity, relationship to caregiver, and caregiver education and HIV status. There were no significant differences in demographic variables between the 151 evaluable participants and youth in 219c who would have been eligible for but did not participate in P1042S (this includes those youth who refused participation). However, a somewhat higher proportion of participants in P1042S had a viral load less than 400 copies/ml (59% vs. 48%, p =.05) and a higher proportion of participants in P1042S were on three or more ART drugs from two or more classes (94% vs. 79%, p = 01). Of the 151 evaluable participants, 137 caregivers and 132 youth validly completed all responsibility items yielding 123 child–caregiver pairs. No significant differences in most demographic variables or in viral load were observed between those with completed data (n = 123) and those without (n = 28) with one exception. Participants without responsibility data completed by both youth and caregiver had a higher percentage of caregivers with no high school diploma than those with completed responsibility data (Mantel–Haenszel p =.04). For the measures described below, research nurses asked parents and youth to complete study questionnaires in separate private rooms. Nurses were available for help with reading when necessary.
Socio-demographic data such as age and relationship with caregiver were collected in P219c at regular intervals by abstraction from the participant's medical record.
A variety of youth and parent self-report adherence assessment methods were utilized in P1042S. Farley et al. (in press) reported the most robust association with viral load was with parent response to an item asking for the approximate time since the youth last missed a dose of ART medication (within the last week, 1–2 weeks ago, 3–4 weeks ago, 1–3 months ago, >3 months ago, or never). This measure had good inter-rater agreement and a strong correlation with viral load when adherence was defined dichotomously as “no missed dose in the last month.” Youth response to the same item had a borderline association with viral load. Thus, this dicohotomously coded item was utilized to measure parent and youth reports of adherence in subsequent analyses.
Youth and caregivers completed a 10-item study-specific adaptation (Table I) of the Diabetes Family Responsibility Questionnaire (DFRQ; Anderson, Auslander, Jung, Miller, & Santiago, 1990). Each rater assigned responsibility for HIV-management tasks to the caregiver alone, to the youth alone, to the youth and caregiver as a shared responsibility, to someone else in the home, or endorsed “nobody really does this.” The five likert-type choices were recoded on a three-point scale with increasing scores indicating greater child autonomy as follows: 1 = Adult/s (parent/caregiver/someone else at home) is/are fully responsible, 2 = Youth and adult share responsibility, and 3 = Youth is fully responsible. Between 0% and 2% of parents and youth endorsed “nobody does this” for medication-specific items. Because this response is indicative of nonadherence and not a specific allocation of responsibility, these responses were not included in the coding scheme and were removed from the analysis. Internal consistency reliability for these items (Table I) was good with Cronbach's α of.89 for the youth version and.96 for the caregiver version. Cronbach's α for the four medication-specific items was.83 for the youth version and.91 for the caregiver version.
Frequencies for each of the responsibility items were described first. The four medication-specific responsibility items were utilized to study associations with medication adherence. A single summary variable, degree of responsibility, was obtained by taking the average of the coded responses over the four medication items. Thus, degree of medication responsibility was a continuous outcome ranging from 1 to 3, whereby higher scores indicate greater youth responsibility for medication tasks. Wilcoxon's rank sum tests were performed to study associations of child and caregiver reports of the degree of responsibility for the medication tasks with adherence. Spearman's correlation coefficient was used to determine and test for inter-rater associations. Wilcoxon's signed rank test was used to determine if youth and caregiver ratings differed. Spearman's correlation coefficient also was used to determine and test for associations of youth- and caregiver-rated degree of responsibility with age of youth at study entry.
The majority of participants (86%) self-identified as African-American (58%) or Hispanic (28%). More than half of the youth (61%) were 12 years and older. Seventy percent of youth were aware of their diagnosis. All but nine (6%) were receiving highly active antiretroviral therapy (HAART) regimens including two or more drug classes, with 5 (3%) prescribed a regimen including a fusion inhibitor. Most (63%) primary caregivers completed high school, some college, or were college graduates. Less than half of caregivers (42%) were biological parents. Out of the 137 caregivers, 49 were biological mothers and 8 were biological fathers. All 49 mothers and 3 of the biological fathers were having HIV. For the remaining 80 caregivers who were not biological parents, no information on HIV status was available. Medication adherence in the study sample has been described previously (Farley et al., in press). In summary, 45% of youth reported missing a dose in the past 1 month compared to 37% of parents. There was no relationship between the youth's age and youth-reported adherence (p =.53) or caregiver-reported adherence (p =.50).
Tables I and andIIII show the frequency of responses to the 10 responsibility items corresponding to 10 different HIV-management tasks as rated by the youth and the caregiver separately using all available data. Approximately one-fourth of youth reported being fully responsible for taking medications in the morning (28%) and at night (21%). However, a smaller percentage of caregivers reported full youth responsibility for medications. A smaller percentage of youth were fully responsible for other management tasks such as remembering appointments. The mean responsibility score for the four medication items as rated by youth was 1.72 (SD =.60). The mean caregiver rating was 1.46 (SD =.64). There was a significant relationship between youth-rated degree of responsibility and the age of the youth at study entry (Spearman's correlation =.3454, p <.0001); older youth reported higher degree of responsibility for medication-related tasks. Similarly, caregivers reported having less responsibility for medication-related tasks as their children grew older (Spearman's correlation =.2192, p =.01). Based on the summary measure of degree of responsibility for the four medication-related tasks, a significant association was detected between the youth rating and the caregiver rating (Spearman's correlation = 2972, p-value =.0008), although parents’ ratings of child responsibility were significantly lower than children's ratings (Wilcoxon’ signed rank test, p =.007). Separating comparisons by age group, for the 8 to <12 age group (n = 49 dyads), there was no significant difference between child ratings and caregiver ratings (Wilcoxon's signed rank test p =.31). However, for the 12 to <19 age group (n = 74 dyads), a significant difference was detected (Wilcoxon's signed rank test p =.001). Children in the older age group tended to report that they had higher degree of responsibility compared to what the caregiver reported.
Table III shows comparisons between the measures of adherence to ART medication and degree of responsibility for medication-related tasks, each reported independently by the youth and caregiver. The results suggest youth-reported degree of medication responsibility was not correlated with youth-reported adherence (p = 29). The results also suggest youth-reported degree of medication responsibility was not significantly associated with caregiver-reported adherence (p =.71). Caregiver-reported degree of medication responsibility was significantly correlated with youth-reported adherence, however, and caregivers claimed greater responsibility for youth who reported adherence than for youth who reported they were not adherent to ART medication schedules (p =.004). A marginally significant association emerged between caregiver-reported degree of medication responsibility and caregiver-reported adherence to ART (p =.09).
The purpose of this first multisite study of family allocation of pediatric HIV management was to describe the level of youth and caregiver responsibility across a range of illness-management tasks and to assess the relationship of medication adherence to responsibility for medication-related tasks. Descriptive findings suggested that one-fourth of children age 8–18 report full responsibility for medications and that this responsibility increased with age. These data suggest that caregivers are likely to transition responsibility for care to older children. Yet, caregiver report of greater youth responsibility was associated with poor adherence, suggesting that this transition was not always successful. Compared to youth report, fewer caregivers reported that their children were fully responsible for medications. It is possible that parents think they are fully responsible for medications, yet when other demands and stressors interfere parent involvement may decrease. Caregiver and youth reports of responsibility were more discrepant among older children, suggesting that allocation of responsibility is less clear as youth transition into adolescence. Thus, as youth with perinatally acquired HIV live longer, adherence to medications appears to suffer as youth are prematurely made responsible for their medication management and allocation of responsibility is less clear. However, age alone was not associated with poor adherence. While this finding differs from the two studies finding associations between increasing age and decreasing adherence to HIV (Mellins et al., 2004; Williams et al., 2006), these studies included children younger than age 8, while the present study focused on preadolescents and adolescents. It is possible that age is not associated with adherence within a more restricted sample.
Interestingly, caregivers reported being fully responsible for tasks unrelated to medications such as explaining school absences, but more likely to decrease their responsibility for medication-related tasks critical to maintaining good health outcomes. It appears that parents are more likely to take responsibility for interactions with extra-familial systems, while leaving medication-taking to the individual child. Consequently, interventions are necessary to increase parental oversight of medication tasks with careful transition to shared responsibility with older adolescents (McKay et al., 2007). However, other illness-management tasks, such as making health care appointments, may be helpful for practicing youth responsibility in a way with less detrimental impact upon health if the transition is difficult. Furthermore, learning to successfully accomplish these other illness-management tasks will be necessary for successful transition into adult care as studies suggest young adults with HIV have difficulty with retention in adult HIV primary care (Naar-King, Green-Jones et al., 2007).
Limitations of the study include the reliance on self-report of adherence and the potential lack of generalizability to youth not at PACTG sites or to youth with behaviorally acquired HIV. Furthermore, one-fourth of potential participants refused to enroll suggesting the potential for selection bias. For children and adolescents who have acquired HIV perinatally, the next step is to develop and test family-based interventions that increase parental monitoring of HIV care, reward appropriate completion of care to increase adolescent responsibility, and improve organization of family routines. These interventions should clarify communication about expectations for illness management to ensure clear delineation of responsibility and successful transition of illness-management tasks to adolescents and young adults.
We thank the children and families for their participation in PACTG 1042S, and the individuals and institutions involved in the conduct of P1042S. The study was funded by the United States National Institute of Allergy and Infectious Diseases, and the National Institute of Child Health and Human Development. This work was supported by the Statistical and Data Analysis Center (SDAC) of the Pediatric AIDS Clinical Trials Group at Harvard School of Public Health, under the National Institute of Allergy and Infectious Diseases cooperative agreement No. 5 U01 AI41110. The project described was supported by Grant Number U01AI068632 and 1 U01 AI068616 from the National Institute of Allergy and Infectious Diseases.
Conflicts of interest: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health.
The following institutions and individuals participated in PACTG Protocol 1042S, by order of enrollment: Children's Hospital Boston: K. McIntosh, B. Kammerer, S. Burchett; University of Maryland School of Medicine: S. Allison, V. Tepper, C. Hilyard: State University of New York at Stony Brook School of Medicine: S. Nachman, J. Perillo, M. Kelly, D. Ferraro: St Christopher's Hospital for Children: J. Foster, J. Chen, D. Conway, R. Laguerre; Children's Memorial Hospital: R. Yogev, E. Chadwick, K. Malee; Jacobi Medical Center: A. Wiznia, Y. Iacovella, M. Burey, R. Auguste; University of California San Francisco School of Medicine: D. Wara, M. Muskat, N.Tilton; St Jude Children's Research Hospital: P. Garvie, D. Hopper, M. Donohoe, S. Carr; Tulane Medical School – Charity Hospital Medical Center of Louisiana at New Orleans: R. Van Dyke, P. Sirois, C. Borne, S. Bradford, K. Jacobs, A. Ranftle; Children's Hospital – University of Colorado at Denver and Health Sciences Center: R. McEvoy, S. Paul, E. Barr, M. Abzug; University of Medicine and Dentistry of New Jersey, New Jersey Medical School: J. Oleske, L. Bettica, L. Monti, J. Johnson; Texas Children's Hospital: M. Paul, C. Jackson, L. Noroski, T. Aldape; Baystate Medical Center: B. Stechenberg, D. Fisher, S. McQuiston, M. Toye; University of Miami Miller School of Medicine: G. Scott, C. Mitchell, E. Willen, L. Taybo; University of California San Diego: S. Spector, S. Nichols, State University of New York Downstate Medical Center: H. Moallem, S. Bewley, L. Gogate; San Juan City Hospital: E. Jimenez, J. Gandia, D. Miranda; Duke University School of Medicine: O. Johnson, J. Simonetti, K. Whitfield, F. Wiley; Harlem Hospital Center: E. Abrams, M. Frere, D. Calo, S. Champion; University of Puerto Rico: I. Febo, R. Santos, N. Scalley, L. Lugo; Children's National Medical Center: D. Dobbins, M. Lyon, V. Amos, H. Spiegel; Bronx Lebanon Hospital Center: E. Stuard, A. Cintron; Johns Hopkins University: N. Hutton, B. Griffith; University of North Carolina at Chapel Hill School of Medicine: T. Belhorn, J. McKeeman; New York University School of Medicine: W. Borkowsky, S, Deygoo, E. Frank, S. Akleh; Yale University School of Medicine: W. Andiman, M. Westerveld; State University of New York Upstate Medical University: R. Silverman, J. Schueler-Finlayson; Los Angeles County/University of Southern California Medical Center: A. Stek, A. Kovacs; University of Alabama at Birmingham: R. Pass, J. Ackerson, H. Charlton, M. Crain; Medical College of Georgia School of Medicine: C. Mani; North Broward Hospital District, Children's Diagnostic & Treatment Center: A. Puga, J. Blood, A. Inman; Children's Hospital of Philadelphia: S. Douglas, R. Rutstein, C. Vincent, G. Koutsoubis; Long Beach Memorial Medical Center: A. Deveikis, R. Seay, S. Marks; J. Batra; Howard University Hospital: S. Rana, O. Adeyiga, R. Rigor-Mator, S. Wilson; Children's Hospital and Research Center Oakland: A. Petru T. Courville; Phoenix Children's Hospital: J. Piatt, M. Lavoie.