ABSTRACT. Objective. The complexity of highly active antiretroviral therapy (HAART), with multiple medications, formulations, and dosing intervals, makes adherence challenging. Little is known about the adherence of children to HAART. The objective of this study was to identify correlates of adherence to HAART and the relationship between adherence and study outcomes in a pediatric clinical trial.Methods. Pediatric AIDS Clinical Trials Group 377 is a phase I/II randomized trial of 4 HAART regimens in antiretroviral-experienced, clinically stable children aged 4 months to 17 years. The 4 treatment arms include various 3-or 4-drug combinations of d4T, 3TC, nevirapine, ritonavir, and nelfinavir. After informed consent was obtained, 193 children were enrolled between December 1997 and September 1998. Questionnaires were developed to collect subject-or caregiver-reported adherence to study medications and to identify problems associated with medication administration. Every 3 months, the number of doses of each medication missed during the 3 days preceding the study visit was recorded. Full adherence (FA) and non-full adherence were defined as missing no doses and missing at least 1 dose, respectively.Results. Adherence data from study week 48 or the most recent study visit were available for 125 children (week 48 for 109 children). Overall, 70% of children reported FA and 30% reported non-full adherence. Adherence did not differ by treatment arm, age, or the child's knowledge of his or her human immunodeficiency virus infection status. There was a suggestion that adherence was less for white than nonwhite children (40% vs 73% FA) and did not differ between black and Hispanic children. Rates of FA were 82% for d4T, 79% for 3TC, 83% for nevirapine, 84% for ritonavir, and 68% for nelfinavir. Despite the similar rates of FA, difficulties with taking specific medications were reported most frequently for ritonavir and nelfinavir. These included poor taste, patient refusal, and scheduling problems. Adherence was associated with the virologic response: FA was seen in 92% of children with >2 log 10 drop in viral load and in 64% with <2 log 10 drop in viral load.Conclusion. In children, reported adherence predicts the virologic response to HAART therapy and is a useful measure of adherence. Interventions and regimens to increase adherence to HAART should result in an improved outcome. Pediatrics 2002;109(4). URL: http:// www.pediatrics.org/cgi/content/full/109/4/e61; adherence, compliance, HIV, antiretroviral therapy, protease inhibitors.ABBREVIATIONS. HAART, highly active antiretroviral therapy; HIV, human immunodeficiency virus; PACTG, Pediatric AIDS Clinical Trials Group; RT, reverse transcriptase; BID, twice-daily; TID, 3 times a day; FA, full adherence; NFA, non-full adherence.H ighly active combination antiretroviral therapy (HAART) is effective in suppressing human immunodeficiency virus (HIV) replication, preventing opportunistic infections, reducing mortality, and improving the well-being of children and adults with...

Professionals should note the low rate of disclosure among these families. In the absence of conclusive data regarding impact on child functioning, professionals must remain aware of the complexity of disclosure-related decisions when working with HIV-affected families, particularly in terms of the family and cultural milieu within which families operate.

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Objective-To compare the rates of psychopathology in youths perinatally infected with HIV (N = 319) with a comparison sample of peers (N = 256) either HIV-exposed or living in households with HIV-infected family members.Method-Participants were randomly recruited from 29 sites in the United States and Puerto Rico and completed an extensive battery of measures including standardized DSM-IV-referenced ratings scales.Results-The HIV+ group was relatively healthy (73% with CD4% >25%), and 92% were actively receiving antiretroviral therapy. Youths with HIV (17%) met symptom and impairment criteria for the following disorders: attention-deficit/hyperactivity disorder (12%), oppositional defiant disorder (5%), conduct disorder (1%), generalized anxiety disorder (2%), separation anxiety disorder (1%), depressive disorder (2%), or manic episode (1%). Many youths with HIV (27%) and peers (26%) were rated (either self-or caregiver report) as having psychiatric problems that interfered with academic or social functioning. With the exception of somatization disorder, the HIV+ group did not evidence higher rates or severity of psychopathology than peers, although rates for both groups were higher than the general population. Nevertheless, self-awareness of HIV infection in younger children was associated with more severe symptomatology, and youths with HIV had higher lifetime rates of special education (44 vs 32%), psychopharmacological (23 vs 12%), or behavioral (27 vs 17%) interventions. Youth-caregiver agreement was modest, and youths reported more impairment. NIH-PA Author ManuscriptNIH-PA Author Manuscript NIH-PA Author ManuscriptConclusion-HIV infection was not associated with differentially greater levels of current psychopathology; nevertheless, investigation of relations with developmental changes and specific illness parameters and treatments are ongoing. Index termsHIV; ADHD; psychopathology; children; Child and Adolescent Symptom Inventory-4R; Youth's Self-Report Inventory-4R; Child's Self-Report Inventory-4With the advent of life-prolonging antiretrovirals, HIV infection has become a chronic disease and is no longer the certain death sentence in children that it was in the preantiretroviral era. However, HIV does not just affect the immune system, it is also neurotropic, suggesting its effects may be seen differently at different developmental stages. Often, the first manifestation of HIV before the widespread availability of highly active antiretrovirals (HAART) was progressive encephalopathy. In the post-HAART era, there is a growing literature suggesting that neuropsychiatric illnesses may also be a manifestation of HIV. Compounding the direct and indirect effects of HIV on these growing brains are perhaps the long-term effects of antiretroviral therapies and various stressors (biologic and societal) associated with presence of HIV in the family unit.Several investigators have reported that many children and adolescents with HIV have or meet clinical criteria for psychiatric disorder, particularly att...

Childhood sexual abuse was associated with earlier initiation of injection drug use. These data emphasize the need to integrate substance abuse prevention with postvictimization services for children and adolescents.