Nonadherence With Pediatric Human Immunodeficiency Virus Therapy as Medical Neglect

Abstract

ABSTRACT. Objective. To examine the results of an interventionist approach applied to human immunodeficiency virus (HIV)-infected children for whom caregiver nonadherence was suspected as the cause of treatment failure.Methods. The medical records of a cohort of 16 perinatally HIV-infected children whose care was managed at the Arkansas Children's Hospital Pediatric HIV Clinic for an uninterrupted period of >3 years were reviewed through July 2003. Data collected included date of birth, dates of and explanations for clinic visits and hospitalizations, dates of laboratory evaluations, CD4 ؉ T cell percentages, plasma HIV-1 RNA levels, antiretroviral medications, viral resistance tests (eg, phenotype and genotype), and physician-initiated interventions to enhance adherence to the medication regimen. A stepwise interventionist approach was undertaken when patients continued to demonstrate high viral loads, despite documented viral sensitivity to the medication regimen and caregivers' insistence that medications were being administered regularly.Step 1 was prescribing a home health nurse referral, step 2 was administering directly observed therapy (DOT) while the patient was hospitalized for 4 days, and step 3 was submitting a physicianinitiated medical neglect report to the Arkansas Department of Human Services.Results. The results for 6 patients for whom this stepwise approach was initiated are reported. Home health nurse referrals failed to result in sustained improvements in adherence in all 6 cases. Viral load assays performed before and after DOT provided an objective measure of the effect of adherence, with 12 hospitalizations resulting in a mean ؎ SD decrease in HIV RNA levels of 1.09 ؎ 0.5 log 10 copies per mL, with a range of 0.6 to 2.1 log 10 copies per mL. Four families responded to DOT hospitalization, and sustained decreases in the respective patients' viral loads were noted. In 2 cases, medical neglect reports were submitted when DOT did not result in improved adherence. These patients were eventually placed in foster care, with subsequent improvements in their viral loads and CD4 ؉ T cell percentages.Conclusions. Nonadherence with antiretroviral therapy can be established on the basis of persistently elevated HIV RNA levels that decrease with DOT. Nonadherence poses a danger to the child that is grave and potentially irreversible. Caregivers should be offered all available resources to help them adhere to a sound treatment plan. In cases of demonstrated inability to provide needed care, it is necessary to consider seeking child protection, even for apparently healthy children. Pediatrics 2004;114:e346 -e353. URL: http://www.pediatrics.org/ cgi/content/full/114/3/e346; adherence, HIV, pediatric, neglect.

Virologic Response Using Directly Observed Therapy in Adolescents With HIV: An Adherence Tool

“…In a study by Roberts et al (2004), the authors report success with improving adherence through the use of DOT in a group of HIVinfected pediatric patients who were less treatment-experienced and younger than those we studied. This group instituted a step-wise approach to manage non-adherence, first involving, visits by a home health nurse, followed by DOT during a hospitalization and, subsequently, a medical neglect report.…”

“…These results also demonstrate that heavily treatment-experienced patients can experience a virologic response with DOT and without a change in regimen. Roberts et al (2004) showed that a step-wise approach that emphasized DOT in treatment-naïve patients resulted in improved adherence and clinical responses. A future study should explore whether this stepwise approach can produce persistent improvements and clinical responses in the heavily treatment-experienced patient population that we studied.…”

Adherence to Antiretroviral Therapy for Pediatric HIV Infection: A Qualitative Systematic Review With Recommendations for Research and Clinical Management

“…As described below, only 1 involved a randomized, control trial 51 ; the other reports presented primarily descriptive data on small samples. [52][53][54][55][56][57] Gigliotti et al 52 studied a DOT intervention, primarily to determine if prolonged elevation of VL could be attributable to poor adherence. They identified 6 perinatally infected children aged 3.3 to 11.5 years with elevated VLs for periods of months to years and for whom suboptimal adherence was suspected.…”

“…Roberts et al 53 examined an intensive DOT program among 6 families of children who showed continued high VLs for several years despite documentation of viral sensitivity to the prescribed medication regimen and caregiver assertions of regular medication administration. Their stepwise approach involved an initial referral to a home health nurse and then DOT supplemented by intensive education and counseling provided for patients and caregivers during a 4-day hospitalization and at 2 weeks postdischarge, and, if necessary, a physician-initiated medical-neglect report to state authorities.…”

Recognizing and Responding to Medical Neglect

“…Daily home visits by a nurse or paraprofessional could be considered in cases in which there is lack of compliance with medications. Roberts et al 11 reported on the use of directly observed therapy to ensure that HIV-positive children received their antiretroviral therapy. In 4 of 6 cases, this approach led to sustained decreases in the patients' viral loads and allowed the children to remain in their homes instead of being placed in foster care.…”