CIRA Affiliated Project

BACKGROUND: Advances in the medical treatment of the HIV have dramatically improved morbidity and mortality outcomes, but a cure is still out of reach. Like other incurable chronic illnesses, the goals of HIV medical care are containment, slowing disease progression, and ideally, restoring and maintaining immunologic function. Central to the effectiveness of medical treatment is the self-care behavior of the individual living with HIV since most of the day-to-day management of HIV takes place outside of health care settings. HIV+ individuals must choose among many different types of self-care activities in which they may engage to manage their illness. These choices will ultimately have important bearing on their health outcomes. Unfortunately, rates of adherence are often less than optimal. It is estimated that a third or more of patients in treatment for HIV fail to adhere to their medication regimens. Because it is well established that a high degree of adherence to ART medication regimens is necessary for successful virologic and clinical response, a considerable amount of attention has been given to how providers can support HIV+ patients in their self-management of ART medications. Although a growing knowledge base suggests factors that are predictive of poor adherence, to date, there are few research findings that demonstrate the efficacy and effectiveness of adherence interventions that are both clinically practical and improve virologic outcomes. Identifying measures to effectively support adherence to ART medication regimens is a critical clinical challenge.

PURPOSE: The overall purpose of this study is to implement and evaluate whether enhanced nursing telephone support will improve the clinical outcomes of antiretroviral therapy (ART)-experienced individuals who are at risk for incomplete adherence to a new ART regimen.

METHODS: A randomized design will be used to compare two treatment arms (enhanced nursing telephone support and usual ACTG site care). 296 participants in total (148 in each arm) will be randomized to one of the two arms as they initiate a new ART regimen. The study will enroll ACTG participants who are enrolled or enrolling in an ACTG trial that is an approved A5251 parent study. The primary endpoint is virologic suppression (HIV-1 RNA <200 copies/mL) at week 48. Participants will be followed for a total of 96 weeks (48 weeks of intervention/control and 48 weeks of follow-up). IMPLICATIONS: This study will fill a significant gap in current research by extending our prior adherence-related work in four ways: First, we will test the virologic efficacy of an enhanced nursing telephone support intervention to increase the probability of virologic suppression among HIV+ treatment-experienced individuals at week 48. Second, we will identify which participants are most likely and which are least likely to benefit from the telephone interventions. No intervention is optimal for all participants. This may help to target the use of this intervention (resources) in the future. Third, we will assess the comparative validity and reliability of different measures of adherence in predicting adherence and treatment failure. Fourth, if the intervention is successful, we will evaluate the cost of the adherence telephone interventions using a costing methodology previously developed to evaluate the cost of HIV adherence support interventions. This will help to establish the practicality of the telephone intervention.

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