Abstract
BackgroundHIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. However, the overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. This paper describes the design of a stepped-care, “adaptive” ART adherence intervention protocol for HIV-infected adolescents and young adults.MethodsThis is a randomized controlled trial (RCT) to establish the efficacy of “Positive STEPS,” a behavioral and technology-based intervention to optimize ART adherence and viral suppression among HIV-infected youth, ages 16 to 29. Participants are equally randomized to 1) the Positive STEPS intervention, which begins with two-way daily text messaging as a reminder system to take their medications; participants progress to a more intensive in-person counseling intervention if text messaging is not sufficient to overcome barriers; or 2) or standard of care (SOC). At randomization, all participants receive standardized ART adherence education. During the 4 major study assessment visits (baseline, 4-, 8-, and 12-months), participants have their blood drawn to measure HIV viral load and complete a mix of computer-based self-administered and interviewer-administered behavioral and psychosocial measures. The primary outcomes are improvements in viral load and ART adherence measured via a medication-tracking device (i.e., Wisepill) and self-report.DiscussionBehavioral interventions are greatly needed to improve ART adherence among HIV-infected adolescents and young adults and prevent onward transmission. If effective, the intervention tested here will be one of the first rigorously-designed efficacy trials to promote ART adherence in this population, using an approach that holds promise for being readily integrated into real-world clinical settings.Trial registrationClinicalTrials.gov number NCT03092531, registered March 28, 2017.
Highlights
Human immunodeficiency virus (HIV) infection among youth in the United States is on the rise
We describe the design of the Positive STEPS study, a randomized controlled efficacy trial of a stepped-care, counseling- and technology-based intervention to improve antiretroviral therapy (ART) adherence among HIV-infected adolescents with adherence difficulties
Recognizing the importance of a developmentally-tailored approach to improving health behaviors, the Positive STEPS intervention was informed, developed, and refined with input from the adolescent target population over a period of six years prior to testing the efficacy of the intervention in the current trial [19, 20]. This iterative, community-engaged approach ensured that the intervention content is inclusive of adolescents’ contextual realities and that these realities are addressed in a manner that promotes ART adherence skills building and problem solving as a means of improving ART adherence, health and quality of life through intervention components that are acceptable to youth
Summary
HIV infection among youth in the United States is on the rise. A high level of antiretroviral therapy (ART) adherence is crucial to treatment success and can minimize the population burden of the disease. The overall rate of ART adherence among youth is generally suboptimal and no published efficacious interventions exist to address the specific needs of this population. The typical trajectory of adolescence and young adulthood involves behavioral experimenting, risk taking, and confronting a host of difficult choices with regard to romantic relationships, sexual behavior, substance use, and identity formation [15]. The complexity of these factors is compounded for HIV-infected adolescents and emerging adults (18 to 29 year olds) who must negotiate their lives within the framework of having a chronic and stigmatizing disease [16,17,18]. Developmental cognitive processes, such as concrete thinking and partially developed abstract reasoning, may contribute to difficulties in taking medications for adolescents who are asymptomatic, if the medications have adverse side effects and serve to differentiate them from peers [19, 20]
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