Positive Strategies to Enhance Problem-Solving Skills (STEPS): A Pilot Randomized, Controlled Trial of a Multicomponent, Technology-Enhanced, Customizable Antiretroviral Adherence Intervention for HIV-Infected Adolescents and Young Adults.

Adolescents are disproportionately impacted by HIV in the United States. Optimal effects from antiretroviral therapy (ART) can be achieved through stringent adherence to a daily medication regimen; for adolescents, this may be interrupted due to complex barriers unique to this age group. We previously conducted formative qualitative interviews with HIV-infected adolescents to identify key barriers facing adolescents regarding ART adherence and potential strategies to address these barriers. These data were used to inform an ART adherence intervention designed to overcome difficulties unique to HIV-infected adolescents (e.g., internalized stigma and HIV-related shame, disclosure to sexual partners, social life, and extracurricular activities at school, etc.). The resulting intervention-"Positive Strategies To Enhance Problem-solving Skills (Positive STEPS)"-combines five individual counseling sessions with daily text message reminders. We conducted a pilot randomized controlled trial of the intervention against a standard of care control and report on the feasibility of procedures and participant acceptability of the intervention in terms of content, structure, and format. ART adherence was measured in both arms through Medication Event Monitoring System pill caps and self-report. Feasibility and acceptability of the Positive STEPS intervention was evidenced by 90% retention for the intervention sessions; 100% completion of the four-month assessment; and positive responses on postintervention evaluation forms (all intervention participants rated Positive STEPS as "acceptable" or "very acceptable") and brief exit interviews. At the 4-month assessment visit, the change in ART adherence among the intervention group [mean change score = 13%, standard deviation (SD) = 29.5] was significantly higher compared with the standard of care group (mean change score = -26%, SD = 26.0; Cohen's d effect size = 1.43, confidence interval = 0.17-2.49, p = 0.02). Future testing of the intervention in a fully powered randomized controlled trial to determine efficacy is warranted.