Protocol Number: ATN144

Title of Study: Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living with HIV through Text Messaging and Cell Phone Support Embedded within the Sequential Multiple Assignment Randomized Trial (SMART) Design

Project Leads: Marvin Belzer & Karen MacDonell

Intervention Description: A 24-week program to support youth living with HIV (YLH) to adhere to antiretroviral therapy via randomized assignment to cell phone support or text message reminders. The stepped up program provides additional support for YLH when phone or text support is not enough.

Study Sites: Online nationwide

Publication Based on the Study: Belzer, M. E., Naar-King, S., Olson, J., Sarr, M., Thornton, S., Kahana, S. Y., ... & Adolescent Medicine Trials Network for HIV/AIDS Interventions. (2014). The use of cell phone support for non-adherent HIV-infected youth and young adults: An initial randomized and controlled intervention trial. AIDS and Behavior, 18(4), 686-696. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC3962719

Objectives: An adaptive adherence intervention designed to improve self-management and maintain VL suppression while understanding the context for wide-scale implementation in an effectiveness-implementation Type 1 Hybrid trial.

Study Design: Baseline, 3-month, 6-month, 9-month, and 12-month computerized assessments and viral load measurements.

Participants are randomized at baseline to either daily text messages or weekday cell phone calls to support ART adherence. After 3 months, participants are re-randomized based on their viral load.

Participants with a suppressed viral load of <200 copies/ml continue on the same intervention (text messages or cell phone calls) for 3 months but are re-randomized to either a tapered (2 times per week) intervention or standard care (no text messages or cell phone calls). After 3 months, tapered participants move to standard care.

Participants with an unsuppressed viral load of ≥200 copies/ml are re-randomized to text messages or cell phone support, and for both interventions an incentive of $50 per month is added if the participants respond to the text messages or answer the phone calls 75% of the time. These incentivized arms are implemented for 3 months, and then the participants transition to the tapered (2 times per week) level of their intervention for 3 months. The final 3 months will be standard care.

Number of Subjects: 190

Criteria for Inclusion: Youth living with HIV, ages 15-24, from across the United States, must have a viral load ≥200 copies/ml, must have been prescribed ART for at least 3 months prior to the eligibility viral load, must have a cell phone.

Results of this study will be available soon!