Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Message and Cell Phone Support With and Without Incentives: Protocol for a Sequential Multiple Assignment Randomized Trial (SMART)

Abstract

BackgroundYouth living with HIV (YLH) aged 13 to 24 years made up over a fifth (21%) of new HIV diagnoses in 2016, yet only 27% of YLH are virally suppressed. YLH have been shown to be poorly adherent to antiretroviral therapy (ART); however, there has been limited research investigating how to increase adherence in YLH. Mobile health (mHealth) interventions may be one promising way to do this.ObjectiveThis study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adaptive interventions that could increase ART adherence in YLH aged 15 to 24 years. This includes mHealth initiatives, the tapering of interventions, and the use of incentives. Cost-effectiveness of sequencing the interventions without incentives before providing incentives and the savings on societal costs due to suppressed viral loads will be determined. This protocol is part of the ATN Scale It Up program described in this issue by Naar et al.MethodsThis study uses a Sequential Multiple Assignment Randomized Trial design. Approximately 190 participants are being recruited, enrolled, and randomized to either cell phone support or text message support. Both intervention groups receive 3 months of intervention, followed by a second randomization based on response to the intervention. Responders test tapering their intervention, and nonresponders test receiving incentives.ResultsData collection for this study is projected to begin in August 2018 and last until June 2020.ConclusionsThis is an innovative study, particularly in terms of population, intervention types, focus on cost-effectiveness, and recruitment. This study could be particularly effective in improving adherence in YLH while reducing long-term individual and societal costs.Trial RegistrationClinicalTrials.gov NCT03535337; https://clinicaltrials.gov/ct2/show/NCT03535337 (Archived by WebCite at http://www.webcitation.org/74alXb92z)International Registered Report Identifier (IRRID)PRR1-10.2196/11183

Adolescent Trials Network for HIV-AIDS Scale It Up Program: Protocol for a Rational and Overview

“…ATN 144 is a SMART design that tests the sequencing of SMS text message cell phone support (CPS), and contingency management in youth nonadherent to ART [16]. All study procedures will be conducted over the Web or by phone so that youth need not attend a clinic to participate, and clinics only need to refer participants to the study website instead of staffing for recruitment.…”

“…Several critical issues surrounding incentives and intervention tapering are explored through a second randomization—(1) if CPS or SMS text messaging for 12 weeks is successful, does viral load (VL) suppression persist longer if the intervention dose is tapered (ie, less frequent) over the next 12 weeks versus terminating CPS and receiving standard care; (2) if CPS or SMS text messaging is not successful in the first 12 weeks, will VL suppression occur if incentives for intervention adherence are added for 12 more weeks; and (3) if CPS or SMS text messaging is not successful, will VL suppression occur if youth receive the other intervention condition (with the addition of incentives) or if they are allowed 12 more weeks within their initial condition (with the addition of incentives). Details are provided in ATN 144 SMART [16].…”

“…SIU will achieve its aims through 4 primary study protocols (ATN 144 SMART: Sequential Multiple Assignment Randomized Trial; ATN 145 YMHP: Young Men’s Health Project; ATN 146 TMI: Tailored Motivational Interviewing Intervention; ATN 156 We Test: Couples' Communication and HIV Testing) [16-18], 2 center-wide protocols (ATN 153 EPIS and ATN 154 Cascade Monitoring; Carcone et al, under review, and Pennar et al, under review), and 3 cross-project initiatives. A substantial amount of literature underscores the importance of shortening the time from conceptualization of a research idea to service delivery.…”

Interventions to Improve Antiretroviral Therapy Adherence Among Adolescents and Youth in Low- and Middle-Income Countries: A Systematic Review 2015–2019

“…The increase in the number and location of studies observed compared to the earlier review indicates a positive shift of focus to identify interventions to improve outcomes in regions with the greatest HIV burden. Additional high-quality evidence should be emerging soon from four ongoing RCTs we identified, two from sub-Saharan Africa [62][63][64][65].…”

Implementation Science Research Examining the Integration of Evidence-Based Practices Into HIV Prevention and Clinical Care: Protocol for a Mixed-Methods Study Using the Exploration, Preparation, Implementation, and Sustainment (EPIS) Model

“…Thus, EPIS is 1 study within a larger program of research, “Scale It Up,” to improve HIV-related self-management among youth living with or at risk of contracting HIV [13]. The 4 EBPs include sequential multiple assignment randomized trial (referred to as ATN 144 SMART), an adaptive intervention that combines short message service text messaging and cell phone support to increase antiretroviral therapy adherence among youth living with HIV (see the study by Belzer et al [14] in this issue). Scale It Up also includes a comparative effectiveness trial of clinic- versus telephone-delivery of the Young Men’s Health Project (referred to as ATN 145 YMHP), a 4-session intervention to reduce the risk of HIV infection among young men who have sex with men (see the study by Parsons et al [15] in this issue).…”