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. 2018 Dec 20;7(12):e11183.
doi: 10.2196/11183.

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)

Marvin E Belzer  1 , Karen Kolmodin MacDonell  2 , Samiran Ghosh  2 , Sylvie Naar  3 , Julie McAvoy-Banerjea  1 , Sitaji Gurung  4 , Demetria Cain  4 , Carolyn A Fan  4 , Jeffrey T Parsons  4
Affiliations

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)

Marvin E Belzer et al. JMIR Res Protoc. .

Abstract

Background: Youth 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.

Objective: This 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.

Methods: This 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.

Results: Data collection for this study is projected to begin in August 2018 and last until June 2020.

Conclusions: This 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 registration: ClinicalTrials.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.

Keywords: HIV; adaptive clinical trial; adolescent; antiretroviral therapy; cell phone; mHealth; medical adherence; text messaging.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
The SMART (Sequential Multiple Assignment Randomized Trial) study design. CPS: cell phone support; CPS-I: incentivized cell phone support; CPS-T: tapered cell phone support; MFU: month follow-up; NRsp: nonresponders; Rsp: responders; SC: standard care; SMS: text messaging support; SMS-I: incentivized text messaging support; SMS-T: tapered cell phone support; VL: viral load.
Figure 2
Figure 2
The SMART (Sequential Multiple Assignment Randomized Trial) recruitment card.
Figure 3
Figure 3
SMART (Sequential Multiple Assignment Randomized Trial) text-in recruitment.
Figure 4
Figure 4
The SMART (Sequential Multiple Assignment Randomized Trial) recruitment flowchart. ART: antiretroviral therapy; ATN: Adolescent Medicine Trials Network for HIV/AIDS Interventions; CASI; computer-assisted self-interview; PID: participant ID; OMS: online master screener; ROI: release of information; VL:viral load.
See this image and copyright information in PMC

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References

    1. Centers for Disease Control and Prevention. Atlanta, GA: 2017. [2018-11-07]. HIV Among Youth in the US https://www.cdc.gov/vitalsigns/hivamongyouth/
    1. Centers for Disease Control and Prevention. 2018. Apr 1, [2018-11-08]. HIV Among Youth https://www.cdc.gov/hiv/pdf/group/age/youth/cdc-hiv-youth.pdf .
    1. Panel on Antiretroviral Guidelines for Adults and Adolescents AIDSinfo. 2016. [2018-11-12]. Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents https://aidsinfo.nih.gov/contentfiles/adultandadolescentgl003093.pdf .
    1. Cohen MS, Chen YQ, McCauley M, Gamble T, Hosseinipour MC, Kumarasamy N, Hakim JG, Kumwenda J, Grinsztejn B, Pilotto JH, Godbole SV, Chariyalertsak S, Santos BR, Mayer KH, Hoffman IF, Eshleman SH, Piwowar-Manning E, Cottle L, Zhang XC, Makhema J, Mills LA, Panchia R, Faesen S, Eron J, Gallant J, Havlir D, Swindells S, Elharrar V, Burns D, Taha TE, Nielsen-Saines K, Celentano DD, Essex M, Hudelson SE, Redd AD, Fleming TR, HPTN 052 Study Team Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med. 2016 Dec 01;375(9):830–9. doi: 10.1056/NEJMoa1600693. http://europepmc.org/abstract/MED/27424812 - DOI - PMC - PubMed
    1. Nachega JB, Marconi VC, van Zyl GU, Gardner EM, Preiser W, Hong SY, Mills EJ, Gross R. HIV treatment adherence, drug resistance, virologic failure: evolving concepts. Infect Disord Drug Targets. 2011 Apr;11(2):167–74. http://europepmc.org/abstract/MED/21406048 BSP/ ID DT /E-Pub/-00010-11-2 - PMC - PubMed

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