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      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)

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          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

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          Most cited references55

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          Antiretroviral Therapy for the Prevention of HIV-1 Transmission.

          Myron S Cohen, Ying Q Chen, Marybeth McCauley … (2016)
          An interim analysis of data from the HIV Prevention Trials Network (HPTN) 052 trial showed that antiretroviral therapy (ART) prevented more than 96% of genetically linked infections caused by human immunodeficiency virus type 1 (HIV-1) in serodiscordant couples. ART was then offered to all patients with HIV-1 infection (index participants). The study included more than 5 years of follow-up to assess the durability of such therapy for the prevention of HIV-1 transmission.
          Article 0 comments Cited 573 times – based on 0 reviews     Review now
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            Longitudinal Data Analysis Using Generalized Linear Models

            Scott Zeger, Kung-Yee Liang (1986)
            Article 0 comments Cited 154 times – based on 0 reviews     Review now
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              Mobile phone text messaging for promoting adherence to antiretroviral therapy in patients with HIV infection.

              Tara Horvath, Hana Azman, Gail E Kennedy … (2012)
              More than 34 million people are presently living with HIV infection. Antiretroviral therapy (ART) can help these people to live longer, healthier lives, but adherence to ART can be difficult. Mobile phone text-messaging has the potential to help promote adherence in these patients. To determine whether mobile phone text-messaging is efficacious in enhancing adherence to ART in patients with HIV infection. Using the Cochrane Collaboration's validated search strategies for identifying randomised controlled trials and reports of HIV interventions, along with appropriate keywords and MeSH terms, we searched a range of electronic databases, including the Cochrane Central Register of Controlled Trials (CENTRAL), EMBASE, Literatura Latino-Americana e do Caribe em Ciências da Saúde (LILACS), MEDLINE (via PubMed), PsycINFO, Web of Science, and the World Health Organization (WHO) Global Index Medicus. The date range was from  01 January 1980 to 01 November 2011. There were no limits to language or publication status. Randomised controlled trials (RCTs) in which patients or their caregivers (in the case of infants and children) of any age, in any setting, and receiving ART were provided with mobile phone text messages as a means of promoting adherence to ART. Two authors independently examined the abstracts of all identified trials. We initially identified 243 references. Seventeen full-text articles were closely reviewed. Both authors abstracted data independently, using a pre-designed, standardised data collection form. When appropriate, data were combined in meta-analysis. Two RCTs from Kenya were included in the review. One trial compared short weekly text messages against standard care. The other trial compared short daily, long daily, short weekly and long weekly messages against standard care. Both trials were with adult patients.In the trial comparing only short weekly messages to standard care, text messaging was associated with a lower risk of non-adherence at 12 months (RR 0.77, 95% CI 0.63 to 0.93) and with the non-occurrence of virologic failure at 12 months (RR 0.83, 95% CI 0.69 to 0.99).In the trial that compared different intervals and lengths for text-messaging to standard care, long weekly text-messaging was not significantly associated with a lower risk of non-adherence compared to standard care (RR 0.79, 95% CI 0.60 to 1.04). Patients receiving weekly text-messages of any length were at lower risk of non-adherence at 48 weeks than were patients receiving daily messages of any length (RR 0.79, 95% CI 0.64 to 0.99). There were no significant differences between weekly text-messaging of any length (RR 1.01, 95% CI 0.75 to 1.37) and between short or long messaging at either interval (RR 0.99, 95% CI 0.78 to 1.27). Compared to standard care, any daily text-messaging, whether short or long, did not reduce the risk for non-adherence (RR 0.99, 95% CI 0.82 to 1.20).In meta-analysis of both trials, any weekly text-messaging (i.e. whether short or long messages) was associated with a lower risk of non-adherence at 48-52 weeks (RR 0.78, 95% CI 0.68 to 0.89). The effect of short weekly text-messaging was also significant (RR 0.77, 95% CI 0.67 to 0.89). There is high-quality evidence from the two RCTs that mobile phone text-messaging at weekly intervals is efficacious in enhancing adherence to ART, compared to standard care. There is high quality evidence from one trial that weekly mobile phone text-messaging is efficacious in improving HIV viral load suppression. Policy-makers should consider funding programs proposing to provide weekly mobile phone text-messaging as a means for promoting adherence to antiretroviral therapy. Clinics and hospitals should consider implementing such programs. There is a need for large RCTs of this intervention in adolescent populations, as well as in high-income countries.
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                Author and article information

                Contributors
                Sylvie Naar:
                College of MedicineFlorida State UniversityMain CampusTallahassee, FL, 32306United States1 248 207 2903sylvie.naar@med.fsu.edu
                ORCID: http://orcid.org/0000-0001-6369-4685
                Journal
                Journal ID (nlm-ta): JMIR Res Protoc
                Journal ID (iso-abbrev): JMIR Res Protoc
                Journal ID (publisher-id): ResProt
                Title: JMIR Research Protocols
                Publisher: JMIR Publications (Toronto, Canada )
                ISSN (Electronic): 1929-0748
                Publication date Collection: December 2018
                Publication date (Electronic): 20 December 2018
                Volume: 7
                Issue: 12
                Electronic Location Identifier: e11183
                Affiliations
                [1 ] Children’s Hospital Los Angeles Los Angeles, CA United States
                [2 ] Department of Family Medicine and Public Health Sciences Wayne State University School of Medicine Detroit, MI United States
                [3 ] College of Medicine Florida State University Tallahassee, FL United States
                [4 ] Hunter College Center for HIV Educational Studies and Training New York, NY United States
                Author notes
                Corresponding Author: Sylvie Naar sylvie.naar@ 123456med.fsu.edu
                Author information
                http://orcid.org/0000-0002-8870-9326
                http://orcid.org/0000-0001-8916-624X
                http://orcid.org/0000-0003-3117-7055
                http://orcid.org/0000-0001-6369-4685
                http://orcid.org/0000-0002-5753-5941
                http://orcid.org/0000-0003-4713-4228
                http://orcid.org/0000-0002-9360-9928
                http://orcid.org/0000-0003-3382-1289
                http://orcid.org/0000-0002-6875-7566
                Article
                Publisher ID: v7i12e11183
                DOI: 10.2196/11183
                PMC ID: 6320399
                PubMed ID: 30573448
                SO-VID: 1ea3dad0-084a-41b1-afaa-3e9d84c88bec
                Copyright © ©Marvin E Belzer, Karen Kolmodin MacDonell, Samiran Ghosh, Sylvie Naar, Julie McAvoy-Banerjea, Sitaji Gurung, Demetria Cain, Carolyn A Fan, Jeffrey T Parsons. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 20.12.2018.
                License:

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org.as well as this copyright and license information must be included.

                History
                Date received : 30 May 2018
                Date revision requested : 30 July 2018
                Date revision received : 24 September 2018
                Date accepted : 26 September 2018
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: adaptive clinical trial,antiretroviral therapy,medical adherence,cell phone,hiv,mhealth,text messaging,adolescent
                Data availability:
                Keywords: adaptive clinical trial, antiretroviral therapy, medical adherence, cell phone, hiv, mhealth, text messaging, adolescent

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