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      The Stepped Care Intervention to Suppress Viral Load in Youth Living With HIV: Protocol for a Randomized Controlled Trial

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          Abstract

          Background

          Among youth living with HIV (YLH) aged 12-24 years who have health care in the United States, only 30% to 40% are virally suppressed. YLH must achieve viral suppression in order to reduce the probability of infecting others as well as increasing the length and quality of their own life.

          Objective

          This randomized controlled trial aimed to evaluate the efficacy of an Enhanced Standard Care condition (n=110) compared to an Enhanced Stepped Care intervention condition (n=110) to increase viral suppression among YLH aged 12-24 years with established infection (not acutely infected).

          Methods

          YLH (N=220) who are not virally suppressed will be identified at homeless shelters, health clinics, and gay-identified community-based organizations in Los Angeles, CA, and New Orleans, LA. Informed consent will be obtained from all participants. YLH will be randomly assigned to one of two study conditions: Enhanced Standard Care, which includes standard clinical care plus an automated messaging and monitoring intervention (AMMI), or an Enhanced Stepped Care, which includes three levels of intervention (AMMI, Peer Support via social media plus AMMI, or Coaching plus Peer Support and AMMI). The primary outcome is viral suppression of HIV, and YLH will be assessed at 4-month intervals for 24 months. For the Enhanced Stepped Care intervention group, those who do not achieve viral suppression (via blood draw, viral load<200 copies/mL) at any 4-month assessment will “step up” to the next level of intervention. Secondary outcomes will be retention in care, antiretroviral therapy adherence, alcohol use, substance use, sexual behavior, and mental health symptoms.

          Results

          Recruitment for this study began in June 2017 and is ongoing. We estimate data collection to be completed by the end of 2020.

          Conclusions

          This is the first known application of an Enhanced Stepped Care intervention model for YLH. By providing the lowest level of intervention needed to achieve viral suppression, this model has the potential to be a cost-effective method of helping YLH achieve viral suppression and improve their quality of life.

          Trial Registration

          ClinicalTrials.gov NCT03109431; https://clinicaltrials.gov/ct2/show/NCT03109431

          International Registered Report Identifier (IRRID)

          DERR1-10.2196/10791

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          Most cited references76

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          Adolescent development.

          L. Steinberg, A S Morris (2001)
          This chapter identifies the most robust conclusions and ideas about adolescent development and psychological functioning that have emerged since Petersen's 1988 review. We begin with a discussion of topics that have dominated recent research, including adolescent problem behavior, parent-adolescent relations, puberty, the development of the self, and peer relations. We then identify and examine what seem to us to be the most important new directions that have come to the fore in the last decade, including research on diverse populations, contextual influences on development, behavioral genetics, and siblings. We conclude with a series of recommendations for future research on adolescence.
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            Depression and HIV/AIDS treatment nonadherence: a review and meta-analysis.

            Jeffrey S. Gonzalez, Abigail Batchelder, Christina Psaros … (2011)
            We meta-analyzed the relationship between depression and HIV medication nonadherence to calculate the overall effect size and examine potential moderators. Overall, across 95 independent samples, depression was significantly (P < 0.0001) associated with nonadherence (r = 0.19; 95% confidence interval = 0.14 to 0.25). Studies evaluating medication adherence via interview found significantly larger effects than those using self-administered questionnaires. Studies measuring adherence along a continuum found significantly stronger effects than studies comparing dichotomies. Effect size was not significantly related to other aspects of adherence or depression measurement, assessment interval (ie, cross-sectional vs. longitudinal), sex, IV drug use, sexual orientation, or study location. The relationship between depression and HIV treatment nonadherence is consistent across samples and over time, is not limited to those with clinical depression, and is not inflated by self-report bias. Our results suggest that interventions aimed at reducing depressive symptom severity, even at subclinical levels, should be a behavioral research priority.
            Article 0 comments Cited 205 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
                Elizabeth Mayfield Arnold:
                Department of Family and Community MedicineUT Southwestern Medical Center5959 Harry Hines Blvd, POB 1, Suite 720Dallas, TX, 75390-9194United States1 214 648 8140liz.arnold@utsouthwestern.edu
                ORCID: http://orcid.org/0000-0002-4279-8896
                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: February 2019
                Publication date (Electronic): 27 February 2019
                Volume: 8
                Issue: 2
                Electronic Location Identifier: e10791
                Affiliations
                [1 ] Department of Family and Community Medicine UT Southwestern Medical Center Dallas, TX United States
                [2 ] Department of Psychiatry and Biobehavioral Sciences University of California, Los Angeles Los Angeles, CA United States
                [3 ] Section of Adolescent Medicine Department of Pediatrics Tulane University New Orleans, LA United States
                Author notes
                Corresponding Author: Elizabeth Mayfield Arnold liz.arnold@ 123456utsouthwestern.edu
                Author information
                http://orcid.org/0000-0002-4279-8896
                http://orcid.org/0000-0002-4570-6352
                http://orcid.org/0000-0001-8412-3662
                http://orcid.org/0000-0003-4256-9476
                http://orcid.org/0000-0003-1847-1903
                http://orcid.org/0000-0002-7666-1185
                http://orcid.org/0000-0001-6395-5187
                Article
                Publisher ID: v8i2e10791
                DOI: 10.2196/10791
                PMC ID: 6414817
                PubMed ID: 30810536
                SO-VID: 43386cdb-2714-437f-b045-f8e1b5ecbfab
                Copyright © ©Elizabeth Mayfield Arnold, Dallas Swendeman, Danielle Harris, Jasmine Fournier, Leslie Kozina, Susan Abdalian, Mary Jane Rotheram, Adolescent Medicine Trials Network CARES Team. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 27.02.2019.
                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 : 16 April 2018
                Date revision requested : 13 July 2018
                Date revision received : 30 October 2018
                Date accepted : 13 December 2018
                Categories
                Subject: Protocol
                Subject: Protocol

                Keywords: hiv seroposivity,adolescent,young adult,sustained virologic responses
                Data availability:
                Keywords: hiv seroposivity, adolescent, young adult, sustained virologic responses

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