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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).

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.

SUBMITTER: Belzer ME

PROVIDER: S-EPMC6320399 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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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).

Belzer Marvin E ME MacDonell Karen Kolmodin KK Ghosh Samiran S Naar Sylvie S McAvoy-Banerjea Julie J Gurung Sitaji S Cain Demetria D Fan Carolyn A CA Parsons Jeffrey T JT

JMIR research protocols 20181220 12

<h4>Background</h4>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.<h4>Objective</h4>This study (ATN [Adolescent Trials Network] 144 SMART) aimed to compare adap ...[more]

PMID: 30573448

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Project description:BackgroundPoor adherence to antiretroviral therapy in adolescents living with HIV is a global challenge. One of the key strategies to improve adherence is believed to be the use of digital adherence tools. However, evidence is limited in this area. Our objective was to investigate the effectiveness of mobile phone text message reminders in improving ART adherence for adolescents.MethodsThe preferred reporting item for systematic review and meta-analysis guideline was followed. A literature search was done in five databases (PubMed, Web of Science, Embase, Global Health and Cochrane) in August 2020. Additional searches for studies and grey literature were performed manually. We included studies with quantitative design exploring the effectiveness of text message reminders, targeting adolescents aged 10-19 years. Studies were excluded if the intervention involved phone calls, phone-based applications, or other complex tech services. Mean differences between intervention and standard of care were computed using a random effects model. Subgroup analyses were performed to identify sources of heterogeneity between one-way and two-way text messages.ResultsOf 2517 study titles screened, seven eligible studies were included in the systematic review. The total number of participants in the included studies was 987, and the study sample varied from 14 to 332. Five studies showed a positive impact of text messaging in improving adherence, while no significant difference was found between the intervention and the control (standard of care) group in the remaining two studies. The pooled mean difference between the intervention and the control group was 0.05 (95% CI: -0.08 to 0.17). There was considerable heterogeneity among the studies (I2 = 78%).Conclusion and recommendationThe meta-analysis of text message reminder interventions did not show a statistically significant difference in the improvement of ART adherence among adolescents living with HIV. The included studies were heterogeneous in the reported clinical outcomes, where the effectiveness of the intervention was identified in small studies which had a short follow-up period. Studies with bigger sample size and a longer follow-up period are needed.

Dataset Information

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).

Publications

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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