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Adaptive Antiretroviral Therapy Adherence Interventions for Youth Living With HIV Through Text Messaging and Cell Phone Support Embedded Within the Sequential Multiple Assignment Randomized Trial (SMART) Design
The purpose of this study is to test an adaptive adherence intervention, which utilizes two mobile health (mHealth) intervention designs, in an effort to promote adherence to antiretroviral therapy (ART) and achieve and maintain viral load (VL) suppression in youth living with HIV (YLH) while increasing understanding of the context for wide-scale implementation of cell phone support (CPS) and text messaging support (SMS), with and without incentives.
The study will consist of two points of randomization. The first step involves randomization of participants to receive either CPS or SMS using a 1:1 allocation ratio. Both intervention conditions will receive 3 months of intervention (i.e., 12 weeks of CPS or SMS). The second step involves a stratified randomization in blocks with 8 possible intervention trajectories. Within each condition, participants are categorized into two groups - responders with VL\<200 (Rsp) and non-responders with VL ≥200 (NRsp). Responders in the CPS condition will be randomly assigned to receive either 3 months of CPS tapered (CPS-T) intervention followed by standard care (SC) or only SC. Similarly, responders in the SMScondition will be randomly assigned to receive either 3 months of SMS tapered (SMS-T) intervention followed by SC or only SC. Non-responders in both CPS and SMS conditions will be randomly assigned to receive either 3 months of incentivized CPS (CPS-I) followed by 3 months of CPS-T and 3 months of SC or 3 months of incentivized SMS (SMS-I) followed by 3 months of SMS-T and 3 months of SC.
Age
15 - 24 years
Sex
ALL
Healthy Volunteers
No
The City University of New York
New York, New York, United States
Start Date
September 1, 2018
Primary Completion Date
May 31, 2022
Completion Date
May 31, 2022
Last Updated
December 13, 2024
83
ACTUAL participants
CPS
BEHAVIORAL
SMS
BEHAVIORAL
Lead Sponsor
Florida State University
Collaborators
NCT04142047
NCT06694805
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07428330