Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
NCT ID: NCT03535337
Last Updated: 2024-12-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
83 participants
INTERVENTIONAL
2018-09-01
2022-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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CPS-Rsp-T
After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.
CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
CPS-Rsp-SC
After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only
CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
CPS-NRsp-I
After 3 months of intervention, this group of CPS NRsp will receive 3 months of CPS-I followed by 3 months of CPS-T and 3 months of SC.
CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
CPS-NRsp-SMS-I
After 3 months of intervention, this group of CPS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC
CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
SMS-Rsp-T
After 3 months of intervention, this group of SMS Rsp will receive 3 months of SMS tapered (SMS-T) intervention followed by SC.
SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
SMS-Rsp-SC
After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only
SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
SMS-NRsp-CPS-I
After 3 months of intervention, this group of SMS NRsp will receive 3 months of CPS-I followed by 3 months CPS-T and 3 months SC
SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
SMS-NRsp-I
After 3 months of intervention, this group of SMS NRsp will receive 3 months of SMS-I followed by 3 months of SMS-T and 3 months of SC
SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
Interventions
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CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
Eligibility Criteria
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Inclusion Criteria
* Viral load ≥ 200 copies/mL within 3 months prior to enrollment or self-reported adherence ≤ 80%
* ART medication regimen prescribed minimum of 3 months prior to eligibility VL or self-reported adherence
* Sole owner of device capable of sending/receiving calls and text messages
* Willingness to permit research team to communicate with their HIV care provider team
Exclusion Criteria
* Inability to understand written/spoken English
* Concurrent participant in any adherence behavioral research intervention
15 Years
24 Years
ALL
No
Sponsors
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Children's Hospital Los Angeles
OTHER
Hunter College of City University of New York
OTHER
Wayne State University
OTHER
Florida State University
OTHER
Responsible Party
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Sylvie Naar
Principal Investigator
Locations
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The City University of New York
New York, New York, United States
Countries
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References
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Belzer ME, MacDonell KK, Ghosh S, Naar S, McAvoy-Banerjea J, Gurung S, Cain D, Fan CA, Parsons JT. 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). JMIR Res Protoc. 2018 Dec 20;7(12):e11183. doi: 10.2196/11183.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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ATN 144
Identifier Type: -
Identifier Source: org_study_id