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Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART) (SMART)

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ClinicalTrials.gov Identifier: NCT03535337
Recruitment Status : Active, not recruiting
First Posted : May 24, 2018
Last Update Posted : April 7, 2022
Sponsor:
Collaborators:
Children's Hospital Los Angeles
Hunter College of City University of New York
Wayne State University
Information provided by (Responsible Party):
Sylvie Naar, Florida State University

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE May 24, 2018
Last Update Posted Date April 7, 2022
Actual Study Start Date  ICMJE September 1, 2018
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
Viral Load Comparison [ Time Frame: 3 months ]
Viral Load (VL) suppression rate will be compared between the CPS and SMS groups using an X2 test. Also the drop in VL will be compared between the two groups.
Original Primary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Viral Load Comparison [ Time Frame: 12 months ]
Viral Load (VL) suppression rate will be compared between the CPS and SMS groups using an X2 test. Also the drop in VL will be compared between the two groups.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2020)
Medication Adherence Rate [ Time Frame: 3 months ]
Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2018)
Medication Adherence Rate [ Time Frame: 12 months ]
Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Multiple Assignment Randomized Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Behavioral: CPS
    Assessment of participant's medication adherence and barrier problem solving via phone conversation
  • Behavioral: SMS
    Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
Study Arms  ICMJE
  • Active Comparator: CPS-Rsp-T
    After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.
    Intervention: Behavioral: CPS
  • Active Comparator: CPS-Rsp-SC
    After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only
    Intervention: Behavioral: CPS
  • Active Comparator: 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.
    Intervention: Behavioral: CPS
  • Active Comparator: 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
    Intervention: Behavioral: CPS
  • Active Comparator: 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.
    Intervention: Behavioral: SMS
  • Active Comparator: SMS-Rsp-SC
    After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only
    Intervention: Behavioral: SMS
  • Active Comparator: 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
    Intervention: Behavioral: SMS
  • Active Comparator: 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
    Intervention: Behavioral: SMS
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
90
Original Estimated Enrollment  ICMJE
 (submitted: May 22, 2018)
190
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HIV diagnosis
  • 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:

  • Mental, physical, or emotional capacity prevents completion of protocol as written
  • Inability to understand written/spoken English
  • Concurrent participant in any adherence behavioral research intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 24 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03535337
Other Study ID Numbers  ICMJE ATN 144
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sylvie Naar, Florida State University
Study Sponsor  ICMJE Florida State University
Collaborators  ICMJE
  • Children's Hospital Los Angeles
  • Hunter College of City University of New York
  • Wayne State University
Investigators  ICMJE Not Provided
PRS Account Florida State University
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP