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

• ClinicalTrials.gov Identifier: NCT03535337
• Recruitment Status: Active, not recruiting
• First Posted: May 24, 2018
• Last Update Posted: December 17, 2021
• Sponsor: Florida State University
• 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: April 12, 2018
• First Posted Date: May 24, 2018
• Last Update Posted Date: December 17, 2021
• Actual Study Start Date: September 1, 2018
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Adherence Interventions for HIV Youth Via Text & Cell Phone - Sequential Multiple Assignment Randomized Trial (SMART)
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

Multiple Assignment Randomized Trial

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: HIV Infections

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: January 29, 2020): 90
• Original Estimated Enrollment (submitted: May 22, 2018): 190
• Estimated Study Completion Date: December 31, 2022
• Estimated Primary Completion Date: December 31, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 15 Years to 24 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03535337
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Sylvie Naar, Florida State University
• Study Sponsor: Florida State University

Collaborators

• Children's Hospital Los Angeles
• Hunter College of City University of New York
• Wayne State University

• Investigators: Not Provided
• PRS Account: Florida State University
• Verification Date: December 2021