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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 : Recruiting
First Posted : May 24, 2018
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Florida State University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Behavioral: CPS Behavioral: SMS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Multiple Assignment Randomized Trial
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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.
Behavioral: CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation

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
Behavioral: CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation

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.
Behavioral: CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation

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
Behavioral: CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation

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.
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.

Active Comparator: SMS-Rsp-SC
After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only
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.

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
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.

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
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Medication Adherence Rate [ Time Frame: 12 months ]
    Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   15 Years to 24 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HIV positive
  • Provide proof of VL >or= 200 copies/mL or blood specimens 3 months prior to enrollment
  • ART medication regimen prescribed minimum of 3 months prior to eligibility VL
  • Sole owner of capable device for sending/receiving calls and text messages
  • Provide for 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03535337


Contacts
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Contact: Sylvie Naar, PhD 248-207-2903 sylvie.naar@med.fsu.edu

Locations
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United States, New York
The City University of New York Recruiting
New York, New York, United States, 10018
Contact: Karen MacDonell, PhD    212-206-7919      
Sponsors and Collaborators
Florida State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT03535337     History of Changes
Other Study ID Numbers: ATN 144
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Florida State University:
Interventions
youth living with HIV
mHealth
ART adherence
adaptive intervention
cell phone
text messaging

Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases