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

July 5, 2022 updated by: Sylvie Naar, Florida State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

83

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10018
        • The City University of New York

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 24 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Adherence Rate
Time Frame: 3 months
Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Florida State University

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

May 31, 2022

Study Completion (ACTUAL)

May 31, 2022

Study Registration Dates

First Submitted

April 12, 2018

First Submitted That Met QC Criteria

May 22, 2018

First Posted (ACTUAL)

May 24, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2022

Last Update Submitted That Met QC Criteria

July 5, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATN 144

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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