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Completed

NCT Number: NCT03535337

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

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.

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Key information

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The City University of New York

New York, 10018, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPS

Behavioral

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

SMS

Behavioral

Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.

Primary outcomes

  1. Undetectable Viral Load

    Time frame: baseline, month 3, month 6, month 9, and month 12

    Percent of participants that have an undetectable HIV Viral Load.

  2. Medication Adherence Rate - 7 Day

    Time frame: baseline, month 3, month 6, month 9, and month 12

    Self reported percentage of medication taken in the past 7 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.

  3. Medication Adherence - 30 Days

    Time frame: baseline, month 3, month 6, month 9, and month 12

    Self reported percentage of medication taken in the past 30 days prior to assessment point. Medication adherence rates will be compared between CPS and SMS groups.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Collaborators

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

Registry information

Official study 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

Acronym: SMART

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 24, 2018
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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