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

HIV Infections Clinical 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03535337
• Other study ID #: ATN 144
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 31, 2022

Study information

• Verified date: July 2022
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• HIV Infections

Intervention

Behavioral:
• CPS
Assessment of participant's medication adherence and barrier problem solving via phone conversation
• SMS
Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.

Locations

Country	Name	City	State
United States	The City University of New York	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Florida State University	Children's Hospital Los Angeles, Hunter College of City University of New York, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral Load Comparison	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	Medication Adherence Rate	Medication adherence rates will be compared between CPS and SMS groups, focusing on non-responders.	3 months