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

NCT03535337 | Completed Results

• 1 other identifier: ATN 144
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections

Keywords

Interventions; youth living with HIV; mHealth; ART adherence; adaptive intervention; cell phone; text messaging

Outcome Measures

Primary Outcomes (3)

• Undetectable Viral Load

  Percent of participants that have an undetectable HIV Viral Load.

  baseline, month 3, month 6, month 9, and month 12

• Medication Adherence Rate - 7 Day

  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.

  baseline, month 3, month 6, month 9, and month 12

• Medication Adherence - 30 Days

  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.

  baseline, month 3, month 6, month 9, and month 12

Study Arms (8)

CPS-Rsp-T

ACTIVE COMPARATOR

After 3 months of intervention, this group of CPS Rsp will receive 3 months of CPS-T intervention followed by SC.

Behavioral: CPS

CPS-Rsp-SC

ACTIVE COMPARATOR

After 3 months of intervention, this group of CPS Rsp's intervention will discontinue and they'll receive SC only

Behavioral: CPS

CPS-NRsp-I

ACTIVE COMPARATOR

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

CPS-NRsp-SMS-I

ACTIVE COMPARATOR

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

SMS-Rsp-T

ACTIVE COMPARATOR

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

SMS-Rsp-SC

ACTIVE COMPARATOR

After 3 months of intervention, this group of SMS Rsp, intervention will discontinue and they'll receive SC only

Behavioral: SMS

SMS-NRsp-CPS-I

ACTIVE COMPARATOR

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

SMS-NRsp-I

ACTIVE COMPARATOR

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

Interventions

CPS BEHAVIORAL

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

CPS-NRsp-I; CPS-NRsp-SMS-I; CPS-Rsp-SC; CPS-Rsp-T

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.

SMS-NRsp-CPS-I; SMS-NRsp-I; SMS-Rsp-SC; SMS-Rsp-T

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The City University of New York

New York, New York, 10018, United States

Location

Related Publications (1)

• 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.

  PMID: 30573448 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Sylvie Naar, PhD; Distinguished Endowed Professor
• Organization: Florida State University

sylvie.naar@med.fsu.edu

18506442334

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multiple Assignment Randomized Trial

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: May 24, 2018
• Study Start: September 1, 2018
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: December 13, 2024
• Results First Posted: December 13, 2024

Record last verified: 2024-12

Locations

US (1)