Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth
TXTXT
1 other identifier
interventional
110
1 country
1
Brief Summary
The purpose of the proposed study is to test SMS (short message service) text messaging technology to improve medication adherence among youth living with HIV (YLH). The proposed study is a randomized controlled trial of the effect of text message reminders on ART (anti-retroviral therapy) adherence among non-adherent YLH. Daily text message reminders will be sent to patients randomized to the intervention group according to their medication schedule, for 6 months. The investigators will enroll non-adherent YLH, ages 16-29. Half of the sample, randomized to the intervention, will receive daily SMS text message medication reminders and half will be randomized to the control condition and receive standard of care (SOC) only. For the controlled trial, adherence levels and viral load will be collected at baseline, 3-month and 6-month follow-up. In addition, at the end of the initial 6-month enrollment period, participants in the control condition will cross-over to the SMS intervention and participants in the intervention condition will cease to receive the SMS intervention. Adherence and viral load data will be collected from each group at 9- and 12-month follow-up points. The investigators hypothesize that youth in the intervention condition will demonstrate a clinically meaningful increase in adherence at 3 and 6 months post-baseline, from approximately 70% to 90% adherence to ART.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedNovember 15, 2021
November 1, 2021
2.4 years
May 13, 2011
November 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adherence to ART via report on visual analogue scale
Adherence to ART via report on visual analogue scale
prior 30 days
Secondary Outcomes (1)
Viral load
3-month
Study Arms (2)
Standard of care only
NO INTERVENTIONThe SOC for ART adherence consists of viewing a 20-minute animated tutorial which explains the importance of adherence to antiretroviral medication. It is specifically designed for viewers who have no science background and is appropriate for adolescents and young adults.
Intervention
EXPERIMENTALThis study will test a tailored, personalized SMS Text Message Reminder intervention to improve adherence to ART among non-adherent YLH. Participants will use their own cell phones for receipt of the intervention. Participants will have the option to choose a tailored personalized message that may be changed as requested throughout the study period (six months). Taking advantage of the Intelecare technology, participants will be asked to send a text message response indicating that that have successfully (or not) taken their meds per schedule. No identifying patient information will be included in the SMS text to protect patient confidentiality.
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with HIV infection (perinatally, transfusion, or behaviorally acquired; documented by medical record review or verification from referring professional)
- Have cell phone access
- Report regular use of text messaging technology
- to 29 years old
- English-speaking
- On an ART regimen for at least one month at the time of enrollment (i.e., not new to ART) with poor adherence to their antiretroviral regimen. For the purposes of this study, poor adherence will be defined at screening by one or more of the following: a) per the AIDS Clinical Trials Group (ACTG) screening questionnaire, participant reports missing at least one dose in the last week or b) reports missing more than 3 medication doses in the last month.
You may not qualify if:
- Do not report regular follow-up with their physician (at least every 3 months)
- Pregnant and on ART only due to pregnancy (i.e., will no longer be prescribed ART after delivery)
- Unable to provide assent or consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611, United States
Related Publications (1)
Garofalo R, Kuhns LM, Hotton A, Johnson A, Muldoon A, Rice D. A Randomized Controlled Trial of Personalized Text Message Reminders to Promote Medication Adherence Among HIV-Positive Adolescents and Young Adults. AIDS Behav. 2016 May;20(5):1049-59. doi: 10.1007/s10461-015-1192-x.
PMID: 26362167RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Garofalo, MD, MPH
Ann & Robert H Lurie Children's Hospital of Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Division Chief - Adolescent Medicine; Director - Center for Gender, Sexuality and HIV Prevention
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 16, 2011
Study Start
October 1, 2010
Primary Completion
March 1, 2013
Study Completion
February 1, 2014
Last Updated
November 15, 2021
Record last verified: 2021-11