Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth (TXTXT)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth|
- Adherence to ART via report on visual analogue scale [ Time Frame: prior 30 days ] [ Designated as safety issue: No ]
- Viral load [ Time Frame: 3-month ] [ Designated as safety issue: No ]The most recent viral load data will be abstracted from medical records at each time point in RNA copies per milliliter of blood plasma. In addition, as a secondary measure of disease status, CD4 count will also be recorded at each time point in CD4 cells per milliliter of blood.
|Study Start Date:||October 2010|
|Study Completion Date:||February 2014|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
No Intervention: Standard of care only
The 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.
This 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.
Behavioral: SMS Text Message Reminder
The purpose of the proposed study is to test an intervention using SMS text messaging technology to improve medication adherence among YLH. The proposed study is a randomized controlled trial of the effect of text message reminders on ART adherence rates among non-adherent YLH. Daily text message reminders will be sent to all patients randomized to the intervention group according to their medication schedule, for six months. Participants will have the option to choose a tailored personalized message that may be changed as requested throughout the study period. The investigators will enroll YLH, ages 16-29 (i.e., perinatally, transfusion, or behaviorally acquired -- consistent with our feasibility study and the distribution of infection mode in the primary clinic sites) who have demonstrated poor adherence to ART. Half of the sample, randomized to the intervention, will receive daily short message service (SMS; aka "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 for 6 months 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 the 9-month and 12-month follow-up points. The advantages of these additional features are that they allow the investigators to offer the intervention to all participants, to evaluate the intervention effect in the control group (to confirm the intervention effect) and to assess sustained intervention effects in the intervention group (post-intervention). Specific Aims:
- To determine the efficacy of an SMS text messaging intervention on our primary outcome: adherence to ART among poorly adherent YLH, ages 16-29 (a group shown to be at high risk for substance use) over a 6-month intervention period, with effects assessed at 3 and 6-months post-baseline.
- To explore the efficacy of an SMS text messaging intervention on a secondary, exploratory outcome: viral load and cluster of differentiation 4 (CD4) counts, over a 6-month intervention period, with effects assessed at 3 and 6-months post-baseline.
- To assess the feasibility, acceptability, and satisfaction of this intervention and clinical trial approach by both objective (e.g., automated message delivery and response counts) and subjective measures (e.g., reported satisfaction, acceptability).
- Youth randomized to the SMS text messaging intervention will show greater improvements in levels of adherence to ART and secondary outcomes during the intervention period at 3 and 6 months post-baseline, in comparison to those receiving standard of care only. The investigators hypothesize at least a 10-point difference in adherence level between groups at 3 and 6 months for the intervention to be clinically meaningful.
- Youth randomized to SMS text messaging intervention will maintain improvements in adherence (i.e., > 90% adherence) at 9-month and 12-month follow-ups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354210
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Robert Garofalo, MD, MPH||Ann & Robert H Lurie Children's Hospital of Chicago|