Patient AdherenceTXTXTNCT01354210
Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth
A study testing SMS Text Message Reminder in people with Patient Adherence and HIV, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 29 years
- Conditions the study is for
- Patient Adherence, HIV
- What is being tested?
- SMS Text Message Reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- 16 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, 60611
About this study
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.
Read the detailed description
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).
Primary Hypotheses:
- 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.
- Conditions
- Patient Adherence, HIV
- Being tested
- SMS Text Message Reminder
- Keywords
- Patient Adherence, HIV
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS Text Message ReminderBehavioural
Daily
| Study group | Role | What they receive |
|---|---|---|
| Standard of care only | No intervention | 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. |
| Intervention | Experimental | 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. Receives: Behavioral: SMS Text Message Reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to ART via report on visual analogue scale
Adherence to ART via report on visual analogue scale
Measured: prior 30 days
Secondary outcomes (1)
Viral load
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.
Measured: 3-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2011 (estimated)
- Study startOct 2010
- Primary completionMar 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Garofalo, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Robert Garofalo, MD, MPH, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354210
- Sponsor's protocol ID
- R34DA031053
- Other IDs
- R34DA031053
- Acronym
- TXTXT
- Status last verified
- Nov 2021
- First submitted
- 13 May 2011
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26362167
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging Intervention to Improve ART Adherence Among HIV-positive Youth
- ClinicalTrials.gov ID
- NCT01354210
- Acronym / sponsor ID
- TXTXT / R34DA031053
- Conditions
- Patient Adherence, HIV
- Keywords
- Patient Adherence, HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Primary Hypotheses:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care only | No intervention | –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. |
| Intervention | Experimental | Behavioral: SMS Text Message ReminderThis 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. |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- 16 to 29 years old
- English-speaking
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMS Text Message ReminderDaily | Behavioural | Intervention |
Primary outcome
Adherence to ART via report on visual analogue scale
Time frame: prior 30 days
Adherence to ART via report on visual analogue scale
1 secondary outcome
Viral load
Time frame: 3-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Results publication: PubMed 26362167Garofalo 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Garofalo, MD, MPH principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMS Text Message Reminder in people with Patient Adherence and HIV, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to ART via report on visual analogue scale (time frame: prior 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01354210, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.