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Behavioral Intervention
TXTXT Intervention for HIV Adherence
N/A
Recruiting
Led By Amy Johnson, PhD
Research Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
Study Summary
This trial will evaluate if TXTXT intervention can help improve adherence & viral load suppression in young people living with HIV.
Who is the study for?
This trial is for young people aged 16-35 with HIV who are on antiretroviral therapy (ART) but have a viral load of ≥200c/mL or haven't been taking their medication regularly. They must be able to get text messages and give informed consent, and they should already be patients at one of the participating clinics.Check my eligibility
What is being tested?
The study compares two groups in different clinics: one gets standard HIV care, while the other receives an additional text message-based intervention called TXTXT aimed at improving medication adherence. The effectiveness will be measured by how well participants stick to their ART regimen and their viral load after 3 and 6 months.See study design
What are the potential side effects?
Since this trial involves a non-medical intervention (text messaging), there are no direct medical side effects associated with it. However, participants may experience issues related to privacy if personal information is shared via texts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HIV Medication Adherence
HIV-1 RNA Viral Load
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
Clinics randomized to the intervention arm will have participants complete a 6-month intervention period. Clinics will sign up eligible participants to receive automated SMS messages from the Dimagi CommCare platform during the participant's baseline study visit. Participants will have the option to tailor the message content based on their own preferences and will be able to select to receive messages in English or in Spanish, the time the messages are delivered, and frequency of messages. Clinic staff will enter this information in the Dimagi CommCare platform, and then test receipt of text messages by the participant before they complete this baseline visit.
Group II: ComparisonActive Control1 Intervention
Clinics randomized to the comparison arm will have participants receive standard of care ART adherence support for 3 months, and will receive the TXTXT intervention for 3 months. The standard of care for ART adherence across clinic sites consists of routine follow-up from assigned case managers for appointment reminders and adherence counseling at scheduled visits .
Find a Location
Who is running the clinical trial?
Howard Brown Health CenterOTHER
10 Previous Clinical Trials
7,612 Total Patients Enrolled
KC Care Health CenterUNKNOWN
1 Previous Clinical Trials
200 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
260 Previous Clinical Trials
5,188,638 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 16 and 35 years old.I have been on HIV treatment for at least one month.I am not between the ages of 16 and 35.I am unable to understand and give consent for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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