What side effects are associated with this type of intervention?

Common treatments for HIV, such as antiretroviral therapy (ART), can have several side effects. These include gastrointestinal issues like nausea and diarrhea, metabolic changes such as lipodystrophy and insulin resistance, cardiovascular problems, liver toxicity, and neuropsychiatric effects including depression and anxiety. Specific drug classes within ART have unique side effects; for instance, nucleoside reverse transcriptase inhibitors (NRTIs) can cause lactic acidosis and peripheral neuropathy, while protease inhibitors (PIs) are linked to increased cholesterol levels.

What prior FDA approvals exist?

The FDA has approved numerous antiretroviral drugs for the treatment of HIV, including nucleoside reverse transcriptase inhibitors (NRTIs) like tenofovir and abacavir, non-nucleoside reverse transcriptase inhibitors (NNRTIs) such as efavirenz, protease inhibitors (PIs) like darunavir, and integrase strand transfer inhibitors (INSTIs) such as bictegravir. Combination therapies, which include multiple antiretroviral drugs in a single pill, have also been approved to improve adherence and viral load suppression. Examples include Bictegravir/Emtricitabine/Tenofovir alafenamide (Biktarvy) and Dolutegravir/Abacavir/Lamivudine (Triumeq). These treatments are similar to those being studied in the TXTXT trial, which aims to enhance adherence and viral suppression through text messaging interventions.

What other types of research exist?

Promising alternatives to TXTXT for HIV patients include: 1) Real-time adherence monitoring using devices like Wisepill, which provide objective adherence data and triggered reminders. 2) Personalized text messaging systems such as iTAB, which offer tailored medication reminders and mood assessments. 3) Mobile phone reminders combined with peer counseling, which have shown effectiveness in improving adherence and treatment outcomes.

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Behavioral Intervention

TXTXT Intervention for HIV Adherence

N/A

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests if sending text message reminders can help young people with HIV stick to their medication and keep the virus levels low. The study focuses on youth and young adults who often forget to take their medicine. The text messages serve as reminders to help them stay on track with their treatment.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

HIV Medication Adherence

HIV-1 RNA Viral Load

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 .

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiretroviral therapy (ART) is the cornerstone of HIV treatment, involving a combination of drugs that target various stages of the HIV life cycle. These include nucleoside reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitors (NNRTIs) that block the reverse transcription process, protease inhibitors (PIs) that inhibit viral protease enzymes, integrase strand transfer inhibitors (INSTIs) that prevent viral DNA from integrating into the host genome, and entry inhibitors that block the virus from entering host cells. These mechanisms collectively prevent HIV from replicating, thereby reducing the viral load. This is critical for HIV patients as it helps preserve immune function, reduces HIV-related health issues, and lowers the risk of transmission. The TXTXT trial aims to enhance adherence to ART through text message reminders, emphasizing the importance of consistent medication intake for effective viral suppression.

Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials.Safety, adherence and acceptability of intermittent tenofovir/emtricitabine as HIV pre-exposure prophylaxis (PrEP) among HIV-uninfected Ugandan volunteers living in HIV-serodiscordant relationships: a randomized, clinical trial.A Randomized Controlled Trial of Real-Time Electronic Adherence Monitoring With Text Message Dosing Reminders in People Starting First-Line Antiretroviral Therapy.