TXTXT Intervention for HIV Adherence

Not currently recruiting at 11 trial locations

Overseen By Katie Nikolajuk, MSW, MBE

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: ART

Disqualifiers: Age, Informed consent, Other study, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a text message system can help young people with HIV adhere to their treatment plans and reduce their viral load (the amount of virus in the blood) over six months. Some clinics will maintain their usual care (Standard of Care), while others will implement the text message system. The trial seeks participants aged 16-35 who have been on HIV medication for at least a month, struggle with medication adherence, and can receive text messages. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in HIV care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since participants must already be on an ART regimen, it seems likely you will continue your current HIV treatment.

What prior data suggests that the TXTXT intervention is safe for youth and young adults with HIV?

Research has shown that text messaging programs, like the TXTXT intervention, are generally safe and easy to manage. Studies have found that these programs can help people take their medication more regularly without causing major side effects. For example, one study found that mobile health strategies, including text messages, improved medication adherence by 4% and helped more patients meet their medication goals.

These programs typically involve receiving regular, automated text messages reminding participants to take their medication. The messages can be customized based on participant preferences. Since this method doesn't involve changing medications and is non-invasive, it is considered low-risk.

Overall, using text messages to support health habits, especially for managing HIV, has proven safe with very few reports of negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the TXTXT intervention for HIV treatment adherence because it offers a personalized approach using automated SMS messages. Unlike the standard of care, which relies on routine follow-up and adherence counseling by case managers, the TXTXT intervention allows patients to customize the content, timing, and frequency of messages, making it more tailored to individual preferences. This method aims to improve adherence by engaging patients in a language they understand (English or Spanish) and at times that suit their schedules, potentially leading to better health outcomes.

What evidence suggests that the TXTXT intervention is effective for improving HIV adherence?

Research has shown that the Treatment Text (TXTXT) program, provided to participants in the intervention arm of this trial, can assist people with HIV in adhering to their medication regimen. One study found that individuals who received regular text messages about their treatment adhered better, with 96% taking their medicine correctly compared to 92% who did not receive messages. Another study discovered that similar programs boosted confidence in managing treatment and reduced risky behaviors. These findings suggest that TXTXT could effectively help young people with HIV maintain their treatment regimen and enhance their health. ^{3 6 7 8 9}

Who Is on the Research Team?

Amy Johnson, PhD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have a viral load ≥200c/mL and/or report poor adherence (<90% of pills taken in the last 30 days)

Current patient of a participating clinic

Can provide informed consent for research component

Exclusion Criteria

Participant is participating in another study related to ART adherence

I am not between the ages of 16 and 35.

I am unable to understand and give consent for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard of Care

Participants in the comparison arm receive standard ART adherence support for 3 months

3 months

Routine follow-up visits with case managers

TXTXT Intervention

Participants receive the TXTXT intervention with automated SMS messages for 3-6 months

3-6 months

Baseline visit for setup and testing of SMS messages

Follow-up

Participants are monitored for ART adherence, viral suppression, and retention in care

6-12 months

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care
• Treatment Text (TXTXT)

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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: Comparison Active Control 1 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 .

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Howard Brown Health Center

Collaborator

Trials

11

Recruited

8,200+

KC Care Health Center

Collaborator

Trials

2

Recruited

800+

Eskenazi Health

Collaborator

Trials

14

Recruited

3,700+

Corktown Health Center

Collaborator

Trials

1

Recruited

600+

Amity Medical Group

Collaborator

Trials

1

Recruited

600+

AIDS Healthcare Foundation

Collaborator

Trials

19

Recruited

147,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

KC Care Health Center

Collaborator

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/pmc/articles/11793196

Effectiveness of an mHealth Intervention With Short Text ... The intervention group had greater adherence to ART than the control group (96% vs 92%; P<.001). In addition, the intervention group had better ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05783297

Study Details | NCT05783297 | Midwest TXTXT Scale up of ... This research study uses a cluster randomized controlled trial design to evaluate the effectiveness of Treatment Text (TXTXT) intervention on adherence and ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05783297/midwest-txtxt-scale-up-of-an-evidence-based-intervention-to-promote-hiv-medication-adherence

Midwest TXTXT Scale up of an Evidence-Based ... This research study uses a cluster randomized controlled trial design to evaluate the effectiveness of Treatment Text (TXTXT) intervention ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0376871621007249

Promising outcomes from a cognitive behavioral therapy ... Those who received TXT-CBT reduced HIV-risk behaviors and increased their self-efficacy related to medication adherence. •. TXT-CBT is a potentially scalable ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12166660/

A Review of Interventions to Enhance HIV Medication ... In a RCT among PLWH (n =436), the intervention was effective for improving medication adherence (β = 0.07, p < 0.05) and reducing unprotected sex (β = 0.43, p < ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5678388/

No Effects After 1 Year in a Randomized Controlled Trial ... Pop-Eleches et al. reported a 13-percentage-point increase in the likelihood of achieving at least 90% electronically monitored adherence over 48 weeks in the ...

7. stacks.cdc.gov stacks.cdc.gov/view/cdc/149439/cdc_149439_DS1.pdf

Text Messaging TXTXT COMPENDIUM OF EVIDENCE-BASED INTERVENTIONS AND BEST PRACTICES FOR HIV PREVENTION. MEDICATION ADHERENCE (MA) CHAPTER – TXTXT. Last updated November 4, 2016.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30621784/

Effectiveness of text messaging interventions on prevention ... We conducted a meta-analysis to evaluate text messaging to support STI/HIV prevention and treatment interventions.

9. mhealth.jmir.org mhealth.jmir.org/2025/1/e57540

Effectiveness of an mHealth Intervention With Short Text ... In this study, we show that mHealth strategies improve adherence to treatment by 4% (P<.001) and increase the probability of reaching a 95% of ...