TXTXT Intervention for HIV Adherence

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

600 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the TXTXT treatment for HIV adherence?

Research shows that interventions like two-way text messaging reminders can help people stick to their HIV medication schedules. These reminders are part of a broader strategy to improve adherence, which is crucial for keeping the virus under control and preventing its spread. ^{1 2 3 4 5}

Is the TXTXT intervention for HIV adherence safe for humans?

The available research does not provide specific safety data for the TXTXT intervention, but it focuses on promoting adherence to HIV treatment, which generally involves behavioral strategies rather than direct medical interventions, suggesting it is likely safe. ^{2 6 7 8 9}

How does the TXTXT Intervention for HIV Adherence differ from standard treatment?

The TXTXT Intervention is unique because it uses two-way short-text messaging (SMS) reminders to help patients stick to their HIV medication schedule, which is not a standard part of usual care. This approach is designed to improve adherence by providing regular, personalized reminders, making it different from traditional methods that rely solely on patient self-management. ^{4 5 10 11 12}

Research Team

Amy Johnson, PhD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Valley AIDS Council

Collaborator

Trials

2

Recruited

650+

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Effectiveness of interventions for adherence to antiretroviral therapy in adults with HIV: a systematic review. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies for promoting adherence to antiretroviral therapy: a review of the literature. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Optimizing ART adherence: update for HIV treatment and prevention. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Medication Adherence Among HIV-Infected Patients: Understanding the Complex Behavior of Patients Taking This Complex Therapy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

What we know and what we do not know about factors associated with and interventions to promote antiretroviral adherence. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A qualitative study of participant adherence in a randomized controlled trial of herpes suppressive therapy for HIV prevention in Tanzania. [2021]

7. England pubmed.ncbi.nlm.nih.gov

How does hard-to-reach status affect antiretroviral therapy adherence in the HIV-infected population? Results from a meta-analysis of observational studies. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Individualized texting for adherence building (iTAB) for methamphetamine users living with HIV: A pilot randomized clinical trial. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Adherence to HIV drug therapy. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Assessing adherence to antiretroviral therapy in randomized HIV clinical trials: a review of currently used methods. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Antiretroviral adherence interventions: translating research findings to the real world clinic. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Development of Stage of Readiness and decisional balance instruments: tools to enhance clinical decision-making for adherence to antiretroviral therapy. [2019]