mHealth + e-Navigator for Medication Adherence

(Project STEP Trial)

Overseen By Diana M Sheehan, Ph.D, M.P.H

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Florida International University

Must be taking: ART

Disqualifiers: Non-Latino, Female, Under 18, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks better methods to help Latino men who have sex with men and live with HIV adhere to their antiretroviral therapy (ART). It tests two strategies: one involves a program called TXTXT, which sends supportive text messages, and the other includes e-Navigation, a remote guidance system. Participants who do not respond well may receive additional support. Eligible participants should be Latino or Hispanic, identify as male, have HIV, and have experienced difficulty adhering to their medication in the past. They must also own a cell phone and use text messaging. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance support systems for others facing similar challenges.

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 the study focuses on improving adherence to ART (antiretroviral therapy), it is likely that you will continue your current ART regimen.

What prior data suggests that these interventions are safe for improving ART adherence?

Research shows that the TXTXT program, which sends text message reminders to help people take their medication, is generally safe. Although specific safety data is not available, TXTXT is a mobile health tool that sends messages to phones. This method is non-invasive, as it does not involve medical procedures or entering the body.

When combined with e-Navigation, these tools effectively help people manage their medication. E-Navigation typically includes remote support from a healthcare provider or counselor, which is also considered safe and well-tolerated.

Adding EMA (Ecological Momentary Assessment) to TXTXT and e-Navigation involves collecting feedback from participants throughout the day. This approach provides personalized support based on individual needs. Like the other methods, it is non-invasive and has been used in other studies without major safety issues.

Overall, these digital tools are non-invasive and aim to help people maintain their medication schedules. Research has not reported any significant negative side effects from using these methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth + e-Navigator protocol because it aims to tackle medication adherence in a novel way. Unlike traditional approaches that might focus solely on patient education or reminders, this protocol uses digital interventions, like TXTXT and e-Navigation, to actively engage patients. By tailoring support based on adherence levels and using electronic tools, it offers a dynamic and personalized way to help patients stick to their medication regimen. This approach not only leverages technology but also provides flexibility, potentially leading to better long-term health outcomes for patients.

What evidence suggests that this trial's treatments could be effective for improving ART adherence among Latino MSM with HIV?

Studies have shown that text message reminders can help people with HIV adhere to their medication schedules. Specifically, tools like TXTXT, which sends regular reminders, have been linked to improved medication habits. In this trial, participants in Arm 1 will use TXTXT only, while those in Arm 2 will use both TXTXT and e-Navigation. Research suggests that combining TXTXT with e-Navigation, which provides additional support, can enhance these results. This combination has helped people take their medication consistently and maintain viral control. For some participants in Arm 2, adding EMA (ecological momentary assessment), which offers real-time feedback, can provide further support and improve medication habits. Overall, these strategies have shown promise in helping people with HIV adhere to their medication plans effectively. ^{1 6 7 8 9}

Who Is on the Research Team?

Diana M Sheehan, Ph.D, M.P.H

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for adult Latino men who have sex with men (MSM) and are living with HIV. Participants should be currently on antiretroviral therapy (ART) but may struggle with taking their medication consistently.

Inclusion Criteria

Cell phone ownership and SMS use: Participants must own a personal cell phone for the intervention.

I have been on HIV treatment for at least 1 month.

I am a man who identifies as gay or bisexual, or I have had sex with men.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TXTXT or TXTXT + e-Navigation for 6 months, with potential adjustments based on adherence

6 months

Monthly visits for adherence assessment

Follow-up

Participants are monitored for ART adherence and viral suppression after treatment

6 months

Visits at 6 and 12 months post-intervention

What Are the Treatments Tested in This Trial?

Interventions

• Ecological Momentary Assessment (EMA) supported e-Navigation
• e-Navigation
• TXTXT

Trial Overview The study tests two strategies to improve ART adherence using text messages and e-Navigation, which includes remote patient guidance. Some participants will start with texts only and add e-Navigation if needed, while others get both from the start and may add extra EMA-supported navigation.

How Is the Trial Designed?

Group I: Arm 2 (starts with TXTXT and e-Navigation) Experimental Treatment 3 Interventions

Arm 2 will begin with TXTXT and e-Navigation. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT and e-Navigation only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized into staying only with TXTXT and e-Navigation, or into receiving TXTXT, e-Navigation plus EMA support for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.

Group II: Arm 1 (starts on TXTXT only) Experimental Treatment 2 Interventions

Arm 1 will begin with TXTXT only. ART adherence will be assessed at 3 months. If they are 90% adherent or above, they will continue with TXTXT only for an additional 3 months. If they are less than 90% adherent, they will be re-randomized (1:1) into staying only with TXTXT, or into receiving TXTXT plus e-Navigation for an additional 3 months. At 6 months, all interventions will end. Participants in this arm will be followed for 6 months after interventions cease.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Care Resource Community Health Centers

Collaborator

Trials

1

Recruited

250+

Care Resource Community Health Centers, Inc.

Collaborator

Trials

1

Recruited

70+

Published Research Related to This Trial

A meta-analysis of 16 randomized clinical trials involving 2742 patients found that mobile phone text messaging significantly improves medication adherence in adults with chronic diseases, doubling the odds of adherence (odds ratio of 2.11).

The increase in adherence rates from approximately 50% to 67.8% suggests that text messaging can be an effective and scalable intervention, although results should be interpreted cautiously due to the reliance on self-reported data and the short duration of the studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Telephone Text Messaging for Medication Adherence in Chronic Disease: A Meta-analysis. Thakkar, J., Kurup, R., Laba, TL., et al.[2022]

A meta-analysis of 8 randomized trials involving 1994 patients found that 2-way text messaging significantly improves medication adherence compared to 1-way text messaging, with a relative risk of 1.23 versus 1.04, respectively.

The study highlights that 2-way text messaging, which includes receiving replies from patients, is more effective in ensuring patients take their medications as directed, suggesting a valuable tool for managing chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-way versus two-way text messaging on improving medication adherence: meta-analysis of randomized trials. Wald, DS., Butt, S., Bestwick, JP.[2022]

The pilot study involving 29 women with metastatic breast cancer demonstrated that the CONnected CUstomized Treatment Platform effectively maintained a high palbociclib adherence rate of 95.8%, indicating its potential for improving medication compliance.

Despite the high adherence rate, participants reported no significant changes in symptom burden or quality of life over three months, suggesting that while the intervention is feasible, further improvements in usability are needed to enhance overall patient experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving palbociclib adherence among women with metastatic breast cancer using a CONnected CUstomized Treatment Platform: A pilot study. Sadigh, G., Meisel, JL., Byers, K., et al.[2023]

A review of 16 studies on e-Health interventions for improving medication adherence found that 10 of these studies reported significant improvements in adherence rates.

The most effective e-Health interventions were simpler in design, suggesting that complexity may hinder their success in helping patients stick to their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[e-Health interventions and improvement in treatment adherence]. Sieben, A., Bredie, SJ., van Laarhoven, CJ., et al.[2018]

The EpxMedTracking system, a fully automated SMS-based medication adherence tool, achieved a high engagement rate of 85.9% among 25 patients over 11 weeks, indicating its feasibility in real-world settings.

Patients using EpxMedTracking reported higher medication adherence and provided valuable feedback on reasons for missed doses, allowing healthcare providers to address these issues in real time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EpxMedTracking: Feasibility Evaluation of an SMS-Based Medication Adherence Tracking System in Community Practice. Tricarico, C., Peters, R., Som, A., et al.[2020]

A study validated expert-developed text messages aimed at improving medication adherence by addressing barriers like disease beliefs and forgetfulness, with 40 participants initially grouping 32 messages into various categories.

After refining the messages, a second group of 37 participants successfully categorized 36 messages into 5 distinct groups, confirming the effectiveness of the message structure for future research on enhancing adherence to anti-hypertensive medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Confirming the theoretical structure of expert-developed text messages to improve adherence to anti-hypertensive medications. Farris, KB., Salgado, TM., Batra, P., et al.[2019]

Only 61% of providers were aware of the external medication history (EMH) function in the electronic health record, with primary care providers being more aware than surgical providers, indicating a need for better communication about this tool.

Among patients, 34% believed the EMH could change their medication-taking behavior, and 48% felt it already had, suggesting that awareness of the EMH may enhance medication adherence and improve patient safety by revealing nonadherence and prescription discrepancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider and Patient Perceptions of an External Medication History Function. Wolver, SE., Stultz, JS., Aggarwal, A., et al.[2019]

The pilot study involving 49 patients showed that those using the Smart About Meds (SAM) app had better adherence to medication changes after hospital discharge (83.7%) compared to those receiving usual care (77.8%).

Patients using the SAM app also had a lower rate of hospital readmissions (8.7%) compared to the control group (15.4%), suggesting that the app may help reduce adverse events related to medication management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smart About Meds (SAM): a pilot randomized controlled trial of a mobile application to improve medication adherence following hospital discharge. Habib, B., Buckeridge, D., Bustillo, M., et al.[2022]

Medication non-adherence is a significant global issue, contributing to 33% to 69% of medication-related hospital admissions in the USA and costing the healthcare system over $100 billion annually.

To improve medication adherence, hospitals should implement integrated technologies and strategies, such as mobile health tools and medication reminders, to enhance patient quality of life and reduce unnecessary healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population-based medication adherence programmes: a window of opportunities. Russo, HE., Kirsh, WD.[2013]

A review of 75 medication adherence apps revealed that only 7 unique behavior change techniques (BCTs) were included, with an average of 3.3 BCTs per app, indicating a limited application of effective strategies for improving medication adherence.

Usability testing with 20 adolescents and young adults highlighted that the Medisafe app was rated highest in quality and user engagement, suggesting that app developers should focus on user preferences and evidence-based techniques to enhance the effectiveness of medication adherence tools for younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content and Usability Evaluation of Medication Adherence Mobile Applications for Use in Pediatrics. Carmody, JK., Denson, LA., Hommel, KA.[2020]

This study will evaluate the feasibility and preliminary effectiveness of a text message intervention aimed at improving medication adherence among 75 adult patients prescribed oral anti-cancer agents over an 8-week period.

The intervention group will receive timed text messages alongside usual care, which may help address common barriers to adherence, such as complex regimens and forgetfulness, particularly in older cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of the feasibility and preliminary efficacy of a texting intervention on medication adherence in adults prescribed oral anti-cancer agents: study protocol. Spoelstra, SL., Given, CW., Sikorskii, A., et al.[2018]

The eHealth program significantly improved overall treatment adherence in patients with type 2 diabetes mellitus (T2DM) compared to a control group, with a small effect size (d=0.27) after 6 months.

Participants in the intervention group showed a significant reduction in caloric intake from unhealthy snacks (d=0.36), although no significant changes were observed in physical activity or adherence to medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Computer-Tailored Program to Improve Treatment Adherence in Patients With Type 2 Diabetes: Randomized Controlled Trial. Vluggen, S., Candel, M., Hoving, C., et al.[2021]

Citations

1. 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 ...

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

Effectiveness of an mHealth Intervention With Short Text ... These results show that an mHealth intervention significantly improves ART adherence. Implementing mHealth programs could enhance the commitment ...

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

Promising outcomes from a cognitive behavioral therapy ... Conclusions. Findings demonstrated promising preliminary evidence for the efficacy of TXT-CBT in improving ART adherence and reducing drug use and HIV-risk ...

4. aidsrestherapy.biomedcentral.com aidsrestherapy.biomedcentral.com/articles/10.1186/s12981-020-00275-2

Effect of mobile text messages on antiretroviral medication ... In summary, our study showed that 1-way daily SMS reminders over 6-months did not significantly improve ART adherence in HIV care among patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4939231/

The Effectiveness of Mobile Phone Text Messaging in ... The results of this systematic review indicated that text messaging interventions have improved patients' medication adherence rate (85%, 29.34).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8363866/

Real-World Adherence to Antiretroviral Therapy Among ... Recent changes in antiretroviral therapies (ARTs) may have affected medication adherence of people living with human immunodeficiency ...

7. clinicalinfo.hiv.gov clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/adherence-continuum-care

Adherence to the Continuum of Care | NIH View recommendations to optimize adherence to antiretroviral therapy in adults and adolescents with HIV.

8. withpower.com withpower.com/trial/phase-hiv-infections-2-2023-bf959

TXTXT Intervention for HIV Adherence · Info for Participants 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 ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39881127/

Effectiveness of an mHealth Intervention With Short Text ... Conclusions: These results show that an mHealth intervention significantly improves ART adherence. Implementing mHealth programs could enhance ...