Mobile Health App for HIV Care Management in Stimulant Users

(START Trial)

Not currently recruiting at 2 trial locations

Overseen By Adam W Carrico, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Florida International University

Must be taking: Antiretrovirals

Disqualifiers: HIV-negative, No ART, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app called START to determine if it helps men who use stimulants, such as methamphetamine, manage their HIV treatment more effectively. The app supports those who are HIV-positive and currently taking medication but may struggle with adherence. Participants will either use the app or access a website with resources about substance use and HIV care. Men diagnosed with HIV for at least three months, currently on HIV medication, and who have recently used stimulants might be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance HIV care for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be currently taking anti-retroviral therapy (ART) to participate.

What prior data suggests that the START mHealth app is safe for users?

Research shows that mobile health (mHealth) apps are generally safe and well-received by people living with HIV. These apps help users adhere to their treatment plans and improve their health. For instance, studies have found that mHealth tools enable effective management of HIV treatment without harm.

One study found that users of a similar app experienced better coordination of care and access to healthcare services without major safety issues. Another review showed that mHealth tools are effective and well-liked by people with HIV, indicating comfort in using these tools.

While specific safety data for the START app is not available, evidence from similar mHealth tools suggests they are safe and acceptable. This suggests that using the START app is likely safe based on knowledge from other similar tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the START mHealth Intervention because it leverages a mobile health app to support HIV care management specifically for those using stimulants. Unlike traditional treatments, which often rely on in-person visits and medication adherence, this app offers a digital solution for tracking health and accessing resources anytime, anywhere. The app's unique approach aims to improve engagement and treatment outcomes by meeting users where they are, providing a personalized and accessible tool that fits into their daily lives.

What evidence suggests that the START mHealth app is effective for HIV care management in stimulant users?

Research shows that mobile health apps like START, which participants in this trial may receive, help people adhere to their HIV treatment plans more effectively. Studies have found that these apps improve medication adherence. This is crucial for managing HIV, especially for those using drugs like methamphetamine. One study found that these apps can save money by reducing the need for healthcare services. Overall, evidence suggests that the START app may enhance health outcomes for people living with HIV. ^{1 2 6 7 8}

Who Is on the Research Team?

Adam W Carrico, PhD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

The START trial is for men who were assigned male at birth, are HIV-positive, over 18 years old, live in the continental US, and have struggled with sticking to their HIV treatment while using stimulants like methamphetamine. They must speak English and be willing to use a cell phone app to help manage their medication adherence.

Inclusion Criteria

Reads and speaks English

I identify as male.

I have had a detectable viral load in the past year or haven't been fully adherent to my ART.

Exclusion Criteria

I am an HIV-positive man not currently on ART.

HIV-negative or never tested for HIV

Does not return a viable DBS specimen at baseline for viral load testing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• START

Trial Overview This study tests the START mobile health application's effectiveness in helping men adhere better to their HIV treatments while managing stimulant abuse issues. Participants will be randomly placed into groups where some will use this new app as part of their care routine.

How Is the Trial Designed?

Group I: START mHealth Intervention Experimental Treatment 1 Intervention

Participants randomized to receive the START mHealth intervention will have access to the mHealth application for 6 months following randomization.

Group II: Website referrals Active Control 1 Intervention

Participants in this condition will receive no intervention and will have access to a website with resources related to substance use disorder treatment and HIV treatment.

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

The WiseApp, a mobile health application designed for people living with HIV, underwent a thorough usability evaluation involving end-users and experts, leading to important design improvements for better user experience.

The iterative feedback process from think-aloud protocols and cognitive walkthroughs confirmed that the app and its linked devices are user-friendly, enhancing the potential for effective self-management of health in individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Multi-step Usability Evaluation of a Self-Management App to Support Medication Adherence in Persons Living with HIV. Beauchemin, M., Gradilla, M., Baik, D., et al.[2020]

A study involving focus groups of stimulant-using HIV-positive men revealed that app features such as user control, perceived usefulness, and security significantly influence their decision to download and continue using mobile health apps.

Participants suggested that effective ART adherence apps should include social networking features, local resource connections, and engaging feedback mechanisms, highlighting the importance of tailoring app design to meet the specific needs of this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Creating Effective Mobile Phone Apps to Optimize Antiretroviral Therapy Adherence: Perspectives From Stimulant-Using HIV-Positive Men Who Have Sex With Men. Horvath, KJ., Alemu, D., Danh, T., et al.[2023]

A study involving 20 HIV-negative men who have sex with men (MSM) showed that participants found a digital pill system (DPS) helpful for promoting adherence to pre-exposure prophylaxis (PrEP), indicating its potential as a supportive tool in HIV prevention.

Participants responded positively to cognitive behavioral therapy (CBT)-based messaging components of the intervention, particularly corrective feedback and contingent reinforcement, but expressed concerns about stigma related to substance use screening, which could hinder the use of the DPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a digital pill and respondent behavioral intervention (PrEPSteps) for HIV pre-exposure prophylaxis adherence among stimulant using men who have sex with men. Chai, PR., Mohamed, Y., Goodman, G., et al.[2023]

The Heart2HAART smartphone application was found to be feasible and user-friendly for participants, with 63.2% reporting no difficulty using it and 94.7% stating that medication reminders did not disrupt their daily activities.

Despite the positive feedback on usability, the study found no significant difference in adherence to HIV medication between those using Heart2HAART and the control group, suggesting that further refinements may be needed for the intervention to enhance medication adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. Himelhoch, S., Kreyenbuhl, J., Palmer-Bacon, J., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11360769/

Supporting treatment adherence for resilience and thriving ... Our team is also assessing the potential cost-effectiveness of the START mHealth application, including net savings with respect to averted healthcare ...

2. withpower.com withpower.com/trial/phase-2-2-2022-09b1b

Mobile Health App for HIV Care Management in Stimulant ... Trial Overview This study tests the START mobile health application's effectiveness in helping men adhere better to their HIV treatments while managing ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12419757/

User Engagement With a Mobile Health App for People Living ... Mobile health (mHealth) interventions can be effective for people living with HIV, who are sensitive to privacy breach risks.

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

Effectiveness of an mHealth Intervention With Short Text ... The objective of this study is to evaluate the effectiveness of a mobile health (mHealth) intervention based on SMS text messages to increase antiretroviral ...

5. aidsrestherapy.biomedcentral.com aidsrestherapy.biomedcentral.com/articles/10.1186/s12981-024-00653-0

Effect of mobile health intervention on medication time ... This study aimed to assess the impact of Mobile health (M-health) on medication time adherence among people living with HIV/AIDS (PLWHA).

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT02906215

Mobile Application to Improve Care Coordination Among ... The use of a mobile application combined with an evidence-based training model offers an innovative approach to improving care coordination and linking patients ...

7. mhealth.jmir.org mhealth.jmir.org/2022/9/e37868

Using the Positive Peers Mobile App to Improve Clinical ... The Positive Peers App (PPA) is a multifunctional HIV support tool designed to improve HIV-related clinical outcomes for young people with HIV.

8. mhealth.amegroups.org mhealth.amegroups.org/article/view/50231/html

Scale up mHealth HIV interventions: site and public health ... A number of mobile health (mHealth) interventions have been shown to be effective and highly acceptable tools for improving human immunodeficiency virus (HIV) ...