Mobile Health App for HIV Care Management in Stimulant Users

(START Trial)

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

286 Participants Needed

Trial Summary

What is the purpose of this trial?

This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV 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, you must be currently taking anti-retroviral therapy (ART) to participate.

What data supports the effectiveness of the treatment START in the clinical trial 'Mobile Health App for HIV Care Management in Stimulant Users'?

Research shows that mobile health apps can help people with HIV who use stimulants stick to their medication better. In one study, a mobile app improved medication adherence among men who have sex with men using stimulants, suggesting that similar apps could be effective for others in managing HIV care. ^{1 2 3 4 5}

Is the mobile health app for HIV care management safe for stimulant users?

The studies reviewed focus on the feasibility and acceptability of mobile health apps for improving medication adherence among HIV-positive individuals who use stimulants. While they do not directly address safety, the apps were generally well-received and considered acceptable by participants, suggesting no major safety concerns were identified in these trials. ^{1 2 4 6 7}

How is the START treatment different from other treatments for HIV care management in stimulant users?

The START treatment is unique because it uses a mobile health app to improve medication adherence among people with HIV who use stimulants, a group for whom no specific drug treatment exists to reduce stimulant use. This approach leverages technology to provide real-time support and self-management, which is different from traditional medication-based treatments. ^{1 2 3 8 9}

Research Team

Adam W Carrico, PhD

Principal Investigator

Florida International University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

References

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

A Pilot Study of a Mobile App to Support HIV Antiretroviral Therapy Adherence Among Men Who Have Sex with Men Who Use Stimulants. [2023]

2. China pubmed.ncbi.nlm.nih.gov

Assessing mobile health feasibility and acceptability among HIV-infected cocaine users and their healthcare providers: guidance for implementing an intervention. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pilot feasibility study of Heart2HAART: a smartphone application to assist with adherence among substance users living with HIV. [2022]

4. Canada 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. [2023]

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

Recent mobile health interventions to support medication adherence among HIV-positive MSM. [2020]

6. Ireland pubmed.ncbi.nlm.nih.gov

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

7. England 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. [2023]

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

A Multi-step Usability Evaluation of a Self-Management App to Support Medication Adherence in Persons Living with HIV. [2020]

9. France pubmed.ncbi.nlm.nih.gov

E-health. Patterns of use and perceived benefits and barriers among people living with HIV and their physicians. Part 2: Health apps and smart devices. [2021]