Healthy Choices + Text Messages for HIV

Recruiting at 3 trial locations

Overseen By Sara Green, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Must not be taking: Long-acting injectables

Disqualifiers: Prisoners, others

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

Compensation: Varies

Number of Visits: 4

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help young people with HIV better manage their health through a program called Healthy Choices. The main goals are to improve medication adherence and reduce risky alcohol use. Participants will receive text message reminders and engage in coaching sessions via telehealth to support these objectives. Ideal candidates are young Floridians living with HIV who have a history of alcohol use and can access the internet through a smartphone, tablet, or computer. As an unphased trial, this study offers a unique opportunity for participants to contribute to innovative health management strategies while receiving personalized support.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does exclude those using long-acting injectables for HIV treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the Healthy Choices telehealth program is generally safe for people with HIV. Studies on similar programs indicate they can improve health without major side effects. For instance, one study found that telehealth helps people with HIV manage their condition better, suggesting it is well-tolerated.

Regarding text message reminders, research has shown they can help people take their medication on time and improve health habits. These reminders are usually safe and don't cause harm. Text messaging has been used successfully to reduce risky behaviors and support better health, indicating it is a low-risk approach.

Both the telehealth program and text message reminders aim to help manage HIV without adding new risks. Overall, evidence suggests these methods are safe and could be helpful in managing HIV. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Choices approach for HIV because it combines modern technology with personalized support to encourage better health habits. Unlike standard treatments that focus solely on medication, this approach integrates daily text message prompts to remind participants about medication adherence and stress management. Additionally, it offers a telehealth intervention, providing motivational coaching through Computerized Intervention Authoring Software (CIAS), which is not commonly part of typical HIV care. These features aim to improve overall health outcomes by addressing both psychological and adherence challenges in a convenient and accessible way.

What evidence suggests that this trial's treatments could be effective for improving self-management of alcohol and HIV in young people with HIV?

Studies have shown that mobile health tools, such as the Healthy Choices program, significantly aid people with HIV in adhering to their medication plans, which is crucial for disease management. In this trial, participants may receive the Healthy Choices telehealth intervention, which research indicates can improve health by overcoming obstacles to care. Additionally, some participants will receive text message reminders, proven to effectively increase adherence to antiretroviral therapy (ART), the medication used to treat HIV. These digital tools not only remind patients to take their medicine but also help control the virus, reducing its harm. Overall, both the Healthy Choices program and text message reminders have strong evidence supporting their effectiveness in managing HIV. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Young People with HIV (YPWH) who are looking to improve their self-management of alcohol and HIV. Participants should be interested in using mobile health (mHealth) and telehealth platforms, as well as receiving text message prompts.

Inclusion Criteria

Are not pregnant nor trying to conceive within the study's timeline

Are able to read and understand English

Are willing to provide informed consent

Exclusion Criteria

Prisoners

I am unable to give consent for medical procedures.

I am on a long-acting injectable HIV medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial mHealth Intervention

Participants receive an initial Healthy Choices mHealth intervention involving a MI based coaching session via Computerized Intervention Authoring Software (CIAS)

2 weeks

1 virtual session

Daily Micro-randomization

Participants are randomized daily to receive or not receive a text messaged prompt focused on medication adherence or stress

8 weeks

Week 2 Telehealth Coaching

Participants may receive a Healthy Choices telehealth coaching session with a trained interventionist at the end of week 2

1 session at week 2

1 virtual session

Follow-up

Participants are monitored for alcohol use and HIV viral load at 3 and 6 months post-intervention

6 months

2 follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Choices
• Text Message Prompts

Trial Overview

The SHARE Program's SUSTAIN project tests the 'Healthy Choices' intervention delivered via mHealth and telehealth, supplemented by text messages. The aim is to enhance daily medication adherence and reduce risky alcohol use among YPWH.

How Is the Trial Designed?

Group I: Within-participant micro-randomization - Prompt Experimental Treatment 1 Intervention

Participants will be randomized daily to receive a text messaged prompt focused on medication adherence or stress.

Group II: Between-participant randomization - CIAS + Week 2 Coaching Session Experimental Treatment 1 Intervention

Participants will be randomized at the end of week 2 (day 14) to receive the Healthy Choices telehealth intervention with trained interventionist at week 2. All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).

Group III: Within-participant micro-randomization - No Prompt Active Control 1 Intervention

Participants will be randomized daily to not receive a text messaged prompt focused on medication adherence or stress.

Group IV: Between-participant randomization - CIAS + No Week 2 Coaching Session Active Control 1 Intervention

Participants will be randomized at the end of week 2 (day 14) to NOT receive the Healthy Choices telehealth intervention with trained interventionist at week 2. All enrolled participants will receive an initial Healthy Choices mHealth intervention which involves a MI based coaching session via Computerized Intervention Authoring Software (CIAS).

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

CAN Community Health

Collaborator

Trials

1

Recruited

210+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The Connect4Care (C4C) text messaging intervention did not significantly improve virologic suppression rates among HIV patients after 12 months, with 48.8% in the intervention group compared to 45.8% in the control group.

However, newly diagnosed patients showed higher suppression rates (78.3% vs 45.3%), and the study suggests that patient engagement through responses to text messages may be an important factor in achieving better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Trial of a Text Messaging Intervention to Promote Virologic Suppression and Retention in Care in an Urban Safety-Net Human Immunodeficiency Virus Clinic: The Connect4Care Trial. Christopoulos, KA., Riley, ED., Carrico, AW., et al.[2022]

A review of 51 studies highlighted the importance of developing SMS content for mHealth initiatives aimed at supporting HIV/AIDS treatment adherence, emphasizing the need for formative research and grounding messages in behavior change theory.

Best practices for creating effective SMS messages include consulting with experts and using established behavior change frameworks to enhance the effectiveness of mobile health interventions in resource-limited settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content guidance for mobile phones short message service (SMS)-based antiretroviral therapy adherence and appointment reminders: a review of the literature. Kerrigan, A., Kaonga, NN., Tang, AM., et al.[2023]

A mobile text messaging intervention for HIV prevention was successfully implemented among 464 employees in the construction industry, achieving a high message delivery rate of 91.6% and 100% read rate, indicating strong engagement.

The intervention led to 21.6% of participants reporting they had taken an additional HIV test since the initial workplace testing, suggesting that SMS messaging can effectively promote HIV testing and awareness even during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Test@Work Texts: Mobile Phone Messaging to Increase Awareness of HIV and HIV Testing in UK Construction Employees during the COVID-19 Pandemic. Middleton, M., Somerset, S., Evans, C., et al.[2020]

In a trial involving 200 HIV-positive adults in Cameroon, motivational text messages sent weekly did not significantly improve adherence to antiretroviral therapy (ART) over six months, as measured by various adherence metrics.

Despite the lack of significant improvement in adherence, the study suggests exploring different messaging strategies or longer study durations to potentially enhance ART adherence in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cameroon Mobile Phone SMS (CAMPS) trial: a randomized trial of text messaging versus usual care for adherence to antiretroviral therapy. Mbuagbaw, L., Thabane, L., Ongolo-Zogo, P., et al.[2022]

Text messaging interventions have been shown to effectively improve adherence to antiretroviral therapy and increase appointment attendance among people living with HIV, based on a systematic review of nine high-quality reviews involving 37 studies across 19 countries.

There are significant knowledge gaps regarding long-term outcomes and patient satisfaction with text messaging interventions, indicating a need for further research to fully understand their impact and potential in managing other chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging interventions for HIV and other chronic diseases: an overview of systematic reviews and framework for evidence transfer. Mbuagbaw, L., Mursleen, S., Lytvyn, L., et al.[2022]

Mobile phones and SMS technology present a promising opportunity to improve HIV self-management and healthcare outcomes for people living with HIV, transforming the disease into a manageable condition.

An effective SMS-based intervention should focus on interactivity, frequency, timing, and message tailoring to enhance medication adherence and promote positive health behaviors, ultimately leading to better clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond reminders: a conceptual framework for using short message service to promote prevention and improve healthcare quality and clinical outcomes for people living with HIV. Coomes, CM., Lewis, MA., Uhrig, JD., et al.[2022]

Using SMS broadcasting to promote influenza vaccinations in HIV-positive patients significantly increased both the number of patients contacted (from 35% to 81%) and vaccinated (from 26% to 47%) compared to traditional phone calls in 2012.

This method not only improved vaccination rates but also reduced staff time and costs associated with promoting the vaccine, demonstrating that SMS is an efficient and cost-effective way to communicate health messages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short message service broadcasting to improve the uptake of influenza vaccination in HIV-positive patients at a metropolitan sexual health clinic. Stowers, C., Healey, L., O'Connor, CC.[2019]

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Project Details

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