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

Trial Summary

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.

What data supports the effectiveness of the treatment Healthy Choices + Text Messages for HIV?

Research shows that text messaging interventions can improve health outcomes for people living with HIV by enhancing medication adherence and reducing risk behaviors. Studies have found that tailored SMS messages can increase HIV knowledge, social support, and patient involvement, which are important for managing the condition. ^{1 2 3 4 5}

Is it safe to use text messaging for health interventions?

Text messaging for health interventions, including those for HIV care and prevention, has been generally well-received and considered safe. Studies show high engagement and low dropout rates, with no significant safety concerns reported. ^{1 6 7 8 9}

How does the Healthy Choices treatment for HIV differ from other treatments?

The Healthy Choices treatment for HIV is unique because it combines behavior change strategies with text message reminders to support adherence to antiretroviral therapy and clinic appointments, which is different from traditional treatments that focus solely on medication. ^{1 7 9 10 11}

What is the purpose of this trial?

The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and scalable intervention designed to improve self-management of alcohol and HIV in Young People with HIV (YPWH) while understanding the context for state-wide implementation and sustainment in a Hybrid Experimental Design (HED). SUSTAIN utilizes mHealth and telehealth intervention delivery of Healthy Choices (HC), combined with text messaging between sessions, to increase the likelihood of daily medication adherence (primary outcome), and increase the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (secondary outcome).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

References

1. England 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. [2023]

2. United States 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. [2022]

3. England 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. [2022]

4. England 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. [2022]

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

Addressing HIV knowledge, risk reduction, social support, and patient involvement using SMS: results of a proof-of-concept study. [2022]

6. United States 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. [2022]

7. Switzerland 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. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Mobile phone text messaging to promote healthy behaviors and weight loss maintenance: a feasibility study. [2022]

9. Australia 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. [2019]

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

Effectiveness of mobile SMS based counselling intervention in improving the knowledge, attitude, and practices of HIV/AIDS patients enrolled in hospitals/NGOs in Terengganu, Malaysia: a mixed mode study protocol. [2021]

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

Patient and staff perspectives on the use of a computer counseling tool for HIV and sexually transmitted infection risk reduction. [2019]