Text Messaging Support for HIV

Overseen By Sean M Murphy, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Friends Research Institute, Inc.

Disqualifiers: HIV negative, Under 18, others

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

71 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to identify the most effective and cost-efficient methods to help transgender women living with HIV manage their health. It tests three approaches: one group receives support through text messages ("Text Me, Alexis!"), another through peer health navigation (one-on-one guidance), and the last group receives both. Ideal participants are transgender women diagnosed with HIV who have not recently visited an HIV care clinic, are not currently taking HIV medication, or have difficulty consistently taking their medication. Participants must be able to receive daily text messages on their phone or email. As an unphased trial, this study provides a unique opportunity to contribute to innovative strategies for improving health management.

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

The trial information does not specify whether you need to stop taking your current medications. It seems focused on supporting HIV care through text messaging and peer navigation, so it's likely you can continue your current medications.

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

Research has shown that text messaging programs like "Text Me, Alexis!" are generally safe and well-received. Studies on similar programs, such as "Text Me, Girl!", found them effective in improving HIV care without significant side effects. Participants receive daily text messages about HIV care and support, and users have responded positively to this approach.

For the Peer Health Navigation (PHN) component, research has proven it safe and effective. Previous studies have demonstrated that PHN helps people stay engaged in HIV care and adhere to their medication without negative effects. Combining PHN with text messaging has also been studied, yielding positive results in supporting people with HIV.

Overall, both the text messaging and peer navigation components have proven safe based on past use in similar situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative support methods for managing HIV. Unlike standard antiretroviral therapies that focus solely on medication, "Text Me, Alexis!" uses daily text messaging to provide encouragement, education, and reminders, helping people stay on track with their care. The PHN and SMS combination adds a personalized touch with peer health navigation, addressing individual barriers and providing tailored support. This approach leverages technology and human connection, aiming to improve adherence and overall health outcomes for people living with HIV.

What evidence suggests that this trial's treatments could be effective for advancing trans women living with HIV to full viral suppression?

Research has shown that text messaging can significantly assist people living with HIV. Studies have found that sending text messages improves medication adherence and helps lower viral loads. In this trial, participants in the "Text Me, Alexis!" program will receive daily motivational and educational texts, which have shown promise in helping young trans women with HIV remain engaged in their care.

Another group in this trial will receive Peer Health Navigation (PHN), which has proven effective in maintaining low viral levels by offering personalized support. Peer navigators help overcome personal challenges to care, keeping individuals on track with their treatment plans.

A third group will receive a combination of PHN and text messaging, potentially offering the best of both approaches. This combination might enhance medication adherence and reduce viral levels by providing both personal support and regular text reminders. ^{1 2 6 7 8}

Who Is on the Research Team?

Cathy J Reback, PhD

Principal Investigator

Friends Research Institute, Inc.

Sean M Murphy, PhD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

This trial is for trans women living with HIV/AIDS. Participants should be interested in interventions aimed at achieving full viral suppression. The study excludes individuals who do not meet the inclusion criteria set by the researchers, which are not specified here.

Inclusion Criteria

I identify as a transgender woman.

Verified HIV positive status

Ability to receive daily text messages on either a personal cell phone or via an email account

Exclusion Criteria

I am under 18 years old.

HIV negative status

Does not have the ability to receive daily text messages on either a personal cell phone or via an email account

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Peer Health Navigation (PHN), SMS text messaging, or a combination of both for 90 days

12 weeks

Unlimited PHN sessions, daily SMS messages

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3, 6, 12, and 18 months post-enrollment

18 months

Assessments at 3, 6, 12, and 18 months

What Are the Treatments Tested in This Trial?

Interventions

• Text Me, Alexis!

Trial Overview 'Text Me, Alexis!' is a study testing three approaches to help trans women with HIV reach full viral suppression: Peer Health Navigation (PHN), text messaging (SMS), or a combination of both PHN and SMS over three months.

How Is the Trial Designed?

Group I: Simple Message System (SMS [text messaging]) Experimental Treatment 1 Intervention

Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.

Group II: Peer Health Navigation (PHN) Experimental Treatment 1 Intervention

PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session.

Group III: PHN and SMS Experimental Treatment 1 Intervention

PHN + SMS is the combined intervention. PHN is a peer navigation intervention to advance trans women through the HIV Care Continuum by identifying their individual needs and barriers to HIV care, including: substance use and behavioral health needs; adherence goal(s); and methods to achieve adherence. Participants receive unlimited navigation sessions over 3 months; PHN sessions are delivered in a private room similar to a one-on-one peer counseling session. Text messages are scripted across: 1) HIV Care Continuum (HIV Positivity/Physical and Emotional Health, Linkage/Retention in HIV Care, and ART Adherence/Viral Load Suppression); and, 2) theoretical foundation (Social Support Theory, Social Cognitive Theory, or Health Belief Model). Participants receive three daily, theory-based text messages for 90 days (270 unique scripted messages), evenly arrayed across the HIV Care Continuum. Text messages are delivered and transmitted to either a cell phone or an email inbox.

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

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]

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]

Text messaging interventions significantly improve adherence to antiretroviral therapy in people living with HIV, with an odds ratio of 1.39, indicating a notable increase compared to control conditions.

Interventions that are less frequent, allow for two-way communication, include personalized messages, and align with participants' medication schedules are particularly effective, also leading to improved viral load and CD4+ counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text message intervention designs to promote adherence to antiretroviral therapy (ART): a meta-analysis of randomized controlled trials. Finitsis, DJ., Pellowski, JA., Johnson, BT.[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]

This study aims to analyze data from three randomized controlled trials involving text messaging interventions for improving adherence to antiretroviral therapy (ART) among people living with HIV, focusing on individual patient data from 2 Kenyan and 1 Cameroonian trial.

The meta-analysis will explore how factors like age, gender, education level, and duration on ART influence the effectiveness of text messaging, potentially identifying which patient groups benefit most from this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile phone text messages for improving adherence to antiretroviral therapy (ART): a protocol for an individual patient data meta-analysis of randomised trials. Mbuagbaw, L., van der Kop, ML., Lester, RT., et al.[2022]

The study involved 100 high-risk youth and young adults, primarily Black men who have sex with men, and found that 62% engaged in monthly text exchanges with their medical case managers, indicating good engagement with the intervention.

Participants showed significant improvements in viral load suppression rates at 6 and 12 months, particularly among those who responded more frequently to automated text messages, suggesting that this text messaging intervention effectively supports better health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More than just Reminders: Using text Messaging to Improve HIV care Outcomes Among Youth and Young Adults Living with HIV. Gerke, DR., Glotfelty, J., Slovacek, S., et al.[2023]

The study demonstrated that text message surveys are a feasible method for assessing HIV-related economic and sexual risk behaviors among economically disadvantaged African-American young adults, with a 65% response rate from participants.

Participants showed a high engagement level, answering an average of 12.6 out of 14 questions each week, indicating that text messaging can effectively gather important data on sensitive topics like sexual health and economic behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Assessing Economic and Sexual Risk Behaviors Using Text Message Surveys in African-American Young Adults Experiencing Homelessness and Unemployment: Single-Group Study. Jennings Mayo-Wilson, L., Glass, NE., Labrique, A., et al.[2021]

Text messaging (SMS) is widely used among teens and young adults, making it a powerful tool for delivering health information.

Innovative programs utilizing text messaging have been developed to promote sexual health and prevent sexually transmitted infections among young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting sexual health with SMS texting technology. Blackburn, L., Blatnik, A.[2018]

A survey of 5,378 men who have sex with men (MSM) found that 49% of mobile phone owners were willing to receive text messages for an HIV-prevention study, indicating moderate interest in this intervention.

Willingness to receive text messages varied by demographics, with Black and Hispanic MSM showing more interest than White non-Hispanic MSM, and younger participants (under 22) being more receptive than older participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are MSM willing to SMS for HIV prevention? Khosropour, CM., Lake, JG., Sullivan, PS.[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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11803334/

Comparative- and Cost-Effectiveness Research ... Interventions including PHN have been shown to be efficacious in improving rates of HIV care engagement, ART adherence, and viral suppression among transgender ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6904539/

A Novel Adaptation of Peer Health Navigation and ... The Alexis Project was a combined Peer Health Navigation (PHN) and Contingency Management (CM) intervention that targeted HIV milestones associated with ...

3. researchgate.net researchgate.net/publication/385338515_Comparative-_and_Cost-effectiveness_Research_Determining_the_Optimal_Intervention_for_Advancing_Transgender_Women_with_HIV_to_Full_Viral_Suppression_Text_Me_Alexis_Protocol_for_a_Randomized_Controlled

and Cost-effectiveness Research Determining the Optimal ... text messaging arm will receive a combined PHN and SMS text message intervention. The desired outcome of Text Me, Alexis! is viral suppression ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06408350/optimal-intervention-to-full-viral-suppression-text-me-alexis

Optimal Intervention to Full Viral Suppression: Text Me, ... Text Me, Alexis! is a three-arm randomized controlled trial (RCT) to determine the optimal (considering effectiveness and cost-effectiveness) ...

5. researchgate.net researchgate.net/publication/358004242_HIV_Care_Continuum_Interventions_Transgender_Women_A_Topical_Review

HIV Care Continuum Interventions Transgender Women However, due to the intensity of PHN, some transgender women may prefer a lower-intensity intervention such as SMS text messaging to deliver gender-affirming, ...

6. 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 It is estimated that only approximately 69% of people with complete data were virologically suppressed within 6 months of diagnosis. This low ...

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

Effect of mobile text messages on antiretroviral medication ... We investigated whether a daily text messaging intervention improves ART adherence and retention in early HIV care in PHIV in a south Florida ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6486190/

Mobile phone text messaging for promoting adherence to ... In the trial comparing only short weekly messages to standard care, text messaging was associated with lower risk of non‐adherence at 12 months, and with the ...