Text-Based Intervention for HIV and Substance Use Disorders

(MATTER Trial)

Recruiting at 1 trial location

Overseen By Christopher Chiu, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Cisgender women, Cisgender heterosexual men

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

Compensation: Varies

Number of Visits: 11

Duration: 5 weeks

256 Participants Needed

Trial Summary

What is the purpose of this trial?

Men who have sex with men (MSM), and gender minority individuals who have sex with men, living with HIV and substance use disorders (SUDs) are less likely to be virally suppressed, which can lead to HIV transmission and negative health outcomes. This hybrid type 1 study will assess the efficacy, mechanisms, as well as facilitators and barriers to implementing the MATTER intervention, a virtually delivered 5-session text-enhanced psychobehavioral intervention designed to facilitate viral suppression by addressing internalized stigma and shame as barriers to engagement in HIV care among MSM and gender minority individuals living with HIV and SUDs in two locations with different levels of HIV resources (i.e., the Boston, Massachusetts and Miami, Florida metro areas). MATTER aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) developing behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of emotions and cognitions), and c) teaching and reinforcing compassionate self-restructuring (i.e., self- compassion), in addition to providing access to phone-based resource navigation. Scalable interventions such as MATTER are essential to our efforts to end the HIV epidemic in high priority regions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of this treatment for HIV and substance use disorders?

Research shows that text messaging interventions can help people with HIV stick to their medication schedules and reduce substance use. Studies found that these messages are well-received and can improve medication adherence and clinical outcomes, making them a promising tool for managing HIV and substance use disorders. ^{1 2 3 4 5}

Is the text-based intervention for HIV and substance use disorders safe for humans?

The text-based intervention, which involves sending and receiving personalized messages to support medication adherence and reduce substance use, has been found to be acceptable and feasible for people with HIV and substance use disorders. There are no reported safety concerns in the studies, suggesting it is generally safe for human use. ^{1 2 4 6 7}

How is the MATTER Intervention treatment different from other treatments for HIV and substance use disorders?

The MATTER Intervention is unique because it uses a personalized, automated text messaging tool to help people with HIV and substance use disorders manage their medication and mood. This approach allows for real-time, two-way communication, providing personalized support and reminders, which is different from traditional treatments that may not offer such interactive and immediate engagement. ^{1 2 5 8 9}

Eligibility Criteria

This trial is for men and gender minority individuals who have sex with men, are HIV positive with unsuppressed viral loads, and suffer from substance use disorders excluding tobacco, cannabis, or alcohol. Participants must experience internalized stigma related to their HIV status, substance use, sexual orientation or gender identity. They need to be adults able to consent in English and communicate in either English or Spanish. Access to a text-capable cell phone is required.

Inclusion Criteria

I can read and understand English to give informed consent.

Have access to a cell phone with text capacity (study will supplement phones and plans as needed consistent with our pilot work)

I am a man who has sex with men or identify as a gender minority.

Exclusion Criteria

I am a cisgender woman.

I am a cisgender heterosexual man.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the MATTER intervention, a 5-session text-enhanced psychobehavioral intervention delivered virtually to address internalized stigma and shame.

5 weeks

5 virtual therapy sessions

Follow-up

Participants are monitored for viral suppression and other outcomes at 6 and 12 months after the intervention.

12 months

6-month and 12-month follow-up visits

Treatment Details

Interventions

• Control Condition
• MATTER Intervention

Trial Overview The MATTER intervention is being tested against a control condition. It's a virtual program of five sessions designed to help participants manage internalized stigma and shame associated with HIV and substance use by setting self-care goals, increasing awareness of thoughts and feelings without judgment (metacognition), fostering self-compassion, plus offering phone-based resource navigation.

Participant Groups

Group I: Matter Intervention Experimental Treatment 1 Intervention

This 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among MSM and gender minority individuals with SUDs that perpetuate sub-optimal engagement in HIV self-care and consequently inconsistent viral suppression. The intervention involves five virtually delivered one-on-one therapy sessions focused on behavioral goal setting skill development and related self-efficacy, increasing meta-cognitive awareness(i.e.,non-judgmental awareness of emotions and cognitions), and teaching and reinforcing compassionate self-restructuring (i.e., self-compassion). Participants also receive daily text messages querying emotions during the one-on-one portion of the intervention. For eight weeks after the one-on-one portion, participants receive their compassionate self-statements via text in response to their indicated emotions. Participants will also receive phone-based resource navigation, as needed.

Group II: Control Condition Active Control 1 Intervention

The control condition will involve five sessions of prerecorded asynchronous content related to local resources (e.g., information related to substance use treatment and other ancillary services).

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

The MI+HealthCall intervention, which combines Motivational Interviewing with smartphone technology, showed high feasibility with a 95% daily use rate and excellent patient satisfaction (4.5 out of 5) among adults living with HIV.

Participants using MI+HealthCall experienced significantly greater reductions in drug use and spending compared to those receiving only Motivational Interviewing, indicating its potential effectiveness in addressing substance use issues that can hinder HIV treatment adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. Aharonovich, E., Stohl, M., Cannizzaro, D., et al.[2020]

The E-VOLUTION texting intervention, which sent automated reminders and support messages to 100 young adults living with HIV over 26 months, significantly improved adherence to medical appointments and viral load suppression, indicating its efficacy in enhancing HIV care.

Participants found the texting intervention acceptable, and the frequency of alerts triggered by their responses was positively correlated with better health outcomes, suggesting that this culturally responsive approach effectively engages youth in managing their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-VOLUTION: A Text Messaging-Powered Intervention-Connection, Support, and HIV Eradication. Gerke, DR., Glotfelty, J., Schlueter, J., et al.[2021]

The Act Healthy (AH) intervention led to significantly greater reductions in cravings for substance use compared to supportive counseling, although it did not result in a significant decrease in overall substance use among the 61 participants over one year.

Both the AH and supportive counseling groups showed a significant increase in the likelihood of being on antiretroviral therapy (ART), with 86% of participants on ART at 12 months compared to 56% at baseline, indicating improved medication adherence in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS. Magidson, JF., Belus, JM., Seitz-Brown, CJ., et al.[2022]

42% of non-treatment seeking individuals living with HIV (PLWH) and alcohol misuse agreed to participate in a computer-delivered brief alcohol intervention (CBI) in their primary care clinic, indicating a significant interest in addressing alcohol use.

Participants who agreed to CBI were more likely to have detectable viral loads and higher levels of alcohol use and mental health symptoms, suggesting that CBI effectively targets those most in need of support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Computer-delivered Brief Alcohol Intervention in HIV Clinical Settings: Who Agrees to Participate? Yang, C., Crane, HM., Cropsey, K., et al.[2022]

References

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

Development of a personalized bidirectional text messaging tool for HIV adherence assessment and intervention among substance abusers. [2022]

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

Pilot RCT of bidirectional text messaging for ART adherence among nonurban substance users with HIV. [2018]

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

Tailored text messaging intervention for HIV adherence: a proof-of-concept study. [2022]

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

HealthCall delivered via smartphone to reduce co-occurring drug and alcohol use in HIV-infected adults: A randomized pilot trial. [2020]

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

E-VOLUTION: A Text Messaging-Powered Intervention-Connection, Support, and HIV Eradication. [2021]

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

Act Healthy: A Randomized Clinical Trial Evaluating a Behavioral Activation Intervention to Address Substance Use and Medication Adherence Among Low-Income, Black/African American Individuals Living with HIV/AIDS. [2022]

7. Ireland pubmed.ncbi.nlm.nih.gov

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

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

HealthCall: A randomized trial assessing a smartphone enhancement of brief interventions to reduce heavy drinking in HIV care. [2023]

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

Implementation of Computer-delivered Brief Alcohol Intervention in HIV Clinical Settings: Who Agrees to Participate? [2022]