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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help men who have sex with men (MSM) and gender minority individuals with HIV and substance use disorders (SUDs) manage their health better. It tests a new program called MATTER, which includes five text-enhanced therapy sessions to address stigma and shame, helping participants engage more effectively in HIV care. Participants will receive text messages and phone support to boost self-care and emotional awareness. The trial is ideal for those living with HIV and SUDs who experience feelings of stigma and struggle to control their HIV. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for improving health management.

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 prior data suggests that the MATTER intervention is safe for individuals with HIV and substance use disorders?

Research has shown that the MATTER program is designed to assist people with HIV and substance use issues. It employs text messages and online therapy sessions to address feelings of stigma and shame, which can hinder adherence to HIV treatment.

The MATTER program helps participants develop self-care skills, better understand their emotions, and learn self-compassion. This approach has been safely used in other areas. Since it doesn't involve drugs or medical procedures, it typically results in fewer side effects.

Although specific safety data for the MATTER program is not available, it is not a drug trial and involves therapy, making serious side effects unlikely. The methods are based on psychological practices that have been well-received in similar contexts. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MATTER Intervention because it offers a novel approach by combining text-enhanced therapy with traditional one-on-one sessions, specifically targeting internalized stigma and shame among MSM and gender minority individuals with substance use disorders (SUDs). Unlike standard treatments that may focus solely on medication or in-person counseling, this intervention uses compassionate self-restructuring and daily text messages to reinforce self-compassion and emotional awareness over an extended period. This unique blend of behavioral therapy and digital support aims to improve HIV self-care and viral suppression by fostering greater self-efficacy and emotional resilience.

What evidence suggests that the MATTER intervention could be effective for HIV and substance use disorders?

Research has shown that text-based programs can help reduce drug use among people with HIV. One study found that these programs led to a noticeable drop in drug use. Another review found that combining treatments for HIV and drug misuse can improve health. In this trial, participants in the MATTER Intervention arm will receive a text-enhanced program designed to address emotional and behavioral issues, reducing stigma and shame. This approach aims to support individuals in maintaining consistent control over the virus by improving self-care and adherence to HIV treatment plans. Meanwhile, the Control Condition arm will involve prerecorded content related to local resources for substance use treatment and other services. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

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

I can read and understand English to give informed consent.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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