Project Matter for HIV and Substance Use Disorder

Overseen By Abigail W Batchelder, M.P.H., Ph.D.

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Women, Non-cisgender men, others

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

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new therapy called Project Matter, designed to help people with HIV and substance use issues feel more comfortable and motivated to adhere to their HIV care. Participants will either receive five therapy sessions with a therapist plus text reminders or a single session with additional support. The trial seeks HIV-positive men who have sex with men, experience stigma due to HIV, substance use, or homophobia, and are not consistently following their HIV treatment plan. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in HIV care and support.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that this intervention is safe for improving engagement in HIV-care among substance using HIV+ MSM?

Research has shown that combining HIV care with treatment for substance use disorder (SUD) can improve health management. This integrated service supports individuals living with HIV who also encounter substance use challenges. Studies suggest that addressing both HIV and substance use together is promising, although specific safety details for the Project Matter treatment are not available.

Project Matter includes in-person therapy and text message support to assist with mood, substance use, and medication habits. Although specific safety information for this program is not provided, combining care for HIV and substance use is generally considered beneficial and supportive for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Project Matter is unique because it combines face-to-face therapy with a digital component that actively engages patients through bidirectional texting. This approach not only addresses mood and substance use but also supports medication adherence, offering a more holistic treatment method. Unlike traditional treatments for HIV and substance use disorder, which often rely heavily on medication and standard counseling sessions, Project Matter integrates technology to create a more personalized and responsive care experience. Researchers are excited about this trial as it explores innovative ways to blend human interaction with digital tools, potentially improving treatment outcomes for those struggling with these complex conditions.

What evidence suggests that this trial's treatments could be effective for HIV and substance use disorder?

Research shows that combining HIV care with support for substance use benefits individuals facing both challenges. Studies have found that people with HIV who also struggle with substance use often have difficulty adhering to their HIV treatment plans. Addressing both HIV and substance use together better meets their needs and improves their health. In this trial, participants in the Project Matter arm will receive therapy sessions and text check-ins to assist with mood, controlling substance use, and adhering to medication schedules. This combined approach is promising because it addresses both the physical and mental health needs of those living with HIV and substance use challenges. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for HIV-positive, cisgender men who have sex with men (MSM), are at least 18 years old, speak English, and feel internal stigma about their HIV status, substance use, or sexual orientation. Participants should be poorly engaged in their HIV care. Women, non-cisgender men, and those not identifying as gay or bisexual cannot join.

Inclusion Criteria

Elevated levels of internalized stigma related to HIV, substance use, or homophobia

English speaking

Able to provide informed consent

Exclusion Criteria

Do not identify as gay, bisexual, or MSM

I do not identify as a cisgender man.

I am a woman.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either the intervention group with 5 therapy sessions and text queries or the E-TAU group with a single session and counseling

12 weeks

5 therapy sessions (in-person) for intervention group

Follow-up

Participants are monitored for engagement in HIV care and intervention acceptability

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Project Matter

Trial Overview The study is testing 'Project Matter,' an emotion regulation intervention aimed to improve engagement in HIV-care among MSM with substance use disorders. It's a small-scale randomized controlled trial to see if the approach is workable and acceptable.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

This intervention includes 5 face-to-face therapy sessions with a trained clinician plus a bidirectional text component that queries mood, substance use, and medication adherence.

Group II: Enhanced Treatment as Usual (E-TAU) Active Control 1 Intervention

Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11410345/

HIV and Substance Use Disorders - PMC An estimated 30–50% of PWH have an alcohol use disorder (AUD), which increases the risk of poor linkage to HIV care and ART initiation in PWH, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6089366/

Prevalence and predictors of substance use disorders ... Findings were: 1) a 48% SUD prevalence rate (between-site range of 21–71%), with 20% of the sample evidencing polysubstance use disorder; 2) substance-specific ...

3. thelancet.com thelancet.com/journals/lanpsy/article/PIIS2215-0366(22)00159-6/abstract

Integrating HIV and substance misuse services: a person ... Integrating HIV-related care with treatment for substance use disorder provides an opportunity to better meet the needs of people living ...

4. news-medical.net news-medical.net/health/Tackling-the-Dual-Epidemics-of-HIV-and-Addiction.aspx

Tackling the Dual Epidemics of HIV and Addiction This article explores the complex interplay between drug addiction and HIV, highlighting how integrated harm reduction strategies and ...

5. tandfonline.com tandfonline.com/doi/abs/10.1080/19371918.2013.774665

Substance Use Disorders and HIV/AIDS Prevention ... This article presents current data on HIV transmission and research evidence on prevention and intervention with substance abusers and highlights how individual ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12538761/

Barriers and pathways to re-engage people with HIV ... A major factor that undermines retention in HIV care is co-occurring substance use disorders (SUD). Despite 11–48% of PWH in the U.S. having SUD ...

7. reporter.nih.gov reporter.nih.gov/search/maOGaSjux0OaOHFZ1H3vqQ/project-details/10839888

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/20499361251380642

Integrating harm reduction and addiction care in HIV ... New human immunodeficiency virus (HIV) cases related to injection drug use (IDU) in the United States increased between 2016 and 2022.

9. eprints.whiterose.ac.uk eprints.whiterose.ac.uk/188619/1/Revisions_IntegratioSubstanceUseHIV_v4_clean.pdf

Integrating HIV and substance misuse services Integrating HIV-related care with substance use disorder (SUD) treatment provides an opportunity to better meet the needs of people living with HIV (PLHIV) ...