Substance Use DisordersNCT03899220
Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
A study testing Project Matter in people with Substance Use Disorders and HIV/AIDS, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Substance Use Disorders, HIV/AIDS, Homosexuality, Male
- What is being tested?
- Project Matter
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV positive
- Cisgender male
- Man who has sex with men (MSM)
- Elevated levels of internalized stigma related to HIV, substance use, or homophobia
- Poorly engaged in HIV care
- Able to provide informed consent
- 18 years or older
- English speaking
Who cannot join
- Women
- Non-cisgender men
- Do not identify as gay, bisexual, or MSM
Trial locations and contacts
1 site in 1 country.
United States1 site
Fenway Community Health
Boston, Massachusetts, 02215
About this study
Official title: Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders (Project Matter)
This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.
Read the detailed description
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.
- Conditions
- Substance Use Disorders, HIV/AIDS, Homosexuality, Male
- Being tested
- Project Matter
- Medical subject headings
- Substance-Related Disorders, Acquired Immunodeficiency Syndrome, Homosexuality, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project MatterBehavioural
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. Both the intervention group and the enhanced treatment as usual (E-TAU) involve a one-session behavioral engagement in care intervention as well as substance use treatment counseling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Behavioral: Project Matter |
| Enhanced Treatment as Usual (E-TAU) | Active comparator | Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling. Receives: Behavioral: Project Matter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
Measured: change from baseline to 12 weeks after intervention completion
Feasibility of Intervention
Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).
Measured: change from baseline to 12 weeks after intervention completion
Secondary outcomes (1)
Engagement in HIV Care
Summary Score of 6 indicators of HIV treatment engagement: no missed and not rescheduled HIV-related appointments in the past 3 months, no missed and not rescheduled HIV-related lab tests in the past 3 months, maintaining ART prescriptions over the past 3 months, maintaining >=80% ART adherence in the past 30 days, no period of 4 days where ART was stopped in the past 3 months (without guidance from an HIV care provider), and undetectable viral load at the study visit.
Measured: change from baseline to 12 weeks after intervention completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start24 Apr 2019
- Primary completion30 May 2023
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Abigail Batchelder, Ph.D., M.P.H., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899220
- Sponsor's protocol ID
- 2019p001118
- Other IDs
- K23DA043418
- Status last verified
- Dec 2025
- First submitted
- 27 Mar 2019
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Internalized Stigma and Shame as Barriers to Engagement in HIV Care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders (Project Matter)
- ClinicalTrials.gov ID
- NCT03899220
- Acronym / sponsor ID
- 2019p001118
- Conditions
- Substance Use Disorders, HIV/AIDS, Homosexuality, Male
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will implement a pilot randomized controlled trial (RCT, N=60) to assess the feasibility and acceptability a refined emotion regulation intervention designed to improve engagement in HIV-care among substance using HIV+ MSM sub-optimally engaged in HIV care.
Detailed description
Eligible study participants will be screened and enrolled at Fenway Health (Boston, MA). Participants will be randomized to an enhanced treatment as usual (E-TAU) arm or the intervention arm. All participants (in both the E-TAU and intervention groups) will receive a one-session behavioral engagement in care intervention, substance use treatment referral information, and the opportunity to discuss and problem solve barriers to substance use treatment with an interventionist, informed by motivational interviewing principles. After randomization, participants in the intervention group will attend 5 therapy sessions focused on behavioral strategies for improving HIV self-care, meta-cognitive awareness of emotions and thoughts, and cognitive restructuring. All participants will receive texts queries about antiretroviral therapy (ART) adherence and substance use, and participants in the intervention group will also receive text queries about mood. All participants will be compensated for every research visit and completed text message blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Project MatterThis 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. |
| Enhanced Treatment as Usual (E-TAU) | Active comparator | Behavioral: Project MatterEnhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HIV positive
- Cisgender male
- Man who has sex with men (MSM)
- Elevated levels of internalized stigma related to HIV, substance use, or homophobia
- Poorly engaged in HIV care
Key exclusion criteria (3 listed)
- Women
- Non-cisgender men
- Do not identify as gay, bisexual, or MSM
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project MatterThis 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. Both the intervention group and the enhanced treatment as usual (E-TAU) involve a one-session behavioral engagement in care intervention as well as substance use treatment counseling. | Behavioural | Enhanced Treatment as Usual (E-TAU), Intervention |
Primary outcome
Acceptability of Intervention
Time frame: change from baseline to 12 weeks after intervention completion
The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
Feasibility of Intervention
Time frame: change from baseline to 12 weeks after intervention completion
Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).
1 secondary outcome
Engagement in HIV Care
Time frame: change from baseline to 12 weeks after intervention completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Matter in people with Substance Use Disorders and HIV/AIDS, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Intervention (time frame: change from baseline to 12 weeks after intervention completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.