HivMATTERNCT05934305
Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders
A study testing Matter Intervention in people with Hiv and Substance Use Disorders, run by Boston University at 2 sites in United States.
Trial summary
People 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hiv, Substance Use Disorders
- What is being tested?
- Matter Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Mar 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+
- Meet criteria for an illicit (not solely including tobacco, cannabis, or alcohol) SUD
- Endorse internalized stigma related to HIV, substance use, sexual orientation, or gender-identity
- Either the participant reports a detectable viral load during past year OR if on oral ART, they report <80% adherence in the past month OR if on oral ART, they report missing >=7 days of ART in any month in the past year OR for those on long acting injectable (LAI) ART, they report a period of >=14 days in the past year between LAI ART injections OR has a detectable HIV viral load (>20 copies/ mL) in the past year confirmed by medical records or viral load test from blood drawn obtained as part of the baseline visit
- Provide informed consent in English
- Verbally communicate and read in English or Spanish
Show all 10Show fewer
- Be ≥18 years old
- Provide evidence or documentation of HIV+ status
- Release HIV-related health records
- Have access to a cell phone with text capacity (study will supplement phones and plans as needed consistent with our pilot work).
Who cannot join
- HIV-
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Alexandria Miller, PhD contact
United States2 sites, 2 recruiting
- Recruiting
Fenway Health
Boston, Massachusetts, 02215
Abigail Batchelder, PhD, MPH, 617-358-7640, abatchel@bu.edu
Kenneth Mayer, MD, mayer@fenwayhealth.org
- Recruiting
Florida International University
Miami, Florida, 33199
Adam Carrico, PhD, acarrico@fiu.edu
About this study
Official title: Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders
People 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 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.
Read the detailed description
Among individuals living with HIV, substance use disorders (SUDs) are associated with inadequate engagement in HIV care, often leading to episodic unsuppressed viral load (VL) or viral rebound, thus driving the epidemic through elevated HIV transmission risk. Behavioral science identifies that internalized stigmas perpetuated by negative experiences related to drug use and unmet needs influences sub-optimal engagement in HIV care, resultant unsuppressed VL, and transmission among people with SUDs. Stigma and related emotions (e.g., shame) compromise health outcomes both directly (e.g., via sub-optimal adherence and appointment attendance) and indirectly (e.g., as obstacles to needed service engagement). Interventions are needed to address stigma and shame as obstacles to viral suppression among individuals living with HIV and SUDs. To meet this need, we developed, refined, and conducted a pilot RCT (K23DA043418) to assess the feasibility and acceptability of the MATTER intervention, an evidence- and community- informed psychobehavioral intervention to facilitate viral suppression by reducing the impact of internalized stigma and shame on engagement in HIV care among individuals with SUDs. The MATTER intervention aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of cognitions and emotions), and c) compassionate self-restructuring (i.e., self- compassion). It involves 5- one-on-one virtual therapy sessions and bidirectional personalized text messaging to extend the impact of the intervention while using less interventionist time and phone-based resource navigation. The proposed hybrid type 1 efficacy-implementation study will use the RE-AIM framework to assess: 1) the efficacy of the MATTER intervention on viral suppression at the final 12-month follow up visit compared to a time-matched control arm using a fully powered randomized controlled trial (RCT; N=256), 2) the proposed mechanisms of the MATTER intervention to inform future interventions to mitigate the impact of stigma, and 3) facilitators and obstacles to the reach, adoption, implementation, and maintenance of the MATTER intervention to be conducted in two priority locations with key differences: the Boston, Massachusetts and Miami, Florida metro areas. Should the intervention be efficacious, and the innovative internalized stigma mitigation approach be confirmed, we will be well-positioned to leverage the identified facilitators and obstacles to implementing this intervention among people living with HIV and SUDs in a subsequent hybrid type 2 trial to assess the scalability, including a full cost-effectiveness assessment.
- Conditions
- Hiv, Substance Use Disorders
- Being tested
- Matter Intervention, Control Condition
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Matter InterventionBehavioural
This 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among 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.
Control ConditionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Matter Intervention | Experimental | This 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among 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. Receives: Behavioral: Matter Intervention |
| Control Condition | Active comparator | 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). Receives: Behavioral: Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Suppression at 12 month follow-up
Compare the proportion of participants randomized to the intervention to the proportion of those randomized to the time-matched control condition who are virally suppressed at the 12 months follow up visit.
Measured: 12 month follow up
Secondary outcomes (5)
Viral Suppression at 6 month follow-up
Compare the proportion of participants randomized to the intervention to those randomized to the control condition who are virally suppression at the 6 months follow up visit.
Measured: 6 month follow up
Viral Suppression at 6 and 12 months
Compare the proportion of participants randomized to the intervention to those randomized to the control condition who are virally suppressed at both 6- and 12-month visits.
Measured: 6 and 12 months
Internalized HIV Stigma Scale at 6 and 12
Compare changes in self-reported mean scores between baseline and 6 and 12 month follow up visits. Response options to each question range from 0 = none of the time to 4 = all of the time, resulting in a mean response of between 0-4. Higher scores indicate greater internalized stigma.
Measured: 6 and 12 months
Substance Use Severity based on clinical diagnostic interview
Categorically assess the severity of substance use disorder severity (no substance use disorder, mild, moderate, or severe) for each participant at baseline and the final 12-month followup. Investigators will then compare the proportion of participants with severe substance use disorder at final follow up compared to baseline as well as the proportion who reduced their severity between baseline and the final follow up in clinically among participants randomized to the intervention versus the control condition.
Measured: 12 months
Visual Analogue Scale for Antiretroviral Adherence
Participants will be asked to report what percentage of their antiretroviral medication they have taken in the past 4 weeks on a scale of 0-100%.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start12 Mar 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HivStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Florida International University
- Responsible party
- Sponsor
- Investigators
- Abigail Batchelder, PhD, MPH, Principal investigator, CABU School of Medicine, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05934305
- Sponsor's protocol ID
- H-44770
- Other IDs
- R01DA057298
- Acronym
- MATTER
- Status last verified
- Jun 2026
- First submitted
- 20 Jun 2023
- Last updated
- 23 Jun 2026
- 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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among People Living With HIV and Substance Use Disorders
- ClinicalTrials.gov ID
- NCT05934305
- Acronym / sponsor ID
- MATTER / H-44770
- Conditions
- Hiv, Substance Use Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Florida International University
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 6 Jul 2023 (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.
People 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 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.
Detailed description
Among individuals living with HIV, substance use disorders (SUDs) are associated with inadequate engagement in HIV care, often leading to episodic unsuppressed viral load (VL) or viral rebound, thus driving the epidemic through elevated HIV transmission risk. Behavioral science identifies that internalized stigmas perpetuated by negative experiences related to drug use and unmet needs influences sub-optimal engagement in HIV care, resultant unsuppressed VL, and transmission among people with SUDs. Stigma and related emotions (e.g., shame) compromise health outcomes both directly (e.g., via sub-optimal adherence and appointment attendance) and indirectly (e.g., as obstacles to needed service engagement). Interventions are needed to address stigma and shame as obstacles to viral suppression among individuals living with HIV and SUDs. To meet this need, we developed, refined, and conducted a pilot RCT (K23DA043418) to assess the feasibility and acceptability of the MATTER intervention, an evidence- and community- informed psychobehavioral intervention to facilitate viral suppression by reducing the impact of internalized stigma and shame on engagement in HIV care among individuals with SUDs. The MATTER intervention aims to mitigate the negative behavioral consequences of internalized stigma and shame on viral suppression by a) behavioral self-care goal setting skills and related self-efficacy, b) increasing metacognitive awareness (i.e., non-judgmental awareness of cognitions and emotions), and c) compassionate self-restructuring (i.e., self- compassion). It involves 5- one-on-one virtual therapy sessions and bidirectional personalized text messaging to extend the impact of the intervention while using less interventionist time and phone-based resource navigation. The proposed hybrid type 1 efficacy-implementation study will use the RE-AIM framework to assess: 1) the efficacy of the MATTER intervention on viral suppression at the final 12-month follow up visit compared to a time-matched control arm using a fully powered randomized controlled trial (RCT; N=256), 2) the proposed mechanisms of the MATTER intervention to inform future interventions to mitigate the impact of stigma, and 3) facilitators and obstacles to the reach, adoption, implementation, and maintenance of the MATTER intervention to be conducted in two priority locations with key differences: the Boston, Massachusetts and Miami, Florida metro areas. Should the intervention be efficacious, and the innovative internalized stigma mitigation approach be confirmed, we will be well-positioned to leverage the identified facilitators and obstacles to implementing this intervention among people living with HIV and SUDs in a subsequent hybrid type 2 trial to assess the scalability, including a full cost-effectiveness assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Matter Intervention | Experimental | Behavioral: Matter InterventionThis 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among 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. |
| Control Condition | Active comparator | Behavioral: Control ConditionThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- HIV+
- Meet criteria for an illicit (not solely including tobacco, cannabis, or alcohol) SUD
- Endorse internalized stigma related to HIV, substance use, sexual orientation, or gender-identity
- Either the participant reports a detectable viral load during past year OR if on oral ART, they report <80% adherence in the past month OR if on oral ART, they report missing >=7 days of ART in any month in the past year OR for those on long acting injectable (LAI) ART, they report a period of >=14 days in the past year between LAI ART injections OR has a detectable HIV viral load (>20 copies/ mL) in the past year confirmed by medical records or viral load test from blood drawn obtained as part of the baseline visit
- Provide informed consent in English
Key exclusion criteria (1 listed)
- HIV-
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 |
|---|---|---|
| Matter InterventionThis 5-session text-enhanced intervention is designed to mitigate the negative behavioral consequences of internalized stigma and shame among 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. | Behavioural | Matter Intervention |
| Control ConditionThe 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). | Behavioural | Control Condition |
Primary outcome
Viral Suppression at 12 month follow-up
Time frame: 12 month follow up
Compare the proportion of participants randomized to the intervention to the proportion of those randomized to the time-matched control condition who are virally suppressed at the 12 months follow up visit.
5 secondary outcomes
Viral Suppression at 6 month follow-up
Time frame: 6 month follow up
Viral Suppression at 6 and 12 months
Time frame: 6 and 12 months
Internalized HIV Stigma Scale at 6 and 12
Time frame: 6 and 12 months
Substance Use Severity based on clinical diagnostic interview
Time frame: 12 months
Visual Analogue Scale for Antiretroviral Adherence
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- 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.
Alexandria Miller, PhD contact
Abigail Batchelder, PhD, MPH principal investigator
CABU School of Medicine, Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matter Intervention in people with Hiv and Substance Use Disorders, run by Boston University at 2 sites 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 10 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Batchelder, PhD, MPH (6173587640, abatchel@bu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Suppression at 12 month follow-up (time frame: 12 month follow up). 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 23 Jun 2026.