Health TrialsbyHealthPanel

Mitigating the Impact of Stigma and Shame Among People Living With HIV and Substance Use Disorders

ConditionsHivSubstance Use Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoston University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Matter Intervention

    Behavioral

    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 Condition

    Behavioral

    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).

Treatment groups

256 Participants
are divided into 2 treatment groups
Group A: Matter InterventionExperimental treatment 1 intervention
Group B: Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 month follow up

Secondary outcomes

1

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.

Time frame
6 month follow up
2

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.

Time frame
6 and 12 months
3

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.

Time frame
6 and 12 months
4

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Florida International University

Collaborator

Source ClinicalTrials.gov
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