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

Hiv Clinical Trial

— MATTER  

Official title:

Mitigating the Impact of Stigma and Shame as a Barrier to Viral Suppression Among MSM Living With HIV and Substance Use Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05934305
• Other study ID #: 2023P000497
• Secondary ID: R01DA057298
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 18, 2023
• Est. completion date: July 2028

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Abigail Batchelder, PhD, MPH
• Phone: 6172670900
• Email: abatchelder[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Men who have sex with men (MSM), and gender minority individuals who have sex with men, 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 MSM and gender minority 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.

Description:

Men who have sex with men (MSM) make up 69% of people living with HIV in the US. Among MSM and gender minority individuals who have sex with men 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 experienced stigma and structural inequities, influences sub-optimal engagement in HIV care, resultant unsuppressed VL, and transmission among MSM 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 barriers to social services engagement). Interventions are needed to address stigma and shame as barriers to viral suppression among MSM and gender minority individuals living with HIV and SUDs. To meet this need, the investigators 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 MSM 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 barriers 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, the investigators will be well-positioned to leverage the identified facilitators and barriers to implementing this intervention among MSM and gender minority people who have sex with men living with HIV and SUDs in a subsequent hybrid type 2 trial to assess the scalability, including a full cost-effectiveness assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 256
• Est. completion date: July 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• HIV+

• MSM or gender minority individuals who report having sex with men

• 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

• Unsuppressed HIV VL (>20 copies/mL).

• Provide informed consent in English

• Verbally communicate in English and read in English or Spanish

• 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).

Exclusion Criteria:

• Cisgender women

• Cisgender heterosexual men

Related Conditions & MeSH terms

• Hiv
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Matter 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.
• Control Condition
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).

Locations

Country	Name	City	State
United States	Fenway Health	Boston	Massachusetts
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 month follow up
Secondary	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.	6 month follow up
Secondary	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.	6 and 12 months
Secondary	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.	6 and 12 months
Secondary	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.	12 months
Secondary	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%.	12 months