Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders

HIV/AIDS Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03899220
• Other study ID #: 2019p001118
• Secondary ID: K23DA043418
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Women

• Non-cisgender men

• Do not identify as gay, bisexual, or MSM

Related Conditions & MeSH terms

• HIV/AIDS
• Homosexuality, Male
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Project Matter
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.

Locations

Country	Name	City	State
United States	Fenway Community Health	Boston	Massachusetts

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	Acceptability of Intervention	The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).	change from baseline to 12 weeks after intervention completion
Primary	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).	change from baseline to 12 weeks after intervention completion
Secondary	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.	change from baseline to 12 weeks after intervention completion