Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
Primary Purpose
Substance Use Disorders, HIV/AIDS, Homosexuality, Male
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project Matter
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders
Eligibility Criteria
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
Sites / Locations
- Fenway Community Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Enhanced Treatment as Usual (E-TAU)
Arm Description
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.
Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.
Outcomes
Primary Outcome Measures
Acceptability of Intervention
The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
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).
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03899220
First Posted
March 27, 2019
Last Updated
September 26, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT03899220
Brief Title
Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders, HIV/AIDS, Homosexuality, Male
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pilot Randomized Controlled Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Treatment as Usual (E-TAU)
Arm Type
Active Comparator
Arm Description
Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.
Intervention Type
Behavioral
Intervention Name(s)
Project Matter
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability of Intervention
Description
The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4).
Time Frame
change from baseline to 12 weeks after intervention completion
Title
Feasibility of Intervention
Description
Percent of sessions completed (≥70% considered indicative of feasibility) and percent of text messages responded to by participants (≥70% considered indicative of feasibility).
Time Frame
change from baseline to 12 weeks after intervention completion
Secondary Outcome Measure Information:
Title
Engagement in HIV Care
Description
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.
Time Frame
change from baseline to 12 weeks after intervention completion
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Cisgender men who have sex with men
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fenway Community Health
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Project Matter: Intervention to Improve HIV Self-care Among Men Who Have Sex With Men (MSM) With Substance Use Disorders
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