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

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ClinicalTrials.gov Identifier: NCT03899220
Recruitment Status : Not yet recruiting
First Posted : April 2, 2019
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Abigail Batchelder, Ph.D., M.P.H., Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Substance Use Disorders HIV/AIDS Homosexuality, Male Behavioral: Project Matter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Pilot Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Estimated Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Intervention
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.
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.

Active Comparator: Enhanced Treatment as Usual (E-TAU)
Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling.
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.




Primary Outcome Measures :
  1. Acceptability of Intervention [ Time Frame: change from baseline to 12 weeks after intervention completion ]
    How likely are you to recommend this intervention to a friend who is living with HIV? (0=not at all satisfied- 10=very satisfied)

  2. Feasibility of Intervention [ Time Frame: change from baseline to 12 weeks after intervention completion ]
    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 :
  1. Engagement in HIV Care [ Time Frame: change from baseline to 12 weeks after intervention completion ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cisgender men who have sex with men
Accepts Healthy Volunteers:   No
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

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Responsible Party: Abigail Batchelder, Ph.D., M.P.H., Assistant Professor and Staff Psychologist, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03899220     History of Changes
Other Study ID Numbers: Project Matter
K23DA043418 ( U.S. NIH Grant/Contract )
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Disease
Substance-Related Disorders
Pathologic Processes
Chemically-Induced Disorders
Mental Disorders