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

NCT ID: NCT03899220

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Substance Use Disorders HIV/AIDS Homosexuality, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pilot Randomized Controlled Trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Project Matter

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Project Matter

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Abigail Batchelder, Ph.D., M.P.H.

Assistant Professor and Staff Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fenway Community Health

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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K23DA043418

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019p001118

Identifier Type: -

Identifier Source: org_study_id

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