HIV/AIDS, Homosexuality, Male, Substance Use Disorders
Conditions
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.
Interventions
BEHAVIORALProject 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot Randomized Controlled Trial
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability of Intervention | change from baseline to 12 weeks after intervention completion | The summary score of the Client Satisfaction Questionnaire (CSQ-8) (Sum of 8 questions with response options ranging from 1-4). |
| Feasibility of Intervention | 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
| Measure | Time frame | Description |
|---|---|---|
| Engagement in HIV Care | 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. |
Countries
United States
Outcome results
None listed