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| ID | Type | Description | Link |
|---|---|---|---|
| K23DA043418 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
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| Enhanced Treatment as Usual (E-TAU) | Active Comparator | Enhanced treatment as usual includes a one session behavioral engagement in care intervention as well as substance use treatment counseling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Project Matter | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Cisgender men who have sex with men
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fenway Community Health | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D000163 | Acquired Immunodeficiency Syndrome |
| D018451 | Homosexuality, Male |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
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Pilot Randomized Controlled Trial
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| change from baseline to 12 weeks after intervention completion |
| D003141 |
| Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D006716 | Homosexuality |
| D019529 | Sexuality |
| D012725 | Sexual Behavior |
| D001519 | Behavior |