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This Phase Ib pilot RCT will examine the safety, feasibility, and acceptability of a multi-component intervention to address traumatic stress symptoms among HIV-positive, methamphetamine-using men who have sex with men (MSM). Following a baseline assessment, 56 participants will be randomized to receive either: 1) a 7-session intervention to address traumatic stress related to living with HIV/AIDS; or 2) a 7-session, attention-control condition. Follow-up assessments will be administered at 1 and 3 months post-randomization.
In the multi-component intervention protocol, participants will complete expressive writing exercises where they will be asked to write about difficult life experiences. Following expressive writing, participants will receive stress management skills training to assist them with managing any acute increases in distress that arise from the writing experience. Participants in the attention-control condition will write about neutral topics and complete psychological measures. The overarching goals of this Phase Ib RCT will be to: 1) examine the feasibility and acceptability of the intervention and attention-control; and 2) determine whether intervention participants report reductions in traumatic stress symptoms over the 3 months following randomization. Findings from this Phase Ib trial will inform our efforts to implement a more definitive RCT of this intervention with HIV-positive, methamphetamine-using MSM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reslient Affective Processing Therapy (RAPT) | Experimental |
| |
| Attention-Control | No Intervention | Participants will complete 7 sessions where they will be asked to write about neutral topics and complete psychological measures for the purposes of matching for attention and reimbursement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilient Affective Processing Therapy (RAPT) | Behavioral | Participants will be asked to complete 7 intervention sessions which include: 1) expressive writing exercises that focus on exploring thoughts and feelings surrounding a difficult life experience; and 2) stress management skills training to assist participants with managing any acute increases in distress that arise following the writing experience. |
| Measure | Description | Time Frame |
|---|---|---|
| Traumatic stress symptom severity | Our team will use the Impact of Event Scale to measure the self-reported severity of traumatic stress symptoms related to HIV/AIDS. | 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological reactivity to expressive writing | Participants will complete measures of subjective distress and craving of stimulants (i.e., methamphetamine, cocaine, and crack) before and after each expressive writing exercise to provide an index of habituation. Habituation is defined as a 50% reduction in the psychological reactivity to the expressive writing experience using these self-report measures. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Carrico, PhD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF Center for AIDS Prevention Studies | San Francisco | California | 94105 | United States |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| D019966 | Substance-Related Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| 1-month follow-up |
| 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 |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |