HIV Clinical Trial
— STAROfficial title:
A Pilot RCT of Expressive Writing With HIV-Positive Methamphetamine Users
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.
Status | Completed |
Enrollment | 56 |
Est. completion date | May 2014 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older - Speak English - Self-identify as a man who has sex with men - Have been diagnosed with HIV for at least 3 months - Provide evidence of HIV-positive serostatus - Report using methamphetamine during the past 30 days Exclusion Criteria: - Do not have the capacity to provide informed consent |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | UCSF Center for AIDS Prevention Studies | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | 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. | 1-month follow-up | No |
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