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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00797654 |
This study will develop a therapy for men who have sex with men who also have a history of childhood sexual abuse to reduce behaviors that put them at a high risk of HIV infection.
Condition | Intervention |
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HIV Prevention |
Behavioral: Information-motivation-behavior skills and cognitive processing therapy Behavioral: HIV risk reduction counseling |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Integrated HIV Prevention and Trauma Treatment in MSM With Sexual Abuse History (Project THRIVE) |
Estimated Enrollment: | 50 |
Study Start Date: | August 2008 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive information-motivation-behavior skills training combined with cognitive processing therapy
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Behavioral: Information-motivation-behavior skills and cognitive processing therapy
Treatment will include elements from effective interventions for reducing risky sexual behaviors and reducing post-traumatic stress disorder (PTSD) symptoms.
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2: Active Comparator
Participants will receive standard HIV risk reduction counseling
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Behavioral: HIV risk reduction counseling
Treatments are aimed at reducing behaviors that put participants at high risk of HIV infection.
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Men who have sex with men (MSM) represent the largest group of new HIV infections. Rates of childhood sexual abuse (CSA) in MSM have been estimated to be higher than in the rest of the population, with some researchers estimating that 37% of all MSM have experienced CSA. CSA in MSM is associated with both higher rates of HIV risk behavior and higher rates of HIV infection. Treatments for preventing HIV are also less likely to be effective in MSM with a history of CSA, and these individuals tend to have higher rates of depression, anxiety, substance abuse, and post-traumatic stress disorder (PTSD) symptoms. This study will create and then test a new HIV prevention therapy that addresses both HIV risk behaviors and the co-occurring psychological health problems in MSM with a history of CSA.
This study includes a pilot phase and an experimental phase. In the pilot phase, the therapeutic treatment will be developed based on elements of successful interventions for reducing sexual risk-taking behaviors and PTSD symptoms. Information-motivation-behavioral (IMB) skills training for sexual risk reduction will be the basis for one of two treatment components, and it is expected to last for two 50-minute sessions. This intervention will include addressing knowledge about issues surrounding sexual risk, using motivational interviewing to address goals and self-efficacy, and providing strategies for behavioral change. Cognitive processing therapy (CPT) for CSA will be the basis for the other component and is expected to last for eight 50-minute sessions. Elements of this intervention will include identifying sexual abuse events, learning how to identify cognitive distortions, and learning processes to challenge and process these distortions.
During the pilot phase, approximately 10 participants will undergo the new treatment. After completing the treatment sessions, participants will undergo exit interviews, in which researchers will solicit feedback about the strengths and weaknesses of the treatment. This feedback will be used to fine tune the treatment.
During the second phase of the study, approximately 50 individuals will be randomly assigned to either receive the newly developed treatment or partake in a standard HIV risk reduction program. The exact number of sessions for treatment has not been finalized, nor have the exact treatment procedures. Participants will undergo assessments before and after treatment and at follow-up visits 6 and 9 months after enrollment. These assessments will measure sexual risk behaviors, PTSD symptoms, distress, social support, and substance abuse. After all IMB sessions are completed, a set of questionnaires about sexual behavior will be administered, and after each CPT session, participants will complete measures of distress.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Charles Covahey, BS | 617-927-6037 | ccovahey@fenwayhealth.org |
United States, Massachusetts | |
Fenway Community Health | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Principal Investigator: Conall M. O'Cleirigh, PhD |
Responsible Party: | Fenway Community Health ( Conall M. O'Cleirigh, PhD ) |
Study ID Numbers: | R34 MH081760-02 |
Study First Received: | November 24, 2008 |
Last Updated: | December 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00797654 |
Health Authority: | United States: Federal Government |
Sexual Risks for HIV Psychosocial Sequelae Relating to Childhood Sexual Abuse |
HIV Infections Acquired Immunodeficiency Syndrome Wounds and Injuries |