HIV Prevention and Trauma Treatment in Men Who Have Sex With Men and Who Have a History of Sexual Abuse
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ClinicalTrials.gov Identifier: NCT00797654 |
Recruitment Status
:
Completed
First Posted
: November 25, 2008
Last Update Posted
: August 9, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | November 24, 2008 | |||
First Posted Date ICMJE | November 25, 2008 | |||
Last Update Posted Date | August 9, 2016 | |||
Study Start Date ICMJE | August 2008 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Self-reported sexual risk taking [ Time Frame: Measured pre- and post-treatment and after 6 and 9 months ] For both the Treatment (Cognitive Processing Therapy with Information Motivation Behavior) and Control arms, participants will self-report sexual risk taking at baseline, 3-month post baseline, and at 6 and 9-month follow-ups (after enrollment).
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Original Primary Outcome Measures ICMJE |
Self-reported sexual risk taking [ Time Frame: Measured pre- and post-treatment and after 6 and 9 months ] | |||
Change History | Complete list of historical versions of study NCT00797654 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Reductions in negative effects of trauma, with cognitive and behavioral variables tested as potential mediators of treatment outcome [ Time Frame: Measured pre- and post-treatment and after 6 and 9 months ] As with the baseline assessment, the Davidson Post-Traumatic Stress Disorder scale, and the MINI Neuro-psychiatric Interview for PTSD will be administered by an Independent Assessor who will be blind to participant group assignment.
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | HIV Prevention and Trauma Treatment in Men Who Have Sex With Men and Who Have a History of Sexual Abuse | |||
Official Title ICMJE | Integrated HIV Prevention and Trauma Treatment in MSM With Sexual Abuse History (Project THRIVE) | |||
Brief Summary | 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. | |||
Detailed Description | 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 receive either HIV testing with pre/post-test counseling alone or in combination with the newly developed treatment. The experimental, integrated treatment will be administered over 10 individual therapy sessions comprised of sexual risk reduction counseling and cognitive therapy. All participants will undergo assessments at enrollment and after treatment (or approximately 3 months after enrollment in comparator group), 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. Brief questionnaires about sexual behavior and measures of distress will be administered during the integrated treatment sessions. |
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Study Type ICMJE | Interventional | |||
Study Phase | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
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Condition ICMJE | Risk Reduction | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
46 | |||
Original Estimated Enrollment ICMJE |
50 | |||
Actual Study Completion Date | May 2011 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00797654 | |||
Other Study ID Numbers ICMJE | R34MH081760-02( U.S. NIH Grant/Contract ) R34MH081760-02 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Conall O'Cleirigh, Fenway Community Health | |||
Study Sponsor ICMJE | Fenway Community Health | |||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | |||
Investigators ICMJE |
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PRS Account | Fenway Community Health | |||
Verification Date | August 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |