NCT00797654

HIV Prevention and Trauma Treatment in Men Who Have Sex With Men and Who Have a History of Sexual Abuse

Integrated HIV Prevention and Trauma Treatment in MSM With Sexual Abuse History (Project THRIVE)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Fenway Community Health · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Risk Reduction

Interventions

Type	Name	Description
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.
BEHAVIORAL	Pre and Post HIV-Test Counseling	Treatments are aimed at assessing and reducing behaviors that put participants at high risk of HIV infection.

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-09-01
• Completion: 2011-05-01
• First posted: 2008-11-25
• Last updated: 2016-08-09

Locations

2 sites across 1 country: United States