HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
NCT01395979 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 232
Last updated 2018-03-30
Summary
Brief Summary: The specific aims of this study are:
1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse (number and proportion) with serodiscordant partners. The investigators will also examine the intervention effect on CSA-related trauma symptom severity and cognitions and behaviors.
2. To examine the degree to which intervention-related reductions in sexual risk behavior are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.
3. To examine the degree to which the intervention reduces incident sexually transmitted infections (STIs) during the study period, as well as to explore additional potential moderators and mediators of intervention efficacy.
Study hypotheses:
1. For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior.
2. For the secondary outcome, the investigators hypothesize that those who receive the intervention will have reduced trauma symptom severity (cognitions and behaviors).
Conditions
- Sexual Risk Behavior
- Childhood Sexual Abuse
- Stress Disorders, Post-Traumatic
Interventions
- BEHAVIORAL
-
Cognitive Processing Therapy for Sexual Risk
Eight weekly sessions, 4 modules.
- BEHAVIORAL
-
Supportive Psychotherapy
Eight weekly sessions
- BEHAVIORAL
-
Sexual Risk Reduction Intervention
Two weekly sessions.
Sponsors & Collaborators
-
Fenway Community Health
collaborator OTHER -
University of Miami
collaborator OTHER -
Massachusetts General Hospital
lead OTHER
Principal Investigators
-
Conall O'Cleirigh, Ph.D. · Massachusetts General Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-10-31
- Primary Completion
- 2017-05-31
- Completion
- 2017-05-31
Countries
- United States
Study Locations
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