HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories

Completed · Not applicable

Conditions studied: Sexual Risk Behavior, Childhood Sexual Abuse, Stress Disorders, Post-Traumatic

In brief

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).

Key facts

Study ID

NCT01395979

Run by

Massachusetts General Hospital

People needed

232

Starts

2011-10-01

Expected to finish

2017-05-01

Last updated by the study team

2018-03-30

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Identifies as MSM.
• Reports history of CSA (sexual contact before the age of 13 with an adult or person 5 years older or sexual contact with the threat of force or harm between the ages of 13 and 16 inclusive or with a person 10 years older).
• Reports >1 episode of unprotected anal or vaginal intercourse within the past three months.
• Reports HIV-negative status confirmed by rapid HIV test.
• Is capable of completing and fully understanding the informed consent process and the study procedures.

You may not qualify if…

• All episodes of unprotected anal or vaginal intercourse occurred with only a single, primary HIV-negative partner.
• Significant mental health diagnosis requiring immediate treatment (e.g. bipolar disorder; any psychotic disorder).
• Inability to complete informed consent process (e.g. substantial cognitive impairment, inadequate English language skills).
• Has received CPT for PTSD within the past 12 months.

Where it is running

• University of Miami — Coral Gables, Florida, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• The Fenway Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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