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

NCT00797654 | Completed

• 1 other identifier: R34MH081760-02
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

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.

Conditions

Risk Reduction

Keywords

Sexual Risks for HIV; Psychosocial Sequelae Relating to Childhood Sexual Abuse

Outcome Measures

Primary Outcomes (1)

• Self-reported sexual risk taking

  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).

  Measured pre- and post-treatment and after 6 and 9 months

Secondary Outcomes (1)

• Reductions in negative effects of trauma, with cognitive and behavioral variables tested as potential mediators of treatment outcome

  Measured pre- and post-treatment and after 6 and 9 months

Study Arms (2)

1

EXPERIMENTAL

Participants will receive pre and post HIV-test counseling and an information-motivation-behavior skills training combined with cognitive processing therapy

Behavioral: Information-motivation-behavior skills and cognitive processing therapy; Behavioral: Pre and Post HIV-Test Counseling

2

ACTIVE COMPARATOR

Participants will receive pre and post HIV-test counseling

Behavioral: Pre and Post HIV-Test Counseling

Interventions

Information-motivation-behavior skills and cognitive processing therapy BEHAVIORAL

Treatment will include elements from effective interventions for reducing risky sexual behaviors and reducing post-traumatic stress disorder (PTSD) symptoms.

1

Pre and Post HIV-Test Counseling BEHAVIORAL

Treatments are aimed at assessing and reducing behaviors that put participants at high risk of HIV infection.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Identifies as a biological man who has sex with men
• Reports history of childhood sexual abuse (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, with a person 10 years older)
• Reports unprotected anal or vaginal intercourse within the past 3 months
• HIV-negative serostatus
• Able to understand English

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, such as acute major depression, panic disorder, or any psychotic disorder

Sponsors & Collaborators

• Fenway Community Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Fenway Community Health

Boston, Massachusetts, 02215, United States

Location

Fenway Health

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Risk Reduction Behavior

Interventions

Lead

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Metals

Study Officials

• Conall M. O'Cleirigh, PhD

  Fenway Community Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Harvard Medical School, Director, Behavioral Medicine, Department of Psychiatry Massachusetts General Hospital

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: May 1, 2011
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (2)