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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Massachusetts General Hospital
Sponsor:
Collaborators:
Fenway Community Health
University of Miami
Information provided by (Responsible Party):
Conall O'Cleirigh, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01395979
First received: July 11, 2011
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

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).

Condition Intervention Phase
Sexual Risk Behavior
Childhood Sexual Abuse
Stress Disorders, Post-Traumatic
Behavioral: Cognitive Processing Therapy for Sexual Risk
Behavioral: Supportive Psychotherapy
Behavioral: Sexual Risk Reduction Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Changes from Baseline in Sexual Risk Behavior for HIV Acquisition [ Time Frame: Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups ] [ Designated as safety issue: No ]
    Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status.


Secondary Outcome Measures:
  • Changes from Baseline in Trauma Symptom Severity [ Time Frame: Baseline assessment, 3, 6, and 9-month follow-up assessments ] [ Designated as safety issue: No ]
    Davidson Trauma Scale which has been correlated with measures of Post-Traumatic Stress Disorder (PTSD) severity, depression, and general anxiety, and discriminated well between traumatized individuals with and without PTSD.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Processing Therapy for Sexual Risk (CPT-SR)
The CPT-SR condition will be comprised of 10 individual therapy sessions fully integrating sexual risk reduction counseling into cognitive therapy for sexual abuse-related trauma.
Behavioral: Cognitive Processing Therapy for Sexual Risk
Eight weekly sessions, 4 modules.
Other Name: CPT-SR
Behavioral: Sexual Risk Reduction Intervention
Two weekly sessions.
Active Comparator: Time-Matched Control (TMC)
The TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy.
Behavioral: Supportive Psychotherapy
Eight weekly sessions
Other Name: TMC
Behavioral: Sexual Risk Reduction Intervention
Two weekly sessions.

Detailed Description:

The prevalence of HIV among men who have sex with men (MSM) is estimated at an alarming 19% domestically (CDC 2010), rates comparable to endemic settings in certain regions of sub-Saharan Africa where approximately 20% of the adult population is HIV infected. Studies have also demonstrated a staggeringly high prevalence of childhood sexual abuse (CSA) in MSM, and shown an association between CSA and HIV risk in MSM. A successful intervention for MSM with a CSA history to prevent HIV has the potential to avert infections among some of the riskiest members of the most HIV vulnerable group in the U.S. Notwithstanding the ability of the existing HIV prevention interventions to show reductions in sexual risk taking, the recent successes of chemoprophylaxis, current policy initiatives, and empirically supported recommendations, all support development of combination prevention interventions that can specify multiple prevention targets, address related risk factors and barriers, and are grounded in a community context. The pathways from CSA to adult sexual risk behavior are varied and complex and this complexity is appropriately addressed in individual-based interventions where empirically supported interventions for CSA related trauma were efficacy tested. The development of an integrated prevention intervention that utilizes cognitive behavioral technologies to address co-occurring and interfering CSA and sexual risk represents a novel and largely untested innovative application that is theoretically designed to address sexual risk directly and indirectly through reductions in CSA-related trauma symptoms. The flexibility of integrated and combination prevention programs has the potential to support triage of MSM with particular risk profiles to the programs that best meet their prevention needs.

This two-arm RCT is designed to test the efficacy of a psycho-social intervention that addresses intersecting epidemics among MSM, HIV and CSA. The experimental condition integrates sexual risk reduction counseling with Cognitive Processing Therapy for Sexual Risk (CPT-SR). CPT-SR has been specifically piloted on MSM with CSA histories and sexual risk to reduce interfering negative CSA-related thoughts about self, to more accurately appraise sexual risk, and to decrease avoidance of sexual safety considerations through rehearsals of sexual safety behaviors. The active and time-matched comparison condition is risk reduction counseling plus supportive psychotherapy. The investigators will randomize HIV-uninfected MSM who report a history of CSA and multiple recent sexual risk episodes for HIV (unprotected anal/vaginal intercourse) across two sites (Boston and Miami). The primary outcome will be self-reported sexual risk taking as assessed via a computer-based questionnaire. Secondary outcomes include trauma symptom severity, both cognitive and behavioral. Study assessment points are at baseline, 3 (post treatment), 6, 9, and 12-month follow-ups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395979

Contacts
Contact: Conall O'Cleirigh, Ph.D. 617-643-0385 cocleirigh@partners.org
Contact: Joshua S Baker, BS (617) 927-6401 baker@fenwayhealth.org

Locations
United States, Florida
University of Miami Recruiting
Coral Gables, Florida, United States, 33124-0751
Contact: Gail H Ironson, MD. Ph.D.    305-284-5299    gironson@aol.com   
Contact: Janny Rodroguez, MA    305-284-5299    jannyr@miami.edu   
Principal Investigator: Gail H Ironson, MD., Ph.D         
United States, Massachusetts
The Fenway Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Conall O'Cleirigh, Ph.D.    617-643-0385    cocleirigh@partners.org   
Contact: Joshua S Baker, BS    617-927-6401    baker@fenwayhealth.org   
Principal Investigator: Conall O'Cleirigh, Ph.D.         
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114-2919
Sponsors and Collaborators
Massachusetts General Hospital
Fenway Community Health
University of Miami
Investigators
Principal Investigator: Conall O'Cleirigh, Ph.D. Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Conall O'Cleirigh, Ph.D., Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01395979     History of Changes
Other Study ID Numbers: R01 MH095624-01
Study First Received: July 11, 2011
Last Updated: October 30, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 27, 2014