HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
THRIVE
1 other identifier
interventional
232
1 country
3
Brief 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.
- 4.For the primary outcome, the investigators hypothesize that those who receive the intervention will have reduced transmission-risk behavior.
- 5.For the secondary outcome, the investigators hypothesize that those who receive the intervention will have reduced trauma symptom severity (cognitions and behaviors).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2011
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2011
CompletedFirst Posted
Study publicly available on registry
July 18, 2011
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedMarch 30, 2018
March 1, 2018
5.6 years
July 11, 2011
March 29, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Changes from Baseline in Sexual Risk Behavior for HIV Acquisition
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.
Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups
Secondary Outcomes (1)
Changes from Baseline in Trauma Symptom Severity
Baseline assessment, 3, 6, and 9-month follow-up assessments
Study Arms (2)
Cognitive Processing Therapy for Sexual Risk (CPT-SR)
EXPERIMENTALThe 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.
Time-Matched Control (TMC)
ACTIVE COMPARATORThe TMC will be comprised of sexual risk reduction counseling/education and supportive psychotherapy.
Interventions
Eight weekly sessions, 4 modules.
Two weekly sessions.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Fenway Community Healthcollaborator
- University of Miamicollaborator
Study Sites (3)
University of Miami
Coral Gables, Florida, 33124-0751, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114-2919, United States
The Fenway Institute
Boston, Massachusetts, 02215, United States
Related Publications (2)
Batchelder AW, Fitch C, Feinstein BA, Thiim A, O'Cleirigh C. Psychiatric, Substance Use, and Structural Disparities Between Gay and Bisexual Men with Histories of Childhood Sexual Abuse and Recent Sexual Risk Behavior. Arch Sex Behav. 2021 Oct;50(7):2861-2873. doi: 10.1007/s10508-021-02037-1. Epub 2021 Oct 21.
PMID: 34676467DERIVEDBatchelder AW, Choi K, Dale SK, Pierre-Louis C, Sweek EW, Ironson G, Safren SA, O'Cleirigh C. Effects of syndemic psychiatric diagnoses on health indicators in men who have sex with men. Health Psychol. 2019 Jun;38(6):509-517. doi: 10.1037/hea0000724. Epub 2019 Apr 11.
PMID: 30973745DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Conall O'Cleirigh, Ph.D.
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph.D.
Study Record Dates
First Submitted
July 11, 2011
First Posted
July 18, 2011
Study Start
October 1, 2011
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
March 30, 2018
Record last verified: 2018-03