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

Stress Disorders, Post-Traumatic Clinical Trial

— THRIVE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395979
• Other study ID #: R01MH095624-01
• Status: Completed
• Phase: N/A
• First received: July 11, 2011
• Last updated: March 29, 2018
• Start date: October 2011
• Est. completion date: May 2017

Study information

• Verified date: March 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Sexual Abuse
• Sexual Risk Behavior
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Cognitive Processing Therapy for Sexual Risk
Eight weekly sessions, 4 modules.
• Supportive Psychotherapy
Eight weekly sessions
• Sexual Risk Reduction Intervention
Two weekly sessions.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The Fenway Institute	Boston	Massachusetts
United States	University of Miami	Coral Gables	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Fenway Community Health, University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes from Baseline in Trauma Symptom Severity	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.	Baseline assessment, 3, 6, and 9-month follow-up assessments