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Completed Not applicable Interventional

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

ClinicalTrials.gov ID: NCT01395979

Public ClinicalTrials.gov record NCT01395979. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 4:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT01395979
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Enrollment
232 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
Male
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Sep 30, 2011
Primary completion
Apr 30, 2017
Completion
Apr 30, 2017
Last update posted
Mar 29, 2018

2011 – 2017

United States locations

U.S. sites
3
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
University of Miami Coral Gables Florida 33124-0751
Massachusetts General Hospital Boston Massachusetts 02114-2919
The Fenway Institute Boston Massachusetts 02215

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01395979, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2018 · Synced Sep 3, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01395979 live on ClinicalTrials.gov.

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