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NCT01395979 · ClinicalTrials.gov registry record · NA
HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 232
- Enrollment target
NCT01395979: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01395979 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 232 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01395979, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 232 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- BEHAVIORAL Supportive Psychotherapy
- BEHAVIORAL Cognitive Processing Therapy for Sexual Risk
- BEHAVIORAL Sexual Risk Reduction Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2011-10 |
| Est. Completion | 2017-05 |
| Phase | NA |
What the finished NCT01395979 record still lists
NCT01395979 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Supportive Psychotherapy is the first listed.
NCT01395979 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01395979 about?
NCT01395979 is a clinical study titled "HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories". 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 childh...
What is the current status of trial NCT01395979?
This trial is currently completed. It is a NA study. The enrollment target is 232 participants. The study started on 2011-10. Estimated completion is 2017-05.
What interventions are being tested in trial NCT01395979?
The interventions under investigation include: Supportive Psychotherapy (BEHAVIORAL), Cognitive Processing Therapy for Sexual Risk (BEHAVIORAL), Sexual Risk Reduction Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT01395979?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01395979's enrollment target sits among peer trials
232 463rd of 2000 higher than 1,536 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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