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Cognitive-behavioral therapy

Phase 1

Risk Reduction Behavior | Unknown | Other |Harvard Bioscience, Inc.|Last Updated: Aug 9, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMC
Total Trials1
Total Enrollment14
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01291589HIV Prevention in Very High Risk Men Who Have Sex With MenPHASE1 COMPLETED 14Nov 1, 2011Sep 1, 2012Aug 9, 20161 United States
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Study Endpoints
Primary Endpoints
Decrease in self-reported sexual risk taking
Measured at baseline, 3 months post baseline (12 weeks) and again at 3 months post treatment (up to 24 weeks)

The potential for an effect will determine the magnitude of the change in self-reported unprotected anal intercourse acts with HIV-uninfected and HIV-unknown status partners in the previous 3 months from baseline assessment to post treatment and follow-up.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Cognitive-behavioral counselingEXPERIMENTAL -
Interventions
NameTypeDescription
Cognitive-behavioral therapyBEHAVIORALTreatment will include elements from effective interventions for reducing risky sexual behaviors
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Age 18 years old or older * Self-reports as a man who has sex with men (MSM) * Self-reports being HIV-infected * Reports engaging in 10 episodes or more of unprotected anal intercourse (receptive or insertive) in the past three months with male partners who are not HIV-infecte...

Countries:United States
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