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CyberSenga

Phase 1

Sexual Abstinence | Unknown | Other |Harvard Bioscience, Inc.|Last Updated: Aug 11, 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
RandomizedNO_TREATMENT_CONTROLLED
Total Trials1
Total Enrollment366
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00906178CyberSenga: Internet-based HIV Prevention in UgandaPHASE1 COMPLETED 366Aug 1, 2007Oct 1, 2011Aug 11, 20161 Uganda
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Study Endpoints
Primary Endpoints
Sex Without a Condom as Assessed by Self-report
6-months post-intervention

Unprotected sex (i.e., vaginal or anal sex without a condom) in the past three months

Sexual Abstinence
6-months post-intervention

Not having had vaginal or anal sex in the past three months

Secondary Endpoints
Abstinence at Three-month Follow-up
3 months post-intervention
Unprotected Sex at Three-month Follow-up
3 months post-intervention
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
CyberSengaEXPERIMENTAL6-module HIV prevention program tailored for adolescents in Uganda
ControlNO_INTERVENTION"treatment as usual" - the sexual health education adolescents currently receive in secondary school
Interventions
NameTypeDescription
CyberSengaBEHAVIORALInternet-based HIV prevention program
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Enrollment in grades Secondary 1 through 4 at a partner secondary school * Having used a computer or the Internet at least once in the past year * Not having been part of the intervention development activities * Caregiver informed permission and adolescent informed assent Ex...

Countries:Uganda
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