NCT00314028

Brief Summary

This study will test the effectiveness of a brief clinic-based program designed to promote the correct use of condoms among young African-American men newly diagnosed with a sexually transmitted disease.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2003

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

December 16, 2013

Status Verified

December 1, 2013

Enrollment Period

4.4 years

First QC Date

April 10, 2006

Last Update Submit

December 13, 2013

Conditions

Sexually Transmitted DiseasesHIV

Keywords

African AmericanMenSexually Transmitted DiseasesCondoms

Outcome Measures

Primary Outcomes (1)

  • Frequency of unprotected penile vaginal sex

    Measured at Month 3

Secondary Outcomes (1)

  • Frequency of condom use errors and problems

    Measured at Month 3

Study Arms (2)

1

ACTIVE COMPARATOR

Standard of care treatment

Other: Control standard of care treatment

2

EXPERIMENTAL

Educational program designed to motivate and provide information on the correct use of condoms

Behavioral: Focus on the FutureOther: Control standard of care treatment

Interventions

Focus on the FutureBEHAVIORAL

Focus on the Future is an educational program designed to promote proper condom use.

2
Control standard of care treatmentOTHER

Standard of care treatment is the normal treatment that someone would receive for the particular sexually transmitted disease or virus.

12

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Identifies as African American
  • Clinically diagnosed with an STD
  • Reports at least one episode of condom use with a female within 3 months of study entry (this requirement does not restrict men who also have sex with men from study participation)
  • Fluent in English

You may not qualify if:

  • Known HIV infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sexually Transmitted DiseasesMultiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Andrew Forsythe, PhD

    National Institute of Mental Health (NIMH)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

April 1, 2003

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

December 16, 2013

Record last verified: 2013-12