NCT00947947

Brief Summary

The purpose of the current study is to test a computerized HIV/STD prevention program with heterosexual African Americans. The hypothesis is that those exposed to the program will increase their correct and consistent use of condoms compared to those not exposed to the program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
274

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

Enrollment Period

2.2 years

First QC Date

July 24, 2009

Last Update Submit

November 13, 2013

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Keywords

condom useHIV preventionAfrican AmericanBehavioral interventionHIV Seronegativity

Outcome Measures

Primary Outcomes (1)

  • Condom use with main and casual sexual partners

    3 months

Study Arms (2)

intervention media condition

EXPERIMENTAL

Received a stage tailored DVD-based intervention

Behavioral: Tailored Information Program for Safer Sex

standard of care

PLACEBO COMPARATOR

received only clinical standard of care

Behavioral: Tailored Information Program for Safer Sex

Interventions

Tailored Information Program for Safer SexBEHAVIORAL

Health communication intervention delivered on a laptop computer to increase positive perceptions of condoms and increase skills to use condoms.

Also known as: Computerized health intervention
intervention media conditionstandard of care

Eligibility Criteria

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

You may qualify if:

  • African American
  • Aged 18-29
  • Heterosexually active in past 3 months
  • NOT knowingly HIV positive
  • Not pregnant or planning on becoming pregnant/impregnating partner in next 3 months
  • Client of the STI clinic where study is being conducted
  • Not currently enrolled in another condom study at the clinic

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Specialty Clinic, Louisville Metro Health Department

Louisville, Kentucky, 40204, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Richard Crosby, Ph.D.

    Department of Communication, University of Kentucky

    PRINCIPAL INVESTIGATOR

  • Seth M. Noar, PhD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 28, 2009

Study Start

February 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

US(1)