NCT00080093

Brief Summary

This study will evaluate a new program designed to increase condom use in both women and men.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
534

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started Jan 2006

Typical duration for not_applicable hiv-infections

Status
unknown

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

First Submitted

Initial submission to the registry

March 23, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2004

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

September 26, 2008

Status Verified

September 1, 2008

Enrollment Period

1.7 years

First QC Date

March 23, 2004

Last Update Submit

September 25, 2008

Conditions

Keywords

CondomHIV SeronegativityHIV PreventionBehavioral Intervention

Outcome Measures

Primary Outcomes (3)

  • Frequency of condom use

    At 30 days and 2 months before each assessment

  • Number of occurances of unprotected sex

    At 30 days before each assessment

  • Stage of change for condom use with main and nonmain partners, and men and women

    Throughout study

Secondary Outcomes (3)

  • Frequency of condom use with main and nonmain partners, and men and women

    Throughout Study

  • Number and ratios of protected sex occasions with main and nonmain partners, and men and women

    Throughout study

  • Stage of change for condom use with main and nonmain partners, and men and women

    Throughout Study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4

Behavioral: Individual feedback and specially-tailored manuals

2

EXPERIMENTAL

Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Behavioral: General HIV information feedback and the best-available information

Interventions

Individual feedback and specially-tailored manuals

1

General HIV information feedback and the best-available information

2

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • HIV uninfected
  • Sexually active
  • At risk for HIV (as determined by study officials)
  • Speaks English
  • Seen at a participating clinic

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Cho S, Harlow L, Morokoff P, Redding C, Rossi J, Mayer K, Koblin B. Predicting 3-Wave LGCM of Condom Use in High-Risk Community Sample. Annual Meeting of the American Psychological Association, San Francisco, CA, 2007.

    RESULT
  • Cho S, Morokoff P, Redding C, Harlow L, Rossi J, Mayer K, Koblin B. Empirically Investigating Gender in a Multifaceted Model of HIV Risk. 19th Annual Meeting of the American Psychological Society, Washington, DC, 2007.

    RESULT

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

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

Study Officials

  • Patricia Morokoff, PhD

    University of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

March 23, 2004

First Posted

March 24, 2004

Study Start

January 1, 2006

Primary Completion

October 1, 2007

Study Completion

December 1, 2008

Last Updated

September 26, 2008

Record last verified: 2008-09