Increasing Condom Use in People at Risk for HIV Infection - Tabular View

Tracking Information

First Received Date ^ICMJE

March 23, 2004

Last Updated Date

September 25, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Frequency of condom use [ Time Frame: At 30 days and 2 months before each assessment ] [ Designated as safety issue: No ]
Number of occurances of unprotected sex [ Time Frame: At 30 days before each assessment ] [ Designated as safety issue: No ]
Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Frequency of condom use [ Time Frame: At 30 days and 2 months before each assessment ]
Number of occurances of unprotected sex [ Time Frame: At 30 days before each assessment ]
Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout study ]

Change History

Complete list of historical versions of study NCT00080093 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Frequency of condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]
Number and ratios of protected sex occasions with main and nonmain partners, and men and women [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Frequency of condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]
Number and ratios of protected sex occasions with main and nonmain partners, and men and women [ Time Frame: Throughout study ]
Stage of change for condom use with main and nonmain partners, and men and women [ Time Frame: Throughout Study ]

Descriptive Information

Brief Title ^ICMJE

Increasing Condom Use in People at Risk for HIV Infection

Official Title ^ICMJE

Increasing Condom Use With a Stage-Matched Intervention

Brief Summary

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

Detailed Description

As heterosexual HIV transmission increases, effective behavioral interventions to increase condom use are needed. Interventions should be low cost and accessible to large segments of the at-risk population. This study will evaluate the efficacy of a behavioral intervention designed to increase condom use in at-risk, heterosexually active women and men. The intervention is computer-delivered and will be provided in health care settings. The study will also examine additional psychosocial mediators of condom use by testing the predictive efficacy of the Multifaceted Model of HIV Risk.

Participants will be recruited from four health clinic sites that serve local ethnic minority communities. The participants will be randomly assigned to either an individualized intervention designed to increase condom use or to an HIV information comparison group. All participants will receive comparable group-specific informational materials at study entry and at Months 2 and 4. Participants in the intervention group will receive individualized feedback and specially-tailored manuals. Participants in the HIV information comparison group will receive general HIV information feedback and the best-available informational manual.

Assessments for both groups will be conducted at study entry and at Months 6, 12, and 18. At study entry, participants will complete paper and pencil questionnaires lasting about 30 minutes. There will also be computer question sessions at study entry and at Months 2 and 4. Participants will be asked about condom use, contraceptive use, risk behaviors, sexual transmitted disease (STD) history, and personal relationships. Telephone follow-ups at Months 6, 12, and 18 will take approximately 20 to 30 minutes.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

HIV Infections

Intervention ^ICMJE

Behavioral: Individual feedback and specially-tailored manuals
Behavioral: General HIV information feedback and the best-available information

Study Arms / Comparison Groups

Experimental: Participants will receive individual feedback and specially-tailored manuals at study entry and at Months 2 and 4
Experimental: Participants will receive general HIV information feedback and the best-available informational manual at study entry and at Months 2 and 4

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

534

Estimated Completion Date

December 2008

Primary Completion Date

October 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria

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

Exclusion Criteria

Pregnant

Gender

Both

Ages

18 Years to 44 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00080093

Responsible Party

Patricia Morokoff, PhD, University of Rhode Island

Study ID Numbers ^ICMJE

R01AI41323, R01 AI41323

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Patricia Morokoff, PhD

University of Rhode Island

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP