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Clinical Trials/NCT00080093
NCT00080093
Unknown
Not Applicable

Increasing Condom Use With a Stage-Matched Intervention

ConditionsHIV Infections

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
HIV Infections
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Enrollment
534
Primary Endpoint
Frequency of condom use
Last Updated
17 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
December 2008
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Number and ratios of protected sex occasions with main and nonmain partners, and men and women(Throughout study)
  • Frequency of condom use 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)

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