Viewing Study NCT00080093



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Last Modification Date: 2024-10-26 @ 9:10 AM
Study NCT ID: NCT00080093
Status: UNKNOWN
Last Update Posted: 2008-09-26
First Post: 2004-03-23

Brief Title: Increasing Condom Use in People at Risk for HIV Infection
Sponsor: National Institute of Allergy and Infectious Diseases NIAID
Organization: National Institute of Allergy and Infectious Diseases NIAID

Study Overview

Official Title: Increasing Condom Use With a Stage-Matched Intervention
Status: UNKNOWN
Status Verified Date: 2008-09
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01AI041323 NIH None httpsreporternihgovquickSearchR01AI041323