Viewing Study NCT00164619



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Study NCT ID: NCT00164619
Status: COMPLETED
Last Update Posted: 2008-06-05
First Post: 2005-09-12

Brief Title: Testing the Effectiveness of VOICES as Implemented by STD HIV Prevention Agencies in the US and PR
Sponsor: Centers for Disease Control and Prevention
Organization: Centers for Disease Control and Prevention

Study Overview

Official Title: Testing the Effectiveness of the VOICESVOCES Intervention Package as Implemented by STD and HIV Prevention Agencies That Target Hispanics and African Americans in the US and Puerto Rico
Status: COMPLETED
Status Verified Date: 2008-06
Last Known Status: None
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: The purpose of the project is to determine whether the VOICESVOCES intervention that was shown to be effective in a research study is still effective when delivered by STDHIV prevention agencies

VOICESVOCES is a brief single-session intervention for African-American and Latino adult men and women at high risk for STDHIV It encourages condom use and improves condom negotiation skills A health educator delivers the intervention to groups of 4 to 8 clinic patients in a private room Groups are made up of people of the same sex and same race or ethnicity Information on STDHIV risk behaviors and condom use is delivered by culturally-specific videos group discussion and a poster presenting features of various condom brands Participants role-play condom negotiation modeled in the videos At the end of the session they are given sample condoms of their choice

In this project health educators from the health departments of New York City and San Juan Puerto Rico conducted the VOICESVOCES intervention with a sample of patients from one STD clinic in each of their cities Researchers helped the health departments test whether the intervention is effective when local health educators deliver it
Detailed Description: This project was an RCT with 1699 patients assigned to receive the VOICESVOCES intervention and 1707 to receive standard of care at each of the two STD clinics total N3406 Participant outcomes and their measures are

1 Change in knowledge and attitudes about condoms as determined by participant profile and survey data
2 Condom acquisition as determined by project coupon redemption data
3 STD incidence as determined by medical chart review andor surveillance data

In addition cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the interventions cost-effectiveness Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention

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
Contract 200-2001-00132 None None None