- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00164619
Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR
Testing the Effectiveness of the VOICES/VOCES Intervention Package as Implemented by STD and HIV Prevention Agencies That Target Hispanics and African Americans in the U.S. and Puerto Rico
The purpose of the project is to determine whether the VOICES/VOCES intervention, that was shown to be effective in a research study, is still effective when delivered by STD/HIV prevention agencies.
VOICES/VOCES is a brief, single-session intervention for African-American and Latino adult men and women at high risk for STD/HIV. 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 STD/HIV 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 VOICES/VOCES 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This project was an RCT with 1699 patients assigned to receive the VOICES/VOCES intervention and 1707 to receive standard of care at each of the two STD clinics (total N=3406). Participant outcomes and their measures are:
- Change in knowledge and attitudes about condoms as determined by participant profile and survey data
- Condom acquisition as determined by project coupon redemption data
- STD incidence as determined by medical chart review and/or surveillance data
In addition, cost accounting data on the amounts and types of resources required to implement the intervention were used to evaluate the intervention's cost-effectiveness. Process evaluation data allow identification of factors that influenced intervention implementation and the effectiveness of the intervention.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00922
- Centro Latino Americano de Enfermedades de Transmission Sexual
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-
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New York
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New York, New York, United States, 10037
- Central Harlem STD Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- STD infection at time of recruitment
- Accept treatment for STD infection at time of recruitment
Exclusion Criteria:
- Age under 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
Standard STD clinic services and the VOICES/VOCES intervention
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45-minute intervention for small groups of African American and Hispanic heterosexual men and women.
Group members are same gender and race/ethnicity.
View culturally-specific condom promotion video.
Facilitated group discussion to build skills in condom use and condom negotiation.
Education on condom varieties to overcome participants' personal barriers to condoms use.
Distribution of 3 specialty condoms of participant's choice (i.e., different sizes, textures, thicknesses, lubrication, material).
[see Brief Summary above]
Other Names:
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ACTIVE_COMPARATOR: 2
Standard STD clinic services
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Individual physical exam, STD/HIV tests, treatment as indicated
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Repeat STD infection
Time Frame: Average of 15-months post-intervention
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Average of 15-months post-intervention
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in knowledge and attitudes
Time Frame: Immediately post-intervention
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Immediately post-intervention
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Condom coupon redemption
Time Frame: 3-months post-intervention
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3-months post-intervention
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDC-NCHSTP-4048
- Contract 200-2001-00132
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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