Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR
| Tracking Information | |||||
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| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | June 4, 2008 | ||||
| Start Date ICMJE | July 2001 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Repeat STD infection [ Time Frame: Average of 15-months post-intervention ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Repeat STD infection at 6-months post-intervention. | ||||
| Change History | Complete list of historical versions of study NCT00164619 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
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| 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:
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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Sexually Transmitted Diseases | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | O'Donnell CR, O'Donnell L, San Doval A, Duran R, Labes K. Reductions in STD infections subsequent to an STD clinic visit. Using video-based patient education to supplement provider interactions. Sex Transm Dis. 1998 Mar;25(3):161-8. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 3660 | ||||
| Completion Date | March 2008 | ||||
| Primary Completion Date | November 2006 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States, Puerto Rico | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00164619 | ||||
| Other Study ID Numbers ICMJE | CDC-NCHSTP-4048, Contract 200-2001-00132 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Lydia O'Donnell, Education Development Center, Inc. | ||||
| Study Sponsor ICMJE | Centers for Disease Control and Prevention | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centers for Disease Control and Prevention | ||||
| Verification Date | June 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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