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Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Sexually Transmitted Diseases | Behavioral: VOICES/VOCES Biological: Standard STD clinic services | Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Prevention |
| Official Title: | 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 |
- Repeat STD infection [ Time Frame: Average of 15-months post-intervention ]
- Change in knowledge and attitudes [ Time Frame: Immediately post-intervention ]
- Condom coupon redemption [ Time Frame: 3-months post-intervention ]
| Enrollment: | 3660 |
| Study Start Date: | July 2001 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | November 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Standard STD clinic services and the VOICES/VOCES intervention
|
Behavioral: VOICES/VOCES
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 Name: No other names
|
|
Active Comparator: 2
Standard STD clinic services
|
Biological: Standard STD clinic services
Individual physical exam, STD/HIV tests, treatment as indicated
Other Name: No other names
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- STD infection at time of recruitment
- Accept treatment for STD infection at time of recruitment
Exclusion Criteria:
- Age under 18 years
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00164619
| United States, New York | |
| Central Harlem STD Clinic | |
| New York, New York, United States, 10037 | |
| Puerto Rico | |
| Centro Latino Americano de Enfermedades de Transmission Sexual | |
| San Juan, Puerto Rico, 00922 | |
| Principal Investigator: | Lydia O'Donnell, Ed.D. | Education Development Center, Inc. |
More Information
Publications:
| Responsible Party: | Dr. Lydia O'Donnell, Education Development Center, Inc. |
| ClinicalTrials.gov Identifier: | NCT00164619 History of Changes |
| Other Study ID Numbers: |
CDC-NCHSTP-4048 Contract 200-2001-00132 |
| Study First Received: | September 12, 2005 |
| Last Updated: | June 4, 2008 |
Keywords provided by Centers for Disease Control and Prevention:
|
controlled clinical trial behavioral intervention prevention intervention |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Infection Virus Diseases Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on September 20, 2017