Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR

This study has been completed.
Sponsor:
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164619
First received: September 12, 2005
Last updated: June 4, 2008
Last verified: June 2008

September 12, 2005
June 4, 2008
July 2001
November 2006   (final data collection date for primary outcome measure)
Repeat STD infection [ Time Frame: Average of 15-months post-intervention ] [ Designated as safety issue: No ]
Repeat STD infection at 6-months post-intervention.
Complete list of historical versions of study NCT00164619 on ClinicalTrials.gov Archive Site
  • Change in knowledge and attitudes [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]
  • Condom coupon redemption [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]
  • Change in knowledge and attitudes immediately post-intervention.
  • Condom acquisition at 3-months post-intervention.
Not Provided
Not Provided
 
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.

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:

  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 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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Sexually Transmitted Diseases
  • 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
  • Biological: Standard STD clinic services
    Individual physical exam, STD/HIV tests, treatment as indicated
    Other Name: No other names
  • Experimental: 1
    Standard STD clinic services and the VOICES/VOCES intervention
    Intervention: Behavioral: VOICES/VOCES
  • Active Comparator: 2
    Standard STD clinic services
    Intervention: Biological: Standard STD clinic services
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3660
March 2008
November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • STD infection at time of recruitment
  • Accept treatment for STD infection at time of recruitment

Exclusion Criteria:

  • Age under 18 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00164619
CDC-NCHSTP-4048, Contract 200-2001-00132
No
Dr. Lydia O'Donnell, Education Development Center, Inc.
Centers for Disease Control and Prevention
Not Provided
Principal Investigator: Lydia O'Donnell, Ed.D. Education Development Center, Inc.
Centers for Disease Control and Prevention
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP