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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
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • Repeat STD infection [ Time Frame: Average of 15-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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:

  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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00164619

Locations
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
Sponsors and Collaborators
Centers for Disease Control and Prevention
Investigators
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
Health Authority: United States: Federal Government

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 May 23, 2013