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Completed

NCT Number: NCT00164619

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Centro Latino Americano de Enfermedades de Transmission Sexual, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Age under 18 years

Treatment and study plan

VOICES/VOCES

Behavioral

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: No other names

Standard STD clinic services

Biological

Individual physical exam, STD/HIV tests, treatment as indicated

Other names: No other names

Primary outcomes

  1. Repeat STD infection

    Time frame: Average of 15-months post-intervention

Secondary outcomes

  1. Change in knowledge and attitudes

    Time frame: Immediately post-intervention

  2. Condom coupon redemption

    Time frame: 3-months post-intervention

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2008
First posted
Sep 14, 2005
Registry last updated
Jun 5, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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