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

Sexually Transmitted Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164619
• Other study ID #: CDC-NCHSTP-4048
• Secondary ID: Contract 200-200
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: June 4, 2008
• Start date: July 2001
• Est. completion date: March 2008

Study information

• Verified date: June 2008
• Source: Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3660
• Est. completion date: March 2008
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• STD infection at time of recruitment

• Accept treatment for STD infection at time of recruitment

Exclusion Criteria:

• Age under 18 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexually Transmitted Diseases

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]

Biological:
• Standard STD clinic services
Individual physical exam, STD/HIV tests, treatment as indicated

Locations

Country	Name	City	State
Puerto Rico	Centro Latino Americano de Enfermedades de Transmission Sexual	San Juan
United States	Central Harlem STD Clinic	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Centers for Disease Control and Prevention

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repeat STD infection		Average of 15-months post-intervention	No
Secondary	Change in knowledge and attitudes		Immediately post-intervention	No
Secondary	Condom coupon redemption		3-months post-intervention	No