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.

Study Overview

• Status: Completed
• Conditions: Sexually Transmitted Diseases
• Intervention / Treatment: Behavioral: VOICES/VOCES; Biological: Standard STD clinic services

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.

• Study Type: Interventional
• Enrollment (Actual): 3660
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00922
    • Centro Latino Americano de Enfermedades de Transmission Sexual
• United States
  • New York
    • New York, New York, United States, 10037
      • Central Harlem STD Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Age under 18 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: No other names

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Repeat STD infection	Average of 15-months post-intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in knowledge and attitudes	Immediately post-intervention
Condom coupon redemption	3-months post-intervention

Collaborators and Investigators

• Sponsor: Centers for Disease Control and Prevention

Publications and helpful links

General Publications

• 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. doi: 10.1097/00007435-199803000-00010.

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Primary Completion (ACTUAL): November 1, 2006
• Study Completion (ACTUAL): March 1, 2008

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (ESTIMATE): September 14, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): June 5, 2008
• Last Update Submitted That Met QC Criteria: June 4, 2008
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: behavioral intervention; controlled clinical trial; prevention intervention
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: CDC-NCHSTP-4048; Contract 200-2001-00132