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

Phase 2

Completed

• Conditions: Sexually Transmitted Diseases
• Interventions: Biological: Standard STD clinic services; Behavioral: VOICES/VOCES

• Registration Number: NCT00164619
• Lead Sponsor: Centers for Disease Control and Prevention

Brief 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.

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 Timeline

• Study Start: 2001-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-14
• Primary Completion: 2006-11
• Study Completion: 2008-03
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-04
• Last Update Posted: 2008-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3660

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Standard STD clinic services	Standard STD clinic services
1	VOICES/VOCES	Standard STD clinic services and the VOICES/VOCES intervention

Primary Outcome Measures

Name	Time	Method
Repeat STD infection	Average of 15-months post-intervention

Secondary Outcome Measures

Name	Time	Method
Change in knowledge and attitudes	Immediately post-intervention
Condom coupon redemption	3-months post-intervention

Trial Locations

Locations (2)

Central Harlem STD Clinic; 🇺🇸 New York, New York, United States

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