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

NCT ID: NCT00164619

Last Updated: 2008-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-07-31
• Study Completion Date: 2008-03-31

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.

Conditions

Sexually Transmitted Diseases

Keywords

controlled clinical trial; behavioral intervention; prevention intervention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

1

Standard STD clinic services and the VOICES/VOCES intervention

Group Type: EXPERIMENTAL

VOICES/VOCES

Intervention Type: 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). \[see Brief Summary above\]

2

Standard STD clinic services

Group Type: ACTIVE_COMPARATOR

Standard STD clinic services

Intervention Type: BIOLOGICAL

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

Interventions

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). \[see Brief Summary above\]

Intervention Type: BEHAVIORAL

Standard STD clinic services

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

Intervention Type: BIOLOGICAL

Other Intervention Names

No other names; No other names

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Age under 18 years

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: lead

Responsible Party

Education Development Center, Inc.

Principal Investigators

Lydia O'Donnell, Ed.D.

Role: PRINCIPAL_INVESTIGATOR

Education Development Center, Inc.

Locations

Central Harlem STD Clinic

New York, New York, United States

Centro Latino Americano de Enfermedades de Transmission Sexual

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

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.

Reference Type: BACKGROUND

PMID: 9524995 (View on PubMed)

Other Identifiers

Contract 200-2001-00132

Identifier Type: -

Identifier Source: secondary_id

CDC-NCHSTP-4048

Identifier Type: -

Identifier Source: org_study_id