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

Purpose

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.

Condition	Intervention	Phase
Sexually Transmitted Diseases	Behavioral: VOICES/VOCES Biological: Standard STD clinic services	Phase 2 Phase 3


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

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

Repeat STD infection [ Time Frame: Average of 15-months post-intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in knowledge and attitudes [ Time Frame: Immediately post-intervention ] [ Designated as safety issue: No ]
Condom coupon redemption [ Time Frame: 3-months post-intervention ] [ Designated as safety issue: No ]


Enrollment:	3660
Study Start Date:	July 2001
Study Completion Date:	March 2008
Primary Completion Date:	November 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: No other names

Arms

Assigned Interventions

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 Name: 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 Name: No other names

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:

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Age under 18 years

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00164619

Locations


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

Sponsors and Collaborators

Centers for Disease Control and Prevention

Investigators


Principal Investigator:	Lydia O'Donnell, Ed.D.	Education Development Center, Inc.

More Information

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.


Responsible Party:	Dr. Lydia O'Donnell, Education Development Center, Inc.
ClinicalTrials.gov Identifier:	NCT00164619 History of Changes
Other Study ID Numbers:	CDC-NCHSTP-4048, Contract 200-2001-00132
Study First Received:	September 12, 2005
Last Updated:	June 4, 2008
Health Authority:	United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:


controlled clinical trial behavioral intervention prevention intervention

Additional relevant MeSH terms:


Sexually Transmitted Diseases Genital Diseases, Female Genital Diseases, Male Infection Virus Diseases

ClinicalTrials.gov processed this record on March 01, 2015