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

Primary Purpose

Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
VOICES/VOCES
Standard STD clinic services
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Diseases focused on measuring controlled clinical trial, behavioral intervention, prevention intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: STD infection at time of recruitment Accept treatment for STD infection at time of recruitment Exclusion Criteria: Age under 18 years

Sites / Locations

  • Central Harlem STD Clinic
  • Centro Latino Americano de Enfermedades de Transmission Sexual

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Standard STD clinic services and the VOICES/VOCES intervention

Standard STD clinic services

Outcomes

Primary Outcome Measures

Repeat STD infection

Secondary Outcome Measures

Change in knowledge and attitudes
Condom coupon redemption

Full Information

First Posted
September 12, 2005
Last Updated
June 4, 2008
Sponsor
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT00164619
Brief Title
Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Diseases
Keywords
controlled clinical trial, behavioral intervention, prevention intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Standard STD clinic services and the VOICES/VOCES intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard STD clinic services
Intervention Type
Behavioral
Intervention Name(s)
VOICES/VOCES
Other Intervention Name(s)
No other names
Intervention Description
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
Biological
Intervention Name(s)
Standard STD clinic services
Other Intervention Name(s)
No other names
Intervention Description
Individual physical exam, STD/HIV tests, treatment as indicated
Primary Outcome Measure Information:
Title
Repeat STD infection
Time Frame
Average of 15-months post-intervention
Secondary Outcome Measure Information:
Title
Change in knowledge and attitudes
Time Frame
Immediately post-intervention
Title
Condom coupon redemption
Time Frame
3-months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lydia O'Donnell, Ed.D.
Organizational Affiliation
Education Development Center, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Harlem STD Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10037
Country
United States
Facility Name
Centro Latino Americano de Enfermedades de Transmission Sexual
City
San Juan
ZIP/Postal Code
00922
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
9524995
Citation
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.
Results Reference
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Testing the Effectiveness of VOICES as Implemented by STD & HIV Prevention Agencies in the US and PR

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