NCT00164619

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,660

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2001

Longer than P75 for phase_2

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 5, 2008

Status Verified

June 1, 2008

Enrollment Period

5.3 years

First QC Date

September 12, 2005

Last Update Submit

June 4, 2008

Conditions

Sexually Transmitted Diseases

Keywords

controlled clinical trialbehavioral interventionprevention intervention

Outcome Measures

Primary Outcomes (1)

  • Repeat STD infection

    Average of 15-months post-intervention

Secondary Outcomes (2)

  • Change in knowledge and attitudes

    Immediately post-intervention

  • Condom coupon redemption

    3-months post-intervention

Study Arms (2)

1

EXPERIMENTAL

Standard STD clinic services and the VOICES/VOCES intervention

Behavioral: VOICES/VOCES

2

ACTIVE COMPARATOR

Standard STD clinic services

Biological: Standard STD clinic services

Interventions

VOICES/VOCESBEHAVIORAL

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). \[see Brief Summary above\]

Also known as: No other names
1
Standard STD clinic servicesBIOLOGICAL

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

Also known as: No other names
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Harlem STD Clinic

New York, New York, 10037, United States

Location

Centro Latino Americano de Enfermedades de Transmission Sexual

San Juan, 00922, Puerto Rico

Location

Related Publications (1)

  • 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.

    PMID: 9524995BACKGROUND

MeSH Terms

Conditions

Sexually Transmitted Diseases

Interventions

Voice

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Lydia O'Donnell, Ed.D.

    Education Development Center, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

July 1, 2001

Primary Completion

November 1, 2006

Study Completion

March 1, 2008

Last Updated

June 5, 2008

Record last verified: 2008-06

Locations

US(1)PR(1)