Clinical trial NCT00164619: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sexually Transmitted Diseases
Keywords: controlled clinical trial
behavioral intervention
prevention intervention
Lead sponsor: Centers for Disease Control and Prevention
Sponsor class: FED
First posted: 2005-09-14
Enrollment: 3660
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

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

Primary outcomes:
measure: Repeat STD infection
timeFrame: Average of 15-months post-intervention
Secondary outcomes:
measure: Change in knowledge and attitudes
timeFrame: Immediately post-intervention
measure: Condom coupon redemption
timeFrame: 3-months post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: Central Harlem STD Clinic
state: New York
city: San Juan
country: Puerto Rico
facility: Centro Latino Americano de Enfermedades de Transmission Sexual
Study officials:
affiliation: Education Development Center, Inc.
name: Lydia O'Donnell, Ed.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.