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

Study Overview
=================
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.

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

Conditions
-----------------
Sexually Transmitted Diseases

Intervention / Treatment
-----------------
* Behavioral: VOICES/VOCES
* Biological: Standard STD clinic services


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Standard STD clinic services and the VOICES/VOCES intervention | Behavioral: VOICES/VOCES<br>* 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]<br>* Other names: No other names;|
| Active Comparator: 2<br>Standard STD clinic services | Biological: Standard STD clinic services<br>* Individual physical exam, STD/HIV tests, treatment as indicated<br>* Other names: No other names;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeat STD infection |  | Average of 15-months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in knowledge and attitudes |  | Immediately post-intervention | 
| Condom coupon redemption |  | 3-months post-intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
controlled clinical trial, behavioral intervention, prevention intervention