Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Centers for Disease Control and Prevention |
---|---|
Information provided by: | Centers for Disease Control and Prevention |
ClinicalTrials.gov Identifier: | NCT00137670 |
The purpose of this study is to assess the effectiveness of a brief 23-minute video-based educational waiting room intervention to reduce incident STD and high risk behavior among STD patients attending STD clinics in three United States (U.S.) cities.
Condition | Intervention |
---|---|
HIV Infections Sexually Transmitted Diseases |
Device: Video-based HIV/STD prevention intervention |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Effectiveness of a Video-Based Educational Intervention to Prevent Human Immunodeficiency Virus (HIV) and Sexually Transmitted Diseases (STDs) Among Patients Attending STD Clinics |
Estimated Enrollment: | 45000 |
Study Start Date: | April 2002 |
Estimated Study Completion Date: | December 2005 |
Approximately 15 million incident cases of sexually transmitted diseases (STDs) occur annually. As a result, primary prevention of HIV/STDs among persons who have chosen to be sexually active remains a high public health priority. A number of effective interventions to prevent HIV/STDs have been developed, however many require considerable time and resource investments from both service providers and participants. These programs are often difficult to implement and sustain over time. As a result, simple practical interventions that can reduce transmission or acquisition of HIV/STDs among STD clinic patients while being both easily implemented and sustainable are urgently needed, and will ultimately enhance the menu of effective programs that are currently available to the STD clinic population.
The intervention trial was designed to develop and evaluate a video-based HIV/STD prevention intervention for STD clinic clients. The primary goals of this study are to assess whether a brief video-based educational waiting room intervention can reduce STD incidence (STD incidence outcome study) and high risk behavior (behavioral outcome study) among male and female patients attending STD clinics, when compared with patients who receive standard clinic services. This study is being conducted as a multi-site trial in 3 urban STD clinics.
The intervention condition consists of a 23-minute educational video focused on preventing STD and HIV infection shown on a large television in the waiting room. Health promotion posters supplement the video. The control condition consists of the current standard waiting room experience in each city’s STD clinic.
In the STD incidence outcome study, groups of patients attending the participating STD clinics are randomly assigned to blocks of clinic weeks to either the intervention or control condition. A waiver of informed consent was obtained whereby no subjects are actively enrolled for this phase of the study.
Through a retrospective review of existing medical records and STD surveillance registry data, we will determine and compare the incidence of new STDs over a 12-month period (on average) by assigned waiting room conditions.
In the behavioral outcome study, investigators administer computer-based survey instruments to a random sample of ~1600 male and female patients (800 per arm) both at enrollment and at 3 months following their initial clinic visit. The primary objective of the behavioral study is to assess the effectiveness of the video intervention by comparing levels of high-risk behavior between waiting room conditions at 3 months’ follow-up.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
STD Incidence Outcome Study:
Behavioral Outcome Study:
STD clinic patients:
United States, California | |
San Francisco Department of Public Health | |
San Francisco, California, United States, 94103 | |
California State University, Long Beach | |
Long Beach, California, United States, 90815 | |
United States, Colorado | |
Denver Public Health | |
Denver, Colorado, United States, 80204 | |
United States, Massachusetts | |
Education Development Center, Inc. | |
Newton, Massachusetts, United States, 02458 |
Principal Investigator: | Jeff D Klausner, MD, MPH | San Francisco Department of Public Health/ STD Prevention and Control Services |
Principal Investigator: | Cornelis A Rietmeijer, MD, PhD | Denver Public Health |
Principal Investigator: | Kevin Malotte, DrPH | California State University, Long Beach |
Principal Investigator: | Lydia N O’Donnell, Ed.D. | Education Development Center, Inc. |
Study ID Numbers: | CDC-NCHSTP-3500, R18/CCR921007, R18/CCR121005, R18/CCR821004 |
Study First Received: | August 27, 2005 |
Last Updated: | December 12, 2005 |
ClinicalTrials.gov Identifier: | NCT00137670 History of Changes |
Health Authority: | United States: Federal Government |
Intervention studies HIV |
Genital Diseases, Female Virus Diseases Sexually Transmitted Diseases, Viral HIV Infections Acquired Immunodeficiency Syndrome |
Sexually Transmitted Diseases Genital Diseases, Male Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Sexually Transmitted Diseases, Viral Slow Virus Diseases Immune System Diseases Acquired Immunodeficiency Syndrome Infection Genital Diseases, Male |
Immunologic Deficiency Syndromes Genital Diseases, Female Virus Diseases HIV Infections Sexually Transmitted Diseases Lentivirus Infections Retroviridae Infections |