NCT00137670

Video-based Intervention Study to Prevent HIV/Sexually Transmitted Diseases (STDs) Among STD Clinic Patients

Effectiveness of a Video-based Educational Intervention to Prevent Human Immunodeficiency Virus (HIV) and Sexually Transmitted Diseases (STDs) Among Patients Attending STD Clinics

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45,000 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• HIV Infections
• Sexually Transmitted Diseases

Interventions

Type	Name	Description
DEVICE	Video-based HIV/STD prevention intervention

Timeline

• Start date: 2002-04-01
• Primary completion: 2006-03-01
• Completion: 2009-03-01
• First posted: 2005-08-30
• Last updated: 2012-09-27

Locations

4 sites across 1 country: United States