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 US cities.

Condition	Intervention
HIV Sexually Transmitted Diseases	Device: Video-based HIV/STD prevention intervention

Further Study Details: 

Primary Outcomes: STD incidence Outcome Study: Compare STD incidence in groups by intervention and control conditions at 3, 6, and 12 months follow-up.; Behavioral Outcome Study: Compare the incidence of risk behavior during the 3 month follow-up period among intervention and control conditions.
Secondary Outcomes: STD incidence Outcome Study: Compare incidence of STD syndromes, and first episode of genital herpes or genital warts in intervention/control conditions.; Behavioral Outcome Study: Compare additional measures of risk between intervention and control conditions at three months follow-up including potential mediators of risk and clinic utilization.
Expected Total Enrollment:  45000

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 supplemented 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

Criteria

Inclusion Criteria:

STD Incidence Outcome Study: All medical records for STD clinic patients visiting participating STD clinics during study period.

Behavioral Outcome Study:

STD clinic patients:

1. Not returning for a follow-up visit related to a previously diagnosed problem.
2. 18 years of age or older.
3. Not known to be HIV-infected by self-report.
4. Able to understand and speak English fluently.
5. Have not been previously seen as a patient in the clinic during an intervention block when the video was being played.
6. Have never received a diagnosis of a condition that necessitates frequent return visits (e.g., genital warts) by self-report.
7. Have not previously enrolled in the study.
8. Reported being in the clinic waiting room at least 20 minutes.
9. Do not plan to move outside the clinic’s catchment area during the next 6 months.
10. Are willing to provide informed consent for review of their medical record and STD surveillance registry information by study staff.
11. Are not known to be pregnant according to self-report (women only).
12. Are not known by clinicians or counselors to be seriously ill (e.g. new HIV diagnosis or severe PID.
13. Engaged in intercourse in the last three months.

California
      San Francisco Department of Public Health, San Francisco,  California,  94103,  United States
      California State University, Long Beach, Long Beach,  California,  90815,  United States
Colorado
      Denver Public Health, Denver,  Colorado,  80204,  United States
Massachusetts
      Education Development Center, Inc., Newton,  Massachusetts,  02458,  United States

Study chairs or principal investigators

Jeff D Klausner, MD, MPH,  Principal Investigator,  San Francisco Department of Public Health/ STD Prevention and Control Services   
Cornelis A Rietmeijer, MD, PhD,  Principal Investigator,  Denver Public Health   
Kevin Malotte, DrPH,  Principal Investigator,  California State University, Long Beach   
Lydia N O’Donnell, Ed.D.,  Principal Investigator,  Education Development Center, Inc.   

Study ID Numbers:  CDC-NCHSTP-3500; R18/CCR921007; R18/CCR121005; R18/CCR821004
Last Updated:  August 29, 2005
Record first received:  August 27, 2005
ClinicalTrials.gov Identifier:  NCT00137670
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13