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

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ClinicalTrials.gov Identifier: NCT00137670
Recruitment Status : Completed
First Posted : August 30, 2005
Last Update Posted : September 27, 2012
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE August 27, 2005
First Posted Date  ICMJE August 30, 2005
Last Update Posted Date September 27, 2012
Study Start Date  ICMJE April 2002
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 21, 2005)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: August 27, 2005)
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2005)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Video-based Intervention Study to Prevent HIV/Sexually Transmitted Diseases (STDs) Among STD Clinic Patients
Official Title  ICMJE Effectiveness of a Video-based Educational Intervention to Prevent Human Immunodeficiency Virus (HIV) and Sexually Transmitted Diseases (STDs) Among Patients Attending STD Clinics
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Condition  ICMJE
  • HIV Infections
  • Sexually Transmitted Diseases
Intervention  ICMJE Device: Video-based HIV/STD prevention intervention
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 27, 2005)
45000
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

STD Incidence Outcome Study:

  • All medical records for STD clinic patients visiting participating STD clinics during the study period.

Behavioral Outcome Study:

STD clinic patients:

  • Not returning for a follow-up visit related to a previously diagnosed problem.
  • 18 years of age or older.
  • Not known to be HIV-infected by self-report.
  • Able to understand and speak English fluently.
  • Have not been previously seen as a patient in the clinic during an intervention block when the video was being played.
  • Have never received a diagnosis of a condition that necessitates frequent return visits (e.g., genital warts) by self-report.
  • Have not previously enrolled in the study.
  • Reported being in the clinic waiting room at least 20 minutes.
  • Do not plan to move outside the clinic's catchment area during the next 6 months.
  • Are willing to provide informed consent for review of their medical record and STD surveillance registry information by study staff.
  • Are not known to be pregnant according to self-report (women only).
  • Are not known by clinicians or counselors to be seriously ill (e.g. new HIV diagnosis or severe pelvic inflammatory disease [PID]).
  • Engaged in intercourse in the last three months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00137670
Other Study ID Numbers  ICMJE CDC-NCHSTP-3500
R18/CCR921007
R18/CCR121005
R18/CCR821004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centers for Disease Control and Prevention
Study Sponsor  ICMJE Centers for Disease Control and Prevention
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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.
PRS Account Centers for Disease Control and Prevention
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP