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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00137670
First received: August 27, 2005
Last updated: September 26, 2012
Last verified: September 2012
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 45000
Study Start Date: April 2002
Study Completion Date: March 2009
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00137670

Locations
United States, California
California State University, Long Beach
Long Beach, California, United States, 90815
San Francisco Department of Public Health
San Francisco, California, United States, 94103
United States, Colorado
Denver Public Health
Denver, Colorado, United States, 80204
United States, Massachusetts
Education Development Center, Inc.
Newton, Massachusetts, United States, 02458
Sponsors and Collaborators
Investigators
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.
  More Information

No publications provided by Centers for Disease Control and Prevention

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT00137670     History of Changes
Other Study ID Numbers: CDC-NCHSTP-3500, R18/CCR921007, R18/CCR121005, R18/CCR821004
Study First Received: August 27, 2005
Last Updated: September 26, 2012
Health Authority: United States: Federal Government

Keywords provided by Centers for Disease Control and Prevention:
Intervention studies
HIV

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Sexually Transmitted Diseases
Genital Diseases, Female
Genital Diseases, Male
Immune System Diseases
Immunologic Deficiency Syndromes
Infection
Lentivirus Infections
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014