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
4 other identifiers
interventional
45,000
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable hiv-infections
Started Apr 2002
Longer than P75 for not_applicable hiv-infections
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 27, 2005
CompletedFirst Posted
Study publicly available on registry
August 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 27, 2012
September 1, 2012
3.9 years
August 27, 2005
September 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
California State University, Long Beach
Long Beach, California, 90815, United States
San Francisco Department of Public Health
San Francisco, California, 94103, United States
Denver Public Health
Denver, Colorado, 80204, United States
Education Development Center, Inc.
Newton, Massachusetts, 02458, United States
Related Publications (2)
Gallo MF, Margolis AD, Malotte CK, Rietmeijer CA, Klausner JD, O'Donnell L, Warner L; Safe in the City Study Group. Sexual abstinence and other behaviours immediately following a new STI diagnosis among STI clinic patients: Findings from the Safe in the City trial. Sex Transm Infect. 2016 May;92(3):206-10. doi: 10.1136/sextrans-2014-051982. Epub 2015 Dec 15.
PMID: 26670913DERIVEDWarner L, Klausner JD, Rietmeijer CA, Malotte CK, O'Donnell L, Margolis AD, Greenwood GL, Richardson D, Vrungos S, O'Donnell CR, Borkowf CB; Safe in the City Study Group. Effect of a brief video intervention on incident infection among patients attending sexually transmitted disease clinics. PLoS Med. 2008 Jun 24;5(6):e135. doi: 10.1371/journal.pmed.0050135.
PMID: 18578564DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2005
First Posted
August 30, 2005
Study Start
April 1, 2002
Primary Completion
March 1, 2006
Study Completion
March 1, 2009
Last Updated
September 27, 2012
Record last verified: 2012-09