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Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00947271
Recruitment Status : Completed
First Posted : July 28, 2009
Results First Posted : September 17, 2014
Last Update Posted : September 17, 2014
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Rochester
Brown University
Syracuse University
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital

Tracking Information
First Submitted Date  ICMJE July 27, 2009
First Posted Date  ICMJE July 28, 2009
Results First Submitted Date  ICMJE August 25, 2014
Results First Posted Date  ICMJE September 17, 2014
Last Update Posted Date September 17, 2014
Study Start Date  ICMJE October 2009
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
  • Number of Sexual Partners, 3 Months Post Intervention [ Time Frame: Measured after 3 months ]
    number of sexual partners in the past 3 months, assessed 3 months post intervention
  • Number of Sexual Partners, 6 Months Post Intervention [ Time Frame: 6 months post intervention ]
    number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
  • Number of Sexual Partners, 9 Months Post Intervention [ Time Frame: 9 months post intervention ]
    number of sexual partners in the past 3 months, assessed 9 months post intervention
  • Number of Sexual Partners, 12 Months Post Intervention [ Time Frame: 12 months post intervention ]
    number of sexual partners in the past 3 months, assessed 12 months post intervention
Original Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Sexual risk behavior [ Time Frame: Measured at baseline and after 3, 6, 9, and 12 months ]
Change History Complete list of historical versions of study NCT00947271 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2014)
Sexually Transmitted Infection Incidence [ Time Frame: Measured throughout the 12 months post intervention ]
number of participants diagnosed with a new STI (CT, Gc, trichomoniasis, syphilis, or HIV) throughout the entire year of follow-up; includes participants who provided a study urine sample for STI testing at 3, 6, 9, and/or 12 months post intervention and participants who received STI testing through the clinic during the year of follow up
Original Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Sexually Transmitted Infection Incidence [ Time Frame: Measured at baseline and after 3, 6, 9, and 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
Official Title  ICMJE HIV Prevention for STD Clinic Patients
Brief Summary This study will determine whether showing an educational DVD to people at sexually transmitted infection clinics can reduce incidence of new infections and risky sexual behaviors and improve overall health.
Detailed Description

Sexually transmitted infections (STIs) can produce long-term health problems. They are often linked to HIV, which can also be sexually transmitted, because both occur in the same populations and because STIs and HIV interact biologically. Having an STI other than HIV can increase the risk of HIV acquisition and transmission as well as negatively impact HIV progression. The population of people who go to clinics specializing in STIs are particularly at risk of engaging in risky sexual behaviors and having poor health outcomes—like infection with an STI. This study will test the effectiveness of using an educational DVD to reduce incidence of risky sexual behaviors and STI acquisition, including risk of HIV, and to improve overall health.

Participation in this study will involve two phases. In Phase 1, participants will complete both computerized and paper surveys and watch an educational DVD. The educational DVD may include information on diet, physical activity, sleep, smoking, STIs, and stress. Participants will be recruited from among people who are already going to the clinic, and participation will add approximately 1.5 hours to their visits. In Phase 2, participants will be asked to complete four follow-up visits occurring 3, 6, 9, and 12 months after Phase 1. During these follow-up visits, participants will complete a 45-minute computerized survey similar to that in Phase 1 and provide urine and throat samples for STI testing. All surveys will assess health-related thoughts, feelings, and behaviors, including sexual behaviors. Participants will be compensated for completing Phase 1 and each visit in Phase 2.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • HIV
  • Sexually Transmitted Diseases
  • HIV Infections
Intervention  ICMJE
  • Behavioral: DVD 1
    The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health
  • Behavioral: DVD 2
    The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health
Study Arms  ICMJE
  • Experimental: DVD 1 plus assessment 1
    Participants will view educational DVD 1 and complete the first version of the study assessment.
    Intervention: Behavioral: DVD 1
  • Experimental: DVD 1 plus assessment 2
    Participants will view educational DVD 1 and complete the second version of the study assessment.
    Intervention: Behavioral: DVD 1
  • Experimental: DVD 2 plus assessment 1
    Participants will view educational DVD 2 and complete the first version of the study assessment.
    Intervention: Behavioral: DVD 2
  • Experimental: DVD 2 plus assessment 2
    Participants will view educational DVD 2 and complete the second version of the study assessment.
    Intervention: Behavioral: DVD 2
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
Actual Enrollment  ICMJE
 (submitted: September 10, 2014)
1010
Original Estimated Enrollment  ICMJE
 (submitted: July 27, 2009)
1000
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Evidence of sexual risk behavior, defined as either signs, symptoms, or diagnosis indicative of an STD during the past 3 months; or unprotected vaginal or anal intercourse with two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug using partner, or a partner with an STD

Exclusion Criteria:

  • Impaired mental status that would prevent participant from providing informed consent or participating meaningfully
  • Inability to understand English
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (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 NCT00947271
Other Study ID Numbers  ICMJE R01MH068171-06( U.S. NIH Grant/Contract )
R01MH068171-06 ( U.S. NIH Grant/Contract )
PCC: DAHBR 9A-ASPQ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael P. Carey, The Miriam Hospital
Study Sponsor  ICMJE The Miriam Hospital
Collaborators  ICMJE
  • National Institute of Mental Health (NIMH)
  • University of Rochester
  • Brown University
  • Syracuse University
Investigators  ICMJE
Principal Investigator: Michael P. Carey, Ph.D. The Miriam Hospital and Brown University
PRS Account The Miriam Hospital
Verification Date September 2014

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