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

This study has been completed.
Sponsor:
Collaborators:
University of Rochester
Brown University
Syracuse University
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00947271
First received: July 27, 2009
Last updated: September 10, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
HIV
Sexually Transmitted Diseases
HIV Infections
Behavioral: DVD 1
Behavioral: DVD 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: HIV Prevention for STD Clinic Patients

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Number of Sexual Partners, 3 Months Post Intervention [ Time Frame: Measured after 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    number of sexual partners in the past 3 months, assessed 12 months post intervention


Secondary Outcome Measures:
  • Sexually Transmitted Infection Incidence [ Time Frame: Measured throughout the 12 months post intervention ] [ Designated as safety issue: No ]
    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


Enrollment: 1010
Study Start Date: October 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DVD 1 plus assessment 1
Participants will view educational DVD 1 and complete the first version of the study assessment.
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
Experimental: DVD 1 plus assessment 2
Participants will view educational DVD 1 and complete the second version of the study assessment.
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
Experimental: DVD 2 plus assessment 1
Participants will view educational DVD 2 and complete the first version of the study assessment.
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
Experimental: DVD 2 plus assessment 2
Participants will view educational DVD 2 and complete the second version of the study assessment.
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

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00947271

Locations
United States, New York
Monroe County Health Department
Rochester, New York, United States, 14611
Sponsors and Collaborators
The Miriam Hospital
University of Rochester
Brown University
Syracuse University
Investigators
Principal Investigator: Michael P. Carey, Ph.D. The Miriam Hospital and Brown University
  More Information

Publications:
Responsible Party: Michael P. Carey, Director, Centers for Behavioral and Preventive Medicine, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00947271     History of Changes
Other Study ID Numbers: R01 MH068171-06, R01MH068171-06, PCC: DAHBR 9A-ASPQ
Study First Received: July 27, 2009
Results First Received: August 25, 2014
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by The Miriam Hospital:
STD
STI
Sexual Behavior
Prevention
HIV seronegativity

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

ClinicalTrials.gov processed this record on October 21, 2014