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

July 27, 2009
September 10, 2014
October 2009
June 2014   (final data collection date for primary outcome measure)
  • 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
Sexual risk behavior [ Time Frame: Measured at baseline and after 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00947271 on ClinicalTrials.gov Archive Site
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
Sexually transmitted infection incidence [ Time Frame: Measured at baseline and after 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
HIV Prevention for STD Clinic Patients

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
  • HIV
  • Sexually Transmitted Diseases
  • HIV Infections
  • 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
  • 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
Carey MP, Senn TE, Coury-Doniger P, Urban MA, Vanable PA, Carey KB. Optimizing the scientific yield from a randomized controlled trial (RCT): evaluating two behavioral interventions and assessment reactivity with a single trial. Contemp Clin Trials. 2013 Sep;36(1):135-46. doi: 10.1016/j.cct.2013.06.019. Epub 2013 Jun 29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1010
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00947271
R01 MH068171-06, R01MH068171-06, PCC: DAHBR 9A-ASPQ
No
Michael P. Carey, The Miriam Hospital
The Miriam Hospital
  • National Institute of Mental Health (NIMH)
  • University of Rochester
  • Brown University
  • Syracuse University
Principal Investigator: Michael P. Carey, Ph.D. The Miriam Hospital and Brown University
The Miriam Hospital
September 2014

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