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Completed

NCT Number: NCT00947271

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DVD 1

Behavioral

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

DVD 2

Behavioral

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

Primary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • Brown University
  • National Institute of Mental Health (NIMH)
  • Syracuse University
  • University of Rochester

Registry information

Official study title

HIV Prevention for STD Clinic Patients

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2009
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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