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

Phase 3

Completed

Conditions: Sexually Transmitted Diseases
HIV Infections
HIV

Interventions: Behavioral: DVD 1
Behavioral: DVD 2

Registration Number: NCT00947271

Lead Sponsor: The Miriam Hospital

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1010

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DVD 1 plus assessment 1	DVD 1	Participants will view educational DVD 1 and complete the first version of the study assessment.
DVD 1 plus assessment 2	DVD 1	Participants will view educational DVD 1 and complete the second version of the study assessment.
DVD 2 plus assessment 1	DVD 2	Participants will view educational DVD 2 and complete the first version of the study assessment.
DVD 2 plus assessment 2	DVD 2	Participants will view educational DVD 2 and complete the second version of the study assessment.

Primary Outcome Measures

Name	Time	Method
Number of Sexual Partners, 3 Months Post Intervention	Measured after 3 months	number of sexual partners in the past 3 months, assessed 3 months post intervention
Number of Sexual Partners, 9 Months Post Intervention	9 months post intervention	number of sexual partners in the past 3 months, assessed 9 months post intervention
Number of Sexual Partners, 6 Months Post Intervention	6 months post intervention	number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Number of Sexual Partners, 12 Months Post Intervention	12 months post intervention	number of sexual partners in the past 3 months, assessed 12 months post intervention

Secondary Outcome Measures

Name	Time	Method
Sexually Transmitted Infection Incidence	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