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

Lifespan

Status and phase: Completed; Phase 3

Conditions: Sexually Transmitted Diseases; HIV; HIV Infections

Treatments: Behavioral: DVD 1; Behavioral: DVD 2

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00947271

R01MH068171-06 (U.S. NIH Grant/Contract)

PCC: DAHBR 9A-ASPQ

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,010 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,010 participants in 4 patient groups

DVD 1 plus assessment 1

Experimental group

Description:

Participants will view educational DVD 1 and complete the first version of the study assessment.

Treatment:

Behavioral: DVD 1

DVD 1 plus assessment 2

Experimental group

Description:

Participants will view educational DVD 1 and complete the second version of the study assessment.

Treatment:

Behavioral: DVD 1

DVD 2 plus assessment 1

Experimental group

Description:

Participants will view educational DVD 2 and complete the first version of the study assessment.

Treatment:

Behavioral: DVD 2

DVD 2 plus assessment 2

Experimental group

Description:

Participants will view educational DVD 2 and complete the second version of the study assessment.

Treatment:

Behavioral: DVD 2