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

HIV Infections Clinical Trial

Official title:

HIV Prevention for STD Clinic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947271
• Other study ID #: R01MH068171-06
• Secondary ID: R01MH068171-06PC
• Status: Completed
• Phase: Phase 3
• First received: July 27, 2009
• Last updated: September 10, 2014
• Start date: October 2009
• Est. completion date: June 2014

Study information

• Verified date: September 2014
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1010
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV
• HIV Infections
• Sexually Transmitted Diseases

Intervention

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
• 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

Locations

Country	Name	City	State
United States	Monroe County Health Department	Rochester	New York

Sponsors (5)

Lead Sponsor	Collaborator
The Miriam Hospital	Brown University, National Institute of Mental Health (NIMH), Syracuse University, University of Rochester

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Sexual Partners, 3 Months Post Intervention	number of sexual partners in the past 3 months, assessed 3 months post intervention	Measured after 3 months	No
Primary	Number of Sexual Partners, 6 Months Post Intervention	number of sexual partners reported in the past 3 months, assessed 6 months post intervention.	6 months post intervention	No
Primary	Number of Sexual Partners, 9 Months Post Intervention	number of sexual partners in the past 3 months, assessed 9 months post intervention	9 months post intervention	No
Primary	Number of Sexual Partners, 12 Months Post Intervention	number of sexual partners in the past 3 months, assessed 12 months post intervention	12 months post intervention	No
Secondary	Sexually Transmitted Infection Incidence	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	Measured throughout the 12 months post intervention	No