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

September 10, 2014 updated by: Michael P. Carey, The Miriam Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1010

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14611
        • Monroe County Health Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DVD 1 plus assessment 1
Participants will view educational DVD 1 and complete the first version of the study assessment.
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
Experimental: DVD 1 plus assessment 2
Participants will view educational DVD 1 and complete the second version of the study assessment.
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
Experimental: DVD 2 plus assessment 1
Participants will view educational DVD 2 and complete the first version of the study assessment.
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 2 plus assessment 2
Participants will view educational DVD 2 and complete the second version of the study assessment.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured after 3 months
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.
6 months post intervention
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
9 months post intervention
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
12 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured throughout the 12 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Miriam Hospital

Collaborators

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

Investigators

  • Principal Investigator: Michael P. Carey, Ph.D., The Miriam Hospital and Brown University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

July 27, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (Estimate)

July 28, 2009

Study Record Updates

Last Update Posted (Estimate)

September 17, 2014

Last Update Submitted That Met QC Criteria

September 10, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH068171-06 (U.S. NIH Grant/Contract)
  • PCC: DAHBR 9A-ASPQ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on HIV Infections

Clinical Trials on DVD 1

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe