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

Primary Purpose

HIV, Sexually Transmitted Diseases, HIV Infections

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DVD 1
DVD 2
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV focused on measuring STD, STI, Sexual Behavior, Prevention, HIV seronegativity

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Monroe County Health Department

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

DVD 1 plus assessment 1

DVD 1 plus assessment 2

DVD 2 plus assessment 1

DVD 2 plus assessment 2

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 27, 2009
Last Updated
September 10, 2014
Sponsor
The Miriam Hospital
Collaborators
National Institute of Mental Health (NIMH), University of Rochester, Brown University, Syracuse University
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1. Study Identification

Unique Protocol Identification Number
NCT00947271
Brief Title
Reducing Sexual Risk Behaviors and Improving Health for People at a Sexually Transmitted Infection Clinic
Official Title
HIV Prevention for STD Clinic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Miriam Hospital
Collaborators
National Institute of Mental Health (NIMH), University of Rochester, Brown University, Syracuse University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases, HIV Infections
Keywords
STD, STI, Sexual Behavior, Prevention, HIV seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
1010 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DVD 1 plus assessment 1
Arm Type
Experimental
Arm Description
Participants will view educational DVD 1 and complete the first version of the study assessment.
Arm Title
DVD 1 plus assessment 2
Arm Type
Experimental
Arm Description
Participants will view educational DVD 1 and complete the second version of the study assessment.
Arm Title
DVD 2 plus assessment 1
Arm Type
Experimental
Arm Description
Participants will view educational DVD 2 and complete the first version of the study assessment.
Arm Title
DVD 2 plus assessment 2
Arm Type
Experimental
Arm Description
Participants will view educational DVD 2 and complete the second version of the study assessment.
Intervention Type
Behavioral
Intervention Name(s)
DVD 1
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
DVD 2
Intervention Description
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 Outcome Measure Information:
Title
Number of Sexual Partners, 3 Months Post Intervention
Description
number of sexual partners in the past 3 months, assessed 3 months post intervention
Time Frame
Measured after 3 months
Title
Number of Sexual Partners, 6 Months Post Intervention
Description
number of sexual partners reported in the past 3 months, assessed 6 months post intervention.
Time Frame
6 months post intervention
Title
Number of Sexual Partners, 9 Months Post Intervention
Description
number of sexual partners in the past 3 months, assessed 9 months post intervention
Time Frame
9 months post intervention
Title
Number of Sexual Partners, 12 Months Post Intervention
Description
number of sexual partners in the past 3 months, assessed 12 months post intervention
Time Frame
12 months post intervention
Secondary Outcome Measure Information:
Title
Sexually Transmitted Infection Incidence
Description
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
Time Frame
Measured throughout the 12 months post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P. Carey, Ph.D.
Organizational Affiliation
The Miriam Hospital and Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Monroe County Health Department
City
Rochester
State/Province
New York
ZIP/Postal Code
14611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23816489
Citation
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.
Results Reference
background
PubMed Identifier
26310596
Citation
Carey KB, Senn TE, Walsh JL, Scott-Sheldon LA, Carey MP. Alcohol Use Predicts Number of Sexual Partners for Female but not Male STI Clinic Patients. AIDS Behav. 2016 Jan;20 Suppl 1(0 1):S52-9. doi: 10.1007/s10461-015-1177-9.
Results Reference
derived
PubMed Identifier
25433653
Citation
Carey MP, Senn TE, Walsh JL, Coury-Doniger P, Urban MA, Fortune T, Vanable PA, Carey KB. Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial. AIDS Behav. 2015 Jul;19(7):1228-46. doi: 10.1007/s10461-014-0960-3.
Results Reference
derived

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

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