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HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic

Primary Purpose

HIV Infections, Sexually Transmitted Diseases

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief Motivational Intervention
Brief Informational Intervention
Intensive Informational Intervention
Intensive Info-Motivation-Behavioral Skills Intervention
Sponsored by
The Miriam Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring STDs, Sexual Behavior, Health Behavior, HIV Seronegativity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: 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 Able to understand English Exclusion Criteria: Psychosis or impaired mental status that would prevent participant from providing informed consent Have been tested for HIV within 3 months prior to study entry HIV infected

Sites / Locations

  • Syracuse University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

5

6

Arm Description

Brief Motivational Intervention only

Brief Informational Intervention only

Brief Motivational Intervention + Intensive Informational Intervention

Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention

Brief Informational Intervention + Intensive Informational Intervention

Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention

Outcomes

Primary Outcome Measures

Sexual behavior

Secondary Outcome Measures

STD incidence

Full Information

First Posted
September 13, 2005
Last Updated
June 6, 2013
Sponsor
The Miriam Hospital
Collaborators
National Institute of Mental Health (NIMH), University of Rochester, Syracuse University
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1. Study Identification

Unique Protocol Identification Number
NCT00183573
Brief Title
HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
Official Title
HIV Prevention for STD Clinic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (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, Syracuse University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).
Detailed Description
Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention. At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention. Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Sexually Transmitted Diseases
Keywords
STDs, Sexual Behavior, Health Behavior, HIV Seronegativity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1554 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Brief Motivational Intervention only
Arm Title
2
Arm Type
Experimental
Arm Description
Brief Informational Intervention only
Arm Title
3
Arm Type
Experimental
Arm Description
Brief Motivational Intervention + Intensive Informational Intervention
Arm Title
4
Arm Type
Experimental
Arm Description
Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Arm Title
5
Arm Type
Experimental
Arm Description
Brief Informational Intervention + Intensive Informational Intervention
Arm Title
6
Arm Type
Experimental
Arm Description
Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention
Intervention Description
15-20 minute, motivational one-on-one counseling
Intervention Type
Behavioral
Intervention Name(s)
Brief Informational Intervention
Intervention Description
15 minute informational DVD on safer sex
Intervention Type
Behavioral
Intervention Name(s)
Intensive Informational Intervention
Intervention Description
4-hour, information-only intensive group workshop
Intervention Type
Behavioral
Intervention Name(s)
Intensive Info-Motivation-Behavioral Skills Intervention
Intervention Description
4-hour, intensive group workshop with emphasis on motivation and skills
Primary Outcome Measure Information:
Title
Sexual behavior
Time Frame
12 months
Secondary Outcome Measure Information:
Title
STD incidence
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: 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 Able to understand English Exclusion Criteria: Psychosis or impaired mental status that would prevent participant from providing informed consent Have been tested for HIV within 3 months prior to study entry HIV infected
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P. Carey, PhD
Organizational Affiliation
Syracuse University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syracuse University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13244
Country
United States

12. IPD Sharing Statement

Learn more about this trial

HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic

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