Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Syracuse, New York 13244


Purpose:

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).


Study summary:

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.


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


Study is Available At:


Original ID:

R01 MH68171


NCT ID:

NCT00183573


Secondary ID:

R01MH068171


Study Acronym:


Brief Title:

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


Official Title:

HIV Prevention for STD Clinic Patients


Overall Status:

Completed


Study Phase:

Phase 2/Phase 3


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

The Miriam Hospital


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

6


Number of Groups:

0


Total Enrollment:

1554


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael P. Carey, PhD
Principal Investigator
Syracuse University

Study Dates

Start Date:March 2004
Completion Date:July 2007
Completion Type:Actual
Primary Completion Date:July 2007
Primary Completion Type:Actual
Verification Date:June 2013
Last Changed Date:June 6, 2013
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:STD incidence
Time Frame:12 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Sexual behavior
Time Frame:12 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Brief Motivational Intervention
Description:15-20 minute, motivational one-on-one counseling
Arm Name:1
Intervention Type:Behavioral
Name:Brief Informational Intervention
Description:15 minute informational DVD on safer sex
Arm Name:2
Intervention Type:Behavioral
Name:Intensive Informational Intervention
Description:4-hour, information-only intensive group workshop
Arm Name:3
Intervention Type:Behavioral
Name:Intensive Info-Motivation-Behavioral Skills Interv
Description:4-hour, intensive group workshop with emphasis on motivation and skills
Arm Name:4

Study Arms

Study Arm Type:Experimental
Arm Name:6
Description:Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Study Arm Type:Experimental
Arm Name:5
Description:Brief Informational Intervention + Intensive Informational Intervention
Study Arm Type:Experimental
Arm Name:4
Description:Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
Study Arm Type:Experimental
Arm Name:3
Description:Brief Motivational Intervention + Intensive Informational Intervention
Study Arm Type:Experimental
Arm Name:2
Description:Brief Informational Intervention only
Study Arm Type:Experimental
Arm Name:1
Description:Brief Motivational Intervention only

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:The Miriam Hospital
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Mental Health (NIMH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.