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Clinical Trials/NCT00183573
NCT00183573CompletedPhase 2

HIV Prevention for STD Clinic Patients

The Miriam Hospital1 site in 1 country1,554 target enrollmentStarted: March 1, 2004Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
1,554
Locations
1
Primary Endpoint
Sexual behavior

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

1

Experimental

Brief Motivational Intervention only

Intervention: Brief Motivational Intervention (Behavioral)

2

Experimental

Brief Informational Intervention only

Intervention: Brief Informational Intervention (Behavioral)

3

Experimental

Brief Motivational Intervention + Intensive Informational Intervention

Intervention: Brief Motivational Intervention (Behavioral)

3

Experimental

Brief Motivational Intervention + Intensive Informational Intervention

Intervention: Intensive Informational Intervention (Behavioral)

4

Experimental

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

Intervention: Brief Motivational Intervention (Behavioral)

4

Experimental

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

Intervention: Intensive Info-Motivation-Behavioral Skills Intervention (Behavioral)

5

Experimental

Brief Informational Intervention + Intensive Informational Intervention

Intervention: Brief Informational Intervention (Behavioral)

5

Experimental

Brief Informational Intervention + Intensive Informational Intervention

Intervention: Intensive Informational Intervention (Behavioral)

6

Experimental

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

Intervention: Brief Informational Intervention (Behavioral)

6

Experimental

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

Intervention: Intensive Info-Motivation-Behavioral Skills Intervention (Behavioral)

Outcomes

Primary Outcomes

Sexual behavior

Time Frame: 12 months

Secondary Outcomes

  • STD incidence(12 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael P. Carey

Director, CBPM

The Miriam Hospital

Study Sites (1)

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