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

HIV Prevention for STD Clinic Patients

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 Overview

• Status: Completed
• Conditions: HIV Infections; Sexually Transmitted Diseases
• Intervention / Treatment: Behavioral: Brief Motivational Intervention; Behavioral: Brief Informational Intervention; Behavioral: Intensive Informational Intervention; Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention

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 Type: Interventional
• Enrollment (Actual): 1554
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Syracuse, New York, United States, 13244
      • Syracuse University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Brief Motivational Intervention only	Behavioral: Brief Motivational Intervention; 15-20 minute, motivational one-on-one counseling
Experimental: 2; Brief Informational Intervention only	Behavioral: Brief Informational Intervention; 15 minute informational DVD on safer sex
Experimental: 3; Brief Motivational Intervention + Intensive Informational Intervention	Behavioral: Brief Motivational Intervention; 15-20 minute, motivational one-on-one counseling; Behavioral: Intensive Informational Intervention; 4-hour, information-only intensive group workshop
Experimental: 4; Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention	Behavioral: Brief Motivational Intervention; 15-20 minute, motivational one-on-one counseling; Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention; 4-hour, intensive group workshop with emphasis on motivation and skills
Experimental: 5; Brief Informational Intervention + Intensive Informational Intervention	Behavioral: Brief Informational Intervention; 15 minute informational DVD on safer sex; Behavioral: Intensive Informational Intervention; 4-hour, information-only intensive group workshop
Experimental: 6; Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention	Behavioral: Brief Informational Intervention; 15 minute informational DVD on safer sex; Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention; 4-hour, intensive group workshop with emphasis on motivation and skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sexual behavior	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
STD incidence	12 months

Collaborators and Investigators

• Sponsor: The Miriam Hospital
• Collaborators: National Institute of Mental Health (NIMH); University of Rochester; Syracuse University
• Investigators: Principal Investigator: Michael P. Carey, PhD, Syracuse University

Study record dates

Study Major Dates

• Study Start: March 1, 2004
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 16, 2005

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: HIV Seronegativity; Sexual Behavior; Health Behavior; STDs
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Communicable Diseases; Disease Attributes; Sexually Transmitted Diseases
• Other Study ID Numbers: R01MH068171 (U.S. NIH Grant/Contract)