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

This study has been completed.
Sponsor:
Collaborators:
University of Rochester
Syracuse University
Information provided by (Responsible Party):
Michael P. Carey, The Miriam Hospital
ClinicalTrials.gov Identifier:
NCT00183573
First received: September 13, 2005
Last updated: June 6, 2013
Last verified: June 2013

September 13, 2005
June 6, 2013
March 2004
July 2007   (final data collection date for primary outcome measure)
Sexual behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Sexual behavior
Complete list of historical versions of study NCT00183573 on ClinicalTrials.gov Archive Site
STD incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
STD incidence
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • HIV Infections
  • Sexually Transmitted Diseases
  • Behavioral: Brief Motivational Intervention
    15-20 minute, motivational one-on-one counseling
  • Behavioral: Brief Informational Intervention
    15 minute informational DVD on safer sex
  • Behavioral: Intensive Informational Intervention
    4-hour, information-only intensive group workshop
  • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
    4-hour, intensive group workshop with emphasis on motivation and skills
  • Experimental: 1
    Brief Motivational Intervention only
    Intervention: Behavioral: Brief Motivational Intervention
  • Experimental: 2
    Brief Informational Intervention only
    Intervention: Behavioral: Brief Informational Intervention
  • Experimental: 3
    Brief Motivational Intervention + Intensive Informational Intervention
    Interventions:
    • Behavioral: Brief Motivational Intervention
    • Behavioral: Intensive Informational Intervention
  • Experimental: 4
    Brief Motivational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
    Interventions:
    • Behavioral: Brief Motivational Intervention
    • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
  • Experimental: 5
    Brief Informational Intervention + Intensive Informational Intervention
    Interventions:
    • Behavioral: Brief Informational Intervention
    • Behavioral: Intensive Informational Intervention
  • Experimental: 6
    Brief Informational Intervention + Intensive Information-Motivation-Behavioral Skills Intervention
    Interventions:
    • Behavioral: Brief Informational Intervention
    • Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1554
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00183573
R01 MH68171, R01MH068171
No
Michael P. Carey, The Miriam Hospital
The Miriam Hospital
  • National Institute of Mental Health (NIMH)
  • University of Rochester
  • Syracuse University
Principal Investigator: Michael P. Carey, PhD Syracuse University
The Miriam Hospital
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP