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
  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).


Condition Intervention Phase
HIV Infections
Sexually Transmitted Diseases
Behavioral: Brief Motivational Intervention
Behavioral: Brief Informational Intervention
Behavioral: Intensive Informational Intervention
Behavioral: Intensive Info-Motivation-Behavioral Skills Intervention
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Prevention for STD Clinic Patients

Resource links provided by NLM:


Further study details as provided by The Miriam Hospital:

Primary Outcome Measures:
  • Sexual behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • STD incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1554
Study Start Date: March 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00183573

Locations
United States, New York
Syracuse University
Syracuse, New York, United States, 13244
Sponsors and Collaborators
The Miriam Hospital
University of Rochester
Syracuse University
Investigators
Principal Investigator: Michael P. Carey, PhD Syracuse University
  More Information

No publications provided

Responsible Party: Michael P. Carey, Director, CBPM, The Miriam Hospital
ClinicalTrials.gov Identifier: NCT00183573     History of Changes
Other Study ID Numbers: R01 MH68171, R01MH068171
Study First Received: September 13, 2005
Last Updated: June 6, 2013
Health Authority: United States: Federal Government

Keywords provided by The Miriam Hospital:
STDs
Sexual Behavior
Health Behavior
HIV Seronegativity

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Infection
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014