HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00183573

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 II Phase III

MedlinePlus related topics: AIDS Sexually Transmitted Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	HIV Prevention for STD Clinic Patients

Further study details as provided by National Institute of Mental Health (NIMH):

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
1: Experimental Brief Motivational Intervention only	Behavioral: Brief Motivational Intervention 15-20 minute, motivational one-on-one counseling
2: Experimental Brief Informational Intervention only	Behavioral: Brief Informational Intervention 15 minute informational DVD on safer sex
3: Experimental 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
4: Experimental 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
5: Experimental 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
6: Experimental 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

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

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Michael P. Carey, PhD

Syracuse University

More Information

Responsible Party:	NIMH ( Andrew Forsyth )
Study ID Numbers:	R01 MH68171, DAHBR 9A-ASL
Study First Received:	September 13, 2005
Last Updated:	February 12, 2008
ClinicalTrials.gov Identifier:	NCT00183573
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

STDs
Sexual Behavior
Health Behavior
HIV Seronegativity

Study placed in the following topic categories:

Genital Diseases, Female
Virus Diseases
Sexually Transmitted Diseases, Viral
HIV Infections
Acquired Immunodeficiency Syndrome

Sexually Transmitted Diseases
Genital Diseases, Male
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:

RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Lentivirus Infections
Infection

ClinicalTrials.gov processed this record on January 15, 2009