HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- Sexual behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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 More Information
No publications provided
| Responsible Party: | Andrew Forsyth, NIMH |
| ClinicalTrials.gov Identifier: | NCT00183573 History of Changes |
| Other Study ID Numbers: | R01 MH68171, DAHBR 9A-ASL |
| Study First Received: | September 13, 2005 |
| Last Updated: | February 12, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
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 May 16, 2013