HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | February 12, 2008 | ||||
| Start Date ICMJE | March 2004 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Sexual behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Sexual behavior | ||||
| Change History | Complete list of historical versions of study NCT00183573 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
STD incidence [ Time Frame: 12 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
STD incidence | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic | ||||
| Official Title ICMJE | HIV Prevention for STD Clinic Patients | ||||
| Brief Summary | 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). |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1554 | ||||
| Completion Date | July 2007 | ||||
| Primary Completion Date | July 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00183573 | ||||
| Other Study ID Numbers ICMJE | R01 MH68171, DAHBR 9A-ASL | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Andrew Forsyth, NIMH | ||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | February 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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