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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 2, 1999 |
| Last Updated Date | June 23, 2005 |
| Start Date ICMJE | |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00000787 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study |
| Official Title ICMJE | Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study |
| Brief Summary | PRIMARY: To identify factors associated with risk of HIV infection through heterosexual activity among urban, inner-city women. SECONDARY: To identify correlates of high-risk behaviors in order to provide a basis for future intervention studies. |
| Detailed Description | At baseline and at 6-month intervals, participants are interviewed about their sexual behavior, drug and alcohol-related behaviors, and recent medical history, and are given a psychosocial assessment. They also undergo a physical exam, including pelvic exam and colposcopy, and have blood and urine specimens collected for HIV testing, drug screening, and STD evaluation. Additionally, participants are given pre- and post-test counseling and education, including information about social services. They are provided with basic gynecological care and either treatment or referral for medical problems. |
| Study Phase | |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment |
| Condition ICMJE | HIV Infections |
| Intervention ICMJE | Behavioral: Pre- and post-test counseling |
| Study Arms / Comparison Groups | |
| Publications * | |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 1000 |
| Completion Date | |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Participants must meet the following criteria:
Personal history of parenteral drug use by self-report or urine test. Heterosexual contact with men at high risk for HIV infection. |
| Gender | Female |
| Ages | 18 Years to 49 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00000787 |
| Responsible Party | |
| Study ID Numbers ICMJE | HATS PROSPECTIVE |
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institute of Allergy and Infectious Diseases (NIAID) |
| Verification Date | April 2003 |
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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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