Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

This study has been completed.

Sponsor:

Information provided by:

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00000787

First received: November 2, 1999

Last updated: June 23, 2005

Last verified: April 2003

History of Changes

Tracking Information
First Received Date ^ICMJE	November 2, 1999
Last Updated Date	June 23, 2005
Start Date ^ICMJE	Not Provided
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00000787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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 Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Behavioral: Pre- and post-test counseling
Study Arm (s)	Not Provided
Publications *	Skurnick J, Bromberg J, Cordell J, Foley M, Wang W, Louria D. Change in couples' sexual activity after knowledge of HIV discordance: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C273 (abstract no PoC 4170) Skurnick J, Bromberg J, Grijalva K, Cordell J, Louria D, Monto A, Weiss S. Behavior changes in heterosexual couples discordant for HIV: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1991 Jun 16-21;7(2):319 (abstract no WC3094) Padian N, Bromberg J, O'Brien T, Vranizan K, Cordell J, Louria D, Van-Devanter N, Landesman S. Smoking and bleeding from trauma during sex: risks for heterosexual transmission of HIV. The HATS/CDC Research Group. Int Conf AIDS. 1993 Jun 6-11;9(2):648 (abstract no PO-C02-2588) Wan J, Bromberg J, Cornell RG, Skurnick J, Cordell J, Vermund S. Generalized additive models for paired covariates in an HIV discordant couples study: a report from The Heterosexual HIV Transmission Study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(3):193 (abstract no PuC 8243) Bromberg J, Wan J, Cornell RG, Grijalva K, Cordell J, Kelly P, Landesman S. Entry criteria bias in studies of high-risk individuals: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C371 (abstract no PoC 4773) Bromberg J, Maher J, Wang W, Grijalva K, Cordell J. Within couple disagreement on condom use: a report from the heterosexual HIV transmission study (HATS/CDC). Int Conf AIDS. 1993 Jun 6-11;9(2):774 (abstract no PO-C33-3345) Sogolow ED, Des Jarlais D, Landesman SH, Kelly P, Sampson-Lee G, Cordell J, Cornell R. The experience of participating in a cohort study of HIV transmission: a report from The Heterosexual HIV Transmission Study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(3):189 (abstract no PuC 8216) Cornell RG, Bromberg J, Grijalva K, Kelly P, Cordell J. Effects of changing recruitment patterns on risk factor estimates: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C324 (abstract no PoC 4477) Strug D, Des Jarlais D, Sogolow E, Handte J, Bromberg J, Cornell R, Cordell J, Landesman S. Types of sexual partner relationships and condom use among women in Brooklyn: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1991 Jun 16-21;7(2):324 (abstract no WC3112)
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1000
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Participants must meet the following criteria: HIV-negative, sexually active women living in social and sexual proximity to men at high risk for acquiring HIV infection. Able to speak English, Spanish, or Creole. Living in the geographic area surrounding Kings County Hospital in Brooklyn, New York. (Hospital-based and community-based recruitment sites will be utilized.) 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 Number ^ICMJE	NCT00000787
Other Study ID Numbers ^ICMJE	HATS PROSPECTIVE
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	National Institute of Allergy and Infectious Diseases (NIAID)
Verification Date	April 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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