Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
Primary Purpose
HIV Infections
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre- and post-test counseling
Sponsored by

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Sex Behavior
Eligibility Criteria
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.
Sites / Locations
- SUNY / Health Sciences Ctr at Brooklyn
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000787
First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
1. Study Identification
Unique Protocol Identification Number
NCT00000787
Brief Title
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
Official Title
Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Sex Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
1000 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Pre- and post-test counseling
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
SUNY / Health Sciences Ctr at Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
12. IPD Sharing Statement
Citations:
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
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Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study
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