Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study - Full Text View

Purpose

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.

Condition	Intervention
HIV Infections	Behavioral: Pre- and post-test counseling


Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):


Estimated Enrollment:	1000

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.

Eligibility


Ages Eligible for Study:	18 Years to 49 Years (Adult)
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000787

Locations


United States, New York
SUNY / Health Sciences Ctr at Brooklyn
Brooklyn, New York, United States, 11203

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

More Information

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)


ClinicalTrials.gov Identifier:	NCT00000787 History of Changes
Other Study ID Numbers:	HATS PROSPECTIVE
Study First Received:	November 2, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):


Sex Behavior

Additional relevant MeSH terms:


HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases	Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

ClinicalTrials.gov processed this record on September 26, 2016