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Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

Heterosexual HIV Transmission Study (HATS). Prospective Cohort Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00000787
Enrollment
1000
Registered
2001-08-31
Start date
Unknown
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Sex Behavior

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.

Interventions

BEHAVIORALPre- and post-test counseling

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)
Lead SponsorNIH

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No

Inclusion 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026