Heterosexual HIV Transmission Study (HATS)

Completed

Conditions studied: HIV Infections, Healthy

In brief

PRIMARY: To identify sexual behaviors and biological factors associated with an increased risk of heterosexual HIV transmission. SECONDARY: To assess the effect of safer sex counseling on behavior of sexually active heterosexuals in which one member of the couple is infected with HIV. To create a repository of serum, peripheral blood mononuclear cells, semen, and cervico-vaginal washings from heterosexual couples who are concordant (both partners HIV infected) and discordant (one partner HIV infected) with respect to HIV infection. In the United States, the number of AIDS cases attributed to heterosexual transmission, although still a small percentage of the total number of reported cases, is the most rapidly growing category. The rate at which HIV is transmitted between heterosexual couples and the factors that may impede or enhance heterosexual transmission are important to understanding and slowing the worldwide HIV epidemic.

Key facts

Study ID

NCT00000783

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

Starts

1994-06-01

Last updated by the study team

2016-10-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Risk Behavior:
• PART B ONLY:
• HIV-infected partner (primary partner) must have a known risk factor for HIV infection, such as
• Bisexual male.
• IV drug user.
• Hemophiliac male.
• Recipient of HIV-contaminated transfusion.
• Participants must meet the following criteria:
• Heterosexual couples in which at least one member is HIV-infected. Comparison group consists of heterosexual couples concordant that are both HIV infected.
• Able to speak English or Spanish.
• PART A secondary partners:
• Risk factor for HIV infection other than heterosexual contact, such as
• Evidence of any past or present parenteral drug use by self report, physical examination, or urine test.
• History of homosexual activity (if male) within 5 years prior to study entry.
• PART B secondary partners:
• Risk factor for HIV infection other than sexual contact with the primary partner, such as
• Evidence of any past or present parenteral drug use by self-report or by urine test.
• History of homosexual activity (if male) at any time since 1978.
• Sexual contact with another person with an HIV risk factor at any time since 1978, unless secondary partner is documented to be HIV uninfected subsequent to the last contact with such person.

Where it is running

• UMDNJ - New Jersey Med School — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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