Heterosexual HIV Transmission Study (HATS)

Study Overview
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Brief Summary
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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.

Detailed Description
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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. This epidemiologic study is composed of three parts. PART A: In a prospective study, heterosexual couples who are discordant with respect to HIV infection will be evaluated at 6-month intervals to determine whether HIV transmission has occurred and to identify biological and behavioral factors associated with HIV transmission from the infected partner to the uninfected partner. PART B: A case-control study will compare behavioral and biological data from heterosexual couples who are concordant for HIV infection at study entry with data from appropriate discordant couples enrolled in the prospective study. Cases will be HIV-infected secondary partners (from concordant couples) and controls will be uninfected secondary partners (from discordant couples). PART C: In a cross-sectional study, semen and cervico-vaginal washings will be collected from HIV-infected men and women in Parts A and B and evaluated for presence of HIV by virologic and serologic methods. Members of each couple will be interviewed separately by different interviewers. Demographic, sexual behavior and drug use history, and psychosocial information will be obtained. Participants will undergo clinical examination and various diagnostic laboratory tests (e.g., blood tests, urine screening, and gynecological tests). They will receive post-test counseling.

Official Title
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Heterosexual HIV Transmission Study (HATS)

Conditions
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HIV Infections, Healthy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Sexually active HIV-infected concordant couples | |
| 2<br>Sexually active HIV-infected discordant couples | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify sexual behaviors and biological factors associated with an increased risk of heterosexual HIV transmission |  | Throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of safer sex counseling on the behavior of sexually active heterosexuals in which one member of the couple is infected with HIV |  | Throughout study | 
| To create a repository of serum, peripheral blood mononuclear cells, semen, and cervico-vaginal washings from heterosexual couples who are concordant (both partners HIV positive) and discordant (one partner HIV positive) with respect to HIV infection |  | Throughout study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sex Behavior, Sexual Partners