Healthy Clinical Trial
Official title:
Heterosexual HIV Transmission Study (HATS)
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.
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.
;
Observational Model: Case Control, Time Perspective: Prospective
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