Heterosexual HIV Transmission Study (HATS)
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Heterosexual HIV Transmission Study (HATS)|
- To identify sexual behaviors and biological factors associated with an increased risk of heterosexual HIV transmission [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||June 1994|
|Primary Completion Date:||November 1999 (Final data collection date for primary outcome measure)|
Sexually active HIV-infected concordant couples
Sexually active HIV-infected discordant couples
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000783
|United States, New Jersey|
|UMDNJ - New Jersey Med School|
|Newark, New Jersey, United States, 071032757|