Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000783
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
1999-11-02
Brief Title:
Heterosexual HIV Transmission Study HATS
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Heterosexual HIV Transmission Study HATS
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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 eg blood tests urine screening and gynecological tests They will receive post-test counseling
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 eg blood tests urine screening and gynecological tests They will receive post-test counseling
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None