Expired Study
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Newark, New Jersey 07103


Purpose:

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 summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

HATS COUPLES


NCT ID:

NCT00000783


Secondary ID:


Study Acronym:


Brief Title:

Heterosexual HIV Transmission Study (HATS)


Official Title:

Heterosexual HIV Transmission Study (HATS)


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute of Allergy and Infectious Diseases (NIAID)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

0


Enrollment Type:


Overall Contact Information

Official Name:O'Brien
Study Chair

Study Dates

Start Date:June 1994
Primary Completion Date:November 1999
Primary Completion Type:Actual
Verification Date:October 2012
Last Changed Date:October 5, 2016
First Received Date:November 2, 1999

Study Outcomes

Outcome Type:Primary Outcome
Measure:To identify sexual behaviors and biological factors associated with an increased risk of heterosexual HIV transmission
Time Frame:Throughout study
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:2
Description:Sexually active HIV-infected discordant couples
Study Arm Type:Other
Arm Name:1
Description:Sexually active HIV-infected concordant couples

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Allergy and Infectious Diseases (NIAID)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Seminal and cervico-vaginal fluids will be collected as well as blood and urine samples.
Study Population: Sexually active HIV-infected concordant and discordant couples
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Skurnick J, Bromberg J, Grijalva K, Cordell J, Louria D, Monto A, Weiss S. Behavior changes in heterosexual couples discordant for HIV: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1991 Jun 16-21;7(2):319 (abstract no WC3094)
Reference Type:Reference
Citation:Skurnick J, Bromberg J, Cordell J, Foley M, Wang W, Louria D. Change in couples' sexual activity after knowledge of HIV discordance: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C273 (abstract no PoC 4170)
Reference Type:Reference
Citation:Bromberg J, Wan J, Cornell RG, Grijalva K, Cordell J, Kelly P, Landesman S. Entry criteria bias in studies of high-risk individuals: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C371 (abstract no PoC 4773)
Reference Type:Reference
Citation:Wan J, Bromberg J, Cornell RG, Skurnick J, Cordell J, Vermund S. Generalized additive models for paired covariates in an HIV discordant couples study: a report from The Heterosexual HIV Transmission Study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(3):193 (abstract no PuC 8243)
Reference Type:Reference
Citation:Bromberg J, Maher J, Wang W, Grijalva K, Cordell J. Within couple disagreement on condom use: a report from the heterosexual HIV transmission study (HATS/CDC). Int Conf AIDS. 1993 Jun 6-11;9(2):774 (abstract no PO-C33-3345)
Reference Type:Reference
Citation:Sogolow ED, Des Jarlais D, Landesman SH, Kelly P, Sampson-Lee G, Cordell J, Cornell R. The experience of participating in a cohort study of HIV transmission: a report from The Heterosexual HIV Transmission Study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(3):189 (abstract no PuC 8216)
Reference Type:Reference
Citation:Padian N, Bromberg J, O'Brien T, Vranizan K, Cordell J, Louria D, Van-Devanter N, Landesman S. Smoking and bleeding from trauma during sex: risks for heterosexual transmission of HIV. The HATS/CDC Research Group. Int Conf AIDS. 1993 Jun 6-11;9(2):648 (abstract no PO-C02-2588)
Reference Type:Reference
Citation:Strug D, Des Jarlais D, Sogolow E, Handte J, Bromberg J, Cornell R, Cordell J, Landesman S. Types of sexual partner relationships and condom use among women in Brooklyn: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1991 Jun 16-21;7(2):324 (abstract no WC3112)
Reference Type:Reference
Citation:Cornell RG, Bromberg J, Grijalva K, Kelly P, Cordell J. Effects of changing recruitment patterns on risk factor estimates: a report from the heterosexual HIV transmission study (HATS). Int Conf AIDS. 1992 Jul 19-24;8(2):C324 (abstract no PoC 4477)

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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