Heterosexual HIV Transmission Study (HATS)

Healthy Clinical Trial

Official title:

Heterosexual HIV Transmission Study (HATS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000783
• Other study ID #: HATS COUPLES
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: October 5, 2016
• Start date: June 1994

Study information

• Verified date: October 2012
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 (e.g., blood tests, urine screening, and gynecological tests). They will receive post-test counseling.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 1999
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy
• HIV Infections

Locations

Country	Name	City	State
United States	UMDNJ - New Jersey Med School	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

References & Publications (9)

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)

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)

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)

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)

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)

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)

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)

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)

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)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify sexual behaviors and biological factors associated with an increased risk of heterosexual HIV transmission		Throughout study	No
Secondary	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	No
Secondary	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	No