Heterosexual HIV Transmission Study (HATS)
Data Collection
Collected from today forward - ProspectiveBlood-Borne Infections+13
+ Urogenital Diseases
+ Genital Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
Study start date: June 1, 1994
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location