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Heterosexual HIV Transmission Study (HATS) Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Heterosexual HIV Transmission Study (HATS) conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Heterosexual HIV Transmission Study (HATS) Clinical research trials and Heterosexual HIV Transmission Study (HATS) healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Heterosexual HIV Transmission Study (HATS). Heterosexual HIV Transmission Study (HATS) Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Heterosexual HIV Transmission Study (HATS) clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Heterosexual HIV Transmission Study (HATS) condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "H" Clinical Trials Conditions > Heterosexual HIV Transmission Study (HATS)  Heterosexual HIV Transmission Study (HATS)
Heterosexual HIV Transmission Study (HATS)
For Condition: HIV Infections,Healthy
Status: No longer recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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 positive) and discordant (one partner HIV positive) 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria Risk Behavior: PART B ONLY: - HIV seropositive 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 seropositive. Comparison group consists of heterosexual couples concordant for HIV seropositivity. - 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 seronegative subsequent to the last contact with such person.
Total Enrollment:
Location and Contact Information:
UMDNJ - New Jersey Med School
Newark, New Jersey, 071032757
United States
Additional Information:
Study ID Numbers: HATS COUPLES;
Study Start Date:
Record last reviewed: June 1994
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000783
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Heterosexual HIV Transmission Study (HATS)
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