Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
4892 participants
INTERVENTIONAL
Brief Summary
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Before studying the effectiveness of a potential HIV vaccine, it is important to learn about the range of HIV risk behaviors in the potential participants of these studies. The probability of HIV infection associated with these risk behaviors should also be examined. This study is designed to increase the ability of HIVNET to put into place HIV prevention trials, to increase the diversity of trial participants, and to target populations at highest risk for HIV infection.
Detailed Description
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Participants complete a total of 6 scheduled study visits: 2 at baseline, 2 at follow-up 6 months later, and 2 at follow-up 12 months after enrollment. Participant risk behaviors and knowledge of and attitudes toward HIV vaccine and other HIV prevention trials are assessed at each time point. HIV infection status is tested by standard HIV ELISA and Western blot at follow-up, as well as at participant request throughout the study. Participants are instructed to recognize and report suspected primary HIV infection based on symptoms or high-risk exposures. HIV pre-test, risk reduction, and post-test counseling is provided in accordance with CDC standards of practice. Participants who become infected with HIV during the study are counseled and referred for medical and psychosocial services.
Conditions
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Study Design
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TREATMENT
Interventions
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Vaccine preparedness
Eligibility Criteria
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Inclusion Criteria
* HIV-seronegative.
* Available for 6 months of the study. (Note:
* Participants who plan to move from one study location to another are eligible.)
* Willing and able to provide information for locator purposes.
* Report one or more of the following risk behaviors:
For men:
* Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
* Anal intercourse (receptive or insertive) with one or more other men in the last year.
For women:
* Intravenous or intramuscular injection of any drug on an average of 3 or more days per week during the last 3 months.
* Having a current male sex partner who is infected with HIV.
* Having a current male sex partner who has injected drugs in the last 5 years.
* Having 5 or more male sex partners in the last year.
* Diagnosis of syphilis, chlamydia, gonorrhea, first episode herpes, pelvic inflammatory disease, and/or trichomoniasis in the last year.
* Exchange of sex for money or drugs in the last year.
* Use of crack cocaine in the last 12 months.
Volunteers must be:
* HIV-positive through HIVNET testing or HIV-seronegative by EIA.
* Presently in a sexual relationship of at least 6 months duration with the intention to remain with this partner for the duration of the study.
* Willing to identify and recruit this sexual partner to which he/she has disclosed or will disclose HIV serostatus.
* Willing to receive counseling and HIV testing (HIV-seronegative partners only).
* Willing to agree to be interviewed with their partner and individually.
* Willing to continue engaging in sex with their partner.
* Willing to participate in a couples-based condom promotion intervention.
* Willing and able to attend each scheduled intervention/follow-up study visit.
Exclusion Criteria
Persons with the following symptoms or conditions are excluded:
* An obvious psychological or psychiatric disorder that would preclude provision of informed consent or otherwise contraindicate study participation.
* Any condition which in the opinion of the principal investigator would interfere with achieving the study objectives.
Men at risk through anal intercourse only are excluded if they:
* Currently have a single HIV-seronegative partner with whom they have been in a mutually monogamous relationship for at least 2 years.
Men and women at risk through injection only are excluded if they:
* Have been participating in any methadone drug treatment program for at least the last 6 months.
* Currently obtain over 50 percent of needles/syringes for injection of drugs from a needle exchange program.
NOTE:
* Using a needle or syringe after one or more known HIV-positive persons 2 or more times in the past 3 months.
* Using a needle or syringe after persons of unknown HIV status in the past 3 months provided the following two conditions are true:
* (1) report using a needle or syringe after someone else 2 or more different times in the past 3 months and (2) report using a needle or syringe after 3 or more different persons in the past 3 months. (This second criterion could be met in 3 episodes of injection with a single injection partner, if the participant used a needle or syringe after a different person each time. Alternatively, the criterion could be met in a single episode of injection, if the participant used a needle or syringe after 3 or more persons had used a single set of works.)
Concurrent Medication:
Excluded:
* Enrollment in an HIV vaccine trial, unless approval is obtained from the Data Management Committee Project Officer.
Risk Behavior:
18 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Principal Investigators
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Dave Metzger
Role: STUDY_CHAIR
George Seage
Role: STUDY_CHAIR
Locations
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Los Angeles County / Health Research Assoc / Drew Med Ctr
Los Angeles, California, United States
Univ of Illinois Hosp at Chicago
Chicago, Illinois, United States
Johns Hopkins Univ
Baltimore, Maryland, United States
New York Univ Med Ctr
New York, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
New York Blood Ctr
The Bronx, New York, United States
Univ of Pennsylvania / HIVNET
Philadelphia, Pennsylvania, United States
Miriam Hosp
Providence, Rhode Island, United States
Countries
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References
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Woody GE, VanEtten-Lee ML, McKirnan D, Donnell D, Metzger D, Seage G 3rd, Gross M; HIVNET VPS 001 Protocol Team. Substance use among men who have sex with men: comparison with a national household survey. J Acquir Immune Defic Syndr. 2001 May 1;27(1):86-90. doi: 10.1097/00126334-200105010-00015.
Other Identifiers
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HIVNET D01
Identifier Type: -
Identifier Source: org_study_id