An HIV Vaccine Preparedness Study

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

Vaccine preparedness studies are necessary in order to prepare for launching preventive HIV vaccine efficacy trials. It is important to gather information on the risk of HIV infection among recruited populations, the extent and stability of HIV risk behaviors in these populations, and the risk of HIV infection associated with risk behaviors. This vaccine preparedness study is designed to expand the capacity of the HIVNET to implement HIV prevention trials, increase the diversity of its participant population, and further target populations at highest risk of HIV infection.

Participants com...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Participants meet the following 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.
• • See General Inclusion Criteria for required risk behaviors.
• 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
• Co-existing Condition:
• 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:
• * Meeting the following extremely high injection risk criteria overrides the exclusion criteria for injection risk as outlined above:
• • 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:
• • See General Exclusion Criteria for excluded risk behaviors.