An HIV Vaccine Preparedness Study

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.