Project UNITY - HIV Risk Reduction and Vaccine Education Interventions

We are currently screening women (approximately 535) from whom we expect 400 HIV-negative
high-risk, non-pregnant NIDU women will be enrolled to participate in a two-arm randomized
trial of an enhanced HIV risk reduction intervention plus an enhanced vaccine education
intervention compared to controls. At screening, women complete an assessment, receive HIV
and HBV pre-test counseling, and are tested for HIV antibody, markers of hepatitis B virus
(HBV) infection and pregnancy. At the enrollment visit (2 weeks later), eligible and
willing participants are randomized to receive either the enhanced HIV risk reduction
intervention plus the enhanced vaccine education intervention or control conditions.
Enrolled women provide urine for pregnancy testing. Enrolled women found to be susceptible
to HBV are offered hepatitis B (HB) vaccine at the enrollment visit. Follow-up visits
coincide with the HB vaccine schedule (1 and 6 months post enrollment) for all women,
regardless of whether or not they received HB vaccine. Pregnancy testing is conducted at
these follow-up visits. Participants provide sera for HIV antibody testing at the 6- and
12-months visits. A final visit will occur at 12 months post enrollment to assess longer
term effects on risk behaviors and knowledge and understanding of vaccine concepts. All
standardized interviews are conducted using Audio Computer Assisted Self-Interview (ACASI)
technology.

The enhanced HIV risk reduction intervention is a series of three, interactive,
individually-delivered, counseling sessions. The enhanced sessions also include tailored
male and female condom demonstrations to build skills, and each session concludes with a
client-initiated sexual risk reduction goal. The follow-up sessions (at 1 and 6 months)
resume by reviewing goal attainment, exploring the reasons and beliefs associated with
progress toward that goal. The control group receives the client-centered HIV counseling
based on the Centers for Disease Control and Prevention (CDC) Project RESPECT model. Both
the control and enhanced risk reduction counseling are delivered at the baseline (time 0)
and at follow up visits (1 month and 6 months).

The enhanced vaccine education component will test the two-session model informed consent
process outlined by Coletti et al but enhanced with simplified illustrated educational
material delivered through flipcharts, video and individual counseling at baseline and 1
week later. The control condition is based on the Coletti two-session informed consent
process.

Inclusion Criteria:

- at least 18 years of age;

- non-injecting use of heroin, cocaine or crack cocaine in the last six months;

- unprotected vaginal sex in the last three months;

- test HIV antibody negative;

- agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to
learn the results of these tests;

- ability to understand spoken English or Spanish;

- agree to be randomized;

- willing to return for visits at 1, 6, and 12 months post-enrollment;

- willing and able to provide informed consent.

Exclusion Criteria:

- history of injection drug use in the previous 3 years;

- pregnant;

- intending to become pregnant in the next 12 months.