HIV Infections Clinical Trial
Official title:
Project UNITY - A Randomized Trial of Enhanced HIV Risk Reduction and Vaccine Education Interventions in Reducing Sexual Risk and Increasing Vaccine Trial Knowledge Among HIV-negative, High-risk Women Who Use Non-injection Drugs
To determine the efficacy of an enhanced HIV risk reduction intervention delivered concurrently with a vaccination schedule to reduce the number of unprotected vaginal and anal sex acts among HIV-negative, high-risk non-injection drug-using (NIDU) women. To determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge and understanding of a potential HIV vaccine among HIV-negative, high-risk NIDU women.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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