The purpose of this study is to develop and test strategies for HIV risk reduction counseling and HIV vaccine education for women who use non-injection drugs (NIDU) and are at high risk of HIV infection, one of the target populations for efficacy trials of promising HIV vaccine candidates. Most risk reduction interventions developed for NIDU women are group-based and time-intensive and may be difficult to integrate into vaccine trials and distribution. The relatively low level of understanding of vaccine trial concepts among the NIDU women emphasizes the need for effective means to communicate complex vaccine trial concepts for the informed consent process.
The specific aims of this study are to: l) 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; and 2) determine the efficacy of an enhanced vaccine education intervention delivered at baseline to increase vaccine knowledge. 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. Hepatitis B vaccine will be offered to provide a follow-up schedule which mirrors a multi-dose HIV vaccine administration schedule and to measure acceptance of a licensed vaccine and completion of vaccinations. Follow-up visits will coincide with the HB vaccine schedule (1 and 6 mos) with a final visit at 12 months to assess longer term effects of the interventions. The enhanced HIV risk reduction intervention will be a series of three, individually-delivered counseling sessions adapted from model involving application vignettes, with tailored condom demonstrations skills and client-initiated sexual risk reduction goals. The control group will receive the current CDC standard of care client-centered HIV counseling. Both the control and enhanced risk reduction counseling will be delivered at the baseline and at 1-mo and 6-mo follow up visits. The enhanced vaccine education component will test a two-session informed consent process combined with simplified illustrated materials delivered through flipcharts, video and individual counseling at baseline and 1 week later. The control condition, delivered at the baseline visit, will be a one-visit flip-chart-based educational approach used in previous HIV vaccine trials. The primary outcomes to be compared are measures of unprotected sex and vaccine knowledge scores.
| Koblin, Beryl A; Hoover, Donald R; Xu, Guozhen et al. (2010) Correlates of anal intercourse vary by partner type among substance-using women: baseline data from the UNITY study. AIDS Behav 14:132-40 |
| Koblin, Beryl A; Bonner, Sebastian; Hoover, Donald R et al. (2010) A randomized trial of enhanced HIV risk-reduction and vaccine trial education interventions among HIV-negative, high-risk women who use noninjection drugs: the UNITY study. J Acquir Immune Defic Syndr 53:378-87 |
| Pardini, Dustin; White, Helene Raskin; Stouthamer-Loeber, Magda (2007) Early adolescent psychopathology as a predictor of alcohol use disorders by young adulthood. Drug Alcohol Depend 88 Suppl 1:S38-49 |
| Koblin, Beryl A; Xu, Guozhen; Lucy, Debbie et al. (2007) Hepatitis B infection and vaccination among high-risk noninjection drug-using women: baseline data from the UNITY study. Sex Transm Dis 34:917-22 |
