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11th International AIDS ConferenceVancouver, British Columbia — July 7-12, 1996 |
Int Conf AIDS 1996 Jul 7-12; 11:231 (abstract no. Tu.B.172)
Kunches LM, DeCristofaro J, DeMaria A, Landers S, Werner B; JSI Research & Training, Boston, MA, USA. Fax: (617) 482-0617. E-mail: laurie_kunches@jsi.com.
ISSUE: Equitable access to HIV clinical trials has been logistically difficult, and most trials have not had appropriate representation of women, IDU's and minority populations.
PROJECT: Through a collaborative process involving consumers, scientists and activists, state funding for clinical research was prioritized to support a Phase I/II therapeutic vaccine trial (gp 160, VaxSyn, MicroGeneSys, Inc.) with two main goals: 1) to provide local access to a promising therapy, and 2) to serve a population closely resembling the local geographic and demographic characteristics of PWA's. A multidisciplinary working group developed the protocol to complement other ongoing trials; CD4 lymphocyte count (under 400/mm3) and other entry criteria were minimally restrictive.
RESULTS: After widely publicizing the trial, 142 participants were selected in a weighted lottery from over 500 interested individuals. Women (30%), IDU's (26%), and racial minorities (37%) were well-represented, and 32% were on no antiretroviral therapy at entry. Community-based clinical sites statewide cooperated by referring eligible patients and providing exam room space for monthly visits. Appointment scheduling, data management, and logistics were coordinated centrally; part-time nurses and nurse practitioners traveled to the sites, performing physical assessment, phlebotomy, vaccine administration and data collection. The overall cost per patient (approx. $2100/yr.) is lower than many other research approaches.
LESSONS LEARNED: This cost-effective model is a "user-friendly" approach to providing high quality clinical data while reaching underserved populations.
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Copyright © 1996 - International AIDS Society (IAS). Reproduction of this abstract (other than one copy for personal reference) must be cleared through the IAS.