Vulvovaginal candidiasis is the source of significant distress and morbidity among HIV infected women. Prophylactic approaches to this difficult problem include aggressive patient education and vaginal hygiene, restoration of normal vaginal flora through the use of exogenous lactobacilli, and local and systemic antifungal prophylaxis. However, little is known about the comparative effectiveness of these strategies for women with HIV. Given the large number of pharmaceuticals prescribed for people with HIV, the potential for significant drug interactions, and concern regarding selection for antifungal resistent organisms, there are good reasons to explore the efficacy of local regimens for prophylaxis of vulvovaginal candidiasis. An effective, non-toxic, and patient-acceptable approach to prophylaxis of vulvovaginal candidiasis would contribute significantly to outpatient management of women with HIV. We propose to conduct a randomized, double-blinded, placebo-controlled trial of three primary care nursing strategies for prophylaxis of vulvovaginal candidiasis, in which HIV infected women who are not receiving systemic antifungal therapy will be stratified according to their baseline CD4 count (<100, 100-300, 300-500, >500) and randomized with equal probability to one of three study arms receiving: 1) standard nurse-midwifery care alone (patient education and monitoring), 2) standard care plus self-administration of Lactobacillus acidophilus gelatin capsules intravaginally once a week, or 3) standard care plus self- administration of clotrimazole 500mg vaginal tablets once a week.
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