Staff

Ann Williams, Principal Investigator
Jane Burgess, Project Coordinator
Jerre Winfrey, Senior Outreach Worker
Karina Dos Santos, Senior Outreach Worker
Danielle Holness, Data Coordinator

Description:

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-resistant organisms, there are good reasons to explore whether the efficacy of local regimes for prophylaxis of vulvovaginal candidiasis would contribute significantly to outpatient management of women with HIV.

Specific Aims:

The long-term objective of this study was the development of a safe and effective approach to prophylaxis of vulvovaginal candidiasis for women with HIV infection.

The specific aims of the study were to:

1. Enroll and follow at least 400 HIV-infected women (this goal was changed to 200 in 1996), providing patient education and monitoring for development of vulvovaginal candidiasis.

2. To perform a randomized, double-blinded, placebo controlled trial of three strategies for prophylaxis of vulvovaginal candidiasis in HIV-infected women.

3. Examine the relationship between immune suppression, vaginal candida colonization, and efficacy of the nursing interventions for prophylaxis of vulvovaginal candidiasis n HIV infected women.

The G.R.A.C.E. (Gynecologic Regimens Addressing Candida Events) Project enrolled its first patient April 25, 1995 and its last on August 15, 1997.

· 44 women completed their 30 month interview/exams
· 71 women completed their 24 month interview/exams
· 91 women completed their 18 month interview/exams
· 116 women completed their 12 month interview/exams
· 145 women completed their 6 month interview/exams

Some of the reasons for study participants not being followed for the entire length of the study were non-compliance, death, progression of illness, and timeline of recruitment and end of study date.

Recruitment:

· A well put together, public relations type of outreach.
· Great motivational posters placed at strategic locations.
· Billboard (Whalley Avenue, Ella Grasso Boulevard)
· Open meetings to community providers and consumers.
· Focus groups with consumers.
· Monetary incentives (only 20 % of our participants considered it a major factor affecting participation).
· Access to local clinics and/or community agencies to spread the word in a safe environment.

Some of the less clear routes included that which an individual outreach worker brought with her to the project. In the case of the G.R.A.C.E. trial, we were fortunate to have a team of outreach workers who had a history within the community and shared some of the community's struggles. One of us has AIDS, and the other one is in recovery - successfully for the last twelve years. Not forgetting that the entire team from the Data Manager to the Project Coordinator, to the Clinicians, were women who had a long history in the AIDS field, and a great desire to work with individuals with AIDS. All of these factors, put together, made a strong case for the initial recruitment. The study ended on March 31, 1998, having had recruited two hundred and one women. The data is currently being analyzed and prepared for presentation and publication.

G.R.A.C.E. has now moved towards a different phase of its research, resulting in the beginning of a home-based compliance study (see ATHENA). 

Visit GRACE's sister projects:
• The Connecticut AIDS Education and Training Center
• The ATHENA Project

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