Rwanda Women’s Interassociation Study and Assessment (RWISA)
Dr. Anastos, Professor of Medicine (General Internal Medicine) and of Epidemiology & Population Health, is the PI of Bronx site of the NIH-funded WIHS study and also the Co-director of the Rwanda Women’s Interassociation Study and Assessment (RWISA), an observational prospective cohort study investigating the effectiveness and toxicity of antiretroviral therapy (ART) and the effect of traumatic rape, HIV infection and immune suppression on multiple clinical outcomes in Rwandan women.
Between May 15 and November 15, 2005, 936 women (715 ART-naïve HIV-infected and 221 HIV-uninfected) were enrolled, with follow-up visits every six months. RWISA was designed as a sister study to The Women’s Interagency HIV Study (WIHS), with a similar protocol and with data collection instruments that facilitate shared analyses, as well as a source of specimens and data for translational research in virology, immunology, metabolic pathophysiology, and host genetics. Start-up funding was provided through supplements to the Bronx WIHS (Dr. Kathryn Anastos, PI) from the Office of AIDS Research, NIAID and NCI. Drs. Kathryn Anastos and Mardge Cohen (the PI of the Chicago WIHS) provide overall leadership to RWISA. RWISA is operated in conjunction with Women’s Equity in Access to Care and Treatment for HIV (WE-ACTx), a non-governmental organization in which Drs. Anastos and Cohen also provide leadership. WE-ACTx Rwanda operates several service-based initiatives including comprehensive care for HIV infection, HIV counseling and testing, sustainable sources of food, income generation, and school fees for children.
A unique feature of RWISA, and of WE-ACTx, is their partnership with grassroots community based women’s organizations in Rwanda. All RWISA participants were recruited through and are followed by their partner associations, with whom trauma counselors have been placed to maintain contact with participants, know their vital status, and ensure follow-up visits. This has been a critical factor in the program’s success in both recruitment and retention of patients for research studies. These partners also assisted their in developing a video informed consent process in Kinyarwanda, and in keeping with Rwandan culture, which was provided in addition to the usual written informed consent process. Approximately 410 HIV+ women in this Cohort have now initiated ART, with specimens from 75% of these individuals obtained 3 months after initiation of ART for CD4 cell count, CBC and repositing of serum and plasma. RWISA follow up visits occur every six months, with expected completion of the fourth wave of visits (V4) on 31 May 2007. This Cohort is already being used for several research projects utilizing CFAR cores including viral subtyping and identification of inter-subtype recombinants using a nonradioactive heteroduplex tracking assay (HTA), determination of HIV coreceptor utilization correlation of local HIV-1 RNA load and inflammatory markers with quantitative microbiology of vaginosis organisms and correlation of systemic markers of inflammation (functional assays of CD8+ cells and measurement of inflammatory cytokines) with measures of post-traumatic stress, depression, and degree of trauma experienced during the genocide.