Assessing the impact of HAART on reproductive health of Rwandan women
12 / 2005 - 08 / 2010
Nederlandse Organisatie voor Wetenschappelijk Onderzoek - NWO
This project aims to evaluate the impact of highly active antiretroviral treatment (HAART) treatment on various aspects of reproductive health in Rwandan women, including sexual and contraceptive behavior, incidence of acute sexually transmitted infections (STI; such as gonorrhea, chlamydia, syphilis and trichomoniasis), incidence and persistence of events associated with chronic reproductive tract infections (RTI; such as cervical dysplasia due to human papillomavirus (HPV), genital outbreaks of herpes simplex type 2 (HSV-2), and vaginal flora disturbances), (un)intended pregnancies and pregnancy outcomes. We will also evaluate the impact of HAART and all of the above on genital shedding of HIV, which in turn could influence female-to-male transmission of HIV. While the impact of HAART on reproductive health has been studied in the United States (HERS and WIHS studies) and in Europe (European Natural History Study), it has not been sufficiently evaluated in Africa. Numerous studies have shown that African women experience more and more severe gynecological morbidity than European and American women. Furthermore, in many African cities, 5-30% of all women of reproductive age may end up using HAART in their lifetime, and the majority of people currently eligible for HAART are women of reproductive age. The impact of HAART on reproductive health outcomes therefore needs to be properly evaluated to inform guidelines for screening and clinical management of gynecological morbidity in HIV-positive women in Africa. In addition, in Rwanda, very little is known about the prevalence and incidence of the above-mentioned reproductive health outcomes. Data collected in this project as well as in the Projet Ubuzima microbicide projects will therefore also provide the Rwanda Ministry of Health with useful estimates of the extent of reproductive morbidity in Rwanda. This project is complementary to Projet Ubuzima's microbicide projects, INTERACT Project E (assessing clinically important adverse effects of HAART treatment), and INTERACT Project G (surveillance of HIV drug resistance). Currently available HIV-prevention tools are limited and not feasible for many women. The need to expand the range of HIV-prevention tools available, especially those that women can use, is urgent. Microbicides are products that are applied topically inside the vagina to prevent infection with HIV and potentially other STIs. They could be formulated as gels, creams, suppositories, or vaginal rings and may or may not be contraceptive. They could be used alone, or in combination with a physical barrier method, to provide increased protection or back-up in case of barrier failure. In the last two years, IATEC, CHUK, TRAC and LNR established an ICH-GCP-compliant microbicide trial site in Kigali (Projet Ubuzima). The first microbicide trial (sponsored by the International Partnership for Microbicides) will be initiated in July 2005. Effectiveness trials of HIV microbicides require the establishment of large cohorts of HIV-negative women who are at risk for HIV. In the process of identifying eligible women for microbicide trials, HIV-positive women will also be identified. Furthermore, some women will seroconvert during the microbicide trials. This poses an ethical dilemma: these HIV-positive women are ineligible for trial participation or have reached a trial endpoint, but it is ethically desirable to offer them the clinical services that the microbicide trial participants are receiving. Through this INTERACT project, we will be able to offer HIV-positive women similar clinical services, while at the same time evaluating the important research questions described above. Finally, this project provides ample opportunities for capacity building related to research, clinical and laboratory skills.