Kara Wools-Kaloustian, Principal Investigator
Constantin Yiannoutsos, Principal Investigator
Paula Braitstein and Rachel Vreeman, Co-Principal Investigators
Indiana University School of Medicine
East African IeDEA Regional Data & Coordinating Center Indiana University School of Medicine serves as the East African IeDEA Regional Data & Coordinating Center in the United States. It provides overall coordination for the East African Consortium including data management and statistical analysis support. In addition the site provides mentoring and practical support to the data managers and biostatisticians at East Africa IeDEA sites.
Mission and Vision Statement: With 67% of the estimated 33 million people living with HIV/AIDS globally, sub-Saharan Africa remains the region most significantly impacted by the epidemic. In Kenya, Uganda and Tanzania, the three countries within the East African IeDEA Consortium have adult HIV prevalence rates ranging between 5-10%. Since the advent of the global antiretroviral therapy (ART) rollout in 2003, there has been a dramatic increase in the percent coverage of those estimated in need of ART (based on the 2006 WHO guidelines), from essentially no patients on in 2003, to 65% coverage in Kenya, 53% in Uganda, and 44% in Tanzania by the end of 2009. Though this dramatic scale-up of HIV treatment has had a positive impact on mortality rates, key questions remain throughout the course of a patient’s engagement in care, from the pre- ART period through ART-initiation, initial clinical response to ART and regimen durability (occurrence of adverse events and drug resistance), to long-term maintenance, loss to follow-up (LTFU), and death. It is the long-range goal of this consortium to provide answers to the questions that clinicians, programs, and ministries of health consider fundamental to the evolution and sustainability of their long term HIV care and treatment strategies.
Our priority areas for the next phase of the EA-IeDEA Consortium are:
- Determine the short and long-term outcomes of adults and children along the entire spectrum of HIV care and examine patient and site-level factors associated with these outcomes.
- In ART-naïve patients: Assess the incidence of ART initiation and quantify the impact of patient and site-level determinants of failure to initiate ART.
- In patients initiating ART: Quantify the types of regimens started, the incidence and determinants of treatment failure, and overall survival. Assess the cost-effectiveness of various ART monitoring and HIV prevention strategies.
Issues related to loss to follow-up: Because the rate of losses to follow-up in HIV treatment programs throughout sub-Saharan Africa is a significant threat to the validity of the work done by IeDEA, in East Africa we will enhance our data collection by expanding the sampling-based methods developed during the first grant period, to accommodate losses to follow-up at several sites in our region.
Penetrance and outcomes of prevention of mother to child transmission of HIV (PMTCT) strategies:
- Assess the outcomes of women and their infants who are exposed to antiretrovirals for PMTCT including examining toxicity, birth outcomes, infant growth and response to subsequent ART (mothers and children).
- Assess the uptake over time and adherence to the new WHO PMTCT guidelines and their impact on these outcomes.
- Enhance the current data collection system by merging PMTCT databases with the pediatric care databases at several sites in our region.
- Monitor the translation of evidence into practice for managing co-infections with an emphasis on Tuberculosis (TB)
- Evaluate the use and determinants of isoniazid preventative therapy for HIV-infected patients in East Africa screened negative for active TB.
- Characterize the rate and determinants of ART initiation for HIV-infected, ART naïve patients with newly diagnosed active TB.
- Evaluate the effect of IPT use and time to ART initiation on survival using a sampling based approach to estimate mortality in setting where loss to follow-up is high.
- Determine the prevalence, incidence, determinants and outcomes of malignancies in East Africa with a focus on Kaposi’s sarcoma (KS) and cervical cancer.
- Continue to improve KS diagnostics at three sites within the consortium and utilize these enhanced surveillance programs to assess the incidence and determinants of KS among ART-treated patients.
- Explore the prevalence and incidence of cervical cancer and its determinants among HIV-infected women receiving care at two sites with cervical cancer screening programs.