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A5300/IMPAACT2003: Study of MDR TB Cases and Their Household Contacts: Operational Feasibility to Inform PHOENIx Trial Design
This clinical trial was terminated July 2017. It was a study conducted under both the AIDS Clinical Trial Group (ACTG) and the the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network, and funded by the U.S. National Institutes of Health.
Dr. Amita Gupta was Protocol Co-Chair for this multinational study conducted in Haiti, South Africa, Uganda, and in India by the Baltimore-Washington-India Clinical Trials Unit, of which CCGHE is a member.
This is a cross-sectional study of adult MDR TB index cases and their identified adult and child household contacts. Adult MDR TB index cases will be identified from the TB Program, or appropriate treatment center or laboratory, and approached for study enrollment. Informed consent will be obtained from the index case for their own participation and for permission to approach their household. Basic demographic, clinical, and laboratory information will be obtained from the adult MDR TB index cases. Household contacts will be invited to participate in the study and to provide informed consent/assent as appropriate. The household members may be screened and enrolled into the study at home, a mobile van clinic, the research clinic, or at other settings based on their stated preference and local site capacity. The efforts made to contact the household members, the location of where household members are assessed, and the proportion interested in enrolling into the study will be documented. Thereafter, among household members providing consent and assent, as appropriate, a baseline evaluation will be conducted, including demographic data (e.g., number and ages of adults, children and pregnant women), HIV infection status and willingness to be tested, if unknown), clinical symptoms and testing for active TB or latent TB infection, co-morbid medical conditions (e.g., alcohol use, smoking), and medication use. A questionnaire will be administered to query household contacts regarding knowledge, attitudes and perceptions (KAP) of MDR TB disease, TB preventive therapy, and research participation.