Program Director/Principal Investigator (Last, First, Middle): Project Summary/Abstract Despite the knowledge that non-adherence to tuberculosis (TB) treatment is the most important cause of treatment failure in TB programmes, a comprehensive understanding of barriers to and facilitators of non- adherence in healthcare service is lacking. Furthemore, a systematic evaluation of HIV influence on adherence to TB treatment is limited, yet it is accepted that HIV has increased the TB epidemic. Patient-centered approach to the administration of TB treatment is recommended to achieve adherence and this can be audited by evaluating whether the healthcare system meets the patients'most relevant expectations or whether the system evaluates the psychological effects of patients'disease on treatment. Such information is lacking in the Ugandan TB program. The goal of the study is to contribute to knowledge that can be used to improve quality of healthcare service in the Uganda TB program to improve treatment outcome in the current HIV era. This project will specifically establish: 1) the patterns and level of non-adherence over time and the impact of HIV on adherence to treatment among 576 pulmonary TB patients followed propectively in urban program clinics in Kampala, Uganda;2) whether patient satisfaction and health-related quality of life (HRQoL) are associated with non-adherence to TB treatment;and 3) the impact of HIV sero-status on patient satisfaction and HRQoL among 576 pulmonary TB patients receiving care at urban program TB clinics in Uganda. A cohort of 288 HIV- seropositive and 288 HIV-seronegative adult (18 or more years of age) patients with new diagnosis of pulmonary TB will be enrolled consecutively over a period of 3 years and followed-up for 8 months untill completion of treatment. The main outcome variables will be patterns and level of adherence to prescribed TB treatment. The independent variables will be HIV-serostatus, patient satisfaction and HRQoL scores. A series of logistic, linear, and longitudinal analytic models will be used to explore the specific aims of the present study. Individual and institutional consent will be obtained and confidentiality will be ensured. Standard instruments that will be used in the present study were piloted in the local population. Preliminay results suggest that the planned HRQoL and patient satisfaction instruments have satisfactory internal reliability. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

Public Health Relevance

Relevance The findings of the present will be an audit to the Uganda TB program in identifying gaps in the existing healthcare system, whether it meets the patients'most important expectations during care so that appropriate patient-centered strategies are instituted to improve adherence to TB treatment. The study will be enable TB policy makers and clinicians to understand HRQoL in TB patients and the burden of non-adherence in the HIV era. The PI will use the present study to establish herself as an independent research in understanding and in developing of strategies that can improve quality of healthcare delivery in the Uganda tuberculosis program. PHS 398/2590 (Rev. 11/07) Page Continuation Format Page

Agency
National Institute of Health (NIH)
Institute
Fogarty International Center (FIC)
Type
Research Project (R01)
Project #
5R01TW008670-05
Application #
8657498
Study Section
International and Cooperative Projects - 1 Study Section (ICP1)
Program Officer
Light, Enid
Project Start
2010-07-12
Project End
2015-04-30
Budget Start
2014-05-01
Budget End
2015-04-30
Support Year
5
Fiscal Year
2014
Total Cost
$53,460
Indirect Cost
$3,960
Name
Makerere University
Department
Type
DUNS #
850536636
City
Kampala
State
Country
Uganda
Zip Code
7062