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S tart T B patients on A RT and R etain on T reatment

the start study. S tart T B patients on A RT and R etain on T reatment. Outline. Background and Rationale Study Aims Study Design Study Interventions Study Sites Study Participants Study Measures and Outcomes Collaboration Capacity Building Progress to date Upcoming activities.

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S tart T B patients on A RT and R etain on T reatment

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  1. the start study StartTB patients onART andRetain onTreatment

  2. Outline • Background and Rationale • Study Aims • Study Design • Study Interventions • Study Sites • Study Participants • Study Measures and Outcomes • Collaboration • Capacity Building • Progress to date • Upcoming activities

  3. Background and Rationale • TB is a leading cause of death, accounts for nearly a quarter of HIV-related deaths worldwide • Early initiation of ART during TB treatment significantly increases AIDS-free survival by 34-68%1-3 • In the African Region only 42% of TB patients were on ART in 2010 • In Lesotho it was as low as 27% in 2010 • Need to identify programmatic interventions that can increase the number of TB/HIV patients starting ART early 1Karim 2011; 2Havlir 2011; 3Blanc 2011

  4. Study Aims Overall Aim: • To identify an effective, cost-effective, acceptable intervention that addresses programmatic, structural and psychosocial barriers to ART initiation and retention during TB treatment

  5. Study Aims (2) Specific Aim 1: • To evaluate the effectiveness of integrating a combination intervention package (CIP) for ART provision during TB treatment

  6. Study Aims (3) Specific Aim 2: • To assess the cost-effectiveness (incremental cost per health adjusted life-year gained) of CIP Specific Aim 3: • To assess provider and patient acceptability of CIP for ART provision during TB treatment Specific Aim 4: • To describe the safety and tolerability of ART during TB treatment under programmatic conditions

  7. Study Design • Two-arm cluster randomized trial, randomized at the TB/HIV clinic level • Twelve TB/HIV clinics at health centers in Berea district, Lesotho • Clinics randomized to deliver CIP or standard of care (SOC) • Stratification by facility type (hospital or health center)

  8. Study Interventions: SOC vs. CIP

  9. Study Sites HC=health center

  10. Study Participants • All newly registered TB/HIV patients • Measurement cohort of ART initiators (with 6-9 months follow up) • CIP (n=192) • SOC (n=192) • Key informant interviews at CIP sites • ART non-initiators (n=30) • ART initiators (n=30) • Health care workers (n=30)

  11. Study Outcomes

  12. Study Measures

  13. Collaboration • Ministry of Health and Social Welfare • National University of Lesotho (NUL) • Stakeholders Advisory Group • MOHSW, Christian Health Association of Lesotho, Lesotho Red Cross, NUL, USAID, PEPFAR, CDC, WHO, UNAIDS, Basotho community

  14. Capacity Building • Improve the research capacity of national and local institutions via training and mentorship • Situation analysis to identify gaps • Training and mentorship on: • protocol development • data collection • data analysis, synthesis, and interpretation • scientific communication • Opportunities to attend regional and international conferences • Opportunities to attend Epidemiology and Population Health Summer Institute (EPIC) at Columbia University.

  15. Progress to date • Recruitment of study staff(Research Assistants) • RAs have gone through motor bike training • Received approval letter from NH-IRB & NH-ERC • Procurement of all study equipment is in place (Vehicle, motor bikes, computers and Printers • Sensitization of DHMT and selected • Selection of Lead VHWs

  16. Upcoming activities • Training of Research Assistants • Training of VHWs • Training of Nurses • Deployment & Introduction of study team in Berea DHMT and Study facilities • Launch of the study and enrolment patients

  17. TB Register

  18. ART Register

  19. ICAP Officials & START team after motor bike training

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