Kristina Wallengren, PhD MPH

Transcription

1 Kristina Wallengren, PhD MPH Head of Clinical Research K-RITH South Africa

2 K-RITH S AIM: TO CONDUCT EXCELLENT BASIC SCIENCE IN TB AND HIV

3 XDR TB outbreak in Tugela Ferry, KwaZulu-Natal, 2005

4 XDR TB PREVALENCE IN KZN DISTRICTS, 2007 In KwaZulu-Natal: 10% of all MDR TB is XDR >50% of MDR cases in umzinyathi (Tugela Ferry) was XDR in % of all XDR cases in KZN are resistant to all 6 drugs tested (INH, RIF, STR, EMB, OFL, KAN) K. Wallengren, EID 2011

5 MDR TB PREVALENCE IN KZN DISTRICTS, 2007 In KwaZulu-Natal: 2.5% of all TB is MDR 3000 MDR TB patients per year 30 MDR TB cases / population Underestimated due to poor sampling K. Wallengren, EID 2011

6 TB AND M/XDR TB COULD BE HIGHER THAN ESTIMATED CULTURE TAKING PRACTICE VS IDENTIFIED LEVEL OF MDR TB POST MORTEM STUDY (N=240) R=0.82, p=0.001 TB Rx (Cult neg) 23% TB Rx (Cult pos) 27% Not TB 31% TB not suspecte d (Cult pos) 17% TB suspects (Cult pos) not yet on Rx 2% Wallengren et al. EID, 2011 Cohen et al. PLoS Med, 2010

7 AVAILABLE MDR TB TREATMENT 2007 IN KZN Only 1 central hospital in the province for MDR TB treatment 160 beds Treatment guidelines: hospitalization during 6-month intensive phase -> Capacity to treat 340 patients per year following the guidelines Situation in 2007: Waiting list for MDR TB treatment was 4 months Average length of stay in hospital was 6 weeks (excluding deaths) Patients discharged while still infectious Patients had to return to the hospital every month to collect treatment J. Steengaard

8 DECENTRALIZED MDR TB TREATMENT IN KZN Site 2 Site 4 Site 1 Centralised Hospital Site 3

9 Greytown MDR TB hospital

10 An MDR TB patient s home

11 Injection teams, Injection consisting team, consisting of driver and of driver nurse, and make nurse, home visits make to MDR home TB patients visits 5 days 5 days per per week during the intensive phase treatment

12 At a home At visit, a home the nurse visit, the from nurse the injection from the team injection is preparing team is preparing to give an MDR TB to give an patient MDR TB his patient injecatable his injectable medication. medication

13 Educating the family of a patient on MDR TB treatment Educating the family of a patient on MDR TB treatment

14 A doctor is reviewing an MDR TB patient s treatment A doctor is reviewing during a patient s his monthly treatment visit to during the clinic. his monthly visit to the clinic

15 EVALUATION OF COMMUNITY BASED MDR TB TREATMENT AIM To compare treatment outcomes in decentralised sites (community based) sites versus centralised sites. To determine the impact of health systems factors on treatment outcomes METHOD A prospective cohort study Enrolment from 1 July 2008 to 30 June MDR TB patients enrolled (736 in decentralised and 813 in centralised care) Patients followed up for outcome of MDR TB treatment Data collected from routine records using standardised data extraction tools (secondary data)

16 EVALUATION OF COMMUNITY BASED MDR TB TREATMENT Characteristics Centralized Decentralized P-value Patients enrolled, n Female, n (%) 413 (51%) 390 (53%) Mean age (yrs), SD 35 (11%) 36 (11%) Previous TB or MDR TB, n (%) 779 (96%) 443 (60%) <0.001 Positive smear at diagnosis, n (%) Patients resistant to 3+ drugs at diagnosis, n (%) Mean treatment initiation delay (days)^, SD HIV status 491 (60%) 557 (76%) < (57%) 410 (56%) , 74 81, 52 <0.001 HIV positive, n/total tested (%) 576/788 (73%) 528/692 (76%) Baseline CD4 count (cells/ul) n, mean, SD On ART at time of MDR TB treatment initiation, n/total HIV+ 282, 229, , 237, /554 (82%) 440/482 (91%) 0.225

17 TREATMENT OUTCOMES Centralised Site: KGV Decentralised sites Treatment outcome No. of patients P-value Cure 280 (34%) 373 (51%) <0.001 Complete 159 (20%) 54 (7%) <0.001 Successful Rx outcome 439 (54%) 427 (60%) Died 113 (14%) 133 (18%) Default 230 (28%) 107 (15%) Failed 29 (4%) 49 (7%) <0.001 Unsuccessful Rx outcome 372 (46%) 289 (40%)

18 PREDICTORS OF SUCCESSFUL OUTCOME Variables Unadjusted Odds Ratio (95% CI) P-value Multivariate Odds Ratio (95% CI) P-value Decentralized site 1.3 ( ) ( ) Female 1.2 ( ) < ( ) Age >30 years 1.3 ( ) ( ) <0.001 HIV and ART status HIV positive on ART 1.6 ( ) < ( ) <0.001 HIV negative 1.4 ( ) ( ) HIV positive, not on ART Reference Reference Weight, >50kg female 1.3 ( ) ( ) No previous TB or MDR TB 1.2 ( ) ( ) Length of hospitalization* 1.0 ( ) ** Culture conversion <90 days from Rx start 1.7 ( ) <0.001 ** * For every additional 14 day stay ** not included in multivariate analysis

19 EVALUATING HEALTH SYSTEMS PERFORMANCE Domain Context Intervention Mechanisms Output Health systems factors affecting service delivery District level: Leadership, ownership + support Facility level: Ownership + support Integrated service delivery Human resources Support services Continuity of care Quality of care A conceptual and analytical approach to comparative analysis of country case studies: HIV and TB control programmes and health systems integration. Coker R, Balen J, Mounier-Jack S, et al. Health Policy and Planning 2010:i21 i31

20 PHARMACEUTICAL SERVICES 1 JULY MAY 2012 PHARMACEUTICAL SERVICES Centralised site Total DC sites Decentralised Sites Site 1 Site 2 Site 3 Site 4 Total days follow up Drug stock outs (days) Rate of stock outs per person year* *Rate ratio=2.45, p=<.0001, decentralized vs centralized

21 HEALTH SYSTEM PERFORMANCE SCORES

22 MDR TB TREATMENT OUTCOMES IN DECENTRALISED SITES

23 IMPACT OF HEALTH SYSTEM PERFORMANCE ON SUCCESSFUL MDR TB TREATMENT OUTCOME

24 HEALTH SYSTEMS FACTORS THAT IMPACT ON MDR-TB TREATMENT OUTCOMES: District ownership of MDR-TB problem; Facility level ownership of MDR-TB problem; Service stability; Service integration; Drug availability; Quality of care

25 Factors compromising the MDR-TB patient's journey FACTORS COMPROMISING MDR TB TREATMENT NHLS website down: Stock out: Ofloxacin - 7 days Medical records lost: Stock out: Ethambutol - 5 days Patient start of MDR Rx. ART started 7 mths after MDR Rx. Public workers strike Sep '09 Weather terrible: Missed visit No transport money: Missed visit MDR-TB MDR-TB MDR-TB MDR-TB MDR-TB MDR-TB ART Mth 0 Mth 1 Mth 2 Mth 3 Mth 4 Mth 5 Mth 6 Mth 7 Mth 8 Mth 9 Mth 10 Mth 11 Mth 12 Mth 13 Mth 14 Mth 15 Mth 16 Mth 17 Mth 18 Mth 19 Mth 20 Mth 21 Mth 22 Mth 23 Mth 24 Summary: Legend No Rx 10/24 mths (42%) - Full and correct Rx Incomplete Rx 4/24 mths (16%) - no treatment Full Rx 10/24 mths (42%) - Incomplete Rx Health system factors Patient factors

26 CONCLUSIONS Community MDR TB treatment can be as effective as centralized care in an endemic setting Health systems performance impacts on MDR TB treatment outcomes In the best performing pilot site for community MDR TB tretment, treatment success was achieved in over 70% (n=125) of the cases (62% cured)

27 ACKNOWLEDGEMENTS Rocio Hurtado Marian Loveday Jacquelin Roberts Dale Nordenberg Gail Cassell Jonas Steengaard All MDR TB patients Department of Health, KZN IZUMI Foundation

28 MYTHS MYTHS IN SOUTH AFRICA DOTS coverage 100%; Supply of first line TB drugs is uninterrupted; Supply of ART will remain uninterrupted; Guidelines are followed (eg. Retreatment regimen); Routine adherence monitoring; Routine monitoring of side effects; Health system is functioning Assume something is not functioning unless proven otherwise

29 INCREASE OF DRUG RESISTANT TB IN KZN K. Wallengren, EID 2011 J. Steengaard