A Way out of Directly Observed Therapy (DOT): Community approaches to Self-Administered Treatment for Rifampicin Resistant Tuberculosis in Khayelitsha, South Africa Busisiwe (Buci) Beko

Directly observed therapy (DOT) “Pillar of Rifampicin Resistant-TB treatment administration” Patient travels to clinic daily Treatment is taken under the watchful eye of a nurse Fears exist that all DR-TB infection is acquired due to poor adherence keeps countries from moving away from DOT Notes:

Could DOT be the barrier to successful treatment? Clinic based DOT DOT may hinder adherence DOT is resource intensive for the clinic Treatment Interruption Loss from treatment Talk about – the journey is long Painful injections Loads of meds Side effects Now ADD- going to the clinic daily- describe – waiting for files, staff going on breaks, frustrations, waiting times, time to swallow meds, difficulties Say that you were there you were on DOTs, a young mom with a new born It is difficult - Could DOT be the barrier to successful treatment?

Self Administered Treatment (SAT) Patients self administer treatment at home Patient can return to work/ school/ other Limits clinic visits Improves quality of life Objective: To improve adherence by removing barriers to treatment posed by DOT

Eligibility Criteria for SAT Intensive phase complete Clinically stable and no TB symptoms present Culture Negative Supportive home environment Fairly good adherence Notes:

Local Community Care Worker (CCW) SAT Description Completion of the Intensive phase Clinic staff flag pt. Standardized DR-TB counseling session Local Community Care Worker (CCW) Home assessment Case presented at Multi-Disciplinary Team (MDT) Not approved for or does not accept SAT Referred for enhanced adherence support Approved for and accepts SAT: Offered a weekly or monthly supply Adherence Planning Session Ongoing at medicine pick-ups CCW adherence support Weekly home visits Clinical Monitoring Patient is assessed monthly during clinical visit Monthly sputum check Assessment Completion of intensive phase (Session 4) Home Assessment by Community Care Worker (CCW) Identification of a treatment supporter Multidisciplinary team discussion and decision Adherence planning if approved Weekly adherence visits and adherence monitoring Referral for treatment interruption counseling if not approved SAT

Methods SAT was progressively implemented in five MSF-supported clinics from January 2012 – December 2014 All RR-TB patients still receiving treatment at the end of the intensive phase within the SAT clinics (SAT phase) were compared to patients in the same five clinics from January 2010 through July 2013 when DOT was the prevailing model of care (DOT phase) Descriptive statistics and chi squared tests were conducted to assess differences in 12 month treatment outcomes.

Results DOT cohort SAT cohort p-value Started RR-TB treatment 160 240 -- Patients in care at the end of intensive phase 122 182 Identified and eligible 17 92 Enrolled in SAT 82 12 month RR-TB treatment outcomes n=112* n=173** Still on treatment n=92 (82.1%) n=149 (86.1%) 0.36 Loss from Treatment n=15 (13.4%) n=16 (9.2%) 0.27 Death n=4 (3.6%) n=7 (4.0%) 0.55 Treatment Failure n=1 (0.89%) n=1 (0.58%) 0.76   *Excluding 10 Transferred Out **Excluding 9 Transferred Out Explanation: Interim outcomes No significant difference in the proportion of patients on tx at 12 months If we look at only those who received SAT in the SAT cohort we see that 78 of the 82 with outcomes at 12 months are still in care. (97.5%)

Conclusions Interim outcomes indicate that structured SAT does not lead to a reduction in the proportion of patients retained in care 12 months post treatment initiation

Adopt and adapt SAT models to fit your programmes Recommendation Lets not punish patients but work with patients and allow them a better quality of life, respecting and trusting them to comply to treatment regimens. Adopt and adapt SAT models to fit your programmes

Resources Acknowledgements City and Province clinic staff RR-TB patients and their families MSF Khayelitsha team and government structures

Results Explanation: Interim outcomes No significant difference in the proportion of patients on tx at 12 months