1. Outcomes from the Scale-up of Antiretroviral Therapy Adherence Clubs in Cape Town, South Africa
Priscilla Tsondai, Lynne Wilkinson,
Anna Grimsrud, Angelina Trivino,
Precious Mdlalo, Andrew Boulle.

2. Outline HIV epidemic in South Africa Background on ART adherence clubs
Background on Scale-up of ART adherence clubs
Overview - Outcomes of ART adherence clubs study
Study design
Data collection
Statistical analysis
Results
Conclusions

3. HIV in South Africa
Over 6 million people living with HIV in South Africa
~3 million on ART
number expected to  - “test and treat” guidelines

4. Need for differentiated models of care
HIV in South Africa
HIV treatment services already congested
Crowding in clinics
Long waiting times
Impact on retention
Need for differentiated models of care

5. ART Adherence Clubs (ACs)
Group model of care
For stable patients on ART
Facilitated by lay ‘HCW’
Support from clinical staff
Allows for “buddy” collection
Meet 5 times per year
brief symptom screen & group discussion
receive pre-packed ART supply
Wilkinson L.S and Wilkinson L.S. et al, 2016.

6. ART ACs
VL assessment at 4th month  clinical consult at 6th month visit  repeated annually
Paper-based register  Electronic Medical Records (EMR)
Attendance
Weight
Blood results
Referrals
Wilkinson L.S and Wilkinson L.S. et al, 2016.

7. ART ACs pilot outcomes
ACs piloted by MSF in clinic in Khayelitsha, Cape Town since 2007
Retention of 97% (club) vs 85% (clinic) over 40 months
67% less virological rebound among AC patients
Luque-Fernandez M.A. et al, PLoS One, 2013.

8. Scale-up of ART ACs Adopted by the WCG DoH
Since 2011  Implemented across Cape Metro district
As of March 2016: ~32% (>45,000) of all patients on ART in district supported within an AC
Wilkinson L.S. et al, TMIH, 2016.

9. Outcomes of ART ACs study
Aim
To determine if the AC model of care is as effective at scale
Outcomes: Retention and viral suppression (≤400 copies/mL)
3 phased study
Phase 1 - Describe outcomes of a portion of patients receiving ART within ACs
Phase 2 - Validate the ability to identify club participation from routine data
Phase 3 - Compare outcomes of AC patients with non-AC patients across entire district based on routine data

10. Study Design Retrospective Observational Cohort study
Eligibility criteria
Enrolled in AC at facility without substantial research support
Enrolled between Jan 2011 – Dec 2014
Sampling
A weighted random sample, with each club as the sampling unit used to sample ~10% of ACs (n=100)
ACs sampled in quintets proportional to the number of ACs at facility

11. Data Collection 3 Data sources used
AC registers - photographic images taken  data abstracted and entered into REDCap
Patient Clinic Folders - reviewed for patients who defaulted from AC or were referred back to clinic
EMR - laboratory and service access data abstracted to validate retention & virologic outcomes

12. Statistical Analysis
Cross-sectional  LTFU, TFO, deaths & VL assessment and suppression
Competing risks regression  LTFU, TFO & deaths
Patients entered analysis on date of 1st club visit & exited at the date of outcome or analysis closure (31 Dec 2014)
LTFU - defined as no AC or clinic contact in the six months following analysis closure (between January – June 2015)
LTFU determined to have happened at the date of the last contact with the service

13. Patient Characteristics
3216 patients followed up for 4019 person years, 71% female
At AC enrolment;
median age 36 years (IQR, 31 – 42),
median time on ART 2.3 years (IQR, 1.5 – 3.6)

14. Retention 4.2% (n=135) were LTFU, 2.6% (n=82) TFO and 0.1% (n=4) died
Before linkage – 280 (8.7%) patients LTFU
Linkage found 52% (n=145) of these patients
Cumulative retention
95.1% (95% CI 94.2 – 95.9) over 12 months
89.7% (95% CI 87.9 – 91.2) over 24 months
83.2% (95% CI 79.6 – 86.3) over 36 months

15. Viral load completion and suppression
Months of follow up 4 16 28
Patients followed (N)
3216
1846
615
Viral loads done
2782
1563
490
Completion (%) 87 85 80
Results (copies/mL)
≤ 400, n (%)
2697 (97)
1496 (96)
461 (94)
24 (1)
11 (1)
4 (1)
> 1000
61 (2)
56 (3)
25 (5)

16. Strengths and Limitations
Challenges
Missing old registers – some patients in initial AC implementation phase who left ACs not included
Strengths
Sampled ACs from non research sites
Linkage enabled us to differentiate true LTFU from silent transfers

17. Conclusion
Substantial reassurance that this model supports good patient outcomes at scale  evaluated model implemented by DoH outside research control
Good outcomes expected  model implemented for stable patients
Can be used to relieve clinic congestion and free up clinician time
Next steps
Health Systems Research  in writing
Phase 2 and 3 – enable comparison between patients in AC model vs routine clinic set-up across entire district

18. Thank you