1. One year retention in community versus clinic-based adherence clubs for stable ART patients in South Africa
C Hanrahan1, V Keyser2, S Schwartz1, P Soyizwaphi2, N West1, L Mutunga2, J Steingo2, J Bassett2, A Van Rie3
1Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA
2Witkoppen Health and Welfare Centre, Johannesburg, South Africa
3University of Antwerp, Antwerp, Belgium

2. Background- Adherence Clubs
Adherence clubs are groups of patients stable on ART
Patients meet for counselling and medication pickup (~1 hour)
Annual medical visit
Facilitate task shifting and decongest busy clinics
Experience from 2 observational studies in Cape Town: adherence clubs promote retention in care and viral suppression compared to clinic-based standard of care
57% reduction in loss-to-care (aHR 0.43, 95% CI: ) (Luque-Fernandez 2013)
67% reduction in virologic rebound (aHR 0.33, 95% CI:  ) (Luque-Fernandez 2013)
67% reduction in risk of LTFU (aHR: 0.33, 95% CI: ) (Grimsrud 2016)

3. Background- Community vs clinic clubs
No direct comparison of effectiveness or patient acceptability has been made between community and clinic-based clubs
Systematic review of community versus clinic-based interventions (not specific to adherence clubs) suggest comparable retention and clinic outcomes (Nachega, in press 2016)
Factors potentially at play:
Stigma
Convenience
Cost
Access to other health care (eg family planning, pediatric care)
Others…???

4. Primary Study Objective
Compare the effectiveness of community versus clinic-based adherence clubs on retention in care and viral suppression

5. Study Design
Unblinded, open-label pragmatic randomized controlled trial
Randomisation of clinic versus community-based clubs was stratified by participant area of residence
2 clubs per residential area (1 community, 1 clinic-based) created each month x 12 months

6. Primary Study Outcome
Return to clinic-based standard of care (whether voluntary or for violating club rules—includes those LTFU from any care)
AND
Viral rebound (VL>400 copies/ml)

7. Study Setting Witkoppen Health and Welfare Centre
High-volume primary care clinic in northern Johannesburg, South Africa
Serves neighboring communities of Diepsloot and other informal settlements (~15-30 mins by public transport)

8. Intervention Description
Each club has participants
Run by a lay HIV counsellor and supported by a PHCN
Meet every 2 months
Screened for pregnancy, TB symptoms and BP (if hypertensive) at each visit
Community clubs held at community venues
Participants were excluded from further participation in adherence clubs and returned back to clinic-based standard of care when:
Missing a club visit and no ART pick-up within 5d
Viral rebound (a viral load >400 copies/ml or 2 viral loads > copies/ml)
Developing excluding comorbidity
Falling pregnant
Sending “buddy” for pickup 2x in a row
Voluntary choice

9. Inclusion/Exclusion Criteria
Inclusion Criteria
Exclusion Criteria
Age ≥ 18 years
Currently on D4T containing regimen
No change in ART regimen in previous year
Currently pregnant or intending to become in ≤6 mos
Virally suppressed for ≥ 12 months (confirmed at baseline)
Current comorbidity or chronic illness (diabetes, epilepsy, active TB, cancer, mental illness, etc)
Uncontrolled hypertension or treatment with >1 drug
Attending clinic with HIV infected child
Currently experiencing ART side effects

10. Inclusion/Exclusion Criteria
Inclusion Criteria
Exclusion Criteria
Age ≥ 18 years
Currently on D4T containing regimen
No change in ART regimen in previous year
Currently pregnant or intending to become in ≤6 mos
Virally suppressed for ≥ 12 months (confirmed at baseline)
Current comorbidity or chronic illness (diabetes, epilepsy, active TB, cancer, mental illness, etc)
Uncontrolled hypertension or on treatment with >1 drug
Viral suppression defined as:
2 most recent VL<400 copies/ml AND
No more than 1 VL copies/ml

11. Files of all ART patients pre-screened daily (~2000/month)
Study Enrollment
Files of all ART patients pre-screened daily (~2000/month)
Screened by clinician
n=1202
Enrollment: Feb 2014-Aug 2015
Ineligible
n=356 (30%)
Randomized
n=846 (70%)
Community Club
n=434 (51%)
Clinic Club
n=412 (49%)
Screening failure
n=35 (8%)
Screening failure
n=26 (6%)
Community Club
n=399 (51%)
Clinic Club
n=386 (49%)

12. Files of all ART patients pre-screened daily (~2000/month)
Study Enrollment
Files of all ART patients pre-screened daily (~2000/month)
Screened by clinician
n=1202
Enrollment: Feb 2014-Aug 2015
Ineligible
n=356 (30%)
Randomized
n=846 (70%)
Not virally suppressed on baseline blood draw
Community Club
n=434 (51%)
Clinic Club
n=412 (49%)
Screening failure
n=35 (8%)
Screening failure
n=26 (6%)
Community Club
n=399 (51%)
Clinic Club
n=386 (49%)

13. Files of all ART patients pre-screened daily (~2000/month)
Study Enrollment
Files of all ART patients pre-screened daily (~2000/month)
Screened by clinician
n=1202
Enrollment: Feb 2014-Aug 2015
Ineligible
n=356 (30%)
Randomized
n=846 (70%)
Community Club
n=434 (51%)
Clinic Club
n=412 (49%)
Screening failure
n=35 (8%)
Screening failure
n=26 (6%)
Community Club
n=399 (51%)
Clinic Club
n=386 (49%)

14. Baseline Participant Characteristics
Community club
Clinic club p
Median age, years (IQR)
38 (32-43)
38 (33-43)
0.604
Female sex, n (%)
266 (68%)
244 (64%)
0.309
Unemployed, n (%)
94 (24%)
63 (17%)
0.041
Median CD4 count, cell/mm3 (IQR)
475 ( )
527 ( )
0.293
On Fixed Dose Combination, n (%)
347 (89%)
326 (88%)
0.263
Hypertensive, n (%)
19 (5%)
22 (6%)
0.255

15. Retention in club care and viral suppression
12 month proportion retained in care and virally suppressed:
Community: 65% (95% CI: 59-70% )
Clinic: 77% (95% CI: 71-81%)
Log-rank test: 0.003
Viral rebound:
Community: 3% (95% CI: 1-4%)
Clinic: 3% (95% CI:2-6%)
p 0.476

16. Adjusted analysis
Cox Proportional Hazards model adjusted for age, sex, regimen, baseline CD4 count and employment status
Community club participants had a higher hazard of returning to clinic-based care or viral suppression compared to clinic-based clubs
aHR 1.6 (95% CI: ), p 0.006

17. Reasons for Club Discontinuation
Community club
Clinic club p
Missing club visit and ART pick-up
112 (68%)
64 (58%)
0.088
Pregnancy
12 (7%)
13 (11%)
0.256
Viral rebound
10 (7%)
13 (12%)
0.148
2 consecutive late ART pick-ups
7 (4%)
7 (6%)
0.463
Voluntarily return to SOC
8 (5%)
6 (5%)
1.00
2 buddy pickups in a row
6 (4%)
0 (0%)
0.009
Developed comorbidity
2 (1%)
Other
8 (7%)
0.299

18. Reasons for Club Discontinuation
Community club
Clinic club p
Missing club visit and ART pick-up
112 (68%)
64 (58%)
0.088
Pregnancy
12 (7%)
13 (11%)
0.256
Viral rebound
10 (7%)
13 (12%)
0.148
2 consecutive late ART pick-ups
7 (4%)
7 (6%)
0.463
Voluntarily return to SOC
8 (5%)
6 (5%)
1.00
2 buddy pickups in a row
6 (4%)
0 (0%)
0.009
Developed comorbidity
2 (1%)
Other
8 (7%)
0.299

19. Reasons for Club Discontinuation
Community club
Clinic club p
Missing club visit and ART pick-up
112 (68%)
64 (58%)
0.088
Pregnancy
12 (7%)
13 (11%)
0.256
Viral rebound
10 (7%)
13 (12%)
0.148
2 consecutive late ART pick-ups
7 (4%)
7 (6%)
0.463
Voluntarily return to SOC
8 (5%)
6 (5%)
1.00
2 buddy pickups in a row
6 (4%)
0 (0%)
0.009
Developed comorbidity
2 (1%)
Other
8 (7%)
0.299

20. Conclusions
12 month retention in club care was higher among participants in clinic-based clubs versus community based clubs
Most common reason for return to SOC was missing club visits
Viral rebound and voluntary withdrawal from clubs were rare
Retention in care in community-based clubs in this pragmatic trial was much lower compared to published findings from Cape Town
This trial: 66%
Grimsrud, 2016: 94%
Luque-Fernandez, 2013 : 97%
Potential reasons:
Lack of randomization (Luque-Fernandez: “only some stable patients were offered participation, based on the clinician’s enthusiasm for the model”)
Differences in definition of outcome (retention in club care versus retention in any ART care)?
Differences in eligibility criteria?
Differences in approach?
Differences in timing of outcome assessed?

21. Limitations
Potential observer bias due to unblended treatment assignment
Generalizability to other settings/ countries?
Retention in HIV care (rather than club care) not presented here

22. Implications for public health
Adherence clubs are currently a heterogeneous intervention, with different degrees of success
Our finding suggest that facility-based adherence clubs are more effective than community-based clubs
A better understanding of which aspects of adherence clubs are associated with success is needed
Careful monitoring of loss to follow-up and virologic rebound is warranted when scaling up adherence clubs under routine care conditions

23. Acknowledgements Community Venues Afrika Tikkun - Diepsloot
Witkoppen Health and Welfare Centre Adherence club patients Elry Rampela Galegole Mokoana Sr. Thobile Mthembu Gauta Moperero Lilian Ngwako Mutsa Mudavanhu Zanele Tshabalala Veronica Modise Collrane Frivold Lavina Ranjan Community Advisory Forum All clinicians
Community Venues
Afrika Tikkun - Diepsloot
Department of Social Development Hall- Diepsloot
Multi-purpose Hall- Cosmo City
Msawawa - Kyasands
St. Mungo Church - Bryanston
Funding Source
USAID Innovations Grant AID-674-A
The contents of this presentation are the sole responsibility of Witkoppen Health and Welfare Centre and do not necessarily reflect the views of USAID or the United States Government.

24. THANK YOU!!

25. Reasons for Ineligibility
Reason for ineligibility %
Hypertensive-uncontrolled or on >1 drug
29%
On current ART regimen <1 year
16%
Not virally suppressed
13%
Excluding comorbidity 9%
Currently experiencing ART side effects 7%
Intending to become pregnant in <6 mos
Currently pregnant
Attend clinic with HIV infected child
Current TB 3%
On D4T containing regimen 1%