1. Community-Based Adherence Support Associated with Improved Virological Suppression in Adults Receiving ART: Five-Year Outcomes from a South African Multicentre Cohort Study Geoffrey Fatti, Ashraf Grimwood, Eula Mothibi, Mokgadi Malahlela, Alfeous Rundare Kheth’Impilo, Cape Town, South Africa

2. Kheth’Impilo SA NGO supports district scale up quality services for the management of HIV/AIDS at PHC level, focusing on providing a family centered comprehensive & integrated service KI operates in: 142 sites in the Eastern Cape, KwaZulu Natal, Mpumalanga & the Western Cape with >145000 patients RIC Programmes: Health Services Cluster (HSC) – ART (Adults & children), TB, HCT & PMTCT linked to Community Support Cluster (CSC) – for Adherence & Psychosocial support

3. Community Adherence Clinic based Community outreach adherence support (CBAS) health care workers called Patient Advocates (PAs) were introduced in 2004; Link clinical services & community; trained in the basics of HIV, patient rights, confidentiality, ethics, etc. Ensure ongoing adherence, counselling and psycho-social support at the community level and support community services to ensure the continuum of care; Special attention paid to very important patients (VIPs); the ill, pregnant, TB, children & adolescents, those who have not disclosed & those showing early signs of defaulting; VIPs make up 40% of PA’s workload; Patients encouraged to contract with themselves & get a treatment buddy to facilitate adherence to positive lifestyle choices that include the taking of treatment & keeping appointments

4. PA Support Structure AREA COORDINATOR PA PRIMARY HEALTH CARE CENTRE (Clinics) DISTRICT OFFICE NATIONAL OFFICE COMMUNITY HEALTH CENTRE  Site Facilitator  CSC District Coordinator  CSC Trainer  Doctor  Nurse  Pharmacist  PMTC Quality Mentor  Social Worker  Data Quality Manager Roving SWAT TEAM  Site Facilitator

5. PAs assist with patient treatment readiness & assess: 1.Psychosocial barriers to adherence including non- disclosure are identified 2.Pre-treatment initiation education to ensure the understanding around the need for adherence 3.Plan support services to suit individual client needs through planned home visits and clinic support 4.Regular follow-ups. Information gathered is presented at the treatment initiation Multidisciplinary Team meetings.

6. Methods Objectives: Estimate effect of CBAS on mortality, loss to follow up, & virological suppression in adults receiving ART. Multicentre cohort analysis using routinely collected data. ART naïve adults starting ART between Jan 2004 and Sep 2010 at 57 government ART sites in 4 provinces. Patients categorised as receiving or not receiving CBAS from the start of ART. Allocation was performed by clinic-based patient facilitators & area coordinators, based on patient consent, programmatic, clinical or psychosocial considerations. Virological suppression (< 400 copies/ml) at six-monthly intervals until 5 years of ART, by intention to treat analysis. XIX International AIDS Conferencewww.aids2012.org

7. Analyses Analyses were primarily by intention-to-treat (including all patients in each group as at allocation). Extreme case sensitivity analyses performed to estimate potential bias due to missing viral load results. Multivariable generalised estimating equations and logistic regression with multiple imputation of missing covariate values. XIX International AIDS Conferencewww.aids2012.org

8. Results: Patients included and baseline characteristics XIX International AIDS Conferencewww.aids2012.org

9. Results (cont) Total observation time was 100,295 person-years Deaths: 970 (4.9%) CBAS patients; 2,968 (6.3%) non- CBAS patients. (P < 0.0001) LTFU: 1,185 (6.0%) CBAS patients and 4,498 (9.5%) non-CBAS patients. (P < 0.0001) Virological suppression (at six months): -CBAS patients: 76.6% (95% CI: 75.8%-77.5%) -Non CBAS patients: 72.0% (95% CI: 71.3%-72.5%) (P < 0.0001) XIX International AIDS Conferencewww.aids2012.org

10. Virological suppression by intention-to-treat on ART XIX International AIDS Conferencewww.aids2012.org Proportions with virological suppression Months on ART

11. Multivariable analysis of virological suppression XIX International AIDS Conferencewww.aids2012.org

12. Sensitivity analysis: Considering all missing test results as suppressed. XIX International AIDS Conferencewww.aids2012.org Proportions with virological suppression Months on ART aOR 1.44 (95% CI: 1.37-1.52)

13. Sensitivity analysis: Considering all missing test results as unsuppressed. XIX International AIDS Conferencewww.aids2012.org Proportions with virological suppression aOR 1.15 (95% CI: 1.11-1.19)

14. On-treatment analysis XIX International AIDS Conferencewww.aids2012.org Proportions with virological suppression RR 0.97 (95% CI: 0.96-0.97)

15. Results: Mortality after starting ART without CBAS with CBAS P < 0.0001 Months on ART Multivariable analyses adjusted for confounding: Mortality in patients with CBAS independently reduced: aHR 0.65 (95% CI: 0.59-0.72)

16. Results: LTF after starting ART without CBAS with CBAS P < 0.0001 Multivariable analyses adjusted for confounding: LTF in patients with CBAS independently reduced: aHR 0.63 (95% CI: 0.59-0.68)

17. Conclusions Adults receiving community based adherence support had reduced mortality, LTFU and improved virological suppression (ITT analyses) after starting ART. Further scale-up of these programs should be considered in low-income settings. Limitations: Non randomised allocation to groups Observational, use of routine data Lack of effect seen in on-treatment VS analyses: May be due to averted mortality and LTF amongst higher-risk patients who received CBAS, who would thus remain in care and at increased risk of viraemia.

18. This research was made possible by the President's Emergency Plan for AIDS Relief (PEPFAR) through the United States Agency for International Development (USAID) under the terms of grant no. P3121A0051. The contents of the presentation are the sole responsibility of “Kheth’Impilo” and do not necessarily reflect the views of USAID, The United States Government or The Global Fund. Acknowledgements Acknowledgements: