Measuring progress against 90-90-90 targets in Zambia using routine data collected by community health workers: HPTN 071 (PopART) trial Kwame Shanaube on behalf of the HPTN 071 (PopART) Study Team Study Site Coordinator-Zambia IAS Durban 2016 I would like to thank the organizers for giving me the opportunity to present on behalf of the HPTN/PopART study team

I Have No Conflict of Interest to Declare

Background UNAIDS 90-90-90 targets for 2020 to achieve HIV epidemic control Mathematical models suggest a substantial reduction in HIV incidence if targets can be achieved Report on data from one of the largest ongoing programmes to deliver UTT at population level to determine how close we have come to these targets after the first annual round of intervention The UN targets were meant to achieve HIV global epidemic control yet it is not know how feasible these targets are in routine programmatic settings The UNAIDS 90-90-90 targets require that 90% of people living with HIV will know their status, 90% of those diagnosed with HIV will receive sustained ART and 90% of those receiving ART will have durable viral suppression. Not know how feasible these targets will be

Primary outcome: HIV incidence at 36 months 2,000 random sample from each community: Population Cohort N = 42,000 12 in Zambia 9 in S. Africa Primary outcome: HIV incidence at 36 months Zambia: Arms B and C transitioned to universal treatment PopART intervention package Annual rounds of Home Based Voluntary HIV Testing by Community HIV-care Providers (CHiPs) Health promotion, Active Referral and/or Retention in Care support by CHiPs for the following: HIV treatment and care for all HIV positive individuals Voluntary Medical Male Circumcision (VMMC) for HIV negative men Prevention of Mother to Child Transmission (PMCT) for HIV positive women Sexual health and TB services Condom provision ART irrespective of CD4-count provided at the local health centre The PopART intervention package is delivered by cadre of staff – a community HIV-care providers (CHiPs) team These are lay counsellors living themselves within the communities employed and trained by the study team to do HIV counselling and testing, ensure linkage to care for any HIV+ individuals, referral for, PMTCT, VMMC for HIV negative men, offer TB and STI symptom screening and referral of symptomatic cases, and condom provision. The CHiPS work consists of annual rounds throughout the entire community with repeat visits to households to conduct these activities. All data is captured in an electronic data capture device.

Questions from HPTN 071 (PopART) Can the 90-90-90 targets be achieved? What coverage was achieved by PopART intervention during the first annual round? How much closer did we get to the 90-90-90 targets as a result of the intervention? What were the main challenges during the first round? The secondary objectives or research questions of the study which are in line with the 90-90-90 target are as follows

Methods CHiPs data from the four Arm A communities in Zambia to determine how close to 90-90-90 targets Used household census data to divide catchment areas in CHIPs zones. Survival analysis used to examine the proportions linking to care and starting ART following CHiP referral. Data used to estimate overall proportions of HIV positive individuals who knew their status and the proportion of these on ART before and after the intervention The household census was carried out prior to the trial and it provided the denominator for the proportion of households visited during the first annual round Every zone is covered by a pair of CHiPs team and has 400-500 households The secondary objectives of the study which are in line with the 90-90-90 target are as follows?

Cascade of care from enumeration through ART initiation for 4 Arm A sites: First round Women 62, 140 enumerated 55,968 consented (90%) 47,032 know HIV status (84%) 8,701 HIV-positive (18%) 4307 (49%) already on ART 4,144 referred to HIV care [among those never previously registered for HIV care, 3,848/3,881 (99%) referred] 41% initiated ART within 6 months (estimated from ‘survival’ analysis) 57% initiated ART within 12 months 59,558 enumerated 45,610 consented (77%) 36,369 know HIV status (80%) 4,139 HIV-positive (11%) 1942 (47%) already on ART 2,053 referred to HIV care [among those never previously registered for HIV care, 1,931/ 1,962 (98%) referred] 43% initiated ART within 6 months (estimated from ‘survival’ analysis) 61% initiated ART within 12 months Data in this flow diagram show the cascade of care from enumeration through ART initiation at 6 and 12 months for the 4 Arm A communities in Zambia divided by sex. To start on the LHS in blue are the men, At the time of the first CHIPS HH visit 4,139 men were HIV positive either through self-report or testing by CHiPs of these 47% were already on ART Of the remaining 2053 not on ART, 98% were referred to care by the CHIPS teams Of those not previously on ART 43% initiated ART within 6 months of a referral and 61% initiated ART within 12 months Similarly for women, in red, of the 8701 HIV+ women identified by the CHIPS intervention, 49% were already on ART Of the remaining 4144 not on ART at the time of the CHIPS HH visit, 99% were referred to the clinic for ART Of those attending the clinic for ART, 42% initiated ART within 6 months of the chips referral and 56% by 12 months For men and women attending the clinic with CD4 counts outside of the current threshold (500) 99% consented to immediate ART initiation So the drop off here is those people who know their status but do not chose to attend the clinic. 8% men refused, 5% women refused; 14% men absent, 4% women absent First annual round -January 2014 to June 2015 46, 676 HHs visited in Arm A communities. -Households (HHs) visited: adult HH member contacted at home and agreed to HH being recorded in register Enumerated: individual HH member’s name, age, gender entered into CHiPs electronic register Consented: individual agreed to participate in intervention Knew HIV status by end of CHiP annual round visit Known HIV status= Adults know HIV status (includes those who self-report an HIV-negative test result within the last 3M_Indictaor 3_3m). Percentages estimated from ‘survival’ analysis  

Assumptions made to calculate 90:90 targets Among those consenting to intervention, all HIV+ who knew their status self-reported this to the CHiP Proportion of HIV+ who knew their status same in those not consenting as in those consenting (at time of CHiP visit) HIV prevalence in those not consenting to intervention same as in those consenting HIV prevalence in those who “do not know status” after CHiPs visit same as in those who accept HTC Proportion of known HIV+ on ART same in those not consenting as in those consenting (at time of CHiP visit) In order for us to calculate whether the 90-90-90 targets can be achieved we made some assumptions?

90-90 Estimated uptake in HIV+ adults who consented to participate, Arm A Zambia R1 Based on these assumptions I have just mentioned we calculated the first two 90s. Here I summarise how far we have come after a complete one year of the PopART intervention in the 4 arm A communities broken down by sex Among those consenting to the intervention, we estimate that prior to the intervention 53% of all HIV-positive men and 56% of all HIV-positive women knew their HIV-positive status. After the first annual round, these proportions increased to 90% of men and 92% of women, reaching or exceeding the first 90 target Similarly, the proportion of HIV-positive adults on ART increased from 47% to 71% in men and from 49% to 72% in women by the end of the first annual round xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx Pre-CHiPs is before the annual round visit so uses reported knowledge of HIV status from prior testing i.e. what is reported in annual round 1 visit. ( EDC register at R1-was client previously tested for HIV and what was the result) Post-CHiPs is after round 1 visit so includes those who tested HIV+ with CHiPs as knowing their HIV+ status Pre-CHiPs Post-CHiPs

90-90 Estimated uptake in total HIV+ adults, Arm A Zambia R1 While the previous slide is confined to only those who consented this is an extrapolation to the total HIV+ adult population, to try to include those who did not consent to participate. Knowledge of HIV status close to 90% for women and around 80% for men. Proportion of HIV positives on ART is 73% for both men and women

Time from CHiPs referral to ART initiation, by calendar quarter, Arm A Zambia Graph shows survival plots for time from referral to linkage to care and ART initiation and indicates that only 30% initiated ART by 3 months, but with additional individuals starting ART over time The time taken for those diagnosed HIV-positive to link to care and commence ART has been longer than anticipated. Our initial target was for ART to be commenced in 80% of individuals within 3 months of referral. In practice, we are seeing around 60% of both men and women commencing ART within 12 months of referral.

Limitations Estimates based on adults who were enumerated and had consented to intervention These represent approximately 72% of men and 85% of women in these communities Assumptions needed to estimate knowledge of HIV+ status and proportion on ART in total adult population In longer term will have data on uptake from Population Cohort (random sample of adults in population)

Lessons learnt Slow linkage to HIV care and ART initiation Uptake of intervention and testing among men challenging Reconciliation of clinic versus community data for effective linkage to care key Robust layers of supervision and constant data checks required Slow linkage to Care-addressed using several strategies including repeated visits to HH; fast tracking those that are newly diagnosed; use of assisted referrals and clinic linkage to care meetings and community models of ART in some sites will be implemented Catching men-use of flexible working hours (early mornings or late evenings), conducting community male campaigns, targeting social and work places Linkage to care lists done quarterly and have proven useful in addressing gaps in the linkage to care cascade Supervision-the data which the CHiPs team collect is monitored at different levels by different people

Measures to improve performance and data quality Regular retrainings Performance Monitoring Strengthening of unaccompanied visits Internal audit team Data monitoring Ongoing Qualitative Analysis Resetting of performance expectations The study team has implemented a number of measures that allow real-time monitoring of CHiPs delivery of the intervention and of the quality of the data they collect. Regular protocol and research and data integrity trainings. Supervisory staff retrained to strengthen supervisory skills Strengthening of unaccompanied visits-Supervisory staff visit randomly selected HHs a week after the CHiPs teams have left with a print-out of the data collected by the CHiPs to validate it. Every Chip team is evaluated every 4-6 weeks. Audit teams also do the unaccompanied visits similar to those of the supervisors but provide independent unbiased performance of the CHiPs teams and data quality Ongoing qualitative assessment (story of the trial)-how intervention is delivered and received by the communities

Use of routine data to answer key questions Coverage achieved following R1 of CHiPs intervention How close we got to the 90-90-90 targets Important barriers to meeting these targets Emphasizing role of CHW and community based strategies in achieving targets Total of 449 personnel Site Coordinator; HIV QA/QC Manager; 2 Data managers 4 clinical research nurses 3 Intervention managers 6 District Intervention Coordinators 19 CHiPs supervisors 412 CHiPs Two categories of indicators- Routine indicators and PopART indicators Certificated counsellors but additional training Finger-prick rapid HIV testing Advanced Counselling supervisions QA/QC SOPs Data monitoring

Conclusion Study addresses delivery, uptake and sustainability of a combination prevention package provided at scale through routine services How to deliver UTT intervention to achieve 90-90-90 targets at population level Primary aim to measure impact on HIV incidence at population level Year 1 data suggest we are making a big difference to HIV test uptake and ART coverage - and already approaching the first of the 90-90-90 targets Main challenges during first round Uptake of intervention and testing among men Rapid linkage to HIV care and ART initiation Unique opportunity to rigorously measure impact and cost-effectiveness of intervention on HIV incidence which will inform policy on UTT for many years to come

acknowledgements Sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) under Cooperative Agreements # UM1 AI068619, UM1-AI068617, and UM1-AI068613 Funded by: The U.S. President's Emergency Plan for AIDS Relief (PEPFAR) The International Initiative for Impact Evaluation (3ie) with support from the Bill & Melinda Gates Foundation NIAID, the National Institute of Mental Health (NIMH), and the National Institute on Drug Abuse (NIDA) all part of the U.S. National Institutes of Health (NIH)