HPTN 071 (PopART): Have we reached the 90-90-90 targets after two years of the PopART intervention IAS Paris July 2017 Richard Hayes

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)

~ 2,000 random sample from each community : HIV incidence at 36 months Original Trial Design Total Population ~ 1M ~ 2,000 random sample from each community : Population Cohort N ~ 43,000 12 in Zambia 9 in S. Africa Primary outcome: HIV incidence at 36 months 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: Voluntary Medical Male Circumcision (VMMC) for HIV negative men Prevention of Mother to Child Transmission (PMCT) for HIV positive women HIV treatment and care for all HIV positive individuals Promotion of sexual health and TB services Condom provision ART irrespective of CD4-count or immune-status provided at the local health centre in Arm A

Revised Trial Design 12 in Zambia 9 in S. Africa Key difference between Arms A&B vs Arm C is the community-based activities: Regular house-to-house HIV testing and re-testing Active linkage and follow-up for HIV+ Adherence support for HIV+ Condom promotion/distribution, VMMC referral, STI counseling, PMTCT referral Active case finding and follow-up for TB

HPTN 071 Timeline Study intervention will finish by the end of December 2017 and data on process measures can be shared mid 2018 the main trial primary endpoint will report at CROI 2019.

Assumptions made to estimate overall community knowledge of HIV status and on ART HIV prevalence in those who “do not know status” after CHiPs visit same as in those who accept HCT Among those consenting to intervention, all HIV+ who knew their status self-reported this to the CHiP HIV prevalence in those not consenting to intervention same as in those consenting Proportion of HIV+ who knew their status same in those not consenting as in those consenting (at time of CHiP visit) Proportion of known HIV+ on ART same in those not consenting as in those consenting (at time of CHiP visit)

1st 90: Percentage of HIV+ adults who know their HIV+ status 90-90 estimates, Zambia Arm A, with extrapolation to total adult population First 90 (%) Second 90 (%) Estimated number of HIV+ adults Immediately before annual round (AR) visit End Round Immediately after annual round (AR) visit Men Round 1 (R1) 6649 52 78 54 74 Round 2 (R2) 6521 67 79 71 81 Women 11037 56 87 53 73 10690 75 91 82 Round 2, Overall 17211 1st 90: Percentage of HIV+ adults who know their HIV+ status 2nd 90: Percentage of HIV+ adults who are on ART, among those who know their HIV+ status

1st 90 estimates, Zambia Round 2 Arm A, with extrapolation to total adult population

2nd 90 estimates, Zambia Round 2 Arm A, with extrapolation to total adult population

ART initiation – based on self-reported information Time from CHiP referral to ART initiation, Zambia & South Africa Arm A comparing Round 1 and 2 In Round 2, ~50% started ART by 6 months after referral, compared with ~40% in Round 1 Median reduced from ~9-10m to 5-6m ART initiation – based on self-reported information CHiP teams request to see patient ART card, on which ART initiation is documented Analysis includes all HIV+ individuals who were referred to HIV care, and were not on ART when referred

90-90 estimates, Zambia Arm A, with extrapolation to total adult population First 90 (%) Second 90 (%) Estimated number of HIV+ adults Immediately before AR visit End Round Immediately after AR visit Men Round 1 (R1) 6649 52 78 54 74 Round 2 (R2) 6521 67 79 71 81 R2, participated R1 2856 87 92 85 R2, not participated R1 3665 51 70 63 77 Women 11037 56 53 73 10690 75 91 82 5885 89 96 86 4805 58 61 76

Summary After second annual round of CHiP intervention in Zambia, we estimate that 87% of HIV+ adults knew their status overall – close to First 90 This had increased from 50-55% prior to intervention Knowledge of HIV+ status was lower in men than women (79% vs 91%) Of known HIV+ adults, 82% were on ART by end of second round Knowledge of HIV+ status and ART coverage lower in young adults than older adults Linkage to care following referral is now much faster than before Rates of mobility/migration in these mainly urban settings are high emphasising importance of frequent testing and re-testing Coverage will be re-examined after third annual round later this year

And now… some HPTN 071 sub-studies PopART in youth (P-ART-Y) Social science Stigma ancillary study Health economics Mathematical modelling

The HPTN 071 Study Team, led by: PEPFAR Implementing Partners: Dr. Richard Hayes Dr. Sarah Fidler Dr. Helen Ayles Dr. Nulda Beyers Government Agencies: PEPFAR Implementing Partners:

With thanks to: All research participants and their families The 21 research communities and their religious, traditional, secular and civil leadership structures Volunteers in the community advisory board structures