Daouda Diouf Executive Director Enda Santé Dakar, Senegal Leveraging Adaptive Implementation Strategies to Achieve Universal Coverage of Antiretroviral Treatment in Senegal Daouda Diouf Executive Director Enda Santé Dakar, Senegal 9th IAS Conference on HIV Science Paris, France July 23, 2017

Outline Background Objective and Study Aims Methods HIV self testing (HIVST) Biometric tracking system Individualized case management Challenges and Opportunities Conclusions

Objectives Assess the: Feasibility Fidelity Cost-effectiveness Individualized case management to support sustained adherence to ART among individuals living with HIV who are not virally suppressed in Dakar and Ziguinchor, Senegal.

Specific Aims Characterize the acceptability of HIV self-testing by people at risk of HIV infection in Senegal, and determine if the promotion of self-testing increases the number of newly diagnosed PLHIV in clinic settings. Compare the effectiveness and durability of existing Standard of Care in Senegal versus individual case management programs to achieve sustained viral suppression among people living with HIV in Senegal. Determine the cost-effectiveness of the universal treatment approach using the CM intervention. Characterize the acceptability of iris scanning as a biometric follow up strategy to enhance the measurement of follow-up and retention of PLHIV receiving ART care.

Study Overview Test and Treat Individualized Case Management Randomized controlled trial Control group Study Arm New HIV diagnoses & enrollment in ART 12 months Viral suppression HIV Self Testing Biometric System Existing Programs Iris Scanning Distribution of Self Test Kits Venue based Network based 2 months 12 months New HIV Diagnoses Measurement

Study Objectives Relating to 90-90-90 HIV self testing Individualized case management Support retention in care Support adherence to ART Increase reach of those being tested Increase identification through new diagnoses Test and Treat Biometric system Enhance measurement of follow up Support adherence to ART 90% of people living with HIV know their status 90% of people who know their status are on ART 90% of people on ART achieve viral suppression

HIV Self Testing – Distribution Approaches Distribution of HIVST Venue-based kit distribution Network-based kit distribution Confirmatory HIV testing Test and Treat RCT enrollment Confirmed HIV positive HIVST positive New diagnosis at facility

HIV Self Testing – Data Collection At Distribution RCT Study Sites Pre test survey HIV testing history HIV risk behaviors Post test survey HIVST use Distribution Acceptability Baseline questionnaire for participants in cohort HIV risk behaviors HIVST history HIVST acceptability Clinic level data on HIV diagnosis Compare historical data to new diagnosis in study sites during enrollment

Biometric System – Iris Scanning Iris scanning is used track participants Supporting evaluation of retention in ART Image is converted into a 12 digit numerical code UNID is linked to participant data

Individualized Case Management – Study Design Randomized control trial Individualized case management + standard of care Standard of care Study sites Government health facilities in Dakar and Ziguinchor Sample size 596 across all sites Primary outcome: Sustained viral suppression <1,000 copies/ml at 12 months after initial randomization.

Individualized Case Management – Study Arms Intervention Arm: Case Management Initial meeting between person living with HIV and case manager Follow up meeting between case manager and participant Biweekly automatic text messages sent to participant Monthly phone calls from case manager Face-to-face meetings between case manager and participant every 6 months Control Arm Standard of Care

HIV Self Testing – Challenges & Opportunities Institutions are interested and want engagement Feedback and approvals take time Identified need to increase monitoring and data collection around HIVST distribution Added pre/post test questionnaires Aligning unique IDs across program Perceived unreliable results

HIV Self Testing – Challenges & Opportunities Government Engagement—Scientific committee Integration in other national programs Engagement of all stakeholders in developing strategies that intervene at all levels Active in policy formulations—developing national strategic plan. Government appropriation- Dissemination of early results in front of the scientific committee Engagement of all KP for the validation of strategies

Biometric System – Challenges & Opportunities New software, needs to be adapted to environment, update frequently Internet connectivity Wait time for code generation

Individualized Case Management – Challenges & Opportunities Test and Treat in Senegal: guidelines vs implementation Government facilities as study sites Interest is high but approvals and agreements are slower Limited resources Case managers Workload Availability Literacy Concerns from clinics of enrolling Patients with TB Pregnant women Randomization First time that people have been randomized in government clinics

Conclusions Significant interest in studying implementation strategies for Test and Treat Difference between enacting guidelines and actually implementing HIVST Biometrics Test and Treat Government Buy In Vs Clinic Buy In Clinic adherence to existing national guidelines

Acknowledgements Study participants Centre de Santé Dominique de Pikine, Centre de Santé de Ziguinchor DLSI CNLS USAID SOAR/Population Council Johns Hopkins University — Key Populations Program

Appendices Evidence Supporting Universal Coverage of ART ANRS 12249 Universal Treatment Trial ANRS 12249 TasP: HIV incidence comparison HPTN 071 (PopART) Preliminary Data HIV Self Testing – Distribution Approaches HIV Self Testing – Supervision Individualized Case Management – Enrollment

Evidence Supporting Universal Coverage of ART Plasma HIV viral load: primary determinant of the risk of HIV transmission (Quinn, NEJM 2000) HPTN052: Cohen, NEJM, 2016 TEMPRANO: TEMPRANO study group, NEJM 2015; 373:808-22 START: INSIGHT START study group, NEJM 2015; 373:795-807 Let’s focus first of all on the main trials which changed everything: HPTN052, Temprano, START. All had the same objectives: to compare the efficacy of early ART versus defered ART in reducing severe morbidity in adults with different levels of CD4 count as you can see: between three hundred and fifty and five hundred and fifty for HPTN052, below height hundred CD4 count for Temprano and above five hundred CD4 count for Start. Hazard Ratio for primary endpoint: TEMPRANO 0.56 (0.41-0.76) START 0.43 (0.30-0.62) HPTN052 (Initial) 0.04 (0.01-0.27)

ANRS 12249 Universal Treatment Trial Objective: To evaluate the effect of early ART, initated irrespective of CD4 count criteria, on HIV incidence in the general population in the same setting Design: Cluster-randomized trial (Iwuji et al. Trials 2013; Orne- Gliemann et al. BMC Public Health 2015) 6-monthly rounds of home-based HIV-testing Control Treat all HIV+ individuals according to South African guidelines (≤350 CD4, WHO stage 3 or 4 until Dec 2014, ≤500 since Jan 2015) Intervention regardless of CD4 count and clinical stage Pendant les 2 premières années Phase 1 2014 2012 2016 Phase 2 Modified from: Dabis, et al, 2016 The impact of Universal Test and Treat on HIV incidence in a rural South African Population IAS 2016

ANRS 12249 Universal Treatment Trial Intervention Control ART initiation within 3 months in TasP clinics among patients not on ART at first TasP clinic visit 91% 52% Viral load <400 copies/ml among patients not on ART at first TasP clinic visit At month 6 93% 92% At month 12 95% Estimated ART coverage* (as of 1st January 2016) 45% 43% ART coverage improvement since baseline +14 +7 * Estimated from TasP + Department of Health data Modified from: Dabis, et al, 2016 The impact of Universal Test and Treat on HIV incidence in a rural South African Population IAS 2016

ANRS 12249 TasP: HIV incidence comparison   Number of HIV-positive DBS tests Person-years Incidence for 100 person-years 95% CI Control 268 11,787 2.27 2.00-2.55 Intervention 227 10,646 2.13 1.85-2.41 TOTAL 495 22,434 2.21 2.01-2.40 Adjusted risk ratio* aRR 95% CI P-value Intervention vs control 0.95 0.79-1.14 0.5821 * Estimated with Poisson regression, adjusted on sex, age, change in national ART guidelines, baseline cluster HIV prevalence and ART coverage Modified from: Dabis, et al, 2016 The impact of Universal Test and Treat on HIV incidence in a rural South African Population IAS 2016

HPTN 071 (PopART) Preliminary Data “Acceptance of HIV testing among those consenting to the intervention was high, although linkage to care and ART initiation took longer than expected”. What about adherence? Hayes, et al. May, 2017 http://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1002292

HIV Self Testing – Distribution Approaches Peer educator trained in distribution methods Participant Supervised distribution HIVST Unsupervised distribution HIVST Referral Participant consented and completes survey KEY Venue-based distribution Network-based Distribution

HIV Self Testing – Supervision Location of self testing Supervised distribution Verbal pre-test instructions Demonstration by Peer Educator Unsupervised distribution Distribution without additional guidance At home At study site in private location Can talk about studies here

Individualized Case Management – Enrollment Referrals from HIVST New diagnosis at facility