Impact of Option B+ on ART uptake and retention in Swaziland: a stepped-wedge trial Elaine Abrams 1, Nontokozo Langwenya 2,Averie Gachuhi 1, Allison Zerbe 1, Thabo Hlophe 1, Simangele Mthethwa 3, Harriet Nuwagaba-Biribonwoha 1, Reuben Sahabo 1, Velaphi Okello 3, Landon Myer 2 1 ICAP, Columbia University, New York, USA/SD 2 University of Cape Town, South Africa 3 Ministry of Health, Kingdom of Swaziland

Background Swaziland has a severe generalized HIV epidemic Ministry of Health offered Option A approach for PMTCT – In 2011 only 25% of ART eligible pregnant women newly initiated ART 1 Option B+ calls for lifelong ART for all HIV+ pregnant and breast feeding women ‒Few comparative data on the impact of Option B+ on maternal retention in antenatal and postnatal care Swazi MOH wanted to examine feasibility, impact and cost effectiveness before adopting the Option B+ approach 1 Swaziland Ministry of Health. PMTCT Program Annual Report. 2011

Sitkulwane Lesiphephile - “Safe Generations” Implementation science study at 12 health facilities in Manzini & Lubombo regions Tested hypothesis that the change from Option A to Option B+ would: 1)Increase proportion of mothers and infants successfully completing the PMTCT cascade i.Improve ART uptake among pregnant women entering PMTCT ii.Improve maternal retention during pregnancy and postpartum 2)Be acceptable, feasible and cost-effective

Study Methods Stepped-wedge design 10 facilities transitioned routine PMTCT from Option A to Option B+, Sept Aug 2014 – Additional 2 control sites continued Option A throughout Pregnant HIV+ women not on ART making a 1 st antenatal care (ANC) visit formed monthly facility-level cohorts – Observed from 1 st ANC visit to 6 months postpartum, through Sept 2015 Data abstracted from routine health records including clinic registers and patient files

Analysis Option A and Option B+ compared on: – Proportion of women initiating ART at the 1 st ANC visit during pregnancy – Antenatal retention in care clinic attendance within 56 days before date of delivery – Postpartum retention in care clinic attendance between 3 months and 6 months postpartum Transition months excluded from all analyses Generalized estimating equations to compare Options A vs B+ – Adjusted for age, CD4 count, gestation at 1 st ANC visit, known HIV status – Results presented as adjusted risk ratios (aRR)

Site and cohort characteristics Site Characteristics 75% urban; 86% primary Median 11 HIV+ pregnant women/month (IQR 6-23) Cohort characteristics 2,315 HIV+ women entering PMTCT 1,272 (55%) under Option A 1,043 (45%) under Option B+ Mean age: 26 years; Median gestation: 20 weeks (IQR 15-24) 53% newly diagnosed Median CD4 count 404 cells/µL (IQR ); 33% CD4≤350 cells/µL

Proportion of women initiating ART under Options A and B+

Antenatal retention among women under Options A and B+ Little variation in associations by site or month of observation *Adjusted for age, CD4, gestation at first ANC, known HIV status

Postnatal retention among women under Options A and B+ Little variation in associations by site or month of observation *Adjusted for age, CD4, gestation at first ANC, known HIV status

Retention under Options A and B+

Limitations – Use of routinely collected clinical data resulted in limited set of study variables inability to distinguish true lost-to-follow from undocumented transfer and deaths – Country adopted Option B+ before study conclusion limiting impact of study findings on policy decision Strengths – Novel data providing direct comparison of Option B+ versus Option A in sub-Saharan Africa – Findings reflect ‘real world’ experience of PMTCT service delivery Limitations and strengths

Option B+ resulted in modest improvements in retention However, proportionately more women initiating ART were retained under Option A - These findings are concerning given that Option B+ calls for lifelong ART for all HIV+ pregnant women Further efforts urgently needed for successful engagement in long-term care to achieve full benefits of universal ART Conclusions

Many thanks to the all of the collaborators, health workers and patients who made this study possible Investigators Elaine Abrams Stephen Arpadi William Reidy Harriet Nuwagaba-Biribonwoha Bonsile Nhlabatsi Simangele Mthethwa Edina Sinanovic ICAP NY Study Staff Allison Buba Averie Gachuhi Fatima Tsouris University of Cape Town Lucy Cunnama Nontokozo Langwenya Maia Lesosky Landon Myer ICAP Swaziland Senior Staff Ruben Sahabo Harrison Kamiru Lucia Gonzalez Swaziland, Ministry of Health Velephi Okello Rejoice Nkambule Elizabeth Glazer Pediatric AIDS Foundation Mohammed Mahindi Caspian Chouraya Chris Makwindi Merck Pharmaceuticals Gilead Pharmaceuticals This project is supported by the President’s Emergency Plan for AIDS Relief (PEPFAR) through USAID under the terms of Cooperative Agreement Number AID-OAA-A The contents are the responsibility of ICAP and do not necessarily reflect the views of the United States Government. ICAP Swaziland Study Staff Thabo Hlophe Bhangazi Zwane Dennis Mudoni Joshua Kikuvi Ndumiso Dlamini Samkelo Simelane Wandile Dube Cavan Sibanda Prudence Mkhabela Lwazi Malinga Siphesihle Shongwe Data collectors and clerks USAID Emily Harris Glen Post