Elimination of Mother to Child Transmission of HIV: Performance of Different Models of Care when Initiating Lifelong ART for Pregnant Women in Malawi (Option B+) Monique van Lettow, Richard Bedell, Isabell Mayuni, Gabriel Mateyu, Megan Landes, Adrienne Chan Vanessa van Schoor, Teferi Beyene, Anthony Harries, Stephen Chu, Andrew Mganga, Joep J van Oosterhout

Malawi new PMTCT strategy in 2011 Option B+ Implemented in other countries No formal evidence base and concerns about losses to follow up

Option B+ in Malawi - Learning by Doing No guidelines for integrating Option B+ into the routine service Different approaches had to be considered for:  Location, timing ART  Adherence counseling  Follow-up after delivery or breastfeeding Would this affect uptake, adherence, retention?

Chibwandira et al; MMWR % increase ART pregnant & BF women 4

Nation wide HF level data: 6-month retention 83% Great variation between health facilities: 100 – 42% Limited insight into factors determining uptake and retention AIDS 2014

Study Aims Describe the diversity of approaches to service organization (models of care) for the delivery of Option B+ to pregnant women in health facilities in Malawi Explore associations between the model of care and program indicators at health facility level: - uptake HIV testing in ANC - uptake ART - retention on ART

South East Health Zone 6 out of 28 districts 3.5 million inhabitants Integrated HIV care services in 153 facilities, out of 588 facilities nationwide 154,000 pregnancies annually 14.6% HIV-infected Setting

1. Health Facility survey staff, ART initiation location, adherence counselling, follow-up and transfer  identify models of care 2. Health facility cohort reports to ascertain: - Uptake of HIV testing and ART initiation pregnant women in ANC (July 2012-June 2013) - Cohort survival outcome data to evaluate 6-month outcomes women registered as having started ART under Option B+ (July 2012-Dec 2012) Methods

3. Associations between identified models of care and: I. Uptake of HIV testing and ART among pregnant women II. 6- month treatment outcomes  descriptive analyses and logistic regression models High HIV testing uptake >85% High retention on ART >92%

141/153 health facilities included in the study Results Characteristics (median) District Hospital (n=4) Community Hospitals (n=8) Health Centers (n=120) Private Clinics (n=9) Medical Doctors2000 Other Clinical staff Clinical Officers/Nurses/Medical Assistants Support staff Counselors/Expert Patients/ART clerks Total number of staff per facility Women newly registered for ANC/quarter Women newly registered start ART Option B+ 6-month cohort: July-Dec

A: Facilities where women are initiated and followed on ART at ANC clinic until giving birth (n=75) B: Facilities where women receive only the first dose of ART at ANC clinic, then follow up at ART clinic (n=38) C: Facilities where women are referred from ANC to the ART clinic for ART initiation and follow-up (n=18) D: Facilities serving as ART referral sites (n=9) (not providing ANC) 4 Models of Care identified

PMTCT service delivery Model D No ANC, ART clinic (n=9) Facilities providing both ANC and ART services (n=131) Model B 1 st dose ANC then ART clinic (n=38) Model A All ART in ANC (n=75) Model C All ART in ART clinic (n=18) At day of ART initiation or transfer in (n=9) Same day at ANC (n=29) Next visit at ART (n=2) Both at ANC & ART(n=7) Timing and place of Adherence Counseling for ART initiation Same day at ANC (n=47) Next visit at ANC (n=12) Both at ANC (n=16) At day of ART initiation at ART clinic (n=18) Timing of transfer to ART- or MIP clinic No transfer (n=9) No transfer (n=16) at 6 wks postnatal visit to MIP clinic (n=2) After receiving 1 st dose at ANC to ART clinic (n=38) at 6 wks postnatal visit: to ART clinic (n=24) to MIP clinic (n=51)

ANC indicators of health facilities by Model of Care MODEL A MODEL B MODEL C MODEL D P-value Women newly registered for ANC/quarter (median) Women newly tested positive/quarter (median) Known HIV-infected women already on ART 84%81%85% 0.7 HIV-infected women started ART during ANC 82%81%80% 0.9 Women not tested for HIV during ANC 18%32%30% 0.001

6-Month ART outcomes of health facilities by Model of Care MODEL A MODEL B MODEL C MODEL D P-value Women in cohort (median) Women retained on ART 80%78%89%92%0.008 Defaulted 18%20%10%7%0.02 Stopped <1% 0.6 Died 1%<1%1%<1%0.6

Health Facility variables associated with high HIV testing uptake at ANC Variables ASSOCIATEDVariables NOT associated Low Client : HIV testing Staff ratio District Client : Clinical staff ratio Health Facility type Number women registered in ANC Low number of out of stock observations of HIV test kits Model of Care applied aOR* Model A 3.4 Model B (lowest HTC uptake rate) - Model C n s *Controlled for all variables in the model

Health Facility variables associated with high 6-month retention Variables ASSOCIATEDVariables NOT associated District Health Facility type Client : Clinical staff ratio Timing of Adherence Counseling Availability ART/PMTCT services daily vs. not daily Availability of ART / MIP clinic for follow up Low number of women in Option B+ cohort Model of Care applied aOR* Model A n s Model B (lowest retention rate) - Model C 5.4 Model D n s *Controlled for all variables in the model

Discussion 18-32% of pregnant women not tested for HIV at ANC HIV testing uptake associated with o Client : HIV testing staff ratio o Test kit stock outs o Model of Care 7-20% of women defaulted Option B+ by 6 months Retention associated with o District location o Patient volume o Model of Care Worse program indicators in Model B Facilities where women receive only first dose of ART at ANC

Strengths and Limitations Strengths: Operational research – high quality routine government data: real world findings about Option B+ implementation Large dataset (141 facilities) Limitations: Results may not be representative for whole Malawi Health facility level data only (not patient level) Cross sectional study design –Residual confounding Attrition due to linkage of care not studied –Models of Care C and D

Conclusions Varieties in the way health facilities have integrated Option B+ care into routine service delivery Model of Care is associated with uptake of HIV testing in ANC and retention in care on ART Further patient-level research is needed to guide policy recommendations

USAID and The International Union Against TB and LD for funding Dignitas International medical program, M&E and Data departments Acknowledgements