Loss to follow-up among women in Option B+ PMTCT programme in Lilongwe, Malawi: Understanding outcomes and reasons Hannock Tweya, Salem Gugsa, Mina Hosseinipour, Colin Speight, Wingston Ng’ambi, Mphatso Bokosi, Janet Chikonda, Annie Chauma, Veena Sampathkumar, Tiwonge Mtande, Sam Phiri

Option B+ PMTCT strategy in Malawi Use of antiretroviral therapy in HIV-infected women significantly reduces vertical transmission; from 25% to 2% In 2011, Malawi embarked on a novel PMTCT programme known as “Option B+” Lifelong ART for pregnant and breastfeeding women regardless of WHO clinical stage or CD4 count NVP syrup for 6 weeks for infants Option B+ resulted in a 7-fold increase in the number of women starting ART for PMTCT between the 2nd quarter of 2011 and 3rd quarter 2012

Loss to follow-up in Option B+ PMTCT Loss to follow-up (LTFU) from care is a considerable barrier to the effectiveness of PMTCT 27% are LTFU at 12 month nationally (Malawi HIV Report Dec 2013) 24% are LTFU in the first 6 months in facilities with high patient volume (Tenthani et al AIDS 2013) Information on LTFU in women starting lifelong ART for PMTCT remains limited

Objectives To determine factors associated with LTFU among women starting lifelong ART for PMTCT To determine true outcomes of women who are lost to follow-up from PMTCT care To describe reasons for LTFU from Option B+ PMTCT programme

Methods: Study design & Setting We conducted a retrospective cohort study using data from A real-time, touch screen-based, electronic Medical Records (EMR) A patient tracing programme Bwaila Hospital, Lilongwe Has the busiest ANC and Maternity wings with over 14,000 ANC registrations annually Provision of PMTCT services is a collaborative effort, led by the Lilongwe District Health Office and other partners Starts ~110 women on ART monthly based on Option B+ criteria

Methods: PMTCT services All pregnant women with unknown HIV status undergo A group HIV counselling session ‘Opt-out’ provider-initiated HIV testing “Expert mothers” provide psychosocial and adherence support to HIV-infected women on initial and follow-up visits All HIV-infected women are registered in the EMR System and started on a lifelong ART on the day of HIV diagnosis At each visit, number of remaining ARV pills and new supply are recorded and next appointment is electronically calculated ART clinic visits are scheduled monthly

Methods: Tracing programme The patient tracing programme intends to decrease treatment interruption and prevent LTFU Tracing staff generate a list of women that miss an appointment by at least three weeks The staff confirms the list by checking in patients files Women who consent are traced up to three times by phone call or home visit The staff complete standard paper forms on tracing efforts, outcomes and reasons for missing appointment

Methods: Analysis Tracing outcomes include: Dead, uninterrupted therapy, treatment interruptions, self transfer out, stopped ART, never started ART and not traced For the purpose of the tracing programme, LTFU was defined as missing a scheduled clinic appointment for at least 3 weeks. Multivariable Poisson regression was used investigate factors associated with LTFU 1)‘silent-transfer’ if the patient had arranged the transfer independently; 2) alive on ART (with ‘treatment interruptions’ if a patient took none or fewer than the prescribed drugs before the interview date, or with ‘uninterrupted therapy’ if the patient was still taking ARVs despite missing appointment); 3) stopped ART by themselves; 4) refused to be interviewed; 5) never started ART although they collected drugs

Results: Patients details & LTFU Between September 2011 and September 2013, 2930 HIV-infected women started ART for PMTCT Option B+: 2,458 (84%) were pregnant Median age at ART initiation was 26 years (IQR 22-30) Median follow-up of 8.2 months (IQR 3.1-16.7) Of 2,930 women, 577 (20%) missed a scheduled clinic appointment for at least 3 weeks 272 only collected ARV’s at the time of initiation and did not return Overall incidence of LTFU was 23.5 % per year In terms of retention: 85% at 3 months, 82% at 6 months 79% at 12 months 14% were breastfeeding

Results: Factors associated with LTFU Characteristics Adjusted Rate Ratios (95% CI) P-Value Age at ART initiation (years) <0.001 13 - 24 1.29 (1.09 – .52) 25+ 1.00 Reason for ART initiation Breastfeeding 0.63 (0.49-0.89) Pregnant Employment Status 0.177 Yes 0.87 (0.71-1.07) No Year of B+ Implementation 2011 1.25 (1.06-1.49) 2012 2013 0.41 (0.29-0.58

Results: Tracing Outcomes 577 LTFU women 228 (40%) Successfully Traced 349 (60%) Not traced / Not found *No significant differences between those traced or not

Results: Tracing Outcomes 577 LTFU women 228 (40%) Successfully Traced 349 (60%) Not traced / Not found 67 (30%) Self Transfer 152 (66%) Alive not TO 9 (4%) Died

Results: Tracing Outcomes 577 LTFU women 228 (40%) Successfully Traced 349 (60%) Not traced / Not found 9 (4%) Died 67 (30%) Self Transfer 152 (66%) Alive not TO 9 (6%) ART interruption 7 (5%) Not started ART 5 (3%) Refused interview 118 (77%) Stopped ART 13 (9%) On ART Uninterrupted

Results: Reasons for ART discontinuations (N=111) % Travelled away 42 38% Transport costs 17 16% Limited information about ARVs 11 10% Suspected side effects of ARVs Very weak/sick Non-disclosure of HIV status to the spouse 9 8% Religious belief 5 5% Forgotten to take ARVs Other reasons 49 44% This would be a good opportunity to mention that

Discussion Overall LTFU was 23.5% per year Higher than that reported in the general HIV-infected individuals accessing ART for personal health ( 9.3% per year) 47% of women who were lost to follow-up received ARVs once and never returned for their appointment May suggest that a proportion of these women never started ART Being older ( 25+ years) associated with reduced risk of LTFU May have settled lifestyles which allow them to better manage ARVs Likelihood of LTFU decreased with increasing year of programme implementation between 2011 and 2013 Likely due to the stabilization of the programme

Discussion A sizeable proportion of women could not be traced due to incorrect addresses documented in the patient clinic files. False physical addresses because of fear of stigma and discrimination Among LTFU women that were traced: Half had stopped ART, leaving their infants at high risk of HIV A third self-transferred to another clinic, suggesting underestimation of national retention in PMTCT programme it is likely that a considerable number of women in this study may have deliberately given a false physical addresses because of fear of stigma and discrimination through inadvertent disclosure of their HIV status

Recommendations ANC/ART clinics should further enhance post-test counseling by engaging HIV testing counselors and expert mothers for ongoing counseling and psychosocial support. Establishing targeted programmes for young women ART clinics need to establish data linkages through which information of patients that transfer can be shared. Further decentralization of PMTCT services with good ANC/Maternity services

Acknowledgments Mother2Mother Baobab Health Trust 18