Frank Chimbwandira

Retention in care under universal antiretroviral therapy for HIV-infected pregnant and breastfeeding women ('Option B+') in Malawi

Objective:To explore the levels and determinants of loss to follow-up (LTF) under universal lifelong antiretroviral therapy (ART) for pregnant and breastfeeding women (‘Option B+’) in Malawi. Design, setting, and participants:We examined retention in care, from the date of ART initiation up to 6 months, for women in the Option B+ program. We analysed nationwide facility-level data on women who started ART at 540 facilities (n = 21 939), as well as individual-level data on patients who started ART at 19 large facilities (n = 11 534). Results:Of the women who started ART under Option B+ (n = 21 939), 17% appeared to be lost to follow-up 6 months after ART initiation. Most losses occurred in the first 3 months of therapy. Option B+ patients who started therapy during pregnancy were five times more likely than women who started ART in WHO stage 3/4 or with a CD4+ cell count 350 cells/&mgr;l or less, to never return after their initial clinic visit [odds ratio (OR) 5.0, 95% confidence interval (CI) 4.2–6.1]. Option B+ patients who started therapy while breastfeeding were twice as likely to miss their first follow-up visit (OR 2.2, 95% CI 1.8–2.8). LTF was highest in pregnant Option B+ patients who began ART at large clinics on the day they were diagnosed with HIV. LTF varied considerably between facilities, ranging from 0 to 58%. Conclusion:Decreasing LTF will improve the effectiveness of the Option B+ approach. Tailored interventions, like community or family-based models of care could improve its effectiveness.

Prevention of mother-to-child transmission of HIV and the health-related Millennium Development Goals: time for a public health approach

This article focuses on prevention of mother-to-child transmission (PMTCT) of HIV particularly in Malawi and discusses how the country is preparing to revise its policies for PMTCT of HIV and for antiretroviral therapy (ART) in response to WHOs 2010 guidelines. The authors propose offering all HIV-infected pregnant women lifelong ART which they see as a more feasible alternative to WHOs guidelines in addition to being more ethical. The article also describes the various benefits of their proposed plan and estimates the results and costs associated.

Using touchscreen electronic medical record systems to support and monitor national scale-up of antiretroviral therapy in Malawi.

Gerry Douglas and colleagues describe the rationale and their experience with scaling up electronic health records in six antiretroviral treatment sites in Malawi.

Retention in care during the first 3 years of antiretroviral therapy for women in Malawi's option B+ programme: an observational cohort study

BACKGROUND Studies of Malawis option B+ programme for HIV-positive pregnant and breastfeeding women have reported high loss to follow-up during pregnancy and at the start of antiretroviral therapy (ART), but few data exist about retention during breastfeeding and after weaning. We examined loss to follow-up and retention in care in patients in the option B+ programme during their first 3 years on ART. METHODS We analysed two data sources: aggregated facility-level data about patients in option B+ who started ART between Oct 1, 2011, and June 30, 2012, at 546 health facilities; and patient-level data from 20 large facilities with electronic medical record system for HIV-positive women who started ART between Sept 1, 2011, and Dec 31, 2013, under option B+ or because they had WHO clinical stages 3 or 4 disease or had CD4 counts of less than 350 cells per μL. We used facility-level data to calculate representative estimates of retention and loss to follow-up. We used patient-level data to study temporal trends in retention, timing of loss to follow-up, and predictors of no follow-up and loss to follow-up. We defined patients who were more than 60 days late for their first follow-up visit as having no follow-up and patients who were more than 60 days late for a subsequent visit as being lost to follow-up. We calculated proportions and cumulative probabilities of patients who had died, stopped ART, had no follow-up, were lost to follow-up, or were retained alive on ART for 36 months. We calculated odds ratios and hazard ratios to examine predictors of no follow-up and loss to follow-up. FINDINGS Analysis of facility-level data about patients in option B+ who had not transferred to a different facility showed retention in care to be 76·8% (20 475 of 26,658 patients) after 12 months, 70·8% (18,306 of 25,849 patients) after 24 months, and 69·7% (17,787 of 25,535 patients) after 36 months. Patient-level data included 29,145 patients. 14,630 (50·2%) began treatment under option B+. Patients in option B+ had a higher risk of having no follow-up and, for the first 2 years of ART, higher risk of loss to follow-up than did patients who started ART because they had CD4 counts less than 350 cells per μL or WHO clinical stage 3 or 4 disease. Risk of loss to follow-up during the third year was low and similar for patients retained for 2 years. Retention rates did not change as the option B+ programme matured. INTERPRETATION Our data suggest that pregnant and breastfeeding women who start ART immediately after they are diagnosed with HIV can be retained on ART through the option B+ programme, even after many have stopped breastfeeding. Interventions might be needed to improve retention in the first year on ART in option B+. FUNDING Bill & Melinda Gates Foundation, Partnerships for Enhanced Engagement in Research Health, and National Institute of Allergy and Infectious Diseases.

The Tingathe programme: A pilot intervention using community health workers to create a continuum of care in the prevention of mother to child transmission of HIV (PMTCT) cascade of services in Malawi

Loss to follow‐up is a major challenge in the prevention of mother to child transmission of HIV (PMTCT) programme in Malawi with reported loss to follow‐up of greater than 70%. Tingathe‐PMTCT is a pilot intervention that utilizes dedicated community health workers (CHWs) to create a complete continuum of care within the PMTCT cascade, improving service utilization and retention of mothers and infants. We describe the impact of the intervention on longitudinal care starting with diagnosis of the mother at antenatal care (ANC) through final diagnosis of the infant.

Antiretroviral drug supply challenges in the era of scaling up ART in Malawi

The number of people receiving antiretroviral treatment (ART) has increased considerably in recent years and is expected to continue to grow in the coming years. A major challenge is to maintain uninterrupted supplies of antiretroviral (ARV) drugs and prevent stock outs. This article discusses issues around the management of ARVs and prevention of stock outs in Malawi, a low-income country with a high HIV/AIDS burden, and a weak procurement and supply chain management system. This system for ARVs, paid for by the Global Fund to Fight AIDS, Tuberculosis and Malaria, and bypassing the government Central Medical Stores, is in place, using the United Nations Children’s Fund’s (UNICEF’s) procurement services. The system, managed by a handful of people who spend limited time on supply management, is characterized by a centrally coordinated quantification based on verified data from all national ART clinics, parallel procurement through UNICEF, and direct distribution to ART clinics. The model worked well in the first years of the ART programme with a single first-line ARV regimen, but with more regimens becoming available (e.g., alternative first-line, second-line and paediatric regimens), it has become more difficult to administer. Managing supplies through a parallel system has the advantage that weaknesses in the national system have limited influence on the ARV procurement and supply chain management system. However, as the current system operates without a central warehouse and national buffer stock capacity, it diminishes the ability to prevent ARV stock outs. The process of ordering ARVs, from the time that estimates are made to the arrival of supplies in health facilities, takes approximately one year. Addressing the challenges involved in maintaining ARVs through an efficient procurement and supply chain management system that prevents ARV stock outs through the establishment of a dedicated procurement team, a central warehouse and/or national buffer stock is a priority.

Implementation and Operational Research: The Impact of Option B+ on the Antenatal PMTCT Cascade in Lilongwe, Malawi

Objective:In 2011, Malawi implemented Option B+ (B+), lifelong antiretroviral therapy (ART) for pregnant and breastfeeding women. We aimed to describe changes in service uptake and outcomes along the antenatal prevention of mother-to-child transmission (PMTCT) cascade post-B+ implementation. Design:Pre/post study using routinely collected program data from 2 large Lilongwe-based health centers. Methods:We compared the testing of HIV-infected pregnant women at antenatal care, enrollment into PMTCT services, receipt of ART, and 6-month ART outcomes pre-B+ (October 2009–March 2011) and post-B+ (October 2011–March 2013). Results:A total of 13,926 (pre) and 14,532 (post) women presented to antenatal care. Post-B+, a smaller proportion were HIV-tested (99.3% vs. 87.7% post-B+; P < 0.0001). There were 1654 (pre) and 1535 (post) HIV-infected women identified, with a larger proportion already known to be HIV-infected (18.1% vs. 41.2% post-B+; P < 0.0001) and on ART post-B+ (18.7% vs. 30.2% post-B+; P < 0.0001). A significantly greater proportion enrolled into the PMTCT program (68.3% vs. 92.6% post-B+; P < 0.0001) and was retained through delivery post-B+ (51.1% vs. 65% post-B+; P < 0.0001). Among those not on ART at enrollment, there was no change in the proportion newly initiating ART/antiretrovirals (79% vs. 81.9% post-B+; P = 0.11), although median days to initiation of ART decreased [48 days (19, 130) vs. 0 days (0, 15.5) post-B+; P < 0.0001]. Among those newly initiating ART, a smaller proportion was alive on ART 6 months after initiation (89.3% vs. 78.8% post-B+; P = 0.0004). Conclusions:Although several improvements in PMTCT program performance were noted with implementation of B+, challenges remain at several critical steps along the cascade requiring innovative solutions to ensure an AIDS-free generation.

Multi-Country Analysis of Treatment Costs for HIV/AIDS (MATCH): Facility-Level ART Unit Cost Analysis in Ethiopia, Malawi, Rwanda, South Africa and Zambia

Background Todays uncertain HIV funding landscape threatens to slow progress towards treatment goals. Understanding the costs of antiretroviral therapy (ART) will be essential for governments to make informed policy decisions about the pace of scale-up under the 2013 WHO HIV Treatment Guidelines, which increase the number of people eligible for treatment from 17.6 million to 28.6 million. The study presented here is one of the largest of its kind and the first to describe the facility-level cost of ART in a random sample of facilities in Ethiopia, Malawi, Rwanda, South Africa and Zambia. Methods & Findings In 2010–2011, comprehensive data on one year of facility-level ART costs and patient outcomes were collected from 161 facilities, selected using stratified random sampling. Overall, facility-level ART costs were significantly lower than expected in four of the five countries, with a simple average of

Adherence to Antiretroviral Therapy During and After Pregnancy: Cohort Study on Women Receiving Care in Malawi's Option B+ Program

208 per patient-year (ppy) across Ethiopia, Malawi, Rwanda and Zambia. Costs were higher in South Africa, at

Keeping health facilities safe: one way of strengthening the interaction between disease-specific programmes and health systems

682 ppy. This included medications, laboratory services, direct and indirect personnel, patient support, equipment and administrative services. Facilities demonstrated the ability to retain patients alive and on treatment at these costs, although outcomes for established patients (2–8% annual loss to follow-up or death) were better than outcomes for new patients in their first year of ART (77–95% alive and on treatment). Conclusions This study illustrated that the facility-level costs of ART are lower than previously understood in these five countries. While limitations must be considered, and costs will vary across countries, this suggests that expanded treatment coverage may be affordable. Further research is needed to understand investment costs of treatment scale-up, non-facility costs and opportunities for more efficient resource allocation.