Caryl Feldacker

Are They Really Lost? “True” Status and Reasons for Treatment Discontinuation among HIV Infected Patients on Antiretroviral Therapy Considered Lost to Follow Up in Urban Malawi

Introduction Patients who are lost to follow-up (LTFU) while on antiretroviral therapy (ART) pose challenges to the long-term success of ART programs. We describe the extent to which patients considered LTFU are misclassified as true disengagement from care when they are still alive on ART and explain reasons for ART discontinuation using our active tracing program to further improve ART retention programs and policies. Methods We identified adult ART patients who missed clinic appointment by more than 3 weeks between January 2006 and December 2010, assuming that such patients would miss their doses of antiretroviral drugs. Patients considered LTFU who consented during ART registration were traced by phone or home visits; true ART status after tracing was documented. Reasons for ART discontinuation were also recorded for those who stopped ART. Results Of the 4,560 suspected LTFU cases, 1,384 (30%) could not be traced. Of the 3,176 successfully traced patients, 952 (30%) were dead and 2,224 (70%) were alive, of which 2,183 (99.5%) started ART according to phone-based self-reports or physical verification during in-person interviews. Of those who started ART, 957 (44%) stopped ART and 1,226 (56%) reported still taking ART at the time of interview by sourcing drugs from another clinic, using alternative ART sources or making brief ART interruptions. Among 940 cases with reasons for ART discontinuations, failure to remember (17%), too weak/sick (12%), travel (46%), and lack of transport to the clinic (16%) were frequently cited; reasons differed by gender. Conclusion The LTFU category comprises sizeable proportions of patients still taking ART that may potentially bias retention estimates and misdirect resources at the clinic and national levels if not properly accounted for. Clinics should consider further decentralization efforts, increasing drug allocations for frequent travels, and improving communication on patient transfers between clinics to increase retention and adherence.

Comparison of Treatment Outcomes of New Smear-Positive Pulmonary Tuberculosis Patients by HIV and Antiretroviral Status in a TB/HIV Clinic, Malawi

Background Smear-positive pulmonary TB is the most infectious form of TB. Previous studies on the effect of HIV and antiretroviral therapy on TB treatment outcomes among these highly infectious patients demonstrated conflicting results, reducing understanding of important issues. Methods All adult smear-positive pulmonary TB patients diagnosed between 2008 and 2010 in Malawi’s largest public, integrated TB/HIV clinic were included in the study to assess treatment outcomes by HIV and antiretroviral therapy status using logistic regression. Results Of 2,361 new smear-positive pulmonary TB patients, 86% had successful treatment outcome (were cured or completed treatment), 5% died, 6% were lost to follow-up, 1% failed treatment, and 2% transferred-out. Overall HIV prevalence was 56%. After adjusting for gender, age and TB registration year, treatment success was higher among HIV-negative than HIV-positive patients (adjusted odds ratio 1.49; 95% CI: 1.14–1.94). Of 1,275 HIV-infected pulmonary TB patients, 492 (38%) received antiretroviral therapy during the study. Pulmonary TB patients on antiretroviral therapy were more likely to have successful treatment outcomes than those not on ART (adjusted odds ratio : 1.83; 95% CI: 1.29–2.60). Conclusion HIV co-infection was associated with poor TB treatment outcomes. Despite high HIV prevalence and the integrated TB/HIV setting, only a minority of patients started antiretroviral therapy. Intensified patient education and provider training on the benefits of antiretroviral therapy could increase antiretroviral therapy uptake and improve TB treatment success among these most infectious patients.

Integrated tuberculosis and HIV care in a resource-limited setting: experience from the Martin Preuss centre, Malawi

Objectives  To describe the development and operation of integrated tuberculosis (TB) and HIV care at the Martin Preuss Centre, a multipartner organization bringing together governmental and non‐governmental providers of HIV and TB services in Lilongwe, Malawi.

Who Starts? Factors Associated with Starting Antiretroviral Therapy among Eligible Patients in Two, Public HIV Clinics in Lilongwe, Malawi

Background Lighthouse Trust operates two, public, integrated HIV clinics, Lighthouse (LH) and Martin Preuss Center (MPC), in Lilongwe, Malawi. Approximately 20% of patients eligible for antiretroviral therapy (ART) do not start ART. We explore individual and geographic factors that influence whether ART-eligible patients initiate ART. Methods Adult patients eligible for ART between 2008–2011 were included. Analysis was stratified by clinic. Using logistic regression, we evaluated factors associated with initiating ART including gender, age, body mass index (BMI), employment, tuberculosis (TB), eligible at initial registration, WHO stage, CD4, months in pre-ART care (from initial registration to eligibility date), and patient neighborhood distance to clinic. Results Of 14,216 study patients, 4841 were from LH; 9285 were from MPC. At LH and MPC, respectively, median age was 34.2 and 33.8 years; median BMI was 22.0 and 20.6; and median distance was 5.6 and 4.9 Km. In multivariate models, odds of starting ART was highest among those older than 35 years and those eligible for ART based on WHO stages 3–4 vs. those in WHO stages 1–2 with CD4<250. Patients with 1–12 months in pre-ART were at least 11 times more likely to start ART than peers with less pre-ART time. At LH, living 2.5–5 Km from the clinic increased the likelihood of starting ART over patients living closer. Conclusions Length of the pre-ART period is the most significant predictor of starting ART among eligible patients. Better understanding of motivation for retention in pre-ART care may reduce attrition along the treatment cascade.

Ensuring HIV-infected pregnant women start antiretroviral treatment: an operational cohort study from Lilongwe, Malawi

Objectives  HIV‐infected women identified through antenatal care (ANC) often fail to access antiretroviral treatment (ART), leaving them and their infants at risk for declining health or HIV transmission. We describe results of measures to improve uptake of ART among eligible pregnant women.

Nurse task shifting for antiretroviral treatment services in Namibia: implementation research to move evidence into action.

Background Evidence from several sub-Saharan countries support nurse-initiated antiretroviral treatment as a feasible alternative to doctor-led models characteristic of early responses to the HIV epidemic. However, service delivery models shown to be effective in one country may not be readily adopted in another. This study used an implementation research approach to assist policy makers and other stakeholders to assess the acceptability and feasibility of task shifting in the Namibian context. Methods The Namibian Ministry of Health and Social Services implemented a Task Shifting Demonstration Project (TSDP) at 9 sites at different levels of the health system. Six months after implementation, a mixed methods evaluation was conducted. Seventy semi-structured interviews were conducted with patients, managers, doctors and nurses directly involved with the TSDP. Physician-evaluators observed and compared health service provision between doctors and nurses for 40 patients (80 observations), documenting performance in agreement with the national guidelines on 13 clinical care indicators. Results Doctors, nurses, and patients interviewed believed task shifting would improve access to and quality of HIV services. Doctors and nurses both reported an increase in nurses’ skills as a result of the project. Observation data showed doctors and nurses were in considerable agreement (>80%) with each other on all dimensions of HIV care and ≥90% on eight dimensions. To ensure success of national scale-up of the task shifting model, challenges involving infrastructure, on-going mentoring, and nursing scope of practice should be anticipated and addressed. Conclusion In combination with findings from other studies in the region, data from the TSDP provided critical and timely information to the Namibian Ministry of Health and Social Services, thus helping to move evidence into action. Small-scale implementation research projects enable stakeholders to learn by doing, and provide an opportunity to test and modify the intervention before expansion.

Tracing of patients lost to follow-up and HIV transmission: mathematical modeling study based on 2 large ART programs in Malawi.

Objective:Treatment as prevention depends on retaining HIV-infected patients in care. We investigated the effect on HIV transmission of bringing patients lost to follow-up (LTFU) back into care. Design:Mathematical model. Methods:Stochastic mathematical model of cohorts of 1000 HIV-infected patients on antiretroviral therapy, based on the data from 2 clinics in Lilongwe, Malawi. We calculated cohort viral load (sum of individual mean viral loads each year) and used a mathematical relationship between viral load and transmission probability to estimate the number of new HIV infections. We simulated 4 scenarios: “no LTFU” (all patients stay in care), “no tracing” (patients LTFU are not traced), “immediate tracing” (after missed clinic appointment), and “delayed tracing” (after 6 months). Results:About 440 of 1000 patients were LTFU over 5 years. Cohort viral loads (million copies/mL per 1000 patients) were 3.7 [95% prediction interval (PrI), 2.9–4.9] for no LTFU, 8.6 (95% PrI, 7.3–10.0) for no tracing, 7.7 (95% PrI, 6.2–9.1) for immediate, and 8.0 (95% PrI, 6.7–9.5) for delayed tracing. Comparing no LTFU with no tracing, the number of new infections increased from 33 (95% PrI, 29–38) to 54 (95% PrI, 47–60) per 1000 patients. Immediate tracing prevented 3.6 (95% PrI, −3.3 to 12.8) and delayed tracing 2.5 (95% PrI, −5.8 to 11.1) new infections per 1000. Immediate tracing was more efficient than delayed tracing: to 116 and 142 tracing efforts, respectively, were needed prevent 1 new infection. Conclusions:Tracing of patients LTFU enhances the preventive effect of antiretroviral therapy, but the number of transmissions prevented is small.

Contraceptive adherence among HIV-infected women in Malawi: a randomized controlled trial of the copper intrauterine device and depot medroxyprogesterone acetate.

OBJECTIVE To evaluate contraceptive adherence to the copper intrauterine device (Cu-IUD) and the injectable depot medroxyprogesterone acetate (DMPA) among women with HIV in Lilongwe, Malawi. METHODS We randomized 200 HIV-infected women on highly active antiretroviral therapy (HAART) to either the Cu-IUD or DMPA and followed these women prospectively, evaluating adherence and factors associated with nonadherence. RESULTS There was no difference in contraceptive adherence: 68% of Cu-IUD and 65% of DMPA users were adherent at 48 weeks. Receiving first-choice contraceptive was not associated with adherence. Women commonly cited partners disapproval as an indication for discontinuation. Women who experienced heavy menstruation and first-time contraceptive users were more likely to be nonadherent. Among ongoing users at study conclusion, 95% were happy with their method, and 98% would recommend their method to a friend. CONCLUSION Contraceptive adherence between the Cu-IUD and DMPA was similar at 1 year. With similar adherence and similar high rates of satisfaction among users of both methods at 1 year, the Cu-IUD offers a hormone-free alternative to DMPA. IMPLICATIONS Adherence to the Cu-IUD and DMPA is similar at 1 year among HIV-infected women on HAART in a randomized controlled trial. Despite high method satisfaction, partner disapproval and heavy bleeding contribute to reduced adherence. Receiving a method that differs from participants first-choice method did not influence adherence.

Integrating reproductive health services into HIV care: strategies for successful implementation in a low- resource HIV clinic in Lilongwe, Malawi

Background Lighthouse Trust operates two public HIV testing, treatment and care clinics in Lilongwe, Malawi, caring for over 26 000 people living with HIV, 23 000 of whom are on antiretroviral treatment (ART). In August 2010, Lighthouse Trust piloted a step-wise integration of sexual and reproductive health (SRH) services into routine HIV care at its Lighthouse clinic site. The objectives were to increase uptake of family planning (FP), promote long-term reversible contraceptive methods, and increase access, screening and treatment for cervical cancer using visual inspection with acetic acid. Methods and results Patients found integrated SRH/ART services acceptable; service availability appeared to increase uptake. Between August 2010 and May 2014, over 6000 women at Lighthouse received FP education messages. Of 859 women who initiated FP, 55% chose depot medroxyprogesterone acetate, 19% chose an intrauterine contraceptive device, 14% chose oral contraceptive pills, and 12% chose an implant. By May 2014, 21% of eligible female patients received cervical cancer screening: 11% (166 women) had abnormal cervical findings during screening for cervical cancer and underwent further treatment. Conclusions Several lessons were learned in overcoming initial concerns about integration. First, our integrated services required minimal additional resources over those needed for provision of HIV care alone. Second, patient flow improved during implementation, reducing a barrier for clients seeking multiple services. Lastly, analysis of routine data showed that the proportion of women using some form of modern contraception was 45% higher at Lighthouse than at Lighthouses sister clinic where services were not integrated (42% vs 29%), providing further evidence for promotion of SRH/ART integration.

Developing a point-of-care electronic medical record system for TB/HIV co-infected patients: experiences from Lighthouse Trust, Lilongwe, Malawi

BackgroundImplementation of user-friendly, real-time, electronic medical records for patient management may lead to improved adherence to clinical guidelines and improved quality of patient care. We detail the systematic, iterative process that implementation partners, Lighthouse clinic and Baobab Health Trust, employed to develop and implement a point-of-care electronic medical records system in an integrated, public clinic in Malawi that serves HIV-infected and tuberculosis (TB) patients.MethodsBaobab Health Trust, the system developers, conducted a series of technical and clinical meetings with Lighthouse and Ministry of Health to determine specifications. Multiple pre-testing sessions assessed patient flow, question clarity, information sequencing, and verified compliance to national guidelines. Final components of the TB/HIV electronic medical records system include: patient demographics; anthropometric measurements; laboratory samples and results; HIV testing; WHO clinical staging; TB diagnosis; family planning; clinical review; and drug dispensing.ResultsOur experience suggests that an electronic medical records system can improve patient management, enhance integration of TB/HIV services, and improve provider decision-making. However, despite sufficient funding and motivation, several challenges delayed system launch including: expansion of system components to include of HIV testing and counseling services; changes in the national antiretroviral treatment guidelines that required system revision; and low confidence to use the system among new healthcare workers. To ensure a more robust and agile system that met all stakeholder and user needs, our electronic medical records launch was delayed more than a year. Open communication with stakeholders, careful consideration of ongoing provider input, and a well-functioning, backup, paper-based TB registry helped ensure successful implementation and sustainability of the system. Additional, on-site, technical support provided reassurance and swift problem-solving during the extended launch period.ConclusionEven when system users are closely involved in the design and development of an electronic medical record system, it is critical to allow sufficient time for software development, solicitation of detailed feedback from both users and stakeholders, and iterative system revisions to successfully transition from paper to point-of-care electronic medical records. For those in low-resource settings, electronic medical records for integrated care is a possible and positive innovation.