Early experiences integrating hypertension and diabetes screening and treatment in a human immunodeficiency virus clinic in Malawi.

Background: Human immunodeficiency virus (HIV) programmes can be leveraged to manage the growing burden of non-communicable diseases (NCDs). Methods: In October 2015, a model of integrated HIV-NCD care was developed at a large HIV clinic in southeast Malawi. Blood pressure was measured in adults at every visit and random blood glucose was determined every 2 y. Uncomplicated antiretroviral therapy (ART)-only care was provided by nurses, integrated HIV-NCD management was provided by clinical officers. Waiting times were assessed using the electronic medical record system. The team met monthly to identify bottlenecks. Results: All (n=6036) adult HIV patients were screened and 765 were diagnosed with hypertension (prevalence 12.7% [95% confidence interval {CI} 11.9-13.5). A total of 2979 adult HIV patients were screened and 25 were diagnosed with diabetes mellitus (prevalence 0.8% [95% CI 0.6-1.2]). The mean duration of ART visits by clinical officers increased from 80.5 to 90 min during the first quarter following HIV-NCD integration but returned to 75 min the following quarter. The mean number of patients seen per day by clinical officers increased from 6 to 11 and for nurses decreased from 92 to 82 in that time period. The robust vertical HIV system made the design of integrated tools demanding. Challenges of integrated HIV-NCD care were related to patient flow, waiting times, NCD drug availability, data collection, clinic workload and the timing of diabetes and hypertension screening. Conclusions: Integrated HIV-NCD services provision was feasible in our clinic.

Integrating HIV and hypertension management in low-resource settings: Lessons from Malawi.

Pragna Patel and colleagues describe the implementation of a hypertension management model for HIV-infected people in Malawi.

Anemia in people on second line antiretroviral treatment in Lilongwe, Malawi: a cross-sectional study.

BACKGROUND: Anemia is common among people living with HIV infection and is frequently associated with poor quality of life and poor prognosis. It has been well described in antiretroviral naïve individuals and those on non-nucleoside reverse transcriptase inhibitor-based first line antiretroviral therapy (ART) regimens. However there is limited information on anemia for ART experienced individuals on protease inhibitor-based second line ART regimens in resource limited settings. Our objective was to describe the prevalence and risk factors of anemia in this ART experienced population in Malawi. METHODS: We conducted a cross-sectional study using routine facility data at two HIV clinics in Lilongwe, Malawi. The analysis included individuals receiving protease inhibitor-based second line ART. Clinical and laboratory data were collected at routine clinic visits. We used descriptive statistics, two-sample t-tests and multivariate logistic regression for data analysis. RESULTS: Three hundred seventy-seven records were included in this analysis (37% male, median age 41 years, median CD4 count 415 cells/µL). The prevalence of anemia was 125/377 (33.2%) - mild, moderate and severe anemia was 17.5%, 13.8%, and 1.9% respectively. Female participants had a higher prevalence than male participants (43.6% vs. 15.7%, p < 0.001). In multivariate logistic regression, female sex (adjusted odds ratio (aOR) 5.3; 95% CI 2.9-9.5) and a CD4 count <200 cell/ul (aOR 3.1; 95%CI 1.6-6.0) were associated with increased risk of having anemia while a BMI ≥30 kg/m2 (aOR 0.8; 95% CI 0.6-1.0) and being on ART for more than 10 years (aOR 0.4; 95% CI 0.2-0.9) were associated with reduced risk of anemia. Being on a zidovudine- containing ART regimen was not associated with anemia. CONCLUSION: Anemia is common in people on second line ART in Lilongwe, Malawi. Screening for anemia in this population would be a useful strategy; especially for female patients, those who are underweight and have a low CD4 cell counts.

Assessing Option B+ retention and infant follow-up in Lilongwe, Malawi.

Malawi launched Option B+, a program for all pregnant or breastfeeding HIV-positive women to begin lifelong combination antiretroviral therapy (cART), in July 2011. This study characterises a portion of the continuum of care within an antenatal setting in Lilongwe. Women testing HIV-positive and having a cART initiation record at Bwaila Antenatal Clinic from July 2013 to January 2014 were included. Using logistic regression models, we analysed relationships between maternal characteristics and return for infant testing. Among 490 HIV-positive women with a cART initiation record, 360 (73%) were retained at three months. Of these, 203 (56%) were adherent. Records of infant testing were located for 204 women (42%). Women who were not retained were less likely to have an early infant diagnosis record (aOR = 0.20; 95% CI: 0.10, 0.41). Among the women retained, there was a non-significant association between maternal adherence and infant testing (OR = 1.35; 95% CI: 0.89, 2.06). Women lost at earlier continuum stages, who are at higher risk for mother-to-child-transmission, were less likely to bring infants for testing. Even with a test-and-treat program, many women did not remain in care or bring their infant for testing. Facilitating strategies to improve these measures remains an important unmet need.

Early experiences in integrating cervical cancer screening and treatment into HIV services in Zomba Central Hospital, Malawi.

Background: Malawi has the highest rate of cervical cancer globally and cervical cancer is six to eight times more common in women with HIV. HIV programmes provide an ideal setting to integrate cervical cancer screening. Methods: Tisungane HIV clinic at Zomba Central Hospital has around 3,700 adult women receiving treatment. In October 2015, a model of integrated cervical cancer screening using visual inspection with acetic acid (VIA) was adopted. All women aged 20 and above in the HIV clinic were asked if they had cervical cancer screening in the past three years and, if not, were referred for screening. Screening was done daily by nurses in a room adjacent to the HIV clinic. Cold coagulation was used to treat pre-cancerous lesions. From October 2016, a modification to the HIV programme's electronic medical record was developed that assisted in matching numbers of women sent for screening with daily screening capacity and alerted providers to women with pre-cancerous lesions who missed referrals or treatment. Results: Between May 2016 and March 2017, cervical cancer screening was performed in 957 women from the HIV clinic. Of the 686 (71%) women who underwent first ever screening, 23 (3.4%) were found to have VIA positive lesions suggestive of pre-cancer, of whom 8 (35%) had a same-day cold coagulation procedure, seven (30%) deferred cold coagulation to a later date (of whom 4 came for treatment), and 8 (35%) were referred to surgery due to size of lesion; 5/686 (0.7%) women had lesions suspicious of cancer. Conclusion: Incorporating cervical cancer screening into services at HIV clinics is feasible. A structured approach to screening in the HIV clinic was important.

Integrating family planning services into HIV care: use of a point-of-care electronic medical record system in Lilongwe, Malawi.

BACKGROUND: Integrating family planning (FP) services into human immunodeficiency virus (HIV) clinical care helps improve access to contraceptives for women living with HIV. However, high patient volumes may limit providers' ability to counsel women about pregnancy risks and contraceptive options. OBJECTIVES: To assess trends in the use of contraceptive methods after implementing an  electronic medical record (EMR) system with FP questions and determine the reasons for non-use of contraceptives among women of reproductive age (15-49 years) receiving antiretroviral therapy (ART) at the Martin Preuss Center clinic in Malawi. METHODS: In February 2012, two FP questions were incorporated into the ART EMR system (initial FP EMR module) to prompt providers to offer contraceptives to women. In July 2013, additional questions were added to the FP EMR module (enhanced FP EMR) to prompt providers to assess risks of unintended pregnancies, solicit reasons for non-use of contraceptives and offer contraceptives to non-pregnant women . We conducted a retrospective, longitudinal cohort study using the EMR routinely collected data. The primary outcome was the use of any modern contraceptive method. Descriptive statistics were used to describe the study population and report trends in contraceptive use during the initial and enhanced study periods. RESULTS: Between February 2012 and December 2016, in HIV clinics, 20,253 women of reproductive age received ART, resulting in 163,325 clinic visits observations. The proportion of women using contraceptives increased significantly from 18% to 39% between February 2012 and June 2013, and from 39% to 67% between July 2013 and December 2016 (chi-square for trend p < 0.001). Common reasons reported for the non-use of contraceptives among those at risk of unintended pregnancy were: pregnancy ambivalence (n = 234, 51%) and never thought about it (n = 133, 29%). CONCLUSION: Incorporating the FP EMR module into HIV clinical care prompted healthcare workers to encourage the use of contraceptives.

A cross-sectional study to evaluate second line virological failure and elevated bilirubin as a surrogate for adherence to atazanavir/ritonavir in two urban HIV clinics in Lilongwe, Malawi.

BACKGROUND: Malawi's national antiretroviral therapy program provides atazanavir/ritonavir-based second line regimens which cause concentration-dependent rise in indirect bilirubin. We sought to determine if elevated bilirubin, as a surrogate of atazanavir/ritonavir adherence, can aid in the evaluation of second line virological failure in Malawi. METHODS: We conducted a cross-sectional study of HIV-infected patients ≥15 years who were on boosted protease inhibitor-based second line antiretroviral therapy for at least 6 months in two urban HIV clinics in Lilongwe, Malawi. Antiretroviral therapy history and adherence data were extracted from the electronic medical records and blood was drawn for viral load, complete blood count, total bilirubin, and CD4 cell count at a clinic visit. Factors associated with virological failure were assessed using multivariate logistic regression model. RESULTS: Out of 376 patients on second line antiretroviral therapy evaluated, 372 (98.9%) were on atazanavir/ritonavir-based therapy and 142 (37.8%) were male. Mean age was 40.9 years (SD ± 10.1), mean duration on second line antiretroviral therapy was 41.9 months (SD ± 27.6) and 256 patients (68.1%) had elevated bilirubin >1.3 mg/dL. Overall, 35 (9.3%) patients had viral load >1000 copies/ml (virological failure). Among the virologically failing vs. non-failing patients, bilirubin was elevated in 34.3% vs. 72.0% respectively (p < 0.001), although adherence by pill count was similar (62.9% vs. 60.7%, p = 0.804). The odds of virological failure were higher for adults aged 25-40 years (adjusted odds ratio (aOR) 2.5, p = 0.048), those with CD4 cell count <100 (aOR 17.5, p < 0.001), and those with normal bilirubin levels (aOR 5.4, p < 0.001); but were lower for the overweight/obese patients (aOR 0.3, p = 0.026). Poor pill count adherence (aOR 0.7, p = 0.4) and male gender (aOR 1.2, p = 0.698) were not associated with second line virological failure. CONCLUSIONS: Among patients receiving atazanavir/ritonavir-based second line antiretroviral therapy, bilirubin levels better predicted virological failure than pill count adherence. Therefore, strategic use of bilirubin and viral load testing to target adherence counseling and support may be cost-effective in monitoring second line antiretroviral therapy adherence and virological failure. Drug resistance testing targeted for patients with virological failure despite elevated bilirubin levels would facilitate timely switch to third line antiretroviral regimens whenever available.

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 Lighthouse's sister clinic where services were not integrated (42% vs 29%), providing further evidence for promotion of SRH/ART integration.

Estimation of the true incidence of lactic acidosis within the Lighthouse Clinic cohort, and the likely magnitude of missed diagnoses in the region.

INTRODUCTION: Lactic acidosis is one of the most serious side effects associated with ART, most commonly associated with stavudine. Clinical features are non-specific and specialist laboratory capabilities are essential to confirm the diagnosis, making under-diagnosis likely in resource-constrained settings. Lighthouse Trust is a tertiary referral ART centre with over 23,500 patients on ART. The adjacent University of North Carolina Project laboratory, also serving Kamuzu Central Hospital, has been the only site processing lactate tests in Central Zone for many years. Our objective was to quantify the true incidence within our cohort, and estimate the likely degree of historical missed diagnoses from less central ART clinics. METHODS: All high lactate results between June 2010 and June 2013 were treated as cases, and cross referenced with the Lighthouse database. Patients transferring in to Lighthouse within one month prior to diagnosis were assumed to have been referred due to their lactic acidosis, and moved to the Central Zone cohort to avoid referral bias. Routinely collected quarterly ART cohort data for both Lighthouse and the entire Central Zone were analyzed. RESULTS: Over the three-year period, from within the Lighthouse cohort, there were 138 cases: 74% were female, median duration on ART was 14 months (IQR 10-26), and 98.5% were attributable to stavudine (only two cases to zidovudine). Over this period, the average number of patients taking stavudine at Lighthouse was 10,960 (3,600 on zidovudine). For the whole Central Zone (minus Lighthouse patients) there were 61,000 on stavudine (4,830 on zidovudine), yet only 124 cases of lactic acidosis were apparently diagnosed from within this cohort. CONCLUSIONS: Although cases may, of course, also have been missed at Lighthouse, as a tertiary referral centre the rate observed is likely to be closer to the true incidence. Over the three years, with 138 cases from the 10,960 patients taking stavudine at Lighthouse, it is likely that somewhere in the region of 700 additional cases occurred amongst the 61,000 patients elsewhere in the Central Zone. This equates to somewhere in the region of 550 missed diagnoses or 80% of all cases. Given that the clinical sequelae of undiagnosed lactic acidosis are either death or at best ART default, this provides further vindication for the decision to phase out stavudine in Malawi.

Improving PMTCT uptake and retention services through novel approaches in peer-based family-supported care in the clinic and community: a 3-arm cluster randomized trial (PURE Malawi).

In July 2011, Malawi introduced an ambitious public health program known as "Option B+," which provides all HIV-infected pregnant and breastfeeding women with lifelong combination antiretroviral therapy, regardless of clinical stage or CD4 count. Option B+ is expected to have benefits for HIV-infected women, their HIV-exposed infants, and their HIV-uninfected male sex partners. However, these benefits hinge on early uptake of prevention of mother-to-child transmission, good adherence, and long-term retention in care. The Prevention of mother-to-child transmission Uptake and REtention (PURE) study is a 3-arm cluster randomized controlled trial to evaluate whether clinic- or community-based peer support will improve care-seeking and retention in care by HIV-infected pregnant and breastfeeding women, their HIV-exposed infants, and their male sex partners, and ultimately improve health outcomes in all 3 populations. We describe the PURE Malawi Consortium, the initial work conducted to inform the trial and interventions, the trial design, and the analysis plan. We then discuss concerns and expected contributions to Malawi and the region.

Understanding factors, outcomes and reasons for loss to follow-up among women in Option B+ PMTCT programme in Lilongwe, Malawi.

OBJECTIVE: To assess factors, outcomes and reasons for loss to follow-up (LTFU) among pregnant and breastfeeding women initiated on a lifelong antiretroviral therapy (ART) for PMTCT in a large antenatal clinic in Malawi. METHODS: We identified all pregnant and breastfeeding women who were initiated on ART between September 2011 and September 2013 and had missed their clinic appointment by at least 3 weeks at Bwaila Hospital, the largest antenatal clinic in Malawi. These women were traced by phone or home visits. Their true status and reasons for ART discontinuation were documented during tracing. RESULTS: A total of 2930 women started ART for PMTCT; 2458 (84%) pregnant and 472 (16%) breastfeeding, of which, 577 (20%) missed a scheduled clinic appointment. LTFU was associated with younger age, being pregnant, and earlier year of ART initiation. We successfully traced 229 (40%), of whom, 10 (4%) had died. Of the 219 women found alive, 118 (54%) had stopped taking ARV drugs, 67 (30%) had self-transferred to another ART clinic, 13 (6%) had collected drugs from other sources, 9 (4%) had treatment interruptions and 12 (5%) had other outcomes. Reasons cited for stopping ART were travel (38%), lack of transport money (16%), not understanding the initial ARV education session (10%), being too weak/sick (10%), ARV side effects (10%) and other reasons. CONCLUSION: Approximately half of the women who were traced were taking ARVs. The study emphasises the need for enhanced post-test counselling strategies, ongoing psychosocial support, provision of incentives and further decentralisation efforts of PMTCT services.

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.