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Introduction Point-of-care (POC) technologies in resource-limited settings can circumvent challenges of centralized laboratory testing, improving clinical management. However, higher device costs and uncertain indications for use have inhibited scaling up POC modalities. To address this gap, we investigated the feasibility and cost of targeted near-POC viral load (VL) testing in 2 large HIV clinics in Lilongwe, Malawi. Methods VL testing using GeneXpert was targeted for patients suspected of treatment failure or returning to care after a previously elevated VL (>1000 copies/mL). Descriptive analysis of retrospective clinical and cost data is presented. Results Two thousand eight hundred thirteen near-POC VL tests were conducted. One thousand five hundred eleven (54%) tests were for patients for whom results and reason for the test were documented: 57% (794/1389) of tests were to confirm a previously high VL, and 33% (462/1389) were due to clinical indications. Sixty-one percent (926/1511) of patients had a high VL, of whom 78% (719/926) had a recorded clinical action: 77% (557/719) switched to second line antiretroviral therapy, and 15% (194/719) were referred for intensive adherence counseling. Eighty-two percent (567/687) of patients received a clinical action on the same day as testing. The "all-in" cost was $33.71 for a valid POC VL test, compared with an international benchmark for a centralized VL test of $28.62. Conclusion Targeted, near-POC VL testing was feasible and consistently enabled prompt clinical action. The difference between the "all-in" cost of near-POC VL and centralized testing of $5.09 could be further reduced in an optimized national program by combining targeted near-POC testing and centralized testing.

Background As routine viral load testing among HIV-infected individuals on antiretroviral therapy (ART) expands, virologic failure (VF) among children in developing countries remains poorly understood. We assessed the rate of VF, the proportion failing who were subsequently switched to second-line ART and factors associated with VF among children ≤18 y. Methods An observation cohort study among 1312 children at two public clinics in Lilongwe, Malawi who initiated a first-line ART regimen between January 2014 and December 2017 and remained on treatment for ≥6 mo was conducted. Kaplan-Meier methods estimated the probabilities of VF. Univariable and multivariable Poisson regression models were used to explore predictors of VF. Result Overall, 16% (208/1312) of children experienced VF with an incidence rate of 10.1 events per 100 person-years. Of the 208, 184 (88%) were switched to second-line ART: 68 (43%) switched the same day VF was confirmed and 106 (66%) switched within 90 d of confirmed VF. Use of a Nevirapine (NVP)-based regimen and initiating ART in 2016–2017 compared with 2014–2015 were independent predictors of VF. Conclusion VF is common among children receiving ART. The findings suggest that VF can be reduced by phasing out NVP-based regimen and by ensuring optimal adherence to ART.

Background Cytomegalovirus retinitis is a treatable cause of blindness in people with human immunodeficiency virus (HIV) typically with CD4 counts, Despite an estimated cytomegalovirus retinitis prevalence in people with HIV in Malawi, the logistics and acceptability of intravitreal injections and financial impact on patients hinder treatment. Further data, oral valganciclovir, and strong advocacy are needed to reduce future morbidity/mortality.

11569 Background: Kaposi sarcoma (KS) is the leading cancer in Malawi (34% of cancers). Outside of clinical trials, prospective KS studies from sub-Saharan Africa (SSA) are few and limited by loss to follow up. We conducted a prospective KS cohort study of standard of care bleomycin/vincristine (BV) at Lighthouse HIV clinic, in Lilongwe, Malawi. Methods: We enrolled pathologically confirmed, newly diagnosed, HIV+ KS patients from Feb 2017 to Jun 2019. We collected clinical and treatment characteristics, toxicity, and outcomes of KS with follow-up censored Jun 2020. Patients were treated with bleomycin (25 mg/m2) and vincristine (0.4 mg/m2) every 14 days for a planned maximum of 16 cycles. STATA v13.0 was used to calculate descriptive statistics and Kaplan Meier survival analysis. Toxicity was graded using NCI CTCAE v5.0. Results: We enrolled 138 participants, median age 36 (IQR 32-44) and 110 (80%) male. By ACTG staging, 107 (78%) were T1 (tumour severity), 46 (33%) were S1 (illness severity) and 46 (33%) had Karnofsky performance status ≤70. Presenting symptoms included edema in 69 (53%), visceral disease in 9 (7%), and oral involvement in 43 (33%). Prior to KS diagnosis, 70 (51%) participants were aware of being HIV+ for median 17 months (IQR 6-60) and had been on ART for median 16 months (IQR 6-60). Median CD4 count was 197 (IQR 99-339), median HIV-viral load was 2.6 log copies/mL (IQR 1.6 – 4.8) and 57% were HIV-suppressed ( < 1000 HIV copies/ml). The median number of cycles was 16 (IQR 7-16). 62 (45%) participants missed at least one dose due to stock out. Amongst patients with missed doses, the median number was 3 (IQR 2-4) for bleomycin and 2 (IQR 1-3) for vincristine. 14 (10%) participants experienced at least one reduced dose due to toxicity. 5 (4%) participants suffered grade ≥3 anaemia, 13 (9%) grade ≥3 neutropenia, and one participant had grade 4 bleomycin-induced dermatitis. There was no reported grade ≥3 bleomycin lung toxicity or vincristine-induced neuropathy. Of 115 evaluable participants, responses at the end of therapy were: complete response in 52 (45%), partial response in 27 (23%) stable disease in 5 (4%), and progressive disease in 31 (28%). Median duration of follow-up was 20 months. At censoring, 69 (50%) were alive, 36 (26%) dead, and 33 (24%) lost to follow-up. Overall survival is shown Table as crude and worst-case scenario; worst-case assumes all participants lost to follow up died. Conclusions: Here, we present one of the most complete characterizations of KS presentation and treatment from SSA. As in other studies from the region, the majority of patients presented with advanced disease, chemotherapy stock-outs and loss to follow up were common, and mortality was high. Studies are planned to understand the virologic characteristics, improve therapies, and better implement existing therapies.[Table: see text]

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. Methods: Between October 2006 and December 2009, interventions implemented at ANC and ART facilities in urban Lilongwe aimed to better link services for women with CD4 counts

Objective Malnutrition is common in HIV-infected children in Africa and an indication for antiretroviral treatment (ART). We examined anthropometric status and response to ART in children treated at a large public-sector clinic in Malawi. Methods All children aged

Abstract 68 Background: Cancer burden is increasing in Malawi, particularly for HIV-associated malignancies. Methods: With support from the National Cancer Institute, the Malawi Cancer Consortium (MCC) was initiated in September 2014. Partners include the UNC Lineberger Comprehensive Cancer Center, Malawi Ministry of Health, University of Malawi College of Medicine, and Lighthouse Trust. Spanning Malawi’s two major cities, Lilongwe and Blantyre, MCC includes three support cores (administration, analysis, mentoring) and three multi-institution research projects: (1) a national HIV-cancer match study to assess cancer incidence in the ART era; (2) a longitudinal cohort to identify clinical and molecular correlates of KS chemotherapy response; and (3) a longitudinal cohort to elucidate lymphoma biology and develop better treatments for HIV-associated lymphoma. Results: For project 1, 65,500 records from the Malawi National Cancer Registry and Malawi HIV cohorts have been abstracted, and initial data harmonization completed. Record linkage is planned for February 2016, will be updated at regular intervals, and will contribute to regional analyses through the IeDEA- Southern Africa network. For project 2, KS studies through MCC have led to descriptions of KS biologic subtypes defined by viral gene expression profiling, and detailed characterization of multicentric Castleman disease. Malawi has also led enrollment into multinational phase III KS clinical trials implemented by the AIDS Clinical Trials Group and AIDS Malignancy Consortium. For project 3, more than 300 adults and children with lymphoma have been enrolled since June 2014, with approximately 2/3 of adults being HIV-infected. Patients receive standardized treatment and supportive care, and standardized clinical and laboratory evaluations. Specimen-based correlative studies (virologic, genomic, biomarker studies) are ongoing. Finally, the consortium provides a platform for pilot studies in breast and esophageal cancer, and facilitates career development for Malawian cancer investigators. Conclusions: MCC has initiated a national coalition to address cancer in Malawi, and continued progress is anticipated. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST: Sam Phiri No relationship to disclose Joe Gumulira No relationship to disclose Hannock Tweya No relationship to disclose Lameck Chinula No relationship to disclose Agnes Moses No relationship to disclose Bongani Kaimila No relationship to disclose Christopher Stanley No relationship to disclose Edwards Kasonkanji No relationship to disclose Steady Chasimpha No relationship to disclose Richard Nyasosela No relationship to disclose Leo Masamba No relationship to disclose Tamiwe Tomoka No relationship to disclose Steve Kamiza No relationship to disclose Mina Hosseinipour No relationship to disclose Nora Rosenberg Research Funding: NIH/NCI Ron Mataya No relationship to disclose Charles Dzamalala No relationship to disclose George Liomba No relationship to disclose Irving Hoffman No relationship to disclose Dirk Dittmer No relationship to disclose Yuri Fedoriw Honoraria: Alexion Pharmaceuticals Blossom Damania No relationship to disclose Satish Gopal No relationship to disclose

Purpose: Despite Kaposi’s sarcoma (KS) being the most prevalent AIDS-associated cancer in resource limited settings, optimal treatment options remain unknown. We assessed whether bleomycin/vincristine compared to vincristine monotherapy was associated with improved treatment outcomes for AIDS-associated KS among patients initiating combination antiretroviral therapy (cART) in Malawi. Methods: All patients initiating cART and chemotherapy for AIDS-related KS were identified from an electronic data system from the HIV Lighthouse Clinic from 2002 to 2011. Treatment responses were compared between patients receiving vincristine monotherapy and vincristine/bleomycin. Binomial regression models were implemented to assess probability of tumor improvement for patients receiving vincristine/bleomycin compared to vincristine monotherapy after a complete cycle of chemotherapy (9–10 months). A chi-squared test was used to compare changes in CD4 count after six months of chemotherapy. Results: Of 449 patients with AIDS-associated KS on chemotherapy, 94% received vincristine monotherapy and 6% received bleomycin/vincristine. Distribution of treatment outcomes was different: 29% of patients on vincristine experienced tumor improvement compared to 53% of patients on bleomycin/vincristine. Patients receiving bleomycin/vincristine were 2.25 (95% CI: 1.47, 3.44) times as likely to experience tumor improvement as to those on vincristine monotherapy. This value changed little after adjustment for age and baseline CD4 count: 2.46 (95% CI: 1.57, 3.86). Change in CD4 count was similar for patients receiving vincristine monotherapy and bleomycin/vincristine (p=0.6). Conclusion: Bleomycin/vincristine for the treatment of AIDS-associated KS was associated with better tumor response compared to vincristine monotherapy without impairing CD4 count recovery. Replication in larger datasets and randomized controlled trials is necessary.

Background: In Malawi, as in other sub-Saharan African countries, nurses manage patients of all ages on antiretroviral treatment (ART). Nurse management of children is rarely studied.We compare ART prescribing between nurses and clinical officers during routine clinic visits at an urban, public clinic to inform policy in paediatric ART management. Methods: Caregivers of children on first-line ART provided information about visit dates, pill counts, ART dosage and formulation to a nurse and, subsequently, to a clinical officer. Nurses and clinical officers independently calculated adherence, dosage based on body weight, and set next appointment date. Clinical officers, but not nurses, accessed an electronic data system that made the calculations for them based on information from prior visits, actual and expected pill consumption, and standard drug supplies. Nurses calculated with pen and paper. For numerical variables, Bland-Altman graphs plot differences of each nurse clinical officer pair against the mean, show the 95% limits of agreement (LoA), and also show the mean difference across all reviews. Kappa statistics assess agreement for categorical variables. Results: A total of 704 matched nurse-clinical officer reviews of 367 children attending the ART clinics between March and July 2010 were analyzed. Eight nurses and 18 clinical officers were involved; two nurses and five clinical officers managed 100 visits or more. Overall, there was a good agreement between the two cadres. Differences between nurses and clinical officers were within narrow LoA and mean differences showed little deviation from zero, indicating little skewing towards one cadre. LoA of adherence and morning and evening ART dosages varied from -24% to 24%, -0.4 to 0.4 and -0.41 to 0.40 tablets, respectively, with mean differences (95% CI) of 0.003 (-0.9, 0.91), -0.005 (-0.02, 0.01) and -0.009 (-0.02, 0.01). Next appointment calculations differed more between cadres with LoA from -40 to 42 days [mean difference: 0.96 days (95% CI:-0.6 to 2.5)], but agreement in the ART formulation prescribed was very good (kappa 0.93). Conclusions: Nurses’ ART prescribing practices and calculations of adherence and next appointments are similar to clinical officers, although clinical officers used an electronic system. Our findings support the decision of Malawi’s health officials to utilize nurses to manage paediatric ART patients. Keywords: antiretroviral therapy; child; HIV; task shifting; nurse; adherence; medication safety; Malawi; sub-Saharan Africa (Published: 17 August 2012) To access the supplementary material to this article: Examples for calculation of adherence and next appointment Dosing charts for adult split Triomune tablets and Triomune baby tablets Bland Altman graphs plotting the differences in responses between nurses and clinicians against the mean of both cadres at each visit please see Supplementary Files in the column to the right (under Article Tools). Weigel R et al. Journal of the International AIDS Society 2012, 15 :17432 http://www.jiasociety.org/index.php/jias/article/view/17432 | http://dx.doi.org/10.7448/IAS.15.2.17432

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.Between October 2006 and December 2009, interventions implemented at ANC and ART facilities in urban Lilongwe aimed to better link services for women with CD4 counts250/μl. A monitoring system followed women referred for ART to examine trends and improve practices in referral completion, on-time ART initiation and ART retention.Six hundred and twelve women were ART eligible: 604 (99%) received their CD4 result, 344 (56%) reached the clinic, 286 (47%) started ART while pregnant and 261 (43%) were either alive on ART or transferred out after 6 months. Between 2006 and 2009, the median (IQR) time between CD4 blood draw and ART initiation fell from 41 days (17, 349) to 15 days (7,42) (P = 0.183); the proportion of eligible individuals starting ART while pregnant and retained for 6 months improved from 17% to 65% (P 0.001). Delays generally shortened within the continuum of care from 2006 to 2009; however, time from CD4 blood draw to ART referral increased from 7 to 14 days.Referrals between facilities and delays through CD4 count measurements create bottlenecks in patient care. Retention improved over time, but delays within the linkage process remained. ART initiation at ANC plus use of point-of-care CD4 tests may further enhance ART uptake.