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. © 2013 Tweya et al

Re-Treatment Tuberculosis Cases Categorised as “Other”: Are They Properly Managed?

BACKGROUND: Although the World Health Organization (WHO) provides information on the number of TB patients categorised as "other", there is limited information on treatment regimens or treatment outcomes for "other". Such information is important, as inappropriate treatment can lead to patients remaining infectious and becoming a potential source of drug resistance. Therefore, using a cohort of TB patients from a large registration centre in Lilongwe, Malawi, our study determined the proportion of all TB re-treatment patients who were registered as "other", and described their characteristics and treatment outcomes. METHODS: This retrospective observational study used routine program data to determine the proportion of all TB re-treatment patients who were registered as "other" and describe their characteristics and treatment outcomes between January 2006 and December 2008. RESULTS: 1,384 (12%) of 11,663 TB cases were registered as re-treatment cases. Of these, 898 (65%) were categorised as "other": 707 (79%) had sputum smear-negative pulmonary TB and 191 (21%) had extra pulmonary TB. Compared to the smear-positive relapse, re-treatment after default (RAD) and failure cases, smear-negative "other" cases were older than 34 years and less likely to have their HIV status ascertained. Among those with known HIV status, "other" TB cases were more likely to be HIV positive. Of TB patients categorised as "other", 462 (51%) were managed on the first-line regimen with a treatment success rate of 63%. CONCLUSION: A large proportion of re-treatment patients were categorised as "other". Many of these patients were HIV-infected and over half were treated with a first-line regimen, contrary to national guidelines. Treatment success was low. More attention to recording, diagnosis and management of these patients is warranted as incorrect treatment regimen and poor outcomes could lead to the development of drug resistant forms of TB

Managing HIV-infected children in a low-resource, public clinic: a comparison of nurse vs. clinical officer practices in ART refill, calculation of adherence and subsequent appointments

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

Implementation and Operational Research: Early Tracing of Children Lost to Follow-Up From Antiretroviral Treatment: True Outcomes and Future Risks

Background: Loss to follow-up (LTFU) challenges the success of antiretroviral therapy (ART) scale-up among pediatric patients. Little is known about children who drop out of care. We aim to analyze risk factors for LTFU among children on ART, find their true outcomes through tracing, and investigate their final outcomes after resuming ART. Methods: This is a descriptive, retrospective, cohort study of children on ART between April 2006 and December 2010 in 2 clinics in urban Malawi. Routine data from an electronic data system were used and matched with information obtained through routine tracing procedures. Results: Of 985 children (1999 child-years) on ART, 251 were LTFU: 12.6/100 child-years. At ART initiation, wasting [adjusted hazard ratio (AHR) 1.58 and 95% confidence interval (CI): 1.02 to 2.44] was independently associated with higher risk of LTFU. Of 201 LTFU children traced, 79% were found: 11% died, 25% stopped, 26% transferred-out, and 37% were still on ART. Median time between last visit and first tracing was 84 days (interquartile range: 64–101 days). Tracing reduced risk of LTFU by 38% (AHR 0.62 and 95% CI: 0.42 to 0.91) and decreased LTFU from 23.2% to 8.5%. Additional outcomes of stop, death, and transfer-out increased 4.4-fold, 1.8-fold, and 1.3-fold, respectively. Traced children with gaps in ART intake who resumed ART had higher risk of stopping (AHR 4.92 and 95% CI: 1.67 to 14.5) and transfer out (AHR 2.70 and 95% CI: 1.75 to 4.17) as final outcome. Conclusions: Early tracing substantially reduces LTFU; approximately one-third presumed LTFU was found to be still on ART. Children with wasting at initiation and those traced and found to have irregular ART intake require targeted interventions

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. 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 <250/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. Results:  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. Conclusions:  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

Proportion of older patients (50+years) receiving antiretroviral therapy (ART) at Martin Preuss and Lighthouse clinics between 2006 and 2015.

<p>Proportion of older patients (50+years) receiving antiretroviral therapy (ART) at Martin Preuss and Lighthouse clinics between 2006 and 2015.</p

Characteristics and outcomes of older HIV-infected patients receiving antiretroviral therapy in Malawi: A retrospective observation cohort study

<div><p>Objective</p><p>To estimate patients enrolling on antiretroviral therapy (ART) over time; describe trends in baseline characteristics; and compare immunological response, loss to follow-up (LTFU), and mortality by three age groups (25–39, 40–49 and ≥50 years).</p><p>Design</p><p>A retrospective observation cohort study.</p><p>Methods</p><p>This study used routine ART data from two public clinics in Lilongwe, Malawi. All HIV-infected individuals, except pregnant or breastfeeding women, aged ≥ 25 years at ART initiation between 2006 and 2015 were included. Poisson regression models estimated risk of mortality, stratified by age groups.</p><p>Results</p><p>Of 37,378 ART patients, 3,406 were ≥ 50 years old. Patients aged ≥ 50 years initiated ART with more advanced WHO clinical stage and lower CD4 cell count than their younger counterparts. Older patients had a significantly slower immunological response to ART in the first 18 months on ART compared to patients aged 25–39 years (p = 0.04). Overall mortality rates were 2.3 (95% confidence Interval (CI) 2.2–2.4), 2.9 (95% CI 2.7–3.2) and 4.6 (95% CI 4.2–5.1) per 100 person-years in patients aged 25–39 years, 40–49 years and 50 years and older, respectively. Overall LTFU rates were 6.3 (95% CI 6.1–6.5), 4.5 (95% CI 4.2–4.7), and 5.6 (95% CI 5.1–6.1) per 100 person years among increasing age cohorts. The proportion of patients aged ≥ 50 years and newly enrolling into ART care remained stable at 9% while the proportion of active ART patients aged ≥50 years increased from 10% in 2006 to 15% in 2015.</p><p>Conclusion</p><p>Older people had slower immunological response and higher mortality. Malawi appears to be undergoing a demographic shift in people living with HIV. Increased consideration of long-term ART-related problems, drug-drug interactions and age-related non-communicable diseases is warranted.</p></div

Univariable and multivariable model of characteristics associated with mortality among adult ART patients aged 25–49 years and those aged ≥ 50 years.

<p>Univariable and multivariable model of characteristics associated with mortality among adult ART patients aged 25–49 years and those aged ≥ 50 years.</p

Median CD4 count by age at antiretroviral therapy (ART) and duration on ART.

<p>Median CD4 count by age at antiretroviral therapy (ART) and duration on ART.</p